ANTIVIRAL COMPOSITIONS AND METHODS FOR THEIR USE

CROSS-REFERENCE TO RELATED APPLICATIONS

[1] This claims the benefit of United States Provisional Patent Application No. 63/059,970, filed July 31, 2020, the entirety of which is incorporated herein by reference.

BACKGROUND

Field of the Invention

[2] This relates generally to compositions having antiviral properties and methods of using them in the treatment or prevention of viral disease. More particularly this relates to antiviral nutraceutical and/or pharmaceutical compositions comprising mushrooms or extracts thereof, cannabis extracts, terpenes, and flavonoids, and the like.

Description of Related Art

[3] Although anti-bacterial compounds were first discovered over one hundred years ago and ushered in the golden age of antibiotics during which penicillin was discovered by Fleming, the precursor to the sulfonamides was discovered by Domagk, and streptomycin, chloramphenicol, erythromycin and tetracycline were discovered by Waksman by the mid 1940s.

[4] Antivirals, unlike their early cousins, took decades longer to develop and reach a period of rapid development. The first antiviral compounds were recognized in the 1950s, however; even then the discovery of antivirals was rather empirical as the biological mechanism(s) by which antiviral compounds worked were not understood. As mechanisms were revealed and better tools were developed, the development path shortened, and better and less cytotoxic antiviral agents could be discovered.

[5] At present it is possible to quickly screen massive libraries of compounds to look for antiviral candidates using powerful tools such as modern computers, combinatorial chemistry, and high-throughput screening. However, as the viral pandemic of 2020 has shown, all the modern technology in the world cannot always provide the answers to nature's mysteries. [6] Notwithstanding the availability of our present technology, there is renewed interest in finding and identifying less toxic and more natural remedies.

Scientists often look to the practices of shaman, medicine men, healers, and the like to learn about new sources and powerful drugs. There is great passion these days about Cannabis and the many interesting properties of compounds found in this plant. In particular, the many cannabinoids, terpenes, flavonoids, and other phenolics are attracting interest.

[7] In addition, there is renewed interest in mushrooms, including psychedelic and non-psychedelic, medicinal and edible, as sources of healthful compounds as both food and drug. Among the multitude of potentially therapeutic compounds present in mushrooms are complex sugars and polysaccharides (substituted or not) (e.g. glucans, glycosides, gly copeptides, and glycoproteins), terpenes and/or terpenoids, sterols, peptides, amino acids, and other small and large molecules.

[8] Our understanding of the role and potential therapeutic value of such compounds, and others from the natural world is ongoing. The use of e.g. exogenous cannabinoids and their ability to regulate the endocannabinoid system as a therapeutic approach is being studied. Likewise many compounds from various mushrooms are being found to have interesting biological properties.

[9] There is an ongoing need for new antiviral compositions and method that are useful for treating viral diseases or reducing susceptibility to them.

SUMMARY

[10] In a first of the several aspects of this disclosure, the inventor has discovered that certain antiviral pharmaceutical and / or nutraceutical compositions generally comprising combinations of one or more edible or medicinal mushrooms or an extract, fraction, or isolate thereof, one or more cannabinoids, one or more terpenes, and optionally, one or more flavonoids.

[11] The mushroom or mushroom extract present in the compositions is from any edible or medicinal mushroom species. The edible or medicinal mushroom in various embodiments comprises one or more of Agaricus blazei, A. bisporus, A. subrufescens, Agrocybe aegerita, A. cylindracea, Albatrellus caeruleoporus, Amanita muscaria, Boletus edulis, Cantharellus cibarius, C. tubaeformis, Cordyceps militaris, C. pruinose, Caripia montagnei, Cyathus africanus, C. hookeri, Daldinia childiae, Dictyophora indusiata (synonym: Phallus indusiatus), Elaphomyces granulatus, Flammulina velutipes, Fomitopsis pinicola, Grifola frondosa, Ganoderma lucidum, Geastrum saccatum, Inonotus oblic _j uus, Lactarius deliciosus, L. rufus, Lentinus edodes,

L. polychrous, Lyophyllum decastes, Phellinus linteus, Pholiota nameko, Pleurotus pulmonarius, Poria cocos, and Termitomyces albuminosus.

[12] The cannabinoids can be derived from any Cannabis spp. The terpenes and flavonoids can be derived from Cannabis or from any natural or synthetic source. The compositions optionally include other nutraceutical or botanical compounds to provide additional functionality or support.

[13] The inventor has surprisingly discovered that a composition comprising one or more edible or medicinal mushrooms, one or more cannabinoids, one or more terpenes, and at least one flavonoid with has many benefits for viral disease process treatment, and the compositions provide certain useful properties, such as effectiveness including over a long period of time, low toxicity, no serious side effects, and good tolerance on the part of a wide range of subjects.

[14] In another of its several aspects, provided are methods of treating a subject suffering from viral disease process. The methods generally comprise administering a therapeutically effective dose of a composition to the subject. The compositions generally comprise one or more edible or medicinal mushrooms or an extract, fraction, or isolate thereof, one or more cannabinoids, one or more terpenes, and optionally, one or more flavonoids. Additional components can also be included, such as S-adenosylmethionine, methylfolate, omega-3 fatty acids, or a B vitamin, vitamin A, vitamin C, vitamin D, vitamin E, or a compound providing a biologically-available form thereof, or a variety of other nutraceutical or beneficial compounds or substances.

[15] The disclosure also provides a plurality of dosing regimens that utilize the compositions, and variations thereof, on various schedules as dictated by the physiological or psychological health of the subject, and the status of the viral disease.

[16] In yet another aspect, methods are provided for optimizing a composition for use in treatment of a subject suffering from a viral disease process. The methods generally employ the use of artificial intelligence algorithms, such as classification algorithms, regression algorithms, clustering algorithms, or a combination thereof.

[17] The methods generally comprise:

[18] a) providing data on the therapeutic effect on the viral disease process of each of:

[19] i) a plurality of edible or medicinal mushrooms, mushroom extracts, or components thereof;

[20] ii) a plurality of cannabinoids or combinations thereof;

[21] iii) a plurality of terpenes or combinations thereof;

[22] iv) a plurality of flavonoids or combinations thereof; and optionally,

[23] v) a plurality of combinations of compositions comprising one or more of mushrooms or extracts thereof, cannabinoids, terpenes, and flavonoid; or

[24] vi) a plurality of optional ingredients comprising S- adenosylmethionine, methylfolate, omega-3 fatty acids, or a B vitamin, vitamin A, vitamin C, vitamin D, vitamin E, or a compound providing a biologically- available form thereof, or combinations thereof;

[25] b) using an artificial intelligence algorithm to analyze the data for the mushrooms or extracts, cannabinoids, terpenes, and flavonoids; and

[26] c) generating one or more base profiles of compositions optimized for therapeutic treatment of the viral disease process;

[27] d) optionally, using the artificial intelligence algorithm to analyze the data for the combination compositions and the optional ingredients, and

[28] e) generating one or more complete profiles of compositions with and without the optional ingredients.

[29] The viral disease generally comprises a prevalent virus, or a virus for which other treatment options are limited or nonexistent.

[30] The data for use in the artificial intelligence algorithm can be obtained from original experiments or literature review.

[31] In a final aspect, this disclosure provides methods for treating viral disease process in a patient in need thereof. The methods generally comprise the step of administering a composition comprising at least one edible or medicinal mushroom or extract thereof, in combination with at least one cannabinoid, at least one terpene, and at least one flavonoid. The at least one cannabinoid, at least one terpene, and at least one flavonoid are conveniently administered separately from, sequentially to, or simultaneously with the edible or medicinal mushroom. The at least one edible or medicinal mushroom or extract thereof is also administered separately from, sequentially to, or simultaneously with the cannabinoid, terpene, and flavonoid.

[32] These and/or further aspects, features, and advantages of the present invention will become apparent to those skilled in the art in view of this disclosure.

BRIEF DESCRIPTION OF THE DRAWINGS

DETAILED DESCRIPTION

[33] Provided herein are compositions and methods for treating inflammation viral disease processes. The methods are applicable to acute or chronic viral infections, as well as latent viral diseases in a subject. Surprisingly, the compositions allow a modern practitioner to combine the benefits of certain compounds found in edible and medicinal mushrooms (such as used for centuries in Chinese and other traditional medicine practices, and by e.g. herbalists throughout the world), with the positive benefits of another natural substance, cannabis, also used for centuries. The compositions further include certain beneficial terpenes and flavonoids derived from Cannabis and other natural or synthetic sources, and other nutraceutical or pharmaceutical compounds. Used properly, these compositions have little risk, few side effects, and are effective for producing measurable and lasting results in patients suffering from chronic inflammation or any viral disease process.

Definitions & Abbreviations

[34] Unless expressly defined otherwise, all technical and scientific terms, terms of art, and acronyms used herein have the meanings commonly understood by one of ordinary skill in the art in the field(s) of the invention, or in the field(s) where the term is used. In accordance with this description, the following abbreviations and definitions apply.

[35] The term "viral disease" as used herein includes both acute and chronic viral infection, active and latent, and any diseases where the causation or symptomology substantially includes a viral infection including one that occurred at a time in the past. Viral diseases / agents include, for example, smallpox, the common cold, influenza, parainfluenza, respiratory syncytial virus, adenovirus, measles, mumps, rubella, chicken pox /shingles, roseola, Chikungunya virus, Fifth disease, hepatitis A, hepatitis B, hepatitis C, hepatitis D, hepatitis E, herpes and cold sores, polio, viral encephalitis, viral meningitis, rabies, Ebola, Lassa fever, yellow fever, Marburg hemorrhagic fever, Crimean- Congo hemorrhagic fever, Hanta fever, HIV, severe acute respiratory syndrome (SARS), Covid-19, Dengue fever, Zika, Epstein-Barr, human papilloma virus (HPV), rotavirus, no ro virus, astrovirus, genital warts, genital herpes, molluscum contagiosum, and others. Viruses are often grouped by families, by means of transmission, or by their usual targets. For example virus can be grouped as respiratory, gastrointestinal, hepatic, cutaneous, hemorrhagic, neurologic, and exanthematous, all of which are useful herein.

[36] The skilled artisan will appreciate that some of the viruses listed above can be prevented by use of vaccines, while other virus for a variety of reasons are not susceptible to vaccines. Some virus are able to hid from the immune system, while other mutate quickly, still others can co-opt cellular machinery - even of immune system cells - and use that against the host. Some viruses have few symptoms and cause little harm to a host, while others are capable of causing great damage, or even killing their host. As we are learning, some viruses, such as coronavirus-SARS2, the causative agent of Covid-19, can do either - many people develop few or no symptoms and for others, it is fatal.

[37] As the skilled artisan will appreciate, as used herein the term "edible" does not mean merely capable of being eaten. In that overly broad sense, even poisonous or toxic mushrooms are 'edible' however lethal or sickening or the like. In contrast "edible mushrooms" is used herein in the sense of mushrooms that are used traditionally or in modern times as sources of food, nutrients, nutraceuticals, flavors, and the like. Edible mushrooms are neither toxic nor poisonous as consumed.

[38] "Medicinal mushrooms" as used herein means any mushroom species that has been used traditionally or in modern times as a source of medicinal or therapeutic benefits, healing properties, and / or healthful compounds. It should be noted that the medicinal mushrooms may not be edible in all embodiments herein, and may in fact be poisonous if eaten, however, one or more extracts therefrom or components extracted or isolated therefrom may be perfectly useful herein.

[39] Notwithstanding the foregoing exception(s), generally, mushrooms that are edible or medicinal may be grouped together, as there may be many crossovers and it may be difficult to clearly distinguish between the two groups. Examples of edible and / or medicinal mushrooms useful herein include mushrooms of the genera Agaricus, Agrocybe, Albatrellus, Amanita, Antrodia, Auricularia, Boletus, Calvatia, Cantharellus, Caripia, Clitocybe, Cordyceps, Cyathus, Daldinia, Dictyophora, Elaphomyces, Flammulina, Pomes, Fomitopsis, Funalia, Ganoderma, Geastrum, Grifola, Hericium, Inocybe, Inonotus, Lactarius, Lentinus, Lentinula, Leucopaxillus,

Lyophyllum, Phellinus, Pholiota, Pleurotus, Poria, Russula, Sarcodona, Schizophyllum, Suillus, Termitomyces, Trametes, or Xerocomus. Species of particular interest include Agaricus blazei, A. bisporus, A. subrufescens, Agrocybe aegerita, A. cylindracea, Albatrellus caeruleoporus, Amanita muscaria, Boletus edulis, Cantharellus cibarius, C. tubaeformis, Cordyceps militaris, C. pruinose, Caripia montagnei, Cyathus africanus, C. hookeri, Daldinia childiae, Dictyophora indusiata (synonym: Phallus indusiatus), Elaphomyces granulatus, Flammulina velutipes, Fomitopsis pinicola, Grifola frondosa, Ganoderma lucidum, Geastrum saccatum, Inonotus obliquus, Lactarius deliciosus, L. rufus, Lentinus edodes, L. polychrous, Lyophyllum decastes, Phellinus linteus, Pholiota nameko, Pleurotus pulmonarius, Poria cocos, and Termitomyces albuminosus.

[40] More generally edible and / or medicinal mushrooms can be useful in connection with the current disclosure for treating inflammation, directly or indirectly. For example, the therapeutic uses may include: preventing and/or treating viral diseases, helping recover from antiviral treatments, particularly those with significant toxicity or side effects, stimulating and / or supporting the immune system, treating primary or secondary infections, or providing antibacterial or antifungal properties, reducing the side effects of other antiviral treatments, reducing or mitigating the psychological affects (e.g. stress, anxiety, or the like) of a serious viral disease, generally promoting of health, providing antioxidant functionality, reducing nausea or swelling, stimulating or promoting immune system health, or the like.

[41] Reishi mushrooms have been reported to calm the central nervous system and/or have neuroprotective effect, stimulate the immune system, and act as a prebiotic to support gut health. Reishi has been reported to have a beneficial effect on the adrenals, and to be anxiolytic; reducing anxiety and promoting sleep. Reishi has also been associated with improved memory, and sharpened concentration and focus. Lion's Mane reportedly calms mental activity and modulates certain neurotransmitters. Cordyceps has been reported to have adaptagenic properties and stimulate the adrenals glands and modulates the nervous system. For purposes herein, the publication by Elsayed, Elsayed A et al. entitled "Mushrooms: a potential natural source of anti-inflammatory compounds for medical applications." (Mediators of Inflammation Vol. 2014 (2014): 805841. doi:10.1155/2014/805841) provides a list of anti-inflammatory mushrooms and active components therein. Any of the mushrooms or anti-inflammatory components described in the publication, which is incorporated herein by reference, may be useful herein.

[42] "Cannabis" or "Cannabis spp." as used herein refers to any plant of the genus Cannabis, including plants that may be classified as Cannabis sativa, Cannabis indica, or Cannabis ruderalis. It is well known that despite the foregoing list, some experts believe that there are only 2 species, and still others consider that there is only a single species (generally, C. sativa). Whatever nomenclature is used, for purposes of this disclosure, "Cannabis" includes all possible members of the genus, without regard to the species to which they are assigned.

[43] As used herein 'cannabinoids' means any of a class of compounds that generally can interact with one or more cannabinoid receptors, including the receptors of the endocannabinoid system, in particular, CB1 and CB2. Cannabinoids include e.g., phytocannabinoids and synthetic cannabinoids. Phytocannabinoids are found in several plant species, especially Cannabis spp. Among the most prevalent and most studied cannabinoids are tetrahydrocannabinol (THC), and cannabidiol (CBD). However, there are at least ~120 known cannabinoids that have been identified in Cannabis within certain classes including the tetrahydrocannabinols, cannabidiols, cannabigerols, cannabinols, cannabichromenes, and cannabinodiol. Other cannabinoids, such as cannabicyclol, cannabieslsoin, and cannabitriol are currently classed as 'miscellaneous' by some researchers. THC is not only a major cannabinoid in Cannabis spp., it is generally the compound responsible for the psychoactive effects of consuming Cannabis. However, other cannabinoids, such as cannabinol may also be at least mildly psychoactive. Certain other cannabinoids such as CBD may help regulate or attenuate the psychoactive effects of other cannabinoids. For purposes herein, compositions may be created with various ratios of cannabinoids, such as the ratio of CBD to THC or other ratios depending the specific person or the specific condition being treated.

[44] As used herein, "curcuminoids" means any of the compounds associated with turmeric or curcumin, as derived rhizome of the plant Curcuma longa, or synthetic versions or derivative thereof. Curcuminoids include but are not limited to curcumin (aka diferuloylmethane), analogs of curcumin such as demethoxycurcumin (DMC), bisdemethoxycurcumin (BDMC), turmerones, and turmeric oil. Also include are metabolites of curcumin such as tetrahydrocurcumin (THCU), hexahydrocurcumin, and octahydrocurcumin.

[45] Conjugates, such as curcumin glucuronide and curcumin sulfate, are also included herein. Conjugation may also provide opportunities for improved delivery of curcumins herein, for example, conjugation to peptide carriers, or polylactic-co-gly colic acid [PLGA]; as well as complexation with essential oils; coadministration with piperine; and encapsulation into nanoparticles, liposomes, phytosomes, polymeric micelles, and cyclodextrins may also be useful herein.

[46] As used herein, "terpenes" means any of the organic compounds commonly known as terpenes or terpenoids. Terpenes are generally aromatic compounds classified as isoprene derivatives. Terpenes suitable for use herein include hemiterpenes, monoterpenes, sesquiterpenes, diterpenes, sesterterpenes, triterpenes, sesquaterpenes, tetraterpenes, polyterpenes, and norisoprenoids. Exemplary terpenes that are particularly useful herein include alpha bisabolol, alpha pinene, beta caryophyllene, beta pinene, borneol, camphor, camphene, caryophyllene, cineole, delta-3 carene, eucalyptol, farnesenes, farnesol, fenchol, fenchone, geraniol, guaiol, humulene, isopulegol, limonene, linalool, menthol, myrcene, nerol, nerolidol, ocimene, pinene, phytol, pulegone, terpinene, terpineol, terpinolene, and valencene. In other embodiments phytol, limonene, humulene, myrcene, cineol, phellandrene, caryophyllene, terpinolene, linalool, ocimene, pinene, or a combination thereof are presently preferred.

[47] As used herein, "flavonoids" includes any of the class of polyphenolic molecules containing 15 carbon atoms that are naturally produced in plants and are soluble in water. Also included herein as "flavonoids" are natural or synthetic derivative or analogs thereof that have biological activity. Flavonoids of use herein can generally be divided in to 6 groups of structurally related compounds: chalcones, flavones, isoflavonoids, flavanones, anthoxanthins, and anthocyanins. Also useful are flavanols and catechins, as well as glucosides or other derivatives or analogs of any of the foregoing. The flavonoids are found in most fruits and vegetables, particular colorful ones. They are also prevalent in legumes (including soybeans), grains, green and black teas, as well as red wine.

[48] Flavonoids have numerous functions in plants, and act as important cell messengers. Various flavonoids are believed to provide healthful benefits and functions to humans such as anti-viral, anti-cancer, anti-inflammatory, anti allergic, and anti-oxidant properties. They may also be cardio-protective, cholesterol-lowering, and anti- atherosclerotic. Natural or synthetic flavonoids from any source may be used herein. Generally natural flavonoids are preferred. Flavonoids isolated from Cannabis, such as cannaflavins A, B, and or C, are of interest in certain applications, as are vitexin, isovitexin, apigenin, kaempferol, quercetin, orientin, and luteolin, as well as the catechins found in Cannabis.

[49] "Traditional Jamaican medicinal plants" means any plant that has been used in traditional or indigenous medicine or herbalism practices in Jamaica or other Caribbean states. The book, "Common Medicinal Plants of Portland, Jamaica" by Thomas and Austin, provides a useful list of a number of such plants. The book was published in its second edition in 2010 by CIEER and is incorporated herein by reference. For purposes herein, the definition of such traditional Jamaican medicinal plants" expressly excludes Cannabis spp. [50] As used herein, the singular form of a word includes the plural, and vice versa, unless the context clearly dictates otherwise. Thus, the references "a",

"an", and "the" are generally inclusive of the plurals of the respective terms. For example, reference to "a composition" or "a mushroom extract" includes a plurality of such "compositions" or "mushroom extracts."

[51] The words "comprise", "comprises", and "comprising" are to be interpreted inclusively rather than exclusively. Likewise, the terms "include", "including" and "or" should all be construed to be inclusive, unless such a construction is clearly prohibited from the context. Further, forms of the terms "comprising" or "including" are intended to include embodiments encompassed by the phrases "consisting essentially of" and "consisting of". Similarly, the phrase "consisting essentially of" is intended to include embodiments encompassed by the phrase "consisting of".

[52] Where used herein, ranges are provided in shorthand, so as to avoid having to list and describe each and every value within the range. Any appropriate value within the range can be selected, where appropriate, as the upper value, lower value, or the terminus of the range.

[53] The methods and devices and/or other advances disclosed here are not limited to particular methodology, protocols, and/or structures described herein because, as the skilled artisan will appreciate, they may vary. Further, the terminology used herein is for the purpose of describing particular embodiments only, and is not intended to, and does not, limit the scope of that which is disclosed or claimed.

[54] Although any devices, methods, articles of manufacture, or other means or materials similar or equivalent to those described herein can be used in the practice of the present invention, the preferred compositions, methods, articles of manufacture, or other means or materials are described herein.

[55] All patents, patent applications, publications, technical and/or scholarly articles, and other references cited or referred to herein are in their entirety incorporated herein by reference to the extent permitted under applicable law. Any discussion of those references is intended merely to summarize the assertions made therein. No admission is made that any such patents, patent applications, publications or references are prior art, or that any portion thereof is either relevant or material to the patentability of what is claimed herein. Applicant specifically reserves the right to challenge the accuracy and pertinence of any assertion that such patents, patent applications, publications, and other references are prior art, or are relevant, and/or material.

Abbreviations

[56] The following abbreviations apply unless indicated otherwise:

APM: "Apollon Medical" strain of C. sativa

CBD: cannabidiol;

CBG: cannabigerol;

CBN: cannabinol;

DMT: N, N -Dimethyl try ptamine ;

5-HT: 5-hydroxytryptamine;

KNN: K Nearest Neighbor;

NK: natural killer cells;

NS AID: nonsteroidal anti-inflammatory drugs; OCD: obsessive compulsive disorder; SVM: Support Vector Machines; and THC: tetrahydrocannabinol .

Detailed Description of Illustrative Embodiments

[57] In a first of its several aspects, compositions generally comprising one or more edible or medicinal mushrooms or extracts, fractions, isolates, or components thereof are provided. The compositions further generally comprise one or more cannabinoids, one or more terpenes, and optionally, one or more flavonoids.

[58] In various embodiments, the edible or medicinal mushroom(s) comprise one or more of the species Agaricus blazei, A. bisporus, A. subrufescens, Agrocybe aegerita, A. cylindracea, Albatrellus caeruleoporus, Amanita muscaria, Boletus edulis, Cantharellus cibarius, C. tubaeformis, Cordyceps militaris, C. pruinose, Caripia montagnei, Cyathus africanus, C. hookeri, Daldinia childiae, Dictyophora indusiata (synonym: Phallus indusiatus), Elaphomyces granulatus, Flammulina velutipes, Fomitopsis pinicola, Grifola frondosa, Ganoderma lucidum, Geastrum saccatum,

Inonotus obliquus, Lactarius deliciosus, L. rufus, Lentinus edodes, L. polychrous, Lyophyllum decastes, Phellinus linteus, Pholiota nameko, Pleurotus pulmonarius, Poria cocos, and Termitomyces albuminosus. The mushroom(s) in other embodiments comprise one or more species such as Albatrellus confluens, Antrodia camphorate, Boletus badius, Clitocybe maxima, Cordyceps sinensis, Cordyceps liangshanensis, Cordyceps gunnii, Cordyceps cicadicola, Pomes fomentarius, Funalia trogii, Hericium erinaceus, Inocybe umbrinella, Lactarius flavidulus, Pleurotus ostreatus, Schizophyllum commune, Suillus placidus, or Trametes versicolor.

[59] More generally, mushrooms of the genera Agaricus, Agrocybe, Albatrellus, Amanita, Antrodia, Auricularia, Boletus, Calvatia, Cantharellus, Caripia, Clitocybe, Cordyceps, Cyathus, Daldinia, Dictyophora, Elaphomyces, Flammulina, Pomes, Fomitopsis, Funalia, Ganoderma, Geastrum, Grifola, Hericium, Inocybe, Inonotus, Lactarius, Lentinus, Lentinula, Leucopaxillus, Lyophyllum, Phellinus, Pholiota, Pleurotus, Poria, Russula, Sarcodona, Schizophyllum, Suillus, Termitomyces, Trametes, or Xerocomus may be useful herein.

[60] These mushrooms are all well-known edible and / or medicinal mushrooms with a long history of use. Without limiting the invention to any particular theory of operation, mushrooms, such as Reishi, shitake, maitake, turkey tail, and many others have a plethora of beneficial and potentially therapeutic compounds present in them. For example, the polysaccharides, peptides, and/or other small molecules in various mushrooms have been shown to regulate the production of certain molecular mediators of inflammation and functions of immune cells (e.g. B- and/or T-cells) as well as pro-inflammatory lymphocytes, T-helper cells, T- killer cells, and macrophages. For example, the beta-1,3 D-glucans from certain mushrooms and other glycans may suppress cytokines such as interleukins tumor necrosis factor (TNF-a), and still other compounds

[61] Regardless of the mechanism(s) responsible, the compositions preferably comprise the benefits of such edible or medicinal mushroom(s) as described above.

[62] The edible or medicinal mushrooms or extracts can be present as fresh mushrooms, or as a dried mushroom or extract thereof, a lyophilized mushroom preparation, a mushroom powder, or an aqueous or alcohol extract (e.g. an ethanolic or other alcohol extract) of mushroom. Extracts for purposes herein can include hot- or cold-water extracts. Mushroom concentrates, or partially purified or even extensively purified mushroom fractions, or fully purified components or isolates from a mushroom are also useful herein.

[63] In certain embodiments, preferably, various extracts, concentrates, or partially purified fractions, or the like, are enriched for one or more advantageous mushroom component, or compounds with desirable effects on treatment of inflammation, immune status, or general health. In one embodiment, the extract, concentrate, partially purified fraction, or the like are enriched for one or more phenolic acids, flavonoids, triterpenes, carotenoids, stilbenes, sterols, fatty acids, lignans, chitosan, polyphenols, polysaccharides, glycosides, glucans, polysaccharide-protein complexes, glycoproteins, polysaccharopeptide, krestin, tocopherols, peptides, cyclic peptides, or other amino compounds found in the mushroom.

[64] While certain edible and / or medicinal mushrooms have been explored for their use as antivirals, the inventors have discovered that by providing mushroom extracts with additional compounds such as cannabinoids, terpenes, flavonoids, and other components, antiviral benefits can be derived from the treatments with better outcomes and fewer side effects.

[65] The compositions in various embodiments therefor also include cannabinoids, comprising one or more of cannabidiol (CBD), cannabinol (CBN), cannabigerol (CBG), or tetrahydrocannabinol (THC).

[66] In certain embodiments, the cannabinoids are derived from hemp, or the THC content is removed from the cannabinoids such that THC is present in the composition at less than about 0.3 percent. In various embodiments, the THC content may be less than 0.2, or even less than 0.1% of the composition.

[67] In other embodiments, the ratio of cannabinoids is set in the compositions.

For example, in certain embodiments, the ratio of CBD to THC ranges from about 1:5 to about 30:1 or more. In other embodiments the ration may range from about 1:2 to about 10:1. In still other embodiments, the ratio of CBD to THC may be about 1:1 to 5:1. In other cases, the ration of e.g. CBD to CBG or CBN may be set based on any of a variety of factors, including the health status of the subject being treated, the symptoms of the subject, the condition(s) being treated, and or one or more physiological or genetic criteria.

[68] In certain embodiments the compositions may be provided in completely customized or personalized formulations for each person being treated - i.e. as personalized medicines. In such cases, the compositions may be adjusted based on initial or subsequent blood work, enzyme test results, bioinformatic data (including measurements of e.g. the genome, transcriptome, proteome, metabolome, or any portion thereof, for a subject), the nature of the inflammation, specific markers, antigen, or mediators of the viral disease process, specific symptomology, or the like. The formulation of the compositions may also be changed based on the results from an initial treatment, subsequent treatment, or based on subsequent tests.

[69] In various presently preferred embodiments, the cannabinoids are derived from Cannabis spp. or an extract thereof. Cannabis can generally be concentrated or extracted (e.g. via mechanical or chemical means) to obtain cannabinoids. Mechanical means of extracting oils from plants, such as pressing, have been used for centuries, and may be suitable for use herein. Extraction via chemical means includes extraction with various volatile solvents that range from hydrocarbon solvents such as butane, hexanes, or propane, to supercritical fluids, alcohol (e.g. isopropanol, butanol, or ethanol), steam, or even water. Two very common methods are extraction with supercritical carbon dioxide, or ethanol, both of which are particularly useful herein. Extracts can be also be distilled e.g. to remove additional compounds of interest, or to concentrate them. Certain components can be removed, e.g. by treatment with steam to strip certain volatiles, which can be captured as an additional component from the Cannabis.

[70] In various embodiments, cannabinoids present in an ethanolic extract or supercritical C0 extract of Cannabis sativa are preferred for use herein. The extract comprises one or more of Ringo's Gift, OG Kush, Strawberry Cough, Orange Cookies, Jack Herer-derived strains (e.g. Black Jack, Super Jack, Jl, and XJ13), and the Lemon family of strains of Cannabis sativa. In other embodiments, the extracts comprise Ringo's Gift, Harle Tsu, ACDC, Charlotte's Web, The Gift, or Pineberry strains. "Apollon Medical" ("APM"), a proprietary strain commercially available from Apollon Formularies, is also useful herein. [71] The compositions, in various embodiments, include terpenes comprising one or more monoterpenes, one or more sesquiterpenes, or a combination thereof. The terpenes generally comprise one or more of alpha bisabolol, alpha pinene, beta caryophyllene, beta pinene, borneol, camphor, camphene, caryophyllene oxide, cineole, delta-3 carene, eucalyptol, farnesenes, farnesol, fenchol, fenchone, geraniol, guaiol, humulene, isopulegol, limonene, linalool, menthol, myrcene, nerol, nerolidol, ocimene, pinene, phytol, pulegone, terpinene, terpineol, terpinolene, or valencene.

[72] In one embodiment, the terpenes comprise phytol, limonene, humulene, myrcene, cineol, phellandrene, caryophyllene, terpinolene, linalool, ocimene, pinene, or a combination thereof. In other embodiments, the terpenes preferably comprise one or more of limonene, myrcene, beta-caryophyllene, linalool, alpha pinene, or a combination thereof. In one embodiment the terpenes include beta- ocimene, 1,8-cineole, alpha-pinene and / or beta-pinene, linalool, limonene, phytol, humulene, myrcene, phellandrene, caryophyllene, terpinolene, linalool, or other cineols or ocimenes, or any combination thereof, and the strains used to isolate terpenes are high in those terpenes, relative to other strains.

[73] In presently preferred embodiments, the terpenes are derived from Cannabis spp. or an extract thereof. The terpenes can be derived from any source and in certain embodiments, they can be present in steam distillate or an ethanolic extract of Cannabis sativa.

[74] The compositions in certain embodiments include extracts of Cannabis spp, such as C. sativa as a source of cannabinoids and/or terpenes. In various embodiments, the C. sativa comprises one or more of Ringo's Gift, OG Kush, Strawberry Cough, Orange Cookies, Jack Herer-derived strains, Lemon family strains, Harle Tsu, ACDC, Charlotte's Web, The Gift, or Pineberry strains. In other embodiments, the C. sativa comprises the proprietary Apollon Formularies strain, APM.

[75] In various other embodiments, the compositions may further comprise one or more flavonoids. The flavonoids can comprise chalcones, flavones, isoflavonoids, flavanones, anthoxanthins, anthocyanins, flavonols, or glucosides or other biologically active derivatives or analogs thereof, and combinations of any number of the foregoing. In certain embodiments, flavonoids are included in the compositions are isolated or derived from a plant, mushroom, or other natural source.

[76] In another embodiment, the composition still further comprises an extract or fraction from one or more traditional Jamaican medicinal plants other than Cannabis spp.. Any of the traditional Jamaican or Carribbean medicinal plants may be useful herein. Examples of Jamaican plants useful herein include ackee, aloe vera, avocado, breadflower, ginger, leaf of life, sorrel, soursop, tamarind, and trumpet. In one embodiment, the traditional medicinal plants comprise Jamaican sorrel ( Hibiscus sabdariffa), guinea hen weed ( Petiveria alliacea), and/or soursop ( Annona murata). In a presently preferred embodiments, the compositions include a whole plant extract, or an extract from any parts or portion thereof including but not limited to leaves (dried, fresh, or extracted), stems, flowers, roots, fruit, seeds, or the like.

[77] In terms of compounding the compositions, the skilled artisan will appreciate that methods of maximizing the efficacy of the composition such as by enhancing the bioavailability of one or more components, or by providing the components in optimized ratios, for example one component to another with which it interacts, or each component to the others in ratio(s) that optimize the absorption into the gut or bloodstream, or enhance the therapeutic effect of the composition. The skilled artisan will also understand that some information useful in improving the compounding may be obtained empirically.

[78] In various embodiments, the compositions, or one or more components thereof, may be solubilized, micronized, provided as, for example, extracts, powders, lyophilized powders, concentrates, tinctures, essential oils, aqueous or lipid suspensions, emulsions, microemulsions, or nano-emulsions, or in whole or part as liposomal, vesicular, or other delivery systems. As described below, the compounding or formulation of any of the compositions provided herein may be optimized for the intended delivery route.

[79] The compositions may be administered and delivered as pharmaceuticals, however, it is also contemplated that one or more of the compositions may be formulated for administration and delivery by oral routes that include as food and beverages, including solid, semisolid, and liquid foods, such as smoothies, shakes, pudding, broths, teas, and soups. The food and or beverage compositions can also include hot, cold, or even frozen foods (such as frozen desserts).

[80] In another aspect of the disclosure, provided are methods of treating a subject suffering from inflammation. The methods generally comprise administering a therapeutically effective dose of a composition to the subject. The composition typically comprises one or more edible or medicinal mushrooms or an extract, fraction, or isolate thereof, one or more cannabinoids, one or more terpenes, and optionally, one or more flavonoids.

[81] The inflammation in various embodiments comprises a viral disease, such as.

[82] The composition for use in the methods is generally as described above for the first aspect. The description of the compositions above is incorporated by reference herein for purposes of the present methods.

[83] In various embodiments, the compositions for use in the methods further comprise one or more optional ingredients comprising S-adenosylmethionine, methylfolate, omega-3 fatty acids, or a B vitamin, vitamin A, vitamin C, vitamin D, vitamin E, or a compound providing a biologically-available form thereof. In still other embodiments fish oil, primrose oil, or an extract of one or more of black cumin, Echinacea, Astralagus, sorrel, ginger, ginseng, bee propolis, bee pollen, honey, fenugreek, goldenseal, licorice, coriander, tomato, carrot, sweet potato, broccoli, green tea, rosemary, hazelnut, walnut, wheat germ, pomegranate, or date, or any combination thereof, can also be included. Garlic extract, alpha lipoic acid (ALA), conjugated linoleic acid (CLA), phytoestrogens, soy isoflavones, selenium, zinc, copper, magnesium, niacin, and/or nicotinamide are also contemplated for use herein.

[84] The terpenes for use with the compositions can comprise one or more monoterpenes, one or more sesquiterpenes, or a combination thereof. In various embodiments, the terpenes comprise one or more of alpha bisabolol, alpha pinene, beta caryophyllene, beta pinene, borneol, camphor, camphene, caryophyllene oxide, cineole, delta-3 carene, eucalyptol, farnesenes, farnesol, fenchol, fenchone, geraniol, guaiol, humulene, isopulegol, limonene, linalool, menthol, myrcene, nerol, nerolidol, ocimene, pinene, phytol, pulegone, terpinene, terpineol, terpinolene, or valencene. Also useful are related polyphenols such as chlorogenic acid. In other embodiments, the terpenes can comprise beta- ocimene, 1,8-cineole, alpha-pinene and / or beta-pinene, linalool, limonene, phytol, humulene, myrcene, phellandrene, caryophyllene, terpinolene, linalool, or other cineols or ocimenes, or any combination thereof,

[85] In certain preferred embodiments, the terpenes are derived from Cannabis spp. or an extract thereof. The terpenes can be present in steam distillate or an ethanolic extract of Cannabis sativa, and can comprise limonene, myrcene, beta- caryophyllene, linalool, alpha pinene, or a combination thereof, in some embodiments. The Cannabis sativa in one embodiment includes one or more of Ringo's Gift, OG Kush, Strawberry Cough, Orange Cookies, Jack Herer-derived strains (e.g. Black Jack, Super Jack, Jl, and XJ13), and the Lemon family of strains of Cannabis sativa. In other embodiments Ringo's Gift, Harle Tsu, ACDC, Charlotte's Web, The Gift, or Pineberry strains are useful.

[86] The compositions for use with the methods also comprise one or more flavonoids that can be chalcones, flavones, isoflavonoids, flavanones, anthoxanthins, anthocyanins, flavonols, or glucosides or other biologically active derivatives or analogs thereof, and preferably they are from a plant, mushroom, or other natural source.

[87] Presently preferred flavonoids include cannaflavin A, cannaflavin B, or cannaflavin C, vitexin, isovitexin, apigenin, kaempferol, quercetin, orientin, luteolin, a catechin found in Cannabis, or a combination of any of the foregoing.

[88] In certain embodiments, the methods further comprise one or more steps of administering an additional therapeutically effective dose of the composition.

[89] Preferably the additional administering steps are performed on a periodic basis of any frequency or schedule. For example, the administration or dosing can conveniently be on e.g. a daily, thrice weekly, twice weekly, weekly, biweekly, monthly, bimonthly, quarterly, semi-annual, or annual basis. The administration need not be the same over every period of time. By way of nonlimiting example, administration could be daily for a week, then weekly for a month. Or the administration could be every 4 months for a year, then every 6 months thereafter. Similarly, the actual amount of the composition or dosage administration can vary. For example, a monthly dosage schedule could feature a dose of x for the first dosage each quarter, and a dose of O.lx for the remaining months in each quarter. [90] Just as the composition can be 'personalized', so can the administration or dosing schedule. Thus, in various embodiments, the methods further comprise the step of periodically assessing one or more of the subject's medication levels, enzyme levels, or other indicators of physiological health or status, genetic markers or metabolic markers or mediator presence, or the like, in order to determine the periodic basis for administration.

[91] The methods provide for administration of the compositions via any useful route, including parenteral (intravenous, intra-arterial, intramuscular, intraperitoneal, or subcutaneous), oral, nasal, ocular, transmucosal (buccal, vaginal, or rectal), transdermal, or via inhalation.

[92] It should be noted that the route of dosing or administration of compositions can vary over the course of treating a subject or patient with multiple steps of treatment, as well as from subject to subject, or with different types of viral disease. For example, administration via one route may be useful when administering a larger dose and a different route may be useful for smaller doses. Or, administration via a particular route may be appropriate initially, with subsequent doses conveniently administered through another route.

[93] In one embodiment, the method further comprises a step of providing to the subject additional treatment of the viral disease comprising: i) one or more doses of an antiviral pharmacological agent; ii) one or more doses of an antibiotic; iii) one or more treatments to reduce the severity or duration of the viral disease process; iv) one or more other treatments specifically provided to support the subject during recovery from the viral disease process; or any combination of any of the foregoing.

[94] Methods that further comprise a step of providing to the subject an additional composition are also provided. The additional composition may be administered in between doses of the base compositions, or may be provided on a separate and independent periodic basis. The addition compositions generally comprise any combination of less than three of the following:

[95] i) one or more edible or medical mushrooms or an extract, fraction, or isolate thereof; [96] ii) one or more cannabinoids;

[97] iii) one or more terpenes; or

[98] iv) one or more flavonoids;

[99] The additional compositions further optionally comprise any combination of one or more of S-adenosylmethionine, methylfolate, omega-3 fatty acids, or a B vitamin, vitamin A, vitamin C, vitamin D, vitamin E, or a compound providing a biologically-available form thereof.

[ 100] In various embodiments of the methods:

[101] i) the one or more edible or medical mushrooms comprise Agaricus,

Agrocybe, Albatrellus, Amanita, Antrodia, Auricularia, Boletus, Calvatia, Cantharellus, Caripia, Clitocybe, Cordyceps, Cyathus, Daldinia, Dictyophora, Elaphomyces, Flammulina, Pomes, Fomitopsis, Funalia, Ganoderma, Geastrum, Grifola, Hericium, Inocybe, Inonotus, Lactarius, Lentinus, Lentinula, Leucopaxillus, Lyophyllum,

Phellinus, Pholiota, Pleurotus, Poria, Russula, Sarcodona, Schizophyllum, Suillus, Termitomyces, Trametes, or Xerocomus;

[102] ii) the cannabinoids comprise one or more of cannabidiol (CBD), cannabinol (CBN), cannabigerol (CBG), or tetrahydrocannabinol (THC);

[103] iii) the terpenes comprise one or more of alpha bisabolol, alpha pinene, beta caryophyllene, beta pinene, borneol, camphor, camphene, caryophyllene oxide, cineole, delta-3 carene, eucalyptol, farnesenes, farnesol, fenchol, fenchone, geraniol, guaiol, humulene, isopulegol, limonene, linalool, menthol, myrcene, nerol, nerolidol, ocimene, pinene, phytol, pulegone, terpinene, terpineol, terpinolene, or valencene; and

[104] iv) the one or more flavonoids comprise chal cones, flavones, isoflavonoids, flavanones, anthoxanthins, anthocyanins, flavonols, or glucosides or other biologically active derivatives or analogs thereof.

[105] In one embodiment the terpenes preferably comprise beta-ocimene, 1,8- cineole, alpha-pinene and/or beta-pinene, linalool, limonene, phytol, humulene, myrcene, phellandrene, caryophyllene, terpinolene, linalool, or other cineols or ocimenes, or any combination thereof.

[106] The viral disease process can comprise any of smallpox, the common cold, influenza, parainfluenza, respiratory syncytial virus, adenovirus, measles, mumps, rubella, chicken pox/ shingles, roseola, Chikungunya virus, Fifth disease, hepatitis A, hepatitis B, hepatitis C, hepatitis D, hepatitis E, herpes and cold sores, polio, viral encephalitis, viral meningitis, rabies, Ebola, Lassa fever, yellow fever, Marburg hemorrhagic fever, Crimean-Congo hemorrhagic fever, Hanta fever, HIV, severe acute respiratory syndrome (SARS), Covid-19, Dengue fever, Zika, Epstein-Barr, human papilloma virus (HPV), rotavirus, norovirus, astrovirus, genital warts, genital herpes, molluscum contagiosum, or other virus.

[107] In one embodiment of the methods, the composition further comprises an extract or fraction from one or more traditional Jamaican medicinal plants other than Cannabis spp. The traditional medicinal plants comprise Jamaican sorrel

( Hibiscus sabdariffa), guinea hen weed ( Petiveria alliacea), or soursop ( Annona murata ) in certain embodiments.

[108] The skilled artisan will appreciate that the methods are flexible as set forth herein, an aspect which is particularly useful given the varied and nature of the psychological disorders which they are intended to treat.

[109] In yet another aspect of the disclosure, methods of optimizing a composition for use in treatment of a subject suffering from viral disease process using artificial intelligence are provided herein. The methods generally comprise, for each viral disease process of interest, or for a subject in need of therapeutic compositions for such viral disease process:

[110] a) providing data on the therapeutic effect on the viral disease process of each of:

[111] i) a plurality of edible or medicinal mushrooms, mushroom extracts, or components thereof;

[112] ii) a plurality of cannabinoids or combinations thereof;

[113] iii) a plurality of terpenes or combinations thereof;

[114] iv) a plurality of flavonoids or combinations thereof; and optionally,

[115] v) a plurality of combinations of compositions comprising one or more of mushrooms or extracts thereof, cannabinoids, terpenes, and flavonoid; or

[116] vi) a plurality of optional ingredients comprising S-adenosylmethionine, methylfolate, omega-3 fatty acids, or a B vitamin, vitamin A, vitamin C, vitamin D, vitamin E, or a compound providing a biologically-available form thereof, or combinations thereof;

[117] b) using an artificial intelligence algorithm to analyze the data for the mushrooms or extracts, cannabinoids, terpenes, and flavonoids; and

[118] c) generating one or more base profiles of compositions optimized for therapeutic treatment of the viral disease process;

[119] d) optionally, using the artificial intelligence algorithm to analyze the data for the combination compositions and the optional ingredients, and

[120] e) generating one or more complete profiles of compositions with and without the optional ingredients.

[121] In certain embodiments, the viral disease process comprises smallpox, the common cold, influenza, parainfluenza, respiratory syncytial virus, adenovirus, measles, mumps, rubella, chicken pox/ shingles, roseola, Chikungunya virus, Fifth disease, hepatitis A, hepatitis B, hepatitis C, hepatitis D, hepatitis E, herpes and cold sores, polio, viral encephalitis, viral meningitis, rabies, Ebola, Lassa fever, yellow fever, Marburg hemorrhagic fever, Crimean-Congo hemorrhagic fever, Hanta fever, HIV, severe acute respiratory syndrome (SARS), Covid-19, Dengue fever, Zika, Epstein-Barr, human papilloma virus (HPV), rotavirus, norovirus, astrovirus, genital warts, genital herpes, molluscum contagiosum, or other viral disease. Generally, the data for the method are obtained from original experiments and/or reviews of the relevant scientific literature.

[122] The artificial intelligence algorithm can comprise any useful software or algorithm approach capable of making the distinctions required. In various embodiments, the algorithm comprises a classification algorithm, a regression algorithm, a clustering algorithm, or a combination thereof.

[123] In one embodiment, the methods comprise a classification algorithm that is a naive Bayes algorithm, decision tree, random forest algorithm, Support Vector Machines, or K Nearest Neighbor algorithm.

[124] In another embodiment, the methods comprise a regression algorithm that is a liner regression, lasso regression, logistic regression, or multivariate regression.

[125] In yet another embodiment, the methods comprise a clustering algorithm that is a K-means clustering, fuzzy C-means algorithm, expectation-maximization algorithm, or hierarchical clustering algorithm. [126] The skilled artisan will appreciate that the methods are designed to optimize the compositions, and that such optimization as set forth above can be with respect to each particular viral disease process or even each particular variant of a viral disease process. However, the compositions can also be optimized for, and a profile of relevant compositions generated for each particular subject, e.g. for a 'personalized medicine' approach.

[127] Thus, also provided herein are the methods comprising the additional step of providing subject-specific data comprising, e.g. initial or subsequent blood work, enzyme test results, bioinformatic data (including measurements of e.g. the genome, transcriptome, proteome, metabolome, or any portion thereof, for a subject), specific symptomology, or the like. The artificial intelligence algorithm is then used to further optimize the composition based on those data in addition to the disorder-specific data. The optimized formulation of the compositions may also be changed based on data from the results from an initial treatment, subsequent treatment, or based on subsequent tests of the subject.

[128] In certain embodiments, the viral disease process comprises a prevalent form of viral disease process such as smallpox, the common cold, influenza, parainfluenza, respiratory syncytial virus, adenovirus, measles, mumps, rubella, chicken pox/ shingles, roseola, Chikungunya virus, Fifth disease, hepatitis A, hepatitis B, hepatitis C, hepatitis D, hepatitis E, herpes and cold sores, polio, viral encephalitis, viral meningitis, rabies, Ebola, Lassa fever, yellow fever, Marburg hemorrhagic fever, Crimean-Congo hemorrhagic fever, Hanta fever, HIV, severe acute respiratory syndrome (SARS), Covid-19, Dengue fever, Zika, Epstein-Barr, human papilloma virus (HPV), rotavirus, norovirus, astrovirus, genital warts, genital herpes, molluscum contagiosum, and the like.

[129] The plurality of edible or medicinal mushrooms, mushroom extracts, or components for which data are analyzed generally comprise one or more of the species Agaricus blazei, Albatrellus confluens, Antrodia camphorate, Boletus badius, Clitocybe maxima, Cordyceps militaris, Flanulina velutipes, Fomes fomentarius, Funalia trogii, Ganoderma lucidum, Grifoloa fondosa, Hericium erinaceus, Inocybe umbrinella, Ionatus olbiquus, Lactarius flavidulus, Lentinula edodes, Phellinus linteus, Pleurotus ostreatus, Schizophyllum commune, Suillus placidus, Trametes versicolor, Cordyceps sinensis, C. liangshanensis, C. gunnii, or C. cicadicola. [130] A further aspect of the invention provides methods for the treatment of viral disease process. The methods generally comprise the step of administering to a patient in need thereof a composition comprising at least one edible or medicinal mushroom or extract thereof, in combination with at least one cannabinoid, at least one terpene, and at least one flavonoid. In one embodiment the at least one cannabinoid, at least one terpene, and at least one flavonoid are administered separately from, sequentially to, or simultaneously with the edible or medicinal mushroom or extract thereof. In another embodiment, the at least one edible or medicinal mushroom or extract thereof is also administered separately from, sequentially to, or simultaneously with the cannabinoid, terpene, and flavonoid.

[131] Again, the composition with respect to this aspect of the disclosure can comprise any of the compositions described hereinabove. In one embodiment of the methods:

[132] i) the at least one edible or medicinal mushroom or extract comprises comprise Agaricus blazei, Albatrellus confluens, Antrodia camphorate, Boletus badius, Clitocybe maxima, Cordyceps militaris, Flanulina velutipes, Fomes fomentarius, Funalia trogii, Ganoderma lucidum, Grifoloa fondosa, Hericium erinaceus, Inocybe umbrinella, Ionatus olbiquus, Lactarius flavidulus, Lentinula edodes, Phellinus linteus, Pleurotus ostreatus, Schizophyllum commune, Suillus placidus, Trametes versicolor, Cordyceps sinensis, C. liangshanensis, C. gunnii, or C. cicadicola,·

[133] ii) the at least one cannabinoid comprises CBD, CBG, CBN, and THC extracted from Cannabis sativa Ringo's Gift, OG Kush, Strawberry Cough, Orange Cookies, Jack Herer-derived strains, Lemon family strains, Harle Tsu, ACDC, Charlotte's Web, The Gift, or Pineberry strains;

[134] iii) the at least one terpene comprises beta-ocimene, 1,8-cineole, alpha- pinene and / or beta-pinene, linalool, limonene, phytol, humulene, myrcene, phellandrene, caryophyllene, terpinolene, linalool, or other cineols or ocimenes, or any combination thereof; and

[135] iv) the at least one flavonoid comprises a chalcone, flavone, isoflavonoid, flavanone, anthoxanthin, anthocyanin, flavonol, or glucoside or other biologically active derivatives or analogs thereof.

[136] In various embodiments of the methods, one or more of the components have one more of the following functions: [137] i) induces apoptosis of cells involved viral disease process;

[138] ii) inhibits one or more viral induced cytokines or other molecular signals;

[139] iii) interferes with viral entry into one or more cells;

[140] iv) blocks replication, transcription, or translation one or more viral nucleic acids or proteins;

[141] v) inhibits one or more viral proteins from functioning properly; or

[142] vi) allows one or more immune T-cells or B-cells to neutralize the virus.

[143] In yet another embodiment of the methods provided in this aspect of the disclosure, the composition further comprises an extract or fraction from one or more traditional Jamaican medicinal plants other than Cannabis spp. Traditional medicinal plants such as Jamaican sorrel ( Hibiscus sabdariffa), guinea hen weed

( Petiveria alliacea), or soursop ( Annona murata) are contemplated as useful herein.

[144] The scope of the invention is set forth in the claims appended hereto, subject, for example, to the limits of language. Although specific terms are employed to describe the invention, those terms are used in a generic and descriptive sense and not for purposes of limitation. Moreover, while certain presently preferred embodiments of the claimed invention have been described herein, those skilled in the art will appreciate that such embodiments are provided by way of example only. In view of the teachings provided herein, certain variations, modifications, and substitutions will occur to those skilled in the art. It is therefore to be understood that the invention may be practiced otherwise than as specifically described, and such ways of practicing the invention are either within the scope of the claims, or equivalent to that which is claimed, and do not depart from the scope and spirit of the invention as claimed.