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WO2021211085A1 - Procédé de prévention et de traitement de maladies induites par des virus comportant une enveloppe, y compris des coronavirus (variantes), et kit de préparations pharmaceutiques pour sa mise en oeuvre - Google Patents

Procédé de prévention et de traitement de maladies induites par des virus comportant une enveloppe, y compris des coronavirus (variantes), et kit de préparations pharmaceutiques pour sa mise en oeuvre Download PDF

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Publication number
WO2021211085A1
WO2021211085A1 PCT/UA2021/000038 UA2021000038W WO2021211085A1 WO 2021211085 A1 WO2021211085 A1 WO 2021211085A1 UA 2021000038 W UA2021000038 W UA 2021000038W WO 2021211085 A1 WO2021211085 A1 WO 2021211085A1
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Prior art keywords
ascorbic acid
patient
solution
treatment
diseases caused
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PCT/UA2021/000038
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English (en)
Russian (ru)
Inventor
Кумар ГУНЬЯН
Владимир Степанович ТАРАСЕНКО
Давид Анатолиевич НОГА
Юрий Сергеевич ЛИСАЙЧУК
Александр Андреевич ТАРАСОВ
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/33—Heterocyclic compounds
    • A61K31/335—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin
    • A61K31/365—Lactones
    • A61K31/375—Ascorbic acid, i.e. vitamin C; Salts thereof
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K33/00—Medicinal preparations containing inorganic active ingredients
    • A61K33/24—Heavy metals; Compounds thereof
    • A61K33/34—Copper; Compounds thereof
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
    • A61P31/12—Antivirals

Definitions

  • the invention relates to medicine, in particular to methods for the prevention and treatment of diseases caused by viruses that have an envelope, and can be used in medical practice both at the primary care level - both in outpatient clinics and even under the supervision of a doctor at home and in infectious diseases, intensive care units and established specific hospital departments for the prevention and treatment of COVID-19.
  • a known method for the treatment and prevention of influenza and acute respiratory diseases of viral origin by using an interferon inductor according to which the patient in the first days of the disease is prescribed Amiksin IS in a dose of 0.250 g once on the first day of treatment, 0.125 - in another and 0.125 g after 48 hours against the background of the appointment bicyclol 50 mg 3 times a day 1.5 hours after a meal for 5-7 days, and for prophylaxis, all contacts and people at risk during an outbreak, epidemic, pandemic are prescribed only Amiksin IS 0.125 g 1 time per week within 6-7 weeks [RU 2 107498 C, A61K 33/062013].
  • This method cannot prevent the replication of viruses in the treatment of diseases caused by viruses, in particular coronaviruses.
  • Closest to the claimed invention is a method for the treatment of acute respiratory viral diseases and influenza, including oral administration of the interferon inducer dibazol, additionally intranasally administered thymogen in the form of a 0.01% aqueous solution and orally administered ascorbic acid, and the drugs are taken according to the following scheme: dibazol according to 0.02 g three times a day from the 1st to the 3rd day of the disease, thymogen in the form of a 0.01% aqueous solution of 0.3 ml three times a day from the 2nd to the 4th day of the disease and ascorbic acid 0.1 g three times a day from the 1st to the 4th day of the disease [RU L ° 95 116663 A, A61K 31/00, 1997].
  • This method treats complications of the disease, that is, it acts symptomatically, and does not directly affect the virus, therefore, it cannot be effective for preventing the replication of viruses in the treatment of diseases caused by viruses, in particular coronaviruses.
  • the invention is based on the task of creating a method for the prevention and treatment of diseases caused by enveloped viruses, including coronaviruses, which would be effective against viral load, leading to a positive treatment outcome.
  • the second task underlying the invention is to create a set of drugs for the prevention and treatment of diseases caused by enveloped viruses, including coronaviruses, which would be effective under viral load, leading to a positive treatment result.
  • the third task is to create a set of drugs for the prevention and treatment of diseases caused by enveloped viruses, including coronaviruses, which would be effective under viral load, leading to a positive treatment result.
  • the problem is solved by the fact that in the method of prevention and treatment of diseases caused by viruses that have an envelope, including coronaviruses, including the introduction of drugs, including ascorbic acid into the patient's body, according to the invention, a 0.1% solution of crystalline hydrate is prepared copper sulfate. Next, 1.0-3.0 ml of a previously prepared solution is dissolved in 40-60 ml of water, the patient is allowed to slowly drink the prepared solution in very small sips to ensure absorption in the oral cavity and transport into the bloodstream, after 40-60 minutes, ascorbic acid is injected.
  • Ascorbic acid can be taken orally by slowly dissolving it in the mouth.
  • Ascorbic acid can be injected.
  • the dose of ascorbic acid is calculated individually depending on age, sex and body weight in the range from no more than 0.4 g for children under 14 years old to 2.5 g for adults, while adults can first be administered 1-1.2 g of ascorbic acid , and then 0.5 g two more times during the day.
  • the procedure can be repeated the next day.
  • the patient is recommended to take 0.1 g of ascorbic acid 3 times a day for 5 days.
  • the problem is also solved by the fact that in a method for the prevention and treatment of diseases caused by viruses with an envelope, including coronaviruses, including the introduction into the patient's body of drugs, including ascorbic acid, according to the invention, 1-10 g of crystalline copper sulfate reactive purity is placed in a measuring vessel and 200-300 ml of distilled water is poured, shaken, after dissolving the crystalline hydrate, add distilled water up to 950 ml, then 96% sulfuric acid is added dropwise to the solution in an amount of 5-12 drops (0.1-0.15 ml), then distilled water is added to one liter and the pH of the solution is determined, which should not exceed the value 2.5.
  • the dose of ascorbic acid is calculated individually, depending on age, sex and body weight in the range from no more than 0.4 g for children under 14 to 2.5 g for adults.
  • Ascorbic acid is tableted in a dose of 50 to 500 mg and is protected by a sealed package from contact with air.
  • the second task is solved by the fact that a set of drugs for the prevention and treatment of diseases caused by viruses with an envelope, including coronaviruses, including ascorbic acid, according to the invention, contains copper sulfate.
  • Copper sulfate is a solution of copper sulfate crystalline hydrate with a concentration of 0.05% to 1%.
  • the concentration of ascorbic acid ranges from 50 mg to 1500 mg, and preferably from 100 mg to 500 mg.
  • the third problem is solved by the fact that a set of drugs for the prevention and treatment of diseases caused by viruses that have an envelope, including coronaviruses, including ascorbic acid, according to the invention, contains copper sulfate.
  • Copper sulfate is a crystalline hydrate solution with a concentration of 0.05% to
  • the concentration of ascorbic acid ranges from 400 mg to 1500 mg, and preferably from 100 mg to 500 mg.
  • the inventive method prevents the penetration of viruses into the cell by using a chemical oxidation-reduction reaction on the surface of the virus envelope, leading to the formation of an oxygen-containing free radical, which disrupts the structure of the envelope. Thus, replication of enveloped viruses becomes impossible.
  • the method significantly affects (in terms of preventing the penetration of the RNA of the virus into the cell by disrupting the structure and partial destruction of the protein of its envelope) on all RNA viruses with an envelope.
  • the effectiveness of the method lies in the suppression of RNA viruses of different nature, having an envelope.
  • the method consists in sequential (with an interval of 40-60 minutes) application of well-known components: a solution of crystalline copper sulfate CuSO 4 ⁇ 5HgO (copper sulfate) and ascorbic acid (vitamin C).
  • the method uses reactive grade copper sulfate crystalline hydrate.
  • the technical product is not used.
  • a solution is used in a concentration of 0.05% to 1%.
  • the method for the prevention and treatment of diseases caused by viruses with an envelope including coronaviruses, is carried out according to the first option as follows.
  • a 0.1% solution of crystalline copper sulfate hydrate is prepared.
  • 1.0 - 3.0 ml of the prepared solution is dissolved in 40 - 60 ml of water, the patient is allowed to slowly drink the prepared solution in very small sips to ensure absorption in the oral cavity and transport into the bloodstream, after 40-60 minutes, ascorbic acid is injected.
  • Ascorbic acid can be taken orally by slowly dissolving it in the mouth, or by injection.
  • the dose of ascorbic acid is calculated individually, depending on age, sex and body weight in the range from no more than 0.4 g for children under 14 to 2.5 g for adults.
  • Adults can be administered first 1-1.2 g of ascorbic acid, and then 0.5 g twice more during the day.
  • the procedure can be repeated the next day. And to maintain the process, the patient can be given 0.1 g of ascorbic acid 3 times a day for 5 days.
  • the method can be used for prophylactic purposes in patients without obvious signs of the disease.
  • a solution is prepared (per liter), for which the crystalline copper sulfate is placed in a measuring vessel and 200-300 ml of distilled water is poured, shaken. After dissolving the crystalline hydrate, add distilled water up to 950 ml. Then, concentrated sulfuric acid H2SO4 (96%) in the amount of 5-12 drops (0.1 - 0.15 ml) is added to the solution drop by drop. Then add distilled water to one liter and determine the pH of the solution, which should not exceed 2.5.
  • the second component is ascorbic acid. It is preferable that ascorbic acid be tabletted (from 50 to 500 mg) and protected from contact with air in a sealed package, since such contact results in a loss of the reducing properties of ascorbic acid.
  • the sodium salt of ascorbic acid is not used.
  • a solution of crystalline hydrate of copper sulfate enters the human body, 1 ml of which in terms of copper contains about 0.22 mg, which is 10-25 times less than the physiological daily intake of copper.
  • the invention is illustrated by examples of in vitro studies determining the antiviral activity of the preparation Cu + ascorbic acid in models of influenza virus, herpes and coronavirus of transmissible gastroenteritis of pigs in vitro.
  • ACG - a transplantable culture of pig thyroid cells
  • Vero is a continuous culture of green monkey kidney cells.
  • Influenza virus - during the work a strain of the influenza virus was used, obtained from the Museum of Viruses of the Institute of Virology. D.I. Ivanovsky, (RAMS, Moscow) - strain A / FM / 1/47 (H1N1) - infectious titer of allantoic culture - 9.0 lg EID50 / 0.2 ml, hemagglutinin titer - 1: 512 GAO / 02 ml.
  • Herpes simplex virus type 2 (HSV-2) is a VN strain obtained from the Museum of Viruses of the Ivanovsky Institute of Virology, Russian Academy of Medical Sciences. The virus was maintained by serial passages in Vero cell culture. The HPA infectious titer in the cell culture was 6.5 lg TCD50 / 0.1 ml. By the beginning of experimental studies, the virus was stored at -70 ° C.
  • HTGS TGEV
  • TSS transmissible porcine gastroenteritis
  • D52-5 (BRE79) is a highly pathogenic virus for pigs of all age groups at the 5th passage level in a continuous monolayer culture of testicular cells of the ST piglet.
  • the tropism of the virus of the gastrointestinal tract and the respiratory tract is shown.
  • the strain was provided by Dr. Hubert Laude from the Molecular Virology and Immunology Laboratory of the INRA Biotechnology Center in Joa-en-Josassy (France).
  • -titer of hemagglutinin - 1 512 GAO / 0.2 ml, adapted to the lung tissue of mice; -infectious titer - 5.5 lg LD50;
  • a strain of the influenza virus A / FM / 1/47 (H1N1), adapted to the lungs of white mice, was used, which underwent 15 passages in mice and had an infectious titer of 4.0 lg LD50 / 0.2 ml.
  • Non-inbred mice were injected with 0.2 ml of a solution of crystalline copper hydrate, after 60 minutes, a solution of ascorbic acid was injected.
  • the drugs were administered 24 hours after intranasal infection with the influenza virus adapted to the lung tissue of mice at a dose of 10 LD50 (according to the treatment regimen).
  • the account of the effectiveness of the drugs was carried out according to the indicators of the activity of the investigated substances: the percentage of lethality; coefficient (frequency) of protection (CZ) and efficiency index (IE) of inhibition of lethality and a drop in the infectious titer of the influenza virus in the lung tissue of mice.
  • the multiplicity of protection was calculated by the formula: the percentage of dead animals in the control
  • IE 29% is assessed as negative; 30-39%, 40 - 59%, 60-79% and more than 80% - respectively in one, two, three and four plus points.
  • An antivirus complex is considered active if IE is equal to three or four pluses or exceeds 60%.
  • the study of the anti-influenza activity of Cu + ascorbic acid in vivo was carried out on a model of influenza pneumonia in mice.
  • a strain of the influenza A / FM / 1/47 (H1N1) virus was used, adapted to the lungs of white mice, which underwent 15 passages in mice, the infectious titer was 4.0 - 5.5 lg LD50, 100% lethality of mice was observed during 5 days.
  • the preparation C was injected per os at a dilution of 1: 500, an hour later, a solution of ascorbic acid was injected - 0.2 ml in the same way.
  • Studies to determine the antiinfluenza activity in vivo were carried out according to the therapeutic scheme.
  • the effectiveness of the complex was taken into account by the index of the effectiveness of inhibition of lethality and the infectious titer of the influenza virus in the lung tissue of mice. The research results are presented in the table.
  • the proposed method for the treatment of influenza pneumonia is effective (IE - 60.0, inhibition of infectious titer 2.0 lg CTD50).
  • the method of treatment was applied to more than 2,000 patients, including adults - men and women, infants, children, pregnant women, breastfeeding women, and the elderly.
  • the method of treatment was used both at home and in hospitals and intensive care units. The smallest patient is 3 months old, the oldest patient is 88 years old. Patients started treatment with a positive PCR test and finished treatment with a negative PCR test, although a positive effect was determined on the first day after starting the treatment. In most cases, they were treated by families and groups of people living together, in compliance with the rules of hygiene and epidemiological regime.
  • the patient's condition was assessed both clinically - temperature, taste, smell, cough, general condition, and laboratory - complete blood count, coagulogram, d-dimer, ferritin, procalcitonin, C-reactive protein, and instrumental - CT CT, ultrasound CT. All patients, without exception, recovered.
  • Patient G Presence of symptoms of ARVI and influenza, fever up to 39 ° C.
  • the patient used the method according to the first option in 30 (1983), 60 (2013), and 64 (2017).
  • - summer age After the start of the course of treatment, the next day, the temperature was kept in the range from 36.2 ° C to 36.7 ° C. In the following days, the body temperature did not rise and was normal - 36.6 ° C
  • Patient N 3 months old, is breastfed, temperature 39.1 ° C, anxiety, periodic refusal to breastfeed, PCR with a viral load of 5.4x10 * 4.
  • Patient K After receiving treatment according to the second variant of the method - 1.5 ml of a solution with 1000 mg of ascorbic acid (vitamin C) after 50 minutes, every 8 hours on the first day had a temperature of 36.8 ° C and in the following within 36, 2-36.9 ° C. On the second day - restoration of taste and smell. On the 4th day of treatment - the condition is satisfactory, the temperature is 36.6 ° C, taste, smell is present, the PCR test is negative. The treatment was discontinued. After 3 days, the repeated PCR test is negative.
  • Patient B - application of treatment according to the second variant of the method - 1.5 ml of solution, followed by the intake of 1000 mg of vitamin C every 8 hours.
  • the end of the first day - normalization of temperature, taste, smell, disappearance of weakness, muscle pain.
  • the next days are normal.
  • On the 4th day - PCR is negative.
  • Patient B - 1.0 ml of solution, followed by intake of 500 mg of vitamin C every 8 hours.

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Medicinal Chemistry (AREA)
  • Animal Behavior & Ethology (AREA)
  • Chemical & Material Sciences (AREA)
  • Public Health (AREA)
  • Epidemiology (AREA)
  • Virology (AREA)
  • Inorganic Chemistry (AREA)
  • Communicable Diseases (AREA)
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  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)

Abstract

L'invention se rapporte au domaine de la médecine, et concerne notamment un procédé de prévention et de traitement de maladies induites par des virus comportant une enveloppe. Ce procédé consiste à donner à boire au patient une solution préalablement préparée d'hydrate cristallin de sulfate de cuivre, et à administrer pendant 40-60 minutes de l'acide ascorbique. L'invention concerne en outre un kit de préparations pharmaceutiques pour la mise en oeuvre dudit procédé.
PCT/UA2021/000038 2020-04-17 2021-04-16 Procédé de prévention et de traitement de maladies induites par des virus comportant une enveloppe, y compris des coronavirus (variantes), et kit de préparations pharmaceutiques pour sa mise en oeuvre Ceased WO2021211085A1 (fr)

Applications Claiming Priority (6)

Application Number Priority Date Filing Date Title
UAA202002463 2020-04-17
UAA202002463 2020-04-17
IN202041046651 2020-10-26
IN202041046651 2020-10-26
UAA202101730 2021-04-05
UAA202101730 2021-04-05

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Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2004064867A1 (fr) * 2003-01-13 2004-08-05 The Procter & Gamble Company Compositions pour la prevention et pour le traitement de rhumes et de symptomes de type grippe, comprenant des polymeres mucoadhesifs selectionnes
WO2007091037A2 (fr) * 2006-02-06 2007-08-16 Remedy Research Limited Compositions à base de virucides et leurs utilisations

Patent Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2004064867A1 (fr) * 2003-01-13 2004-08-05 The Procter & Gamble Company Compositions pour la prevention et pour le traitement de rhumes et de symptomes de type grippe, comprenant des polymeres mucoadhesifs selectionnes
WO2007091037A2 (fr) * 2006-02-06 2007-08-16 Remedy Research Limited Compositions à base de virucides et leurs utilisations

Non-Patent Citations (5)

* Cited by examiner, † Cited by third party
Title
BETANZOS-CABRERA GABRIEL, FRANCISCO J RAMÍREZ, JOSÉ L MUÑOZ, BLANCA L BARRÓN, ROGELIO MALDONADO: "Inactivation of HSV-2 by ascorbate-Cu(ll) and its protecting evaluation in CF-1 mice against encephalitis", JOURNAL OF VIROLOGICAL METHODS, vol. 120, no. 2, 15 September 2004 (2004-09-15), pages 161 - 165, XP055864633, DOI: 10.1016/j.jviromet.2004.05.003 *
M. HORIE ; H. OGAWA ; Y. YOSHIDA ; K. YAMADA ; A. HARA ; K. OZAWA ; S. MATSUDA ; C. MIZOTA ; M. TANI ; Y. YAMAMOTO ; M. YAMADA ; K: "Inactivation and morphological changes of avian influenza virus by copper ions", ARCHIVES OF VIROLOGY ; OFFICIAL JOURNAL OF THE VIROLOGY DIVISIONOF THE INTERNATIONAL UNION OF MICROBIOLOGICAL SOCIETIES, SPRINGER-VERLAG, VI, vol. 153, no. 8, 1 July 2008 (2008-07-01), Vi , pages 1467 - 1472, XP019634110, ISSN: 1432-8798 *
MADHUSUDANA SHAMPUR NARAYAN, RANJINI SHAMSUNDAR, SARASWATI SEETHARAMAN: "In vitro inactivation of the rabies virus by ascorbic acid", INTERNATIONAL JOURNAL OF INFECTIOUS DISEASES, vol. 8, no. 1, 31 January 2004 (2004-01-31), pages 21 - 25, XP055864631, DOI: 10.1016/j.ijid.2003.09.002 *
NELSON, V.A.: "Nelson-Town anti virus theory", MEDICAL HYPOTHESES, EDEN PRESS, PENRITH., US, vol. 4, no. 4, 1 July 1978 (1978-07-01), US , pages 340 - 352, XP026325216, ISSN: 0306-9877, DOI: 10.1016/0306-9877(78)90069-5 *
SAGRIPANTI J-L, ET AL.: "MECHANISM OF COPPER-MEDIATED INACTIVATION OF HERPES SIMPLEX VIRUS", ANTIMICROBIAL AGENTS AND CHEMOTHERAPY, AMERICAN SOCIETY FOR MICROBIOLOGY, US, vol. 41, no. 04, 1 April 1997 (1997-04-01), US , pages 812 - 817, XP001154705, ISSN: 0066-4804 *

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