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This is a two-arm, randomized, open label, monocenter, controlled study to evaluate the safety and efficacy of Viusid plus Asbrip in patients with mild and moderate symptoms of respiratory illness caused by Coronavirus 2019 infection.
This is a two-arm, randomized, open label, monocenter, controlled study to evaluate the safety and efficacy of Viusid plus Asbrip in patients with mild and moderate symptoms of respiratory illness caused by Coronavirus 2019 infection.
A total of 80 subjects will be randomized 2:1 in this study. 50 patients will be assigned to receive daily oral doses of 4,5 g of Viusid every 12 hours and 10 ml of Asbrip every 12 hours and standard care with antivirals or not. Other 30 patients will be assigned to receive only standard care.
Treatment duration: 21 days
Objective of the study: to increase the effectiveness of therapy for patients with Covid-19 using food supplements Viusid and Asbrip.
Research objectives:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Viusid Plus Asbrip Adjuvant | Experimental | 25 Patients who received standard therapy Remdesivir IV 200 mg for the first day and then 100 mg daily for the next 4 days AND Viusid (sachets with powder for dilution, oral administration) 1 sachet bid and Asbrip (liquid form, oral administration) 10 ml bid for the total duration of hospitalization. Time Frame: 21 days. |
|
| Viusid Plus Asbrip Monotherapy | Experimental | 25 Patients who did not receive standard antiviral therapy with the inclusion of food supplements Viusid (4.5 gr every 12 hours, oral administration) and Asbrip (10 mL every 12 hours, oral administration). Time Frame: 21 days. |
|
| Control | Active Comparator | 30 patients who received standard therapy (Remdesivir IV 200 mg for the first day and then 100 mg daily for the next 4 days), without the inclusion of food supplements Viusid and Asbrip. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Viusid and Asbrip | Dietary Supplement | Patients will be assigned to receive daily oral doses of 4.5gr of Viusid and 10 ml of Asbrip every 8 hours and standard care. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mean duration of hospitalization. | Media of time in days to discharge in each group. Discharge is considered once the patient complete the following conditions:
Red blood cell count: Male: 4.35-5.65 million cells/mcL; Female: 3.92-5.13 million cells/mcL. Hemoglobin: Male: 13.2-16.6 grams/dL; Female: 11.6-15 grams/dL. Hematocrit: Male: 38.3-48.6 percent; Female: 35.5-44.9 percent. White blood cell count: 3,400 to 9,600 cells/mcL. Platelet count: Male: 135-317 billion/L; Female: 157-371 billion/L.
| 21 days |
| Measure | Description | Time Frame |
|---|---|---|
| Mean levels of IL-6 concentration | Mean of IL-6 concentration measured by blood biochemical analysis at day 0, 5, 10, 15 and 21. IL-6 level lower than doubled normal value: between 0 and 43.5 pg/ml will be considered as normal values. Levels of IL-6 will be determined centrally at OLYMP diagnostics lab (https://www.kdlolymp.kz/). | 21 days |
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The eligibility criteria for inclusion in the study were as follows:
The exclusion criteria were as follows:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| City center for infectious diseases | Astana | Astana | 010000 | Kazakhstan | ||
| City children hospital №1 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17311621 | Result | Vilar Gomez E, Gra Oramas B, Soler E, Llanio Navarro R, Ruenes Domech C. Viusid, a nutritional supplement, in combination with interferon alpha-2b and ribavirin in patients with chronic hepatitis C. Liver Int. 2007 Mar;27(2):247-59. doi: 10.1111/j.1478-3231.2006.01411.x. | |
| 20518086 | Result | Gomez EV, Perez YM, Sanchez HV, Forment GR, Soler EA, Bertot LC, Garcia AY, del Rosario Abreu Vazquez M, Fabian LG. Antioxidant and immunomodulatory effects of Viusid in patients with chronic hepatitis C. World J Gastroenterol. 2010 Jun 7;16(21):2638-47. doi: 10.3748/wjg.v16.i21.2638. |
| Label | URL |
|---|---|
| Related Info | View source |
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| COVID-19 Standard Therapy | Drug | Patients will be assigned to receive the standard therapy for COVID-19 disease: Antibiotic, Antivirals, Analgaesic, Anti-inflammatory drugs. |
|
| Peripheral blood c-reactive protein concentration |
Peripheral blood c-reactive protein concentration measured by blood biochemical analysis at day 0, 5, 10, 15 and 21. - 0.8-1.0 mg/dL (or 8-10 mg/L) or lower will be considered as normal values. Levels of CRP will be determined centrally at OLYMP diagnostics lab (https://www.kdlolymp.kz/). |
| 21 days |
| Mean levels of D-Dimer concentration | Mean of D-dimer measured by blood biochemical analysis at day 0, 5, 10, 15 and 21. D-Dimer level under 250 ng/mL, or under 0.4 μ/mL will be considered as normal value. Levels of D-Dimer will be determined centrally at OLYMP diagnostics lab (https://www.kdlolymp.kz/). | 21 days |
| Mean levels of Ferritin concentration | Mean of D-dimer measured by blood biochemical analysis at day 0, 5, 10, 15 and 21. In adult Males between 12 to 300 ng/mL; in adult Females between 12 to 150 ng/mL will be considered as normal values. Levels of Ferritin will be determined centrally at OLYMP diagnostics lab (https://www.kdlolymp.kz/). | 21 days |
| Astana |
| Astana |
| 020000 |
| Kazakhstan |
| JSC "Astana Medical University | Astana | 010000 | Kazakhstan |
| 19691668 | Result | Vilar Gomez E, Rodriguez De Miranda A, Gra Oramas B, Arus Soler E, Llanio Navarro R, Calzadilla Bertot L, Yasells Garcia A, Del Rosario Abreu Vazquez M. Clinical trial: a nutritional supplement Viusid, in combination with diet and exercise, in patients with nonalcoholic fatty liver disease. Aliment Pharmacol Ther. 2009 Nov 15;30(10):999-1009. doi: 10.1111/j.1365-2036.2009.04122.x. Epub 2009 Aug 18. |
| Related Info | View source |
| Related Info | View source |
| Related Info | View source |
| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| D014777 | Virus Diseases |
| D012141 | Respiratory Tract Infections |
| D018352 | Coronavirus Infections |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D007239 | Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| C551853 | Viusid |
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