Evaluation of the Effectiveness of Therapy for Patients With Covid-19 Using Food Supplements Viusid + Asbrip

Covid19 Clinical Trial

Official title:

Evaluation of the Effectiveness of Therapy for Patients With Covid-19 Using Food Supplements Viusid + Asbrip

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04980534
• Other study ID #: COVID_KAZ_2021
• Status: Completed
• Phase: N/A
• Start date: January 8, 2021
• Est. completion date: September 15, 2021

Study information

• Verified date: July 2021
• Source: Catalysis SL
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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:

1. To assess the clinical symptoms of Covid-19 in patients on the background of combination therapy with the inclusion of food supplements Viusid + Asbrip.

2. To investigate the dynamics of indicators of laboratory diagnostics against the background of complex therapy with the inclusion of food additives Viusid + Asbrip in the complex treatment of Covid -19.

3. To study the dynamics of indicators of instrumental methods of treatment.

4. To develop an algorithm for the management of patients with coronavirus infection in order to increase the effectiveness of therapy and rehabilitation of patients with this pathology.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: September 15, 2021
• Est. primary completion date: June 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

The eligibility criteria for inclusion in the study were as follows:

• Male and female hospitalized patients who have signed an informed consent.

• Aged between 18-85 years old.

• RT-PCR confirmed COVID-19.

• Fever (over 37.2 Celsius degrees).

• CT scan percentage area of lung involvement with ground-glass opacities < 50 %.

• Respiratory rate < 20-30 /min

• SpO2 = 95%.

The exclusion criteria were as follows:

• Oxygen support (ventilation and non-invasive)

• Uncompensated or exacerbated concomitant diseases or conditions that may complicate or make the patient's participation in the study impossible, or make it difficult to explain clinical findings.

• Any known intolerability to any of the study regimens' components.

• Patient's family or official relations with a member of staff of the clinical site.

• Patient's failure to assess his/her physical and/or emotional condition.

• Patient's failure to comply with the study requirements.

• Patient's refusal to participate in the study.

• Pregnancy or breastfeeding.

Related Conditions & MeSH terms

• Communicable Diseases
• Coronavirus Infections
• COVID-19
• COVID-19 Pneumonia
• Covid19
• Infection, Coronavirus
• Infections
• Respiratory Tract Infections
• SARS-CoV2 Infection
• Viral Infection
• Virus Diseases

Intervention

Dietary Supplement:
• Viusid and Asbrip
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.

Drug:
• COVID-19 Standard Therapy
Patients will be assigned to receive the standard therapy for COVID-19 disease: Antibiotic, Antivirals, Analgaesic, Anti-inflammatory drugs.

Locations

Country	Name	City	State
Kazakhstan	City center for infectious diseases	Astana	Nur-Sultan
Kazakhstan	City children hospital ?1	Astana	Nur-Sultan
Kazakhstan	JSC "Astana Medical University	Astana

Sponsors (1)

Lead Sponsor	Collaborator
Catalysis SL

Country where clinical trial is conducted

Kazakhstan, 

References & Publications (3)

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. — View Citation

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. — View Citation

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 wi — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean duration of hospitalization.	Media of time in days to discharge in each group. Discharge is considered once the patient complete the following conditions: Normal body temperature for 2 days (36.1 - 37.2 degrees Celsius will be considered as normal body temperature).; Normal appetite for 4 days.; Normal Complete Blood Count (CBC): Following values will be considered as normal values in CBC: 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.; No requirement in oxygen support.; Decrease in or normal CRP: 0.8-1.0 mg/dL (or 8-10 mg/L) or lower will be considered as normal values.; Any decrease in IL-6 level lower than doubled normal value: between 0 and 43.5 pg/ml will be considered as normal values.	21 days
Secondary	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
Secondary	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
Secondary	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
Secondary	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

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