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

Not Applicable

Completed

• Conditions: Covid19; Viral Infection; SARS-CoV2 Infection; COVID-19 Pneumonia; COVID-19 Respiratory Infection; Infection, Coronavirus; Respiratory Tract Infections
• Interventions: Dietary Supplement: Viusid and Asbrip; Drug: COVID-19 Standard Therapy

• Registration Number: NCT04980534
• Lead Sponsor: Catalysis SL

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2021-01-08
• Primary Completion: 2021-06-30
• Status Verified: 2021-07
• Study First Submitted: 2021-07-26
• Study First Submitted QC: 2021-07-26
• Study First Posted: 2021-07-28
• Study Completion: 2021-09-15
• Last Update Submitted: 2022-04-05
• Last Update Posted: 2022-04-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Viusid Plus Asbrip Adjuvant	Viusid and Asbrip	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	Viusid and Asbrip	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.
Viusid Plus Asbrip Adjuvant	COVID-19 Standard Therapy	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.
Control	COVID-19 Standard Therapy	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.

Primary Outcome Measures

Name	Time	Method
Mean duration of hospitalization.	21 days	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.

Secondary Outcome Measures

Name	Time	Method
Mean levels of IL-6 concentration	21 days	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/).
Mean levels of Ferritin concentration	21 days	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/).
Peripheral blood c-reactive protein concentration	21 days	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/).
Mean levels of D-Dimer concentration	21 days	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/).

Trial Locations

Locations (3)

City children hospital №1; 🇰🇿 Astana, Nur-Sultan, Kazakhstan

JSC "Astana Medical University; 🇰🇿 Astana, Kazakhstan

City center for infectious diseases; 🇰🇿 Astana, Nur-Sultan, Kazakhstan