Efficacy and Safety of Viusid and Asbrip in Hospitalized Patients With Mild and Moderate COVID-19

Phase 2

Completed

• Conditions: Immunomodulator; Respiratory Disease; Covid19; Supportive Care; Antiseptic; Immune System
• Interventions: Dietary Supplement: Viusid; Dietary Supplement: Asbrip; Drug: Standard Care

• Registration Number: NCT04701502
• Lead Sponsor: Catalysis SL

Brief Summary

This is a two-arm, randomized, open label, two-center, 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, two-center, 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 60 subjects will be randomized 2:1 in this study. 40 patients will be assigned to receive daily oral doses of 30 ml of Viusid and 10 ml of Asbrip every 8 hours and standard care. Other 20 patients will be assigned to receive only standard care.

Treatment duration: 21 days

Study Timeline

• Status Verified: 2020-11
• Study Start: 2020-11-09
• Study First Submitted: 2021-01-04
• Study First Submitted QC: 2021-01-07
• Study First Posted: 2021-01-08
• Primary Completion: 2021-02-15
• Study Completion: 2021-02-15
• Last Update Submitted: 2021-10-20
• Last Update Posted: 2021-10-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

1. Male or female adults aged ≥18 years at the time of enrollment.

2. Subjects with mild-to-moderate symptoms of respiratory illness caused by coronavirus 2019 infection as defined below:

   Mild (uncomplicated) Illness:

   • Diagnosed with COVID-19 by a standardized RT-PCR assay and
   • Mild symptoms, such as fever, rhinorrhea, mild cough, sore throat, malaise, headache, muscle pain, or malaise, but with no shortness of breath and
   • No signs of a more serious lower airway disease and
   • RR<20, HR <90, oxygen saturation (pulse oximetry) > 93% on room air

   Moderate Illness:

   • Diagnosed with COVID-19 by a standardized RT-PCR assay and
   • In addition to symptoms above, more significant lower respiratory symptoms, including shortness of breath (at rest or with exertion) or
   • Signs of moderate pneumonia, including RR ≥ 20 but <30, HR ≥ 90 but less than 125, oxygen saturation (pulse oximetry) > 93% on room air and
   • If available, lung infiltrates based on X-ray or CT scan < 50% present

3. Clinically normal resting 12-lead ECG at screening visit or, if abnormal, considered not clinically significant by the Principal Investigator.

4. Subject (or legally authorized representative) provides written informed consent prior to initiation of any study procedures.

5. Understands and agrees to comply with planned study procedures.

Exclusion Criteria

1. Subjects showing signs of acute respiratory distress syndrome (ARDS) or respiratory failure necessitating mechanical ventilation at the time of screening.
2. History of severe chronic respiratory disease and requirement for long-term oxygen therapy.
3. Subjects showing signs of clinical jaundice at the time of screening.
4. History of moderate and severe liver disease (Child-Pugh score >12).
5. Subjects requiring Renal Replacement Therapy (RRT) at the time of screening.
6. History of uncontrolled diabetes.
7. History of severe chronic kidney disease or requiring dialysis.
8. Any uncontrolled active systemic infection requiring admission to an intensive care unit (ICU); Note: Subjects infected with chronic hepatitis B virus or hepatitis C virus will be eligible for the study if they have no signs of hepatic decompensation.
9. Patients with malignant tumor, or other serious systemic diseases.
10. Patients who are participating in other clinical trials.
11. Patients who have a history of allergic reactions attributed to compounds of similar chemical or biologic composition to Viusid or Asbrip are not eligible.

Note: Empirical antibiotic treatment for secondary bacterial infections is allowed during the study.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Interventional	Asbrip	A total of 60 subjects will be randomized 2: 1 in this study. 40 patients will be assigned to Viusid plus Asbrip, plus standard care of the hospital. Treatment duration: 21 days.
Interventional	Standard Care	A total of 60 subjects will be randomized 2: 1 in this study. 40 patients will be assigned to Viusid plus Asbrip, plus standard care of the hospital. Treatment duration: 21 days.
Interventional	Viusid	A total of 60 subjects will be randomized 2: 1 in this study. 40 patients will be assigned to Viusid plus Asbrip, plus standard care of the hospital. Treatment duration: 21 days.
Control	Standard Care	A total of 60 subjects will be randomized 2: 1 in this study. 20 control patients will be assigned to standard care of the hospital only. Treatment duration: 21 days.

Primary Outcome Measures

Name	Time	Method
Symptom resolution	21 days	Symptom resolution of COVID-19 disease The number of days required to reach symptom score \<0,25 for each one of four symptom category mentioned before.
Time to semirecover	21 days	Efficacy will be determined by the number of days required to reach a 50 percent reduction in the composite score, i.e. "time to semirecovery" (primary outcome measure).
Clinical Improvement	21 days	Clinical Improvement as assessed by change in total symptom score ranging from 0-12.; The symptom score includes: \[everyday assessment, up to 21 days\].; 1. Fever (temperature in oC) based on a scale 0-3: 0 \<36,7; 1 =36,7-37,8; 2 =37,8-38,9; 3 \> 38,9.; 2. Cough on a scale 0-3: 0 = no cough, 1 = mild, 2 = moderate, 3 = severe.; 3. Shortness of breath based on a scale 0-3: 0 = no shortness of breath, 1 = with moderate intensity exercise, 2 = with walking on flat surface, 3 = short of breath with getting dressed or daily activities.; 4. Fatigue on a 0-3 scale: 0 = no fatigue, 1 = mild fatigue, 2 = moderate fatigue, 3 = severe fatigue.; Composite score is a sum of mentioned four symptom scores, assessed every day up to 21 days. It ranges from 0 to 12.
Time to recovery	21 days	Time (days) to recovery from COVID-19 disease The number of days required to reach composite score \<1.

Secondary Outcome Measures

Name	Time	Method
Mortality rate	21 days	Number of death per group
Incidence of hospitalization	21 days	Number of Incidence of hospitalization
Incidence of mechanical ventilation supply	21 days	Number of incidences of mechanical ventilation supply per patient
Duration of SARS-CoV-2 PCR positivity	21 days	Daily PCR analysis to measure and compare viral load
Concentration of C-reactive protein in peripheral blood	21 days	Concentration of C-reactive protein in peripheral blood measured by Blood biochemical analysis.
Duration (days) of hospitalization	21 days	Number of days of hospitalization
Duration (days) of oxygen use	21 days	Number of days of oxygen use per patient
Cumulative assessment of disease severity	21 days	Disease severity will be measured using a disease severity clinical event scale (assessed until day 21) Change from baseline in the patient's health status on an ordinal scale of 7 categories.; 1. Death; 2. Hospitalized, with invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 3. Hospitalized, with non-invasive ventilation or high-flow oxygen devices; 4. Hospitalized, requiring supplemental oxygen; 5. Hospitalized, which does not require supplemental oxygen; 6. Not hospitalized, limitation of activities.; 7. Not hospitalized, without limitations in activities. Note: lower scores mean a worse result.; Note: lower scores mean a worse outcome
Incidence of oxygen use	21 days	Number of incidences of oxygen use

Trial Locations

Locations (2)

MBAL, Sv. Mina; 🇧🇬 Plovdiv, Bulgaria

MTB Plovdiv; 🇧🇬 Plovdiv, Bulgaria