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

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.

Study Overview

• Status: Completed
• Conditions: Covid19; Respiratory Disease; Supportive Care; Immune System; Immunomodulator; Antiseptic
• Intervention / Treatment: Dietary supplement: Viusid; Dietary supplement: Asbrip; Drug: Standard Care

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 Type: Interventional
• Enrollment (Actual): 60
• Phase: Phase 2

Contacts and Locations

Study Locations

• Bulgaria
  • Plovdiv, Bulgaria, 4000
    • MBAL, Sv. Mina
  • Plovdiv, Bulgaria, 4004
    • MTB Plovdiv

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Interventional; 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.	Dietary supplement: Viusid; Patients received daily doses of 30 ml of Viusid every 8 hours plus standard care for COVID-19. Viusid is administered orally. Treatment duration: 21 days; Dietary supplement: Asbrip; Patients received daily doses of 10 ml of Asbrip every 8 hours plus standard care for COVID-19. Asbrip is administered orally. Treatment duration: 21 days; Drug: Standard Care; Standard care for COVID-19
Other: Control; 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.	Drug: Standard Care; Standard care for COVID-19

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical Improvement	Clinical Improvement as assessed by change in total symptom score ranging from 0-12. The symptom score includes: [everyday assessment, up to 21 days].; 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.; Cough on a scale 0-3: 0 = no cough, 1 = mild, 2 = moderate, 3 = severe.; 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.; 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.	21 days
Time to semirecover	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).	21 days
Symptom resolution	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.	21 days
Time to recovery	Time (days) to recovery from COVID-19 disease The number of days required to reach composite score <1.	21 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of hospitalization	Number of Incidence of hospitalization	21 days
Duration (days) of hospitalization	Number of days of hospitalization	21 days
Incidence of oxygen use	Number of incidences of oxygen use	21 days
Duration (days) of oxygen use	Number of days of oxygen use per patient	21 days
Mortality rate	Number of death per group	21 days
Cumulative assessment of disease severity	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.; Death; Hospitalized, with invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); Hospitalized, with non-invasive ventilation or high-flow oxygen devices; Hospitalized, requiring supplemental oxygen; Hospitalized, which does not require supplemental oxygen; Not hospitalized, limitation of activities.; Not hospitalized, without limitations in activities. Note: lower scores mean a worse result. Note: lower scores mean a worse outcome	21 days
Duration of SARS-CoV-2 PCR positivity	Daily PCR analysis to measure and compare viral load	21 days
Concentration of C-reactive protein in peripheral blood	Concentration of C-reactive protein in peripheral blood measured by Blood biochemical analysis.	21 days
Incidence of mechanical ventilation supply	Number of incidences of mechanical ventilation supply per patient	21 days

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in liver function test	Change in liver function test (AST, ALT and TBIL) by blood biochemical analysis.	21 days
Change in kidney function test	Change in kidney function with creatine clearance rate by blood and urinary biochemical analysis.	21 days
Change in routine blood test	Change in routine blood test red blood cells concentration by blood biochemical analysis.	21 days
Change in routine blood test	Change in routine blood test white blood cell concentration by blood biochemical analysis.	21 days
Change in routine blood test	Change in routine blood test D-dimer level by blood biochemical analysis.	21 days
Change in routine blood test	Change in routine blood test fibrinogen level by blood biochemical analysis at day.	21 days

Collaborators and Investigators

• Sponsor: Catalysis SL

Study record dates

Study Major Dates

• Study Start (Actual): November 9, 2020
• Primary Completion (Actual): February 15, 2021
• Study Completion (Actual): February 15, 2021

Study Registration Dates

• First Submitted: January 4, 2021
• First Submitted That Met QC Criteria: January 7, 2021
• First Posted (Actual): January 8, 2021

Study Record Updates

• Last Update Posted (Actual): October 21, 2021
• Last Update Submitted That Met QC Criteria: October 20, 2021
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19; Respiration Disorders; Respiratory Tract Diseases
• Other Study ID Numbers: COVID_BULG_2020

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Sharing Supporting Information Type: Study Protocol; Statistical Analysis Plan (SAP); Informed Consent Form (ICF); Clinical Study Report (CSR)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No