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

NCT04701502 | Completed Phase 2

• 1 other identifier: COVID_BULG_2020
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 2

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.

Conditions

Covid19; Respiratory Disease; Immune System; Immunomodulator; Antiseptic; Supportive Care

Outcome Measures

Primary Outcomes (4)

• Clinical Improvement

  Clinical Improvement as assessed by change in total symptom score ranging from 0-12. The symptom score includes: \[everyday assessment, up to 21 days\]. 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.

  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 Outcomes (9)

• Cumulative assessment of disease severity

  21 days

• Duration of SARS-CoV-2 PCR positivity

  21 days

• Concentration of C-reactive protein in peripheral blood

  21 days

• Incidence of hospitalization

  21 days

• Duration (days) of hospitalization

  21 days

Other Outcomes (6)

• Change in liver function test

  21 days

• Change in kidney function test

  21 days

• Change in routine blood test

  21 days

Study Arms (2)

Interventional

EXPERIMENTAL

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; Dietary Supplement: Asbrip; Drug: Standard Care

Control

OTHER

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

Interventions

Viusid DIETARY_SUPPLEMENT

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

Interventional

Asbrip DIETARY_SUPPLEMENT

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

Interventional

Standard Care DRUG

Standard care for COVID-19

Control; Interventional

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female adults aged ≥18 years at the time of enrollment.
• 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
• Clinically normal resting 12-lead ECG at screening visit or, if abnormal, considered not clinically significant by the Principal Investigator.
• Subject (or legally authorized representative) provides written informed consent prior to initiation of any study procedures.
• Understands and agrees to comply with planned study procedures.

You may not qualify if:

• Subjects showing signs of acute respiratory distress syndrome (ARDS) or respiratory failure necessitating mechanical ventilation at the time of screening.
• History of severe chronic respiratory disease and requirement for long-term oxygen therapy.
• Subjects showing signs of clinical jaundice at the time of screening.
• History of moderate and severe liver disease (Child-Pugh score \>12).
• Subjects requiring Renal Replacement Therapy (RRT) at the time of screening.
• History of uncontrolled diabetes.
• History of severe chronic kidney disease or requiring dialysis.
• 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.
• Patients with malignant tumor, or other serious systemic diseases.
• Patients who are participating in other clinical trials.
• 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.

Sponsors & Collaborators

• Catalysis SL: lead

Study Sites (2)

MBAL, Sv. Mina

Plovdiv, 4000, Bulgaria

Location

MTB Plovdiv

Plovdiv, 4004, Bulgaria

Location

MeSH Terms

Conditions

COVID-19; Respiration Disorders

Interventions

Viusid; Standard of Care

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 4, 2021
• First Posted: January 8, 2021
• Study Start: November 9, 2020
• Primary Completion: February 15, 2021
• Study Completion: February 15, 2021
• Last Updated: October 21, 2021

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR

Locations

BU (2)