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

Covid19 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04701502
• Other study ID #: COVID_BULG_2020
• Status: Completed
• Phase: Phase 2
• Start date: November 9, 2020
• Est. completion date: February 15, 2021

Study information

• Verified date: November 2020
• Source: Catalysis SL
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: February 15, 2021
• Est. primary completion date: February 15, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Antiseptic
• COVID-19
• Covid19
• Immune System
• Immunomodulator
• Respiration Disorders
• Respiratory Disease
• Respiratory Tract Diseases
• Supportive Care

Intervention

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
• 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

Locations

Country	Name	City	State
Bulgaria	MBAL, Sv. Mina	Plovdiv
Bulgaria	MTB Plovdiv	Plovdiv

Sponsors (1)

Lead Sponsor	Collaborator
Catalysis SL

Country where clinical trial is conducted

Bulgaria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in liver function test	Change in liver function test (AST, ALT and TBIL) by blood biochemical analysis.	21 days
Other	Change in kidney function test	Change in kidney function with creatine clearance rate by blood and urinary biochemical analysis.	21 days
Other	Change in routine blood test	Change in routine blood test red blood cells concentration by blood biochemical analysis.	21 days
Other	Change in routine blood test	Change in routine blood test white blood cell concentration by blood biochemical analysis.	21 days
Other	Change in routine blood test	Change in routine blood test D-dimer level by blood biochemical analysis.	21 days
Other	Change in routine blood test	Change in routine blood test fibrinogen level by blood biochemical analysis at day.	21 days
Primary	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
Primary	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
Primary	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
Primary	Time to recovery	Time (days) to recovery from COVID-19 disease The number of days required to reach composite score <1.	21 days
Secondary	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
Secondary	Duration of SARS-CoV-2 PCR positivity	Daily PCR analysis to measure and compare viral load	21 days
Secondary	Concentration of C-reactive protein in peripheral blood	Concentration of C-reactive protein in peripheral blood measured by Blood biochemical analysis.	21 days
Secondary	Incidence of hospitalization	Number of Incidence of hospitalization	21 days
Secondary	Duration (days) of hospitalization	Number of days of hospitalization	21 days
Secondary	Incidence of mechanical ventilation supply	Number of incidences of mechanical ventilation supply per patient	21 days
Secondary	Incidence of oxygen use	Number of incidences of oxygen use	21 days
Secondary	Duration (days) of oxygen use	Number of days of oxygen use per patient	21 days
Secondary	Mortality rate	Number of death per group	21 days