Efficacy and Safety of Viusid and Asbrip in Hospitalized Patients With Mild and Moderate COVID-19
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
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 Design
Arms and Interventions
| 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
|
Outcome Measures
Primary Outcome Measures
- 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]. 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.
- 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).
- 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 recovery [21 days]
Time (days) to recovery from COVID-19 disease The number of days required to reach composite score <1.
Secondary Outcome Measures
- 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. 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
- 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.
- Incidence of hospitalization [21 days]
Number of Incidence of hospitalization
- Duration (days) of hospitalization [21 days]
Number of days of hospitalization
- Incidence of mechanical ventilation supply [21 days]
Number of incidences of mechanical ventilation supply per patient
- Incidence of oxygen use [21 days]
Number of incidences of oxygen use
- Duration (days) of oxygen use [21 days]
Number of days of oxygen use per patient
- Mortality rate [21 days]
Number of death per group
Other Outcome Measures
- Change in liver function test [21 days]
Change in liver function test (AST, ALT and TBIL) by blood biochemical analysis.
- Change in kidney function test [21 days]
Change in kidney function with creatine clearance rate by blood and urinary biochemical analysis.
- Change in routine blood test [21 days]
Change in routine blood test red blood cells concentration by blood biochemical analysis.
- Change in routine blood test [21 days]
Change in routine blood test white blood cell concentration by blood biochemical analysis.
- Change in routine blood test [21 days]
Change in routine blood test D-dimer level by blood biochemical analysis.
- Change in routine blood test [21 days]
Change in routine blood test fibrinogen level by blood biochemical analysis at day.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
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
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Mild symptoms, such as fever, rhinorrhea, mild cough, sore throat, malaise, headache, muscle pain, or malaise, but with no shortness of breath and
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No signs of a more serious lower airway disease and
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RR<20, HR <90, oxygen saturation (pulse oximetry) > 93% on room air
Moderate Illness:
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Diagnosed with COVID-19 by a standardized RT-PCR assay and
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In addition to symptoms above, more significant lower respiratory symptoms, including shortness of breath (at rest or with exertion) or
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Signs of moderate pneumonia, including RR ≥ 20 but <30, HR ≥ 90 but less than 125, oxygen saturation (pulse oximetry) > 93% on room air and
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If available, lung infiltrates based on X-ray or CT scan < 50% present
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Clinically normal resting 12-lead ECG at screening visit or, if abnormal, considered not clinically significant by the Principal Investigator.
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Subject (or legally authorized representative) provides written informed consent prior to initiation of any study procedures.
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Understands and agrees to comply with planned study procedures.
Exclusion Criteria:
-
Subjects showing signs of acute respiratory distress syndrome (ARDS) or respiratory failure necessitating mechanical ventilation at the time of screening.
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History of severe chronic respiratory disease and requirement for long-term oxygen therapy.
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Subjects showing signs of clinical jaundice at the time of screening.
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History of moderate and severe liver disease (Child-Pugh score >12).
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Subjects requiring Renal Replacement Therapy (RRT) at the time of screening.
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History of uncontrolled diabetes.
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History of severe chronic kidney disease or requiring dialysis.
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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.
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Patients with malignant tumor, or other serious systemic diseases.
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Patients who are participating in other clinical trials.
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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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | MBAL, Sv. Mina | Plovdiv | Bulgaria | 4000 | |
| 2 | MTB Plovdiv | Plovdiv | Bulgaria | 4004 |
Sponsors and Collaborators
- Catalysis SL
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- COVID_BULG_2020