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.
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
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
60
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
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
Standard care for COVID-19
MBAL, Sv. Mina
Plovdiv, Bulgaria
MTB Plovdiv
Plovdiv, Bulgaria
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.
Time frame: 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).
Time frame: 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.
Time frame: 21 days
Time to recovery
Time (days) to recovery from COVID-19 disease The number of days required to reach composite score \<1.
Time frame: 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. 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
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Time frame: 21 days
Duration of SARS-CoV-2 PCR positivity
Daily PCR analysis to measure and compare viral load
Time frame: 21 days
Concentration of C-reactive protein in peripheral blood
Concentration of C-reactive protein in peripheral blood measured by Blood biochemical analysis.
Time frame: 21 days
Incidence of hospitalization
Number of Incidence of hospitalization
Time frame: 21 days
Duration (days) of hospitalization
Number of days of hospitalization
Time frame: 21 days
Incidence of mechanical ventilation supply
Number of incidences of mechanical ventilation supply per patient
Time frame: 21 days
Incidence of oxygen use
Number of incidences of oxygen use
Time frame: 21 days
Duration (days) of oxygen use
Number of days of oxygen use per patient
Time frame: 21 days
Mortality rate
Number of death per group
Time frame: 21 days