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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| 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].
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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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.
Note: lower scores mean a worse outcome |
| 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. |
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:
Moderate Illness:
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.
Exclusion Criteria:
Note: Empirical antibiotic treatment for secondary bacterial infections is allowed during the study.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| MBAL, Sv. Mina | Plovdiv | 4000 | Bulgaria | |||
| MTB Plovdiv |
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| D012120 | Respiration Disorders |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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| ID | Term |
|---|---|
| C551853 | Viusid |
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
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| 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 |
|
| Standard Care | Drug | Standard care for COVID-19 |
|
| 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 hospitalization | Number of Incidence of hospitalization | 21 days |
| Duration (days) of hospitalization | Number of days of hospitalization | 21 days |
| Incidence of mechanical ventilation supply | Number of incidences of mechanical ventilation supply per patient | 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 |
| 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 |
| Plovdiv |
| 4004 |
| Bulgaria |
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |