Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
Conditions
Interventions
None listed
Sponsors
All India Institute of Ayurveda
Eligibility
Inclusion criteria
Inclusion criteria: Subject aged 20 to 60 years (both inclusive) of both gender Subject with SARS-CoV-2 infection confirmed through reverse transcription followed by polymerase chain reaction (RT- PCR) Subject with mild manifestations of COVID-19 (WHO ordinal score 1 or 2) Subject with oxygen saturation � 95% as measured by pulse oximetry Subject with initial onset of signs/symptoms attributable to COVID-19 for �5 days prior to the day of randomization Subject with ability to swallow and retain oral medication Subject with willingness and ability to comply with trial and follow-up procedures Subject with ability to understand the nature of this trial and give written informed consent
Exclusion criteria
Exclusion criteria: Subject with RT-PCR positive COVID-19 with no symptoms Subject currently hospitalized or expected to need hospitalization for COVID-19 within 48 hours of randomization Subject in which the present episode of infection is a recurrence or reinfection of COVID-19 (within 90 days) Subject having stage 2 hypertension (systolic blood pressure level > 160 mmHg and diastolic blood pressure of > 100 mmHg) Subject using more than 3 anti-hypertensive drugs Subject hospitalized for decompensated congestive heart failure in the last 12 months Subject having HbA1c > 9.0% Subject having Class 3 obesity (BMI � 40) Subject with aspartate aminotransferase (AST)/alanine transaminase (ALT) more than 3 times the upper limit of normal reference range Subject who is pregnant, lactating or planning pregnancy during the study period Subject of childbearing potential, unwilling to use highly effective contraception during their participation in the trial and for 2 weeks after study completion Subject with a history of receiving any allopathic or alternative (herbal) medication, any antiviral drugs with reported activity against COVID-19 (ivermectin, favipiravir, hydroxychloroquine, lopinavir, and remdesivir) or warfarin therapy for the present COVID-19 episode within 7 days before enrolment Subject on steroid or other immunosuppressive medication or having treatment within the last 3 months Subject with unstable or life-threatening systemic diseases like immunodeficiency virus (HIV), hepatitis B virus (HBV) or hepatitis C virus (HCV) with cirrhosis, end-stage liver disease, carcinoma, respiratory failure and end stage renal disease Subject with a platelet count Subject having hypersensitivity or other contraindication to any of the components of the study interventions as determined by the principal investigator. Subject with conditions that could limit gastrointestinal absorption of tablet contents. Subject who is already participating in another trial or have received an experimental drug or have used an experimental medical device within 30 days prior to the planned start of procedure Subject unlikely to comply with the procedure or complete the scheduled follow up visit, in the opinion of principal investigator Employee of the principal investigator or study center with direct involvement in the proposed study or other studies under the direction of that principal investigator or study center Other indication-based exclusion, in opinion of principal investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time to negative COVID-19 RT-PCR test in subjects having RT-PCR confirmed mild COVID-19 (WHO 8-point Ordinal Scale Score 1 or 2)Timepoint: Day-3to-1 Day8to9 Day11-12 Day15 Day30 or early termination visit | — |
Secondary
| Measure | Time frame |
|---|---|
| subjects with negative RT-PCR confirmed COVID-19 through day 30 Time to decline in viral load subjects with clinical worsening through day 30 Time from randomization to clinical worsening subjects getting hospitalized and/or died due to COVID-19 through day 30 subjects admitted to intensive care unit through day 30 subjects who require mechanical ventilation through day 30 subjects who require supplemental oxygen through day 30 Frequency of use of rescue medication through day 30 All-cause mortality within 30 days of randomization Time from randomization to clinical recovery COVID-19 antibody titer Proportion of subjects with appearance of COVID-19 related complications Subjectsââ?¬â?¢ assessment of treatment satisfaction Quality of life subjects with adverse drug reactions and adverse events subjects who discontinued study intervention due to AE Timepoint: Day-3to-1 Day0 Day1 Day3to4 Day5to6 Day8 to 9 Day11-12 Day15 Day30 or early termination visit | — |
Countries
India
Contacts
Public ContactDr Prasantha Dharmarajan
All India Institute of Ayurveda
Outcome results
None listed