Table 1.
S. No. | Procedure | D-1 | D-3 | D-4 to Discharge | Discharge | Days-7, 28, and 42 follow up |
---|---|---|---|---|---|---|
1 | Signed Informed a Consent Form | X | ||||
2 | Medical History | X | ||||
3 | Clinical Examination | X | X | X | X | |
4 | Review of eligibility criteriaa | X | ||||
5 | Vital signsb | X | ||||
6 | Randomization | X | ||||
7 | Study medication administrationc | X | ||||
8 | rRTPCR COVID-19 testd | X | X | |||
9 | AE/SAE recordinge | X | X | X | X | X |
10 | Comorbid conditions | X | ||||
11 | Concomitant medications | X | ||||
12 | Safety follow-upf | X |
X indicates procedure required on that visit day.
Abbreviations: AE=Adverse Event, SAE=Serious Adverse Event, rRTPCR=real time reverse transcription polymerase chain reaction.
3Demographic characteristics captured included age, gender, and date of admission. Other clinical features capture include fever, cough, cold, breathlessness, body ache, diarrhea, tastelessness, loss of smell, concomitant diseases (diabetes, hypertension, ischemic heart disease, and renal disease), rRT-PCR values, and outcomes (discharge/death).
Eligibility criteria were evaluated on Day-1 after informed consent procedure. For the study purpose first day is defined as randomization visit day, on which rRTPCR test was carried out.
Vital signs included blood pressure, pulse rate, and oxygen saturation.
Ayurcov medication was a single day regimen, with 10 ml dose constituted medicine, three times a day.
Specimen samples included swabs from the nose/throat/both nose and throat/nasopharyngeal sites. Specimens collected were kept in 2–8 °C ice bags and immediately transported to the laboratory. Nucleic acid extraction of SARS-CoV-2 was manually carried out in a biosafety cabinet or by automatic nucleic acid extraction system.
Adverse events (AE) were defined as emergence of any new symptom/s or worsening of pre-existing symptoms and were followed until complete resolution of symptoms.
Post discharge follow-up was done at day 7, 28, and 42 using validated functional assessment scale.