Prospective , single center ,open label, randomized controlled , pilot study on evaluation of use of , “AYURCOV†as an adjuvant for treatment purpose in treatment of SARS-CoV-2 infection for covid-19 patients , at tertiary care center.

Prospective, single center ,open label, randomized controlled  , pilot study on evaluation of use of ,“AYURCOV†as an adjuvant  for treatmentpurpose in treatment of SARS-CoV-2 infection for covid-19 patients  , at tertiary care center.

Study procedures shall be initiated post obtaining written informed consent process, as per local regulatory requirements. Randomization of the groups would be done as per computer generated charts , details of the randomization are as per below mentioned chart.  Randomization chart is enclosed along with the protocol for reference .

Study Participants Distribution ( By Randomization technique )

|Group

Group Criteria Definition

Standard of care and Ayurcov

Only Standard of care

|1

COVID -19 Positive patients (Mild and Moderate Cases)

45

45

|2

COVID -19 Positive patients (Severe Cases )

15

15

|

 1. Mild to Moderate Covid-19 Patients:  Non-pneumonia and mild pneumonia

2. Severe  Covid-19 Patients : Dyspnea, respiratory frequency ≥ 30/min, blood oxygen saturation (SpO2) ≤ 93%, PaO2/FiO2 ratio < 300, and/or lung infiltrates > 50% within 24 to 48 hours .

Duration of the study participation is 1 month. As mentioned in the chart above there are four groups in the study .  Every group is further divided in 2 subgroups of which one group will get standard of care and Ayurcov and another group will get only standard of care.

 Study doctor will participants medical records to study, effect of study drug on participant  disease . Study doctor  will examine study participants  during your hospital stay to observe for any side effects .  Study doctor will follow up telephonically 1 week post discharge to enquire study participants about their health status .