A clinical study to evaluate efficacy and safety of Camphora tablets in Covid positive patients

Phase 2

Conditions: Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere

Recruitment & Eligibility

Inclusion Criteria

1.Patients who are able to provide a written informed consent or have a legally accepted representative to provide the same.

2.Patients who are proven to be positive for SARS-CoV-2 infection, as confirmed by the RT-PCR test 48 hours prior to the entry into the study.

3.Patients who are admitted with mild / moderate/ severe COVID-19 (as per MOFHW criteria) for treatment at the hospital

4.Female patients with a negative urine pregnancy test at screening.

5.Patients who are able to take the study drug orally and comply with the study procedures

Exclusion Criteria

1.Patients who are participating in any other clinical trial or experimental treatment for COVID-19.

2.Patients requiring concomitant use of invasive mechanical ventilation.

3.Patients requiring vasopressors or ionotropic medications.

4.Patients requiring anti-viral drugs like ritonavir, lopinavir, remdesivir or monoclonal antibodies like tocilizumab at hospitalization

5.Female Patients who are pregnant or lactating.

6.Patients who are known to be HIV positive or positive for Hepatitis B or C.

7.Patients with liver enzymes (namely alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST)) > 5x upper limit of normal.

8.Patients who are not deemed fit as per the investigator for any other medical reason

Primary Outcome Measures

Name	Time	Method
This will include determination of the proportion of subjects showing clinical improvement in both the treatment groupsTimepoint: Day 0, Day 7, Day 14 or Discharge

Secondary Outcome Measures

Name	Time	Method
The determination of change in the clinical improvement scale, resolution of fever by Tmax response, overall survival of the subjects, survival to hospital discharge, progression of COVID-19 associated pneumonitis, number of ICU days, duration of increased supplemental oxygen requirement, change in oxygen requirement, change in cytokine levels and other biomarkers (CRP, CPK, S. Ferritin, LDH, D-dimer levels) and safety and tolerability of Camphora tablets from baseline to end of treatmentTimepoint: Day 0, Day 7, Day 14, Discharge