Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
Conditions
Interventions
Intervention1: Ambroxol 30 mg two tablets: Ambroxol 30 mg two tablets TDS for 14 days or till discharge whichever is earlier with Standard of care
Control Intervention1: Matching Placebo: Matching Pla
Sponsors
ICMR
Eligibility
Inclusion criteria
Inclusion criteria: Participants who are able to provide a written informed consent or have a legally accepted representative to provide the same. Participants who are between 18 years and 75 years of age. Participants who are proven to be positive for SARS-CoV-2 infection, as confirmed by the RT-PCR test. Participants who are admitted with moderate COVID-19 for treatment at the hospital. Female participants with a negative urine pregnancy test at screening. Participants who are able to take the study drug orally and comply with the study procedures.
Exclusion criteria
Exclusion criteria: Participants who are participating in any other clinical trial or experimental treatment for COVID-19. Participants with pre-existing respiratory illness. Participants with persistent vomiting (more than three episodes of vomiting in 12 hours) and who cannot tolerate oral drugs. Participants requiring concomitant use of invasive or non-invasive mechanical ventilation. Participants requiring vasopressors or ionotropic medications. Female Participants who are lactating. Participants who are known to be HIV positive or positive for Hepatitis B or C. (The same may be noted based on history given by the subject or standards of care followed at the individual sites.) Participants who are not deemed fit as per the investigator or his/her team for any other medical reason. Past history of allergy to Ambroxol.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of patients showing clinical improvement: Clinical improvement is defined as the patients meeting the discharge criteria or a 2-point improvement in the disease severity on the 8-point ordinal scale. Discharge criteria includes resolution of clinical symptoms, biochemical tests or radiological improvement, as per discretion of the Investigator.Timepoint: Timepoints: Baseline, day 1, day 3, day 5, day 7 and day 10 or at discharge, whichever is earlier. (In case the patient is admitted beyond day 10, the scale will be administered till day 10 as per the above-mentioned schedule and again at discharge.) | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival of the subjects: [Time Frame: 14 days]: 14-Day Overall Survival is defined as the status of the subject at the end of 14 days, beginning from the time of study in both the treatment groups. Proportion of patients with progression of COVID-19 associated pneumonitis Number of Intensive care unit (ICU) daysTimepoint: 14 days after study entry Up to 14 days after study entry Up to 14 days after study entry | — |
Countries
India
Contacts
Public ContactDr Nithya Gogtay
Seth GS Medical College & KEM Hospital, Parel, Mumbai-400012
Outcome results
None listed