se of Ambroxol in patients with moderate COVID-19 disease.

Not Applicable

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

Registration Number: CTRI/2021/10/037502

Lead Sponsor: ICMR

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Yet Recruiting

Sex: Not specified

Target Recruitment: 0

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

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.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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. <br/ ><br>(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.) <br/ ><br>

Secondary Outcome Measures

Name	Time	Method
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. <br/ ><br> <br/ ><br> <br/ ><br> <br/ ><br>Proportion of patients with progression of COVID-19 associated pneumonitis <br/ ><br> <br/ ><br> <br/ ><br> <br/ ><br>Number of Intensive care unit (ICU) daysTimepoint: 14 days after study entry <br/ ><br> <br/ ><br> <br/ ><br> <br/ ><br> <br/ ><br> <br/ ><br> <br/ ><br> <br/ ><br>Up to 14 days after study entry <br/ ><br> <br/ ><br> <br/ ><br> <br/ ><br> <br/ ><br>Up to 14 days after study entry <br/ ><br> <br/ ><br> <br/ ><br> <br/ ><br> <br/ ><br> <br/ ><br> <br/ ><br> <br/ ><br> <br/ ><br> <br/ ><br>