Phase 2/Phase 3 Study To Evaluate The Efficacy And Safety Of Ramatroban Along With The Standard Of Care In Subjects Hospitalized For COVID Pneumonia

• Status: Recruiting
• Trial end date: 2026-05-31

Summary

Phase II/Phase III study to evaluate the safety and efficacy of Ramatroban 75 mg tablet against Placebo in subjects hospitalized for pneumonia due to SARS-CoV-2 infection.

Approximately 324 eligible subjects will be randomized in a 1:1 ratio to one of the two treatment groups.

Group I: Ramatroban 75 mg tablet + Standard of care; Group II: Placebo + Standard of care.

Phase 2

Primary Objective:

To evaluate the safety of Ramatroban 75 mg tablet with the standard of care against Placebo with the standard of care in COVID-19 hospitalized subjects.

Secondary Objective:

To assess the efficacy of Ramatroban 75 mg tablet with the standard of care against Placebo with the standard of care in COVID-19 hospitalized subjects.

Phase 3

Primary Objective:

To evaluate the efficacy of Ramatroban 75 mg tablet with the standard of care against Placebo with the standard of care in COVID-19 hospitalized subjects.

Secondary Objective:

To evaluate the safety of Ramatroban 75 mg tablet with the standard of care against Placebo with the standard of care in COVID-19 hospitalized subjects.

Long COVID [Follow-up Phase- Objectives- (Phase 2 & 3)]

1. To examine lipid mediators, specifically thromboxane A2, prostaglandin D2, F2-isoprostane and/or their metabolites in convalescent subjects after treatment.

2. To assess the efficacy of Ramatroban administered during the acute illness in preventing/mitigating subsequent development of long COVID / PASC

• Phase: Phase 2/Phase 3

Details

• Lead Sponsor: KARE Biosciences
• Collaborators: BioLink Life Sciences, Inc.; Biomedical Advanced Research and Development Authority; Charak Foundation; Charak Laboratories India Pvt. Ltd; JSS Medical Research Inc.; Open Philanthropy
• Treatments: Ramatroban