Randomized, Double-Blind, Placebo-Controlled, Parallel-Design, Multi- Centre, Adaptive Phase 2/Phase 3 Study To Evaluate The Efficacy And Safety Of Ramatroban Along With The Standard Of Care In Subjects Hospitalized For SARS-CoV-2 Infection
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
• Male or female subjects of age 18 years and above.
• Subject (or legally authorized representative) willing to provide informed consent and agrees to comply with planned study procedures.
• Subjects hospitalized for SARS-COV-2 infection, having hypoxemia (SpO2: ≤ 93% on room air) and radiological evidence supporting COVID-19 pneumonia.
• Subjects meeting 8-point WHO Ordinal Scale 5 or 6
• Has laboratory-confirmed SARS-CoV-2 infection as determined by PCR or other commercial or public health assay in any specimen, as documented by either of the following:
‣ PCR positive in a sample collected \< 72 hours prior to randomization; OR
⁃ PCR positive in sample collected ≥ 72 hours but \< 10 days prior to randomization AND non-improving or progressive disease suggestive of ongoing SARS-CoV-2 infection.
• i. Note: In case if the subject is not having previous reports, a quantitative analysis will be performed
• Women of childbearing potential must agree to either abstinence or use at least one primary form of contraception not including hormonal contraception from the time of screening through Day 36.
• Agrees to not participate in another clinical trial (both pharmacologic and other types of interventions) for the treatment of COVID-19 through-out the study period