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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
324
Route of Administration: Oral Dose: 75 mg; Frequency: Twice daily; Total duration of intervention: 28 days. Subjects will be evaluated over a study period of approximately 365 days.
Matching placebo will be administered orally twice a day
DEC Health Care
Nellore, Andhra Pradesh, India
RECRUITINGShakti Superspecialty Hospital
Ahmedabad, Gujarat, India
RECRUITINGLifecare Hospital
Mumbai, Maharashtra, India
RECRUITINGSangvi Multispecialty Hospital Pvt Ltd
Pune, Maharashtra, India
RECRUITINGSaikrupa Hospital
Pune, Maharashtra, India
RECRUITINGSpandan Hospital
Pune, Maharashtra, India
RECRUITINGPDEA'S Ayurved Rugnalaya & Sterling Multispeciality Hospital
Pune, Maharashtra, India
RECRUITINGRate of Serious Adverse Events (SAE)
Time frame: Baseline - Day 29
Time to Clinical recovery (TTCR)
Time frame: Baseline - Day 15
Composite endpoint of death or need for mechanical ventilation or ECMO
Time frame: Baseline - Day 29
Rate of mechanical ventilation or vasopressor therapy, or ECMO
Time frame: Day 29
Ventilator free days
Time frame: Baseline-Day 29
Duration of hospitalization
Time frame: Baseline-Day 29
Duration of ICU stay
Time frame: Baseline-Day 29
Number of subjects who had thrombotic events
Time frame: Within Day 29
Mortality rate
Time frame: Till Day 29
Change in hemoglobin, platelets, WBC, creatinine, need for renal replacement.
Time frame: Baseline- Day 29
Occurrence of serious ventricular arrhythmia
Time frame: censored at hospital discharge
Total red blood cell units transfused
Time frame: Baseline -Day 29
Major or Clinically Significant Non-Major Bleeding
Time frame: Baseline -Day 29
Change from baseline of inflammation and coagulation markers
Time frame: Baseline- Day 29
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