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
COVID-19 Pneumonia, COVID-19 Respiratory Infection
About this trial
This is an interventional treatment trial for COVID-19 Pneumonia focused on measuring COVID-19, Ramatroban, Post-Acute Sequelae SARS-CoV-2 infection (PASC), Thromboxane, Prostaglandin D2, F2-Isoprostane
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: Subject with immediately life-threatening SARS-CoV-2 infection. -Life-threatening disease is defined as respiratory failure, septic shock, and/or multiple organ dysfunction or failure Subjects on invasive mechanical ventilation at screening or randomization. Female subject who is pregnant, breastfeeding, or planning to become pregnant. Subject having other clinically significant gastrointestinal (GI) disease/ GI surgery that in the opinion of the investigator would interfere with the absorption of Ramatroban or subject is unable to swallow oral medications. Subject with pre-existing clinically significant spontaneous bleeding abnormality, or any other condition as per investigator's judgment. Known HIV/Hepatitis B or Hepatitis C infection. Severe liver disease (ALT, AST >5 times the upper limit of normal, total bilirubin > 2 times the upper limit of normal). Subject with known severe renal impairment (estimated glomerular filtration rate ≤30 mL/min/1.73 m2) or receiving continuous renal replacement therapy, hemodialysis, peritoneal dialysis. Subject participated in any other clinical study using any investigational drug in the past 30 days before the screening visit. Subject with a history of life-threatening neoplasms within 5 years prior to the screening visit, other than carcinoma in situ of the cervix or basal cell carcinoma of the skin.
Sites / Locations
- DEC Health CareRecruiting
- Shakti Superspecialty HospitalRecruiting
- Lifecare HospitalRecruiting
- Sangvi Multispecialty Hospital Pvt LtdRecruiting
- Saikrupa HospitalRecruiting
- Spandan HospitalRecruiting
- PDEA'S Ayurved Rugnalaya & Sterling Multispeciality HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
Ramatroban 75 mg tablet
Placebo