Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
Conditions
Interventions
Intervention1: Ramatroban 75 mg tablet: 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
Sponsors
Charak Laboratories Pvt. Ltd
JSS Medical Research Asia Pacific Private Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1. Male or female subjects of age 18 years and above. 2. Subject (or legally authorized representative) willing to provide informed consent and agrees to comply with planned study procedures. 3. Subjects hospitalized for SARS-COV-2 infection, having hypoxemia (SpO2: on room air) and radiological evidence supporting COVID-19 pneumonia. 4. Subjects meeting 8-point WHO Ordinal Scale 5 or 6 5. 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: a. PCR positive in a sample collected OR b. PCR positive in sample collected >= 72 hours but 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 6. 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. 7. 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
Exclusion criteria: 1. 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 2. Subjects on invasive mechanical ventilation at screening or randomization. 3. Female subject who is pregnant, breastfeeding, or planning to become pregnant. 4. 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. 5. Subject with pre-existing clinically significant spontaneous bleeding abnormality, or any other condition as per investigatorâ??s judgment. 6. Known HIV/Hepatitis B or Hepatitis C infection. 7. Severe liver disease (ALT, AST >5 times the upper limit of normal, total bilirubin > 2 times the upper limit of normal). 8. Subject with known severe renal impairment (estimated glomerular filtration rate replacement therapy, hemodialysis, peritoneal dialysis. 9. Subject participated in any other clinical study using any investigational drug in the past 30 days before the screening visit. 10. 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Phase II 1. Rate of Serious Adverse Events (SAE) Phase III 1. Time to Clinical recovery (TTCR) Timepoint: Phase II 1. Baseline - Day 29 Phase III 1. Baseline - Day 15 | — |
Secondary
| Measure | Time frame |
|---|---|
| Phase II & III 1. Composite endpoint of death or need for mechanical ventilation or ECMO 2. Rate of mechanical ventilation or vasopressor therapy, or ECMO 3. Ventilator free days 4. Duration of hospitalization & ICU stay 5. Number of subjects who had thrombotic events 6. Mortality rate 7. Change in hemoglobin, platelets, WBC, creatinine, need for renal replacement. 8. Occurrence of serious ventricular arrhythmia 9. Total red blood cell units transfused 10.Major or Clinically Significant Non-Major Bleeding 11. Change from baseline of inflammation and coagulation markers Timepoint: 1. Baseline - Day 29 2. Day 29 3. Baseline-Day 29 4. Baseline-Day 29 5. Within Day 29 6. Till Day 29 7. Baseline- Day 29 8. censored at hospital discharge 9. Baseline -Day 29 10.Baseline -Day 29 11.Baseline- Day 29 | — |
Countries
India
Contacts
Public ContactDr Jayashri Krishnan
JSS Medical Research Asia Pacific Private Limited
Outcome results
None listed