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
Study Details
Study Description
Brief 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)]
-
To examine lipid mediators, specifically thromboxane A2, prostaglandin D2, F2-isoprostane and/or their metabolites in convalescent subjects after treatment.
-
To assess the efficacy of Ramatroban administered during the acute illness in preventing/mitigating subsequent development of long COVID / PASC
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2/Phase 3 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Ramatroban 75 mg tablet
|
Drug: Ramatroban
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.
Other Names:
|
| Placebo Comparator: Placebo
|
Drug: Placebo
Matching placebo will be administered orally twice a day
|
Outcome Measures
Primary Outcome Measures
- Rate of Serious Adverse Events (SAE) [Baseline - Day 29]
- Time to Clinical recovery (TTCR) [Baseline - Day 15]
Secondary Outcome Measures
- Composite endpoint of death or need for mechanical ventilation or ECMO [Baseline - Day 29]
- Rate of mechanical ventilation or vasopressor therapy, or ECMO [Day 29]
- Ventilator free days [Baseline-Day 29]
- Duration of hospitalization [Baseline-Day 29]
- Duration of ICU stay [Baseline-Day 29]
- Number of subjects who had thrombotic events [Within Day 29]
- Mortality rate [Till Day 29]
- Change in hemoglobin, platelets, WBC, creatinine, need for renal replacement. [Baseline- Day 29]
- Occurrence of serious ventricular arrhythmia [censored at hospital discharge]
- Total red blood cell units transfused [Baseline -Day 29]
- Major or Clinically Significant Non-Major Bleeding [Baseline -Day 29]
- Change from baseline of inflammation and coagulation markers [Baseline- Day 29]
Eligibility Criteria
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.
- 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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | DEC Health Care | Nellore | Andhra Pradesh | India | 524001 |
| 2 | Shakti Superspecialty Hospital | Ahmedabad | Gujarat | India | 382405 |
| 3 | Lifecare Hospital | Mumbai | Maharashtra | India | 400028, |
| 4 | Sangvi Multispecialty Hospital Pvt Ltd | Pune | Maharashtra | India | 411027 |
| 5 | Saikrupa Hospital | Pune | Maharashtra | India | 411033 |
| 6 | Spandan Hospital | Pune | Maharashtra | India | 411033 |
| 7 | PDEA'S Ayurved Rugnalaya & Sterling Multispeciality Hospital | Pune | Maharashtra | India | 411044 |
Sponsors and Collaborators
- KARE Biosciences
- JSS Medical Research Inc.
- Biomedical Advanced Research and Development Authority
- Open Philanthropy
- Charak Laboratories India Pvt. Ltd
- Charak Foundation
- BioLink Life Sciences, Inc.
Investigators
- Principal Investigator: Ajay Gupta, MD, KARE Biosciences
- Study Director: Martin Ogletree, PhD, Points & Assists, LLC.
- Study Director: Deanna J Nelson, PhD, BioLink Life Sciences, Inc.
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- RAMBAN-1