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
- Conditions
- COVID-19 PneumoniaCOVID-19 Respiratory Infection
- Interventions
- Drug: Placebo
- Registration Number
- NCT05706454
- Lead Sponsor
- KARE Biosciences
- 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 \[Follow-up Phase- Objectives- (Phase 2 \& 3)\]
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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 324
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Male or female subjects of age 18 years and above.
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Subject (or legally authorized representative) willing to provide informed consent and agrees to comply with planned study procedures.
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Subjects hospitalized for SARS-COV-2 infection, having hypoxemia (SpO2: ≤ 93% on room air) and radiological evidence supporting COVID-19 pneumonia.
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Subjects meeting 8-point WHO Ordinal Scale 5 or 6
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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
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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.
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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
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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
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Subjects on invasive mechanical ventilation at screening or randomization.
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Female subject who is pregnant, breastfeeding, or planning to become pregnant.
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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.
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Subject with pre-existing clinically significant spontaneous bleeding abnormality, or any other condition as per investigator's judgment.
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Known HIV/Hepatitis B or Hepatitis C infection.
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Severe liver disease (ALT, AST >5 times the upper limit of normal, total bilirubin > 2 times the upper limit of normal).
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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.
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Subject participated in any other clinical study using any investigational drug in the past 30 days before the screening visit.
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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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo - Ramatroban 75 mg tablet Ramatroban -
- Primary Outcome Measures
Name Time Method Time to Clinical recovery (TTCR) Baseline - Day 15 Rate of Serious Adverse Events (SAE) Baseline - Day 29
- Secondary Outcome Measures
Name Time Method Change from baseline of inflammation and coagulation markers Baseline- Day 29 Rate of mechanical ventilation or vasopressor therapy, or ECMO Day 29 Duration of ICU stay Baseline-Day 29 Composite endpoint of death or need for mechanical ventilation or ECMO Baseline - Day 29 Ventilator free days Baseline-Day 29 Mortality rate Till Day 29 Occurrence of serious ventricular arrhythmia censored at hospital discharge Major or Clinically Significant Non-Major Bleeding Baseline -Day 29 Duration of hospitalization Baseline-Day 29 Number of subjects who had thrombotic events Within Day 29 Change in hemoglobin, platelets, WBC, creatinine, need for renal replacement. Baseline- Day 29 Total red blood cell units transfused Baseline -Day 29
Trial Locations
- Locations (7)
DEC Health Care
🇮🇳Nellore, Andhra Pradesh, India
Shakti Superspecialty Hospital
🇮🇳Ahmedabad, Gujarat, India
Lifecare Hospital
🇮🇳Mumbai, Maharashtra, India
Sangvi Multispecialty Hospital Pvt Ltd
🇮🇳Pune, Maharashtra, India
Saikrupa Hospital
🇮🇳Pune, Maharashtra, India
Spandan Hospital
🇮🇳Pune, Maharashtra, India
PDEA'S Ayurved Rugnalaya & Sterling Multispeciality Hospital
🇮🇳Pune, Maharashtra, India
DEC Health Care🇮🇳Nellore, Andhra Pradesh, IndiaManoj KumarContact9700487720manojkumarmddec@gmail.com