Actively Recruiting
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
Led by KARE Biosciences · Updated on 2023-01-31
324
Participants Needed
7
Research Sites
185 weeks
Total Duration
On this page
Sponsors
K
KARE Biosciences
Lead Sponsor
J
JSS Medical Research Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
CONDITIONS
Official Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female subjects aged 18 years and older
- Subject or legally authorized representative willing to provide informed consent and comply with study procedures
- Hospitalized for SARS-CoV-2 infection with hypoxemia (SpO2 ≤ 93% on room air) and radiological evidence of COVID-19 pneumonia
- Meet 8-point WHO Ordinal Scale 5 or 6
- Laboratory-confirmed SARS-CoV-2 infection by PCR within 72 hours before randomization, or PCR positive within 10 days with worsening disease
- Women of childbearing potential agree to abstinence or use at least one primary non-hormonal contraception method from screening through Day 36
- Agree not to participate in another COVID-19 clinical trial during the study period
You will not qualify if you...
- Immediately life-threatening SARS-CoV-2 infection (respiratory failure, septic shock, or multiple organ failure)
- On invasive mechanical ventilation at screening or randomization
- Pregnant, breastfeeding, or planning pregnancy
- Clinically significant gastrointestinal disease or surgery interfering with drug absorption or inability to swallow oral medication
- Pre-existing significant spontaneous bleeding disorder or other investigator-judged conditions
- Known HIV, Hepatitis B, or Hepatitis C infection
- Severe liver disease (ALT or AST >5 times upper limit, bilirubin >2 times upper limit)
- Severe renal impairment (eGFR ≤30 mL/min/1.73 m2) or dialysis
- Participation in any other investigational drug study within 30 days before screening
- History of life-threatening cancers within 5 years, except for carcinoma in situ of cervix or basal cell skin carcinoma
AI-Screening
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Trial Site Locations
Total: 7 locations
1
DEC Health Care
Nellore, Andhra Pradesh, India, 524001
Actively Recruiting
2
Shakti Superspecialty Hospital
Ahmedabad, Gujarat, India, 382405
Actively Recruiting
3
Lifecare Hospital
Mumbai, Maharashtra, India, 400028,
Actively Recruiting
4
Sangvi Multispecialty Hospital Pvt Ltd
Pune, Maharashtra, India, 411027
Actively Recruiting
5
Saikrupa Hospital
Pune, Maharashtra, India, 411033
Actively Recruiting
6
Spandan Hospital
Pune, Maharashtra, India, 411033
Actively Recruiting
7
PDEA'S Ayurved Rugnalaya & Sterling Multispeciality Hospital
Pune, Maharashtra, India, 411044
Actively Recruiting
Research Team
J
Jayashri Krishnan, PhD
CONTACT
S
Sonika Newar, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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