Evaluating Ramatroban for COVID Pneumonia Treatment

Randomized, Double-Blind, Placebo-Controlled, Parallel-Design, Multi- Centre, Adaptive Phase 2/Phase 3 Study To Evaluate The Efficacy And Safety Of Ramatroban Along With The Standard Of Care In Subjects Hospitalized For SARS-CoV-2 Infection

This study is testing if adding Ramatroban to standard care can help people with COVID pneumonia feel better while they're in the hospital.

Quick facts

• Phase: PHASE2; PHASE3
• Study type: Interventional
• Enrollment: 324 (estimated)
• Ages: 18 Years to 99 Years
• Sex: All
• Sponsor: KARE Biosciences (industry)
• Locations: 7 sites (Nellore, Andhra Pradesh and 6 other locations)
• Trial ID: NCT05706454 on ClinicalTrials.gov

What this trial studies

This study evaluates the safety and efficacy of Ramatroban, a medication administered in conjunction with standard care, for patients hospitalized with pneumonia due to COVID-19. Approximately 324 participants will be randomly assigned to receive either Ramatroban or a placebo, allowing researchers to compare outcomes between the two groups. The study consists of two phases: Phase 2 focuses on safety, while Phase 3 assesses efficacy. Participants must have confirmed COVID-19 pneumonia and meet specific clinical criteria.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older who are hospitalized with hypoxemia due to confirmed COVID-19 pneumonia.

Not a fit: Patients with mild COVID-19 symptoms or those not requiring hospitalization may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could improve recovery outcomes for patients hospitalized with COVID-19 pneumonia.

How similar studies have performed: Other studies have explored treatments for COVID-19 pneumonia, but the specific use of Ramatroban in this context is novel.

Eligibility 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: ≤ 93% 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:

   1. PCR positive in a sample collected \< 72 hours prior to randomization; OR
   2. 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
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:

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 investigator'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 ≤30 mL/min/1.73 m2) or receiving continuous renal 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.

Where this trial is running

Nellore, Andhra Pradesh and 6 other locations

• DEC Health Care — Nellore, Andhra Pradesh, India (RECRUITING)
• Shakti Superspecialty Hospital — Ahmedabad, Gujarat, India (RECRUITING)
• Lifecare Hospital — Mumbai, Maharashtra, India (RECRUITING)
• Sangvi Multispecialty Hospital Pvt Ltd — Pune, Maharashtra, India (RECRUITING)
• Saikrupa Hospital — Pune, Maharashtra, India (RECRUITING)
• Spandan Hospital — Pune, Maharashtra, India (RECRUITING)
• PDEA'S Ayurved Rugnalaya & Sterling Multispeciality Hospital — Pune, Maharashtra, India (RECRUITING)

Study contacts

• Principal investigator: Ajay Gupta, MD — KARE Biosciences
• Study coordinator: Jayashri Krishnan, PhD

Conditions: COVID-19 Pneumonia, COVID-19 Respiratory Infection, COVID-19, Ramatroban, Post-Acute Sequelae SARS-CoV-2 infection, Thromboxane, Prostaglandin D2, F2-Isoprostane