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

Launched by KARE BIOSCIENCES · Jan 28, 2023

Keywords

ClinConnect Summary

This clinical trial is investigating a medication called Ramatroban to see if it is safe and effective for patients hospitalized with pneumonia caused by COVID-19. About 324 participants will be divided into two groups: one will receive Ramatroban along with standard care, while the other will receive a placebo (a pill with no active medication) along with standard care. The main goals of the study are to determine how safe Ramatroban is and whether it helps improve health outcomes for patients suffering from this serious respiratory infection.

To be eligible for the trial, participants must be at least 18 years old, hospitalized due to a confirmed COVID-19 infection, and have low oxygen levels. They should also be willing to follow the study procedures and provide consent. However, people with life-threatening COVID-19 complications, those on invasive mechanical ventilation, or women who are pregnant or breastfeeding cannot join. Participants can expect to undergo regular monitoring throughout the study and may contribute to important research on how to better treat COVID-19 pneumonia and potentially prevent long-term effects of the illness.

Gender

ALL

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.