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
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
1 other identifier
interventional
324
1 country
7
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Nov 2022
Typical duration for phase_2
7 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 10, 2022
CompletedFirst Submitted
Initial submission to the registry
January 23, 2023
CompletedFirst Posted
Study publicly available on registry
January 31, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
May 31, 2026
ExpectedJanuary 31, 2023
January 1, 2023
1.6 years
January 23, 2023
January 28, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Rate of Serious Adverse Events (SAE)
Baseline - Day 29
Time to Clinical recovery (TTCR)
Baseline - Day 15
Secondary Outcomes (12)
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
- +7 more secondary outcomes
Study Arms (2)
Ramatroban 75 mg tablet
EXPERIMENTALPlacebo
PLACEBO COMPARATORInterventions
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.
Eligibility Criteria
You may qualify if:
- 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.
- i. 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- KARE Bioscienceslead
- JSS Medical Research Inc.collaborator
- Biomedical Advanced Research and Development Authoritycollaborator
- Open Philanthropycollaborator
- Charak Laboratories India Pvt. Ltdcollaborator
- Charak Foundationcollaborator
- BioLink Life Sciences, Inc.collaborator
Study Sites (7)
DEC Health Care
Nellore, Andhra Pradesh, 524001, India
Shakti Superspecialty Hospital
Ahmedabad, Gujarat, 382405, India
Lifecare Hospital
Mumbai, Maharashtra, 400028,, India
Sangvi Multispecialty Hospital Pvt Ltd
Pune, Maharashtra, 411027, India
Saikrupa Hospital
Pune, Maharashtra, 411033, India
Spandan Hospital
Pune, Maharashtra, 411033, India
PDEA'S Ayurved Rugnalaya & Sterling Multispeciality Hospital
Pune, Maharashtra, 411044, India
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- 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.
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Masking Details
- Participant, Investigator and Outcome Assessor Blinded Method of concealment: Pharmacy-controlled Randomization
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 23, 2023
First Posted
January 31, 2023
Study Start
November 10, 2022
Primary Completion
July 1, 2024
Study Completion (Estimated)
May 31, 2026
Last Updated
January 31, 2023
Record last verified: 2023-01