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
NCT ID: NCT05706454
Last Updated: 2023-01-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2/PHASE3
324 participants
INTERVENTIONAL
2022-11-10
2026-05-31
Brief Summary
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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
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Ramatroban 75 mg tablet
Ramatroban
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.
Placebo
Placebo
Matching placebo will be administered orally twice a day
Interventions
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Ramatroban
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.
Placebo
Matching placebo will be administered orally twice a day
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
-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.
18 Years
99 Years
ALL
No
Sponsors
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JSS Medical Research Inc.
INDUSTRY
Biomedical Advanced Research and Development Authority
FED
Open Philanthropy
OTHER
Charak Laboratories India Pvt. Ltd
UNKNOWN
Charak Foundation
UNKNOWN
BioLink Life Sciences, Inc.
INDUSTRY
KARE Biosciences
INDUSTRY
Responsible Party
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Principal Investigators
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Ajay Gupta, MD
Role: PRINCIPAL_INVESTIGATOR
KARE Biosciences
Martin Ogletree, PhD
Role: STUDY_DIRECTOR
Points & Assists, LLC.
Deanna J Nelson, PhD
Role: STUDY_DIRECTOR
BioLink Life Sciences, Inc.
Locations
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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
Countries
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Central Contacts
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Facility Contacts
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Manoj Kumar
Role: primary
Devendra D Gadhadra
Role: primary
Sandeep Gaidhani
Role: primary
Ketan Kshirsagar
Role: primary
Rahul Sonwane
Role: primary
Prakash Shende
Role: primary
Shailesh R Adwani
Role: primary
Other Identifiers
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RAMBAN-1
Identifier Type: -
Identifier Source: org_study_id