Phase II/Phase III study to evaluate the safety and efficacy of Ramatroban 75 mg tabletagainst 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 twotreatment groups.Group I: Ramatroban 75 mg tablet + Standard of care; Group II: Placebo + Standard ofcare.Phase 2Primary Objective:To evaluate the safety of Ramatroban 75 mg tablet with the standard of care againstPlacebo 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 againstPlacebo with the standard of care in COVID-19 hospitalized subjects.Phase 3Primary Objective:To evaluate the efficacy of Ramatroban 75 mg tablet with the standard of care againstPlacebo 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 againstPlacebo 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
Not Provided
Drug: 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.
Other Name: BAYu3405,IUPAC Name: 3-[(3R)-3-[(4-fluorophenyl)sulfonylamino]-1,2,3,4-tetrahydrocarbazol-9-yl]propanoic acid
Drug: Placebo
Matching placebo will be administered orally twice a day
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.
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
Jayashri Krishnan, PhD
9771407484
Jayashri.krishnan@jssresearch.com
Sonika Newar, PhD
8800799887
Sonika.newar@jssresearch.com