A Clinical Study to Evaluate the Efficacy and Safety of Ramatroban along with the standard of care in Hospitalized Subjects with SARS-CoV-2 Infection.
- Conditions
- Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
- Registration Number
- CTRI/2022/11/047189
- Lead Sponsor
- Charak Laboratories Pvt. Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
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:
a.PCR positive in a sample collected < 72 hours prior to randomization;
OR
b.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
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Phase II <br/ ><br>1. Rate of Serious Adverse Events (SAE) <br/ ><br> <br/ ><br>Phase III <br/ ><br>1. Time to Clinical recovery (TTCR) <br/ ><br>Timepoint: Phase II <br/ ><br>1. Baseline - Day 29 <br/ ><br>Phase III <br/ ><br>1. Baseline - Day 15
- Secondary Outcome Measures
Name Time Method
Related Research Topics
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