Phase II, randomized, controlled, open-label study ofPegylated IFN alfa-2b with SARS-CoV-2
- Conditions
- Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
- Registration Number
- CTRI/2020/06/026087
- Lead Sponsor
- Cadila Healthcare Limited Zydus Research Center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 40
1. Ability to comprehend and willingness to sign a written ICF for the study.
2. Male or non-pregnant females, >=18 years of age at the time of enrolment.
3. Understands and agrees to comply with planned study procedures.
4. Agrees to the collection of pharyngeal swabs and blood sample as per protocol.
5. Has laboratory-confirmed SARS-CoV-2 infection as determined by PCR, or other
commercial or public health assay in any specimen
6.Women of childbearing potential must agree to use at least one primary form of
contraception for the duration of the study (acceptable methods will be determined
by the site).
1. Pregnant or breast feeding.
2. Allergy to any study medication.
3. Severe co-morbidity (e.g. uncontrolled hypertension and uncontrolled DM, systemic disease which affect the vital organs severity, immunocompromised patients etc.) as per investigatorâ??s assessment.
4. Comorbid condition like myocardial infarction or heart failure within 90 days of recruitment.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Evaluation of the clinical efficacy of Pegylated IFN-α2b on the basis of change in ordinal <br/ ><br>scale.Timepoint: week 2 and week 4
- Secondary Outcome Measures
Name Time Method 1) Qualitative and quantitative PCR for SARS-CoV-2 in pharyngeal swab. <br/ ><br>2) Safety and tolerabilityTimepoint: screening <br/ ><br>day, day 7 and day 14