CTRI/2020/06/026087
Completed
Phase 2
A phase II, randomized, controlled, open-label study toevaluate the efficacy and safety of Pegylated IFN alfa-2b inthe treatment of adult patients diagnosed with SARS-CoV2(COVID-19).
Cadila Healthcare Limited Zydus Research Center0 sites40 target enrollmentTBD
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
- Sponsor
- Cadila Healthcare Limited Zydus Research Center
- Enrollment
- 40
- Status
- Completed
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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).
Exclusion Criteria
- •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.
Outcomes
Primary Outcomes
Not specified
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