Phase III, Randomized, Controlled, Open-Label Study ofPegylated Interferon Alfa-2b With SARS-CoV-2
- Conditions
- Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
- Registration Number
- CTRI/2020/12/029855
- Lead Sponsor
- Zydus Research Center Cadila Healthcare Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Closed to Recruitment of Participants
- Sex
- Not specified
- Target Recruitment
- 0
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 RT-PCR within 5 days of
enrollment.
6. Patients with pneumonia with no signs of severe disease, respiratory rate >=24breaths/minute,
SpO2 90%- 94%.
7. Illness of any duration, and at least one of the following:
a. Radiographic infiltrates by imaging (chest x-ray/CT scan)
b. Clinical assessment (evidence of rales/crackles or other clinical symptoms related to COVID-19 on examination).
8. Women of childbearing potential must agree to use at least one primary form of contraception
for the entire duration of the study (acceptable methods will be determined by the site).
1. ALT/AST >5 times the upper limit of normal.
2. Stage 4 severe chronic kidney disease or requiring dialysis (i.e. eGFR <30).
3. Pregnant or breast feeding.
4. Allergy to any study medication.
5. 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.
6. Comorbid condition like myocardial infarction or heart failure within 90 days of recruitment.
7. Prolong QT interval ( >450 ms).
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Evaluation of the clinical efficacy of Pegylated interferon alfa-2b on the basis of change in ordinal <br/ ><br>scale at Day 11 ± 1.Timepoint: baseline to Day 11
- Secondary Outcome Measures
Name Time Method