Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
Conditions
Interventions
Intervention1: Pegylated alpha 2b and Standard of care: Administer Day 1 and Day 8
Route-Subcutaneous
Control Intervention1: NIL: NIL
Sponsors
Cadila Healthcare Limited Zydus Research Center
Eligibility
Inclusion 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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Evaluation of the clinical efficacy of Pegylated IFN-α2b on the basis of change in ordinal scale.Timepoint: week 2 and week 4 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) Qualitative and quantitative PCR for SARS-CoV-2 in pharyngeal swab. 2) Safety and tolerabilityTimepoint: screening day, day 7 and day 14 | — |
Countries
India
Contacts
Public ContactDr Kevinkumar Kansagra
Cadila Healthcare Limited
Outcome results
None listed