Phase II, randomized, controlled, open-label study of Pegylated IFN alfa-2b with SARS-CoV-2

Authors
Category Primary study
Registry of TrialsClinical Trials Registry - India
Year 2020
INTERVENTION: Intervention1: Pegylated alpha 2b and Standard of care: Administer Day 1 and Day 8 Route‐Subcutaneous Control Intervention1: NIL: NIL CONDITION: Health Condition 1: B972‐ Coronavirus as the cause of diseases classified elsewhere PRIMARY OUTCOME: Evaluation of the clinical efficacy of Pegylated IFN‐α2b on the basis of change in ordinal ; scale.Timepoint: week 2 and week 4 SECONDARY OUTCOME: 1) Qualitative and quantitative PCR for SARS‐CoV‐2 in pharyngeal swab. ; 2) Safety and tolerabilityTimepoint: screening ; day, day 7 and day 14 INCLUSION CRITERIA: 1. Ability to comprehend and willingness to sign a written ICF for the study. 2. Male or non‐pregnant females, â?Â¥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).
Epistemonikos ID: c431235940de7523e549ed02f7309ba835cd88ad
First added on: Jul 15, 2020