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

• Register: CTRI
• Last refreshed on: 24 November 2021
• Main ID: CTRI/2020/06/026087
• Date of registration: 23-06-2020
• Prospective Registration: Yes
• Primary sponsor: Cadila Healthcare Limited Zydus Research Center
• Public title: Phase II, randomized, controlled, open-label study of Pegylated IFN alfa-2b with SARS-CoV-2
• Scientific title: A phase II, randomized, controlled, open-label study to evaluate the efficacy and safety of Pegylated IFN alfa-2b in the treatment of adult patients diagnosed with SARS-CoV2 (COVID-19).
• Date of first enrolment: 08-07-2020
• Target sample size: 40
• Recruitment status: Completed
• URL: http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=43775
• Study type: Interventional
• Study design: Other; Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:An Open list of random numbers Blinding and masking:Open Label
• Phase: Phase 2

Countries of recruitment

India

Contacts

• Name: Dr Kevinkumar Kansagra
• Affiliation: Cadila Healthcare Limited

• Name: Dr Kevinkumar Kansagra
• Affiliation: Cadila Healthcare Limited

Key inclusion & exclusion 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.

Age minimum:
Age maximum:
Gender:

Health Condition(s) or Problem(s) studied

Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere

Intervention(s)

Intervention1: Pegylated alpha 2b and Standard of care: Administer Day 1 and Day 8
Route-Subcutaneous

Control Intervention1: NIL: NIL

Primary Outcome(s)

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(s)

1) Qualitative and quantitative PCR for SARS-CoV-2 in pharyngeal swab.

2) Safety and tolerabilityTimepoint: screening

day, day 7 and day 14

Secondary ID(s)

PEGI.20.002,Version 3.12May2020

Source(s) of Monetary Support

Cadila Healthcare Limited, Zydus Research Center, Survey No. 396/403, Sarkhej-Bavla National Highway No.8A Moraiya, Ahmedabad - 382213

Ethics review

Status: Approved
Approval date: 15/06/2020
Contact:

IEC, AIIMS, Room No 102, 1st Floor Old OT Block, Ansari Nagar, New Delhi - 110029

Status: Approved
Approval date: 29/06/2020
Contact:

Vrajesh Hospital Institutional Review Board Shree Vrajesh Surgical Hospital Opposite Rajpath Club Cargo Motors lane, S.G. road, 117 Bodakdev Ahmedabad Gujarat - 380015 India

Status: Approved
Approval date: 10/07/2020
Contact:

Rhythm Heart Institute Ethics Committee Rhythm Heart Institute Near Siddharth Bunglows Sama- Savli Road Vadodara Gujarat â?? 390022 India

Status: Approved
Approval date: 14/07/2020
Contact:

Sanjivani Hospital Ethics Committee Sanjivani Super Speciality Hospital Pvt.Ltd. 1,Uday Park Society, Near Sunrise Park Vastrapur Vastrapur Ahmedabad Gujarat - 380015 India

Status: Approved
Approval date: 18/07/2020
Contact:

BAPSPramukhSwamiHospital InstitutionalEthicsCommittee BAPSPramukhSwamiHospital ShriPramukhSwamiMaharajMarg AdajanCharRoad AdajanSurat395009GujaratIndia

Status: Approved
Approval date: 29/07/2020
Contact:

Ethics Committee Of BMCRI Bangalore Medical College And Research Institute Fort K R Road Bengaluru Urban Karnataka 560002 India

Results

• Date Completed: 04/09/2020