COVID-19 trials registries data warehouse

http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=43775

Dr Kevinkumar Kansagra

kevinkumarkansagra@zyduscadila.com

2020-06-23

Not recruiting

RCT

Randomized

Parallel

Open label

multi-center

Treatment

1. Ability to comprehend and willingness to sign a written ICF for the study. <br/ >2. Male or non-pregnant females, â?¥18 years of age at the time of enrolment. <br/ >3. Understands and agrees to comply with planned study procedures. <br/ >4. Agrees to the collection of pharyngeal swabs and blood sample as per protocol. <br/ >5. Has laboratory-confirmed SARS-CoV-2 infection as determined by PCR, or other <br/ >commercial or public health assay in any specimen <br/ >6.Women of childbearing potential must agree to use at least one primary form of <br/ >contraception for the duration of the study (acceptable methods will be determined <br/ >by the site).

1. Pregnant or breast feeding. <br/ >2. Allergy to any study medication. <br/ >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. <br/ >4. Comorbid condition like myocardial infarction or heart failure within 90 days of recruitment.

2

Cadila Healthcare Limited Zydus Research Center

18

85

India

No restriction on type of patients

0: No restriction on type of patients

40

Evaluation of the clinical efficacy of Pegylated IFN-α2b on the basis of change in ordinal <br/ >scale.Timepoint: week 2 and week 4

| Declared number of arm (2.0) differs from found arms (3.0)

Phase 2

[{"arm_notes": "", "treatment_id": 966, "treatment_name": "Pegylated ifn-\u03b12b", "treatment_type": "Interferons", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2188, "treatment_name": "Standard of care", "treatment_type": "Standard of care", "pharmacological_treatment": "Standard of care"}]