COVID-19 trials registries data warehouse

http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=49858

Dr Balaji More

kevinkumarkansagra@zyduscadila.com

2020-12-16

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 RT-PCR within 5 days of <br/ >enrollment. <br/ >6. Patients with pneumonia with no signs of severe disease, respiratory rate â?¥24breaths/minute, <br/ >SpO2 90%- 94%. <br/ >7. Illness of any duration, and at least one of the following: <br/ >a. Radiographic infiltrates by imaging (chest x-ray/CT scan) <br/ >b. Clinical assessment (evidence of rales/crackles or other clinical symptoms related to COVID-19 on examination). <br/ >8. Women of childbearing potential must agree to use at least one primary form of contraception <br/ >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. <br/ >2. Stage 4 severe chronic kidney disease or requiring dialysis (i.e. eGFR <30). <br/ >3. Pregnant or breast feeding. <br/ >4. Allergy to any study medication. <br/ >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. <br/ >6. Comorbid condition like myocardial infarction or heart failure within 90 days of recruitment. <br/ >7. Prolong QT interval ( >450 ms).

2

Zydus Research Center Cadila Healthcare Limited

18

75

India

Moderate/severe disease at enrollment

4: Moderate/severe disease at enrollment

250

Evaluation of the clinical efficacy of Pegylated interferon alfa-2b on the basis of change in ordinal <br/ >scale at Day 11 ± 1.Timepoint: baseline to Day 11

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

Phase 3

[{"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"}]