COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT04480138

Dr Richa Vellanki

richa.vellanki@zyduscadila.com

2020-07-21

Terminated

RCT

Randomized

Parallel

Open label

multi-center

Treatment

inclusion criteria: ability to comprehend and willingness to sign a written icf for the study. male or non-pregnant females, ≥18 years of age at the time of enrolment. understands and agrees to comply with planned study procedures. agrees to the collection of pharyngeal swabs and blood sample as per protocol. has laboratory-confirmed sars-cov-2 infection as determined by pcr, or other commercial or public health assay in any specimen within one week patients with spo2 > 93% and respiratory rate <30 breaths/min. illness of any duration, and at least one of the following: radiographic infiltrates by imaging (chest x-ray) clinical assessment (evidence of rales/crackles or other clinical symptoms on exam). women of childbearing potential must agree to use at least one primary form of contraception

alt/ast >5 times the upper limit of normal. patients with respiratory rate <20 breaths/min and normal spo2 with confirmed sars-cov-2 infection as determined by pcr (mild covid-19 subjects). patients with respiratory rate ≥30 breaths/min and spo2 at rest ≤93% (severe covid-19 subjects). stage ≥4 severe chronic kidney disease or requiring dialysis (i.e. egfr <30 ml/min/1.73 m2). pregnant or breast feeding. allergy to any study medication or usage of test drug during last 14 days prior to screening severe co-morbidity (e.g. uncontrolled hypertension and uncontrolled dm, systemic disease which affect the vital organs severity, immunocompromised patients etc.) as per investigator's assessment. comorbid condition like myocardial infarction or heart failure within 90 days of recruitment. prolong qt interval (>450 ms).

2

Zydus Lifesciences Limited

18

100

Mexico

Moderate disease at enrollment

3: Moderate disease at enrollment

7

Change in Clinical status of subject on a 7-point ordinal scale

None

Phase 2

[{"arm_notes": "", "treatment_id": 667, "treatment_name": "Interferon alpha2b", "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"}]