COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT04463602

Dr Richa Vellanki

richa.vellanki@zyduscadila.com

2020-07-09

Completed

RCT

Randomized

Parallel

Open label

single-center

Treatment

inclusion criteria: ability to comprehend and willingness to sign a written icf by the subject/impartial witness. male and females, age ≥18 years at enrollment. 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. 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 for the duration of the study (acceptable methods will be determined by the site).

alt/ast >5 times the upper limit of normal. stage v ckd (i.e. egfr <15 ml/min/1.73 m2 or requiring dialysis). pregnant or breast feeding. 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). patients on invasive mechanical ventilation.

2

Zydus Lifesciences Limited

18

100

Mexico

Moderate/severe disease at enrollment

4: Moderate/severe disease at enrollment

24

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

None

Phase 2

[{"arm_notes": "", "treatment_id": 398, "treatment_name": "Desidustat", "treatment_type": "Others pharmacological treatment", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2188, "treatment_name": "Standard of care", "treatment_type": "Standard of care", "pharmacological_treatment": "Standard of care"}]