COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT04347174

Sanjay Patel, MBBS

sanjay.p@cadilapharma.co.in

2020-04-15

Completed

RCT

Randomized

Parallel

Blind label

multi-center

Treatment

inclusion criteria: - critically ill patients infected with covid-19 (clinical/confirmed) - patient aged 18 years or more of either gender - illness of any duration with respiratory rate ≥25 breaths/minute, and at least one of the following: - radiographic infiltrates by imaging (chest x-ray, ct scan, etc.), or or - spo2 ≤94% on room air, or - requiring mechanical ventilation and/or supplemental oxygen - female patients of childbearing potential must have a negative pregnancy test within 14 days prior to first dose of study medication. - subject (or legally authorized representative) provides written informed consent prior to initiation of any study procedure.

- pregnant or nursing female. - patients with history of allergy, hypersensitivity, or any serious reaction to study medication - patients with a concomitant medical condition, whose participation, in the opinion of the investigator, may create an unacceptable additional risk. - patient previously enrolled into this study. - patient participating or having participated in a clinical trial with another investigational drug within the last 28 days except for investigational drugs against cancer, leukaemia or hiv. - patients with a life expectancy judged to be less than five days - alt/ast > 5 times the upper limit of normal - stage 4 severe chronic kidney disease or requiring dialysis (i.e. egfr < 30) - patients not likely to complete the trial as per judgment of the investigator.

2

Cadila Pharnmaceuticals

18

None

India

Critical disease at enrollment

8: Critical disease at enrollment

40

7-category ordinal scale that ranges from 1 (not hospitalized with resumption of normal activities) to 7 (death);Sequential Organ Failure Assessment (SOFA) scores

None

Not reported

[{"arm_notes": "", "treatment_id": 842, "treatment_name": "Mycobacterium", "treatment_type": "Microbiota intervention", "pharmacological_treatment": "Non pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]