COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT04341675

Nishant Gupta, MD

guptans@ucmail.uc.edu

2020-04-10

Unknown

RCT

Randomized

Parallel

Blind label

multi-center

Treatment

inclusion criteria: subjects enrolled in the trial must meet all of the following criteria. - confirmed covid-19 pneumonia - hypoxia as defined by room air oxygen saturation less than 92% or supplemental oxygen requirement - presence of at least one additional biomarker that has been shown to predict poor prognosis: a) serum ferritin ≥500ug/l, b) ldh ≥250u/l, c) d-dimer ≥1ug/l, or d) lymphopenia as defined by absolute lymphocyte count <1,000/ul - age ≥ 18 years - completed informed consent

subjects who meet any of the following criteria are not eligible for enrollment as study participants: - known allergy or hypersensitivity to sirolimus - inability or refusal to provide informed consent - advanced respiratory support (high flow oxygen ≥ 15 l/min, cpap, non-invasive or invasive mechanical ventilation) - active enrollment in other interventional clinical drug trials. co-enrollment in observational studies and biorepositories is allowed. - pregnant women - breast feeding - on chronic immunosuppression for other medical conditions such as rheumatological disorders, inflammatory bowel disease, or in patients with organ transplants. a list of these medications is provided in section 12.3.4 - any clinically significant medical disease which in the opinion of the investigator precludes the patient from enrolling in the trial, including (but not limited to): - history of liver cirrhosis - end stage renal disease or need for renal replacement therapy - decompensated heart failure - known active tuberculosis or history of incompletely treated tuberculosis - uncontrolled systemic bacterial or fungal infections - active viral infection other than covid-19

2

University of Cincinnati

18

None

United States

Severe disease at enrollment

6: Severe disease at enrollment

30

Proportion of patients who are alive and free from advanced respiratory support measures at day 28.

None

Phase 2

[{"arm_notes": "", "treatment_id": 1204, "treatment_name": "Sirolimus", "treatment_type": "Immunosuppressants", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]