COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT04382950

M.Sc.Mahmoud Elkazzaz, M.Sc.Biochemistry

mahmoudramadan2051@yahoo.com

2020-05-11

Unknown

RCT

Randomized

Parallel

Open label

unclear

Treatment

inclusion criteria: 1.laboratory diagnosis: adult sari patients with 2019-ncov infection confirmed by pcr; absolute value of lymphocytes < 0. 6x 109/l; severe respiratory failure within 48 hours and requires admission to icu. (severe respiratory failure was defined as pao2/fio2 < 200 mmhg and was supported by positive pressure mechanical ventilation (including non-invasive and invasive mechanical ventilation, peep>=5cmh2o))

- age <18 years; age >80 years - pregnant or breast feeding woman - patient in other therapeutic clinical trial within 30 days before icf - receive any other ace inhibitors (acei), angiotensin-receptor blockers (arb) treatment within 7 days before icf - chronic immunosuppression: current autoimmune diseases or patients who received immunotherapy within 30 days before icf - hematologic malignancy (lymphoma, leukemia, multiple myeloma) - other patient characteristics (not thought to be related to underlying covid-19) that portend a very poor prognosis (e.g, severe liver failure, and ect) - known allergy to study drug or its ingredients related to renin-angiotensin system (ras), or frequent and/or severe allergic reactions with multiple medications - other uncontrolled diseases, as judged by investigators - body weight ≥85 kg - hypercholesterolemia - hypertriglyceridemia - liver disease - renal disease - sjögren syndrome - pregnancy - lactation - depressive disorder - contraindications for hormonal contraception or intrauterine device. - autoimmune diseases a history of organ, bone marrow or hematopoietic stem cell transplantation - patients receiving anti-hcv treatment - permanent blindness in one eye - history of iritis, endophthalmitis, scleral inflammation or retinitis 15-90 days of retinal detachment or eye surgery - the competent physician considered it inappropriate to participate in the study

2

Kafrelsheikh University

18

60

None

Severe disease at enrollment

6: Severe disease at enrollment

24

Time course of body temperature (fever)

None

Phase 1

[{"arm_notes": "", "treatment_id": 2145, "treatment_name": "Empagliflozin", "treatment_type": "Metabolic agents", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]