COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT04396067

Mahmoud Elkazzaz, B.Sc of biochemistry

mahmoudramadan2051@yahoo.com

2020-05-20

Unknown

RCT

Randomized

Parallel

Open label

unclear

Treatment

inclusion criteria: 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 pregnant allergic to experimental drugs and patients have the following conditions: hypercholesterolemia hypertriglyceridemia liver disease renal disease sjögren syndrome pregnancy lactation depressive disorder body mass index less than 18 points or higher than 25 points 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 hiv infection or other immunodeficiency or with an absolute neutrophil count ≤1.0 × 109/l abnormal liver biochemistry (alanine aminotransferase, aspartate aminotransferase, gamma-glutamyl transferase) >1.5 × upper limit of normal or total bilirubin > upper limit of normal (unless gilbert's disease with normal conjugated bilirubin) any of the following laboratory abnormalities are present at baseline: platelet count <150×109/l serum albumin ≤ 3.5 g/dl inr ≥1.2 cpk ≥ uln. significant liver fibrosis as evidenced by fibrosis-4 (fib-4) score >3.25 history of hypersensitivity to retinoic acid or any of its excipients or the class of neutrophil elastase inhibitors known hypersensitivity to medications used in the study procedures (e.g. midazolam, fentanyl, and lidocaine for bronchoscopy)

3

Kafrelsheikh University

18

70

None

Severe/critical disease at enrollment

7: Severe/critical disease at enrollment

360

lung injury score

None

Phase 2

[{"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}, {"arm_notes": "", "treatment_id": 1, "treatment_name": "13 cis retinoic acid", "treatment_type": "Others pharmacological treatment", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 67, "treatment_name": "All trans retinoic acid", "treatment_type": "Others pharmacological treatment", "pharmacological_treatment": "Pharmacological treatment"}]