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Trial - NCT04578236


Column Value
Trial registration number NCT04578236
Full text link
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

https://clinicaltrials.gov/show/NCT04578236

First author
Last imported at : Oct. 27, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

Mahmoud Elkazzaz, B.Sc in Biochemistry

Contact
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

mahmoudramadan2051@yahoo.com

Registration date
Last imported at : Oct. 27, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

2020-10-08

Recruitment status
Last imported at : Oct. 5, 2022, 7:30 a.m.
Source : ClinicalTrials.gov

Unknown

Study design
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

RCT

Allocation
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

Randomized

Design
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

Parallel

Masking
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

Open label

Center
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

unclear

Study aim
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

Treatment

Inclusion criteria
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

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))

Exclusion criteria
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

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 - history of ace-inhibitor allergy - history of angio-oedema - co-infection with another respiratory pathogen which could be responsible of pneumonia - hypersensitivity to captopril, to any other angiotensin converting enzyme inhibitor or any of the excipients of the specialty used - shock requiring vasopressor infusion - patient on state medical ai - the competent physician considered it inappropriate to participate in the study

Number of arms
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

2

Funding
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

Kafrelsheikh University

Inclusion age min
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

18

Inclusion age max
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

80

Countries
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

None

Type of patients
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

Critical disease at enrollment

Severity scale
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

8: Critical disease at enrollment

Total sample size
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

360

primary outcome
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

lung injury score

Notes
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

None

Phase
Last imported at : Feb. 25, 2021, 7:58 p.m.
Source : ClinicalTrials.gov

Phase 2

Arms
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

[{"arm_notes": "", "treatment_id": 1594, "treatment_name": "Captopril+isotretinoin", "treatment_type": "Cardiovascular agents+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"}]