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Trial - NCT04389580


Column Value
Trial registration number NCT04389580
Full text link
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

https://clinicaltrials.gov/show/NCT04389580

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

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

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

mahmoudramadan2051@yahoo.com

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

2020-05-15

Recruitment status
Last imported at : July 6, 2023, midnight
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

Sequential assignment

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 : Nov. 16, 2021, 6:30 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 the competent physician considered it inappropriate to participate in the study bleeding dyscrasia 16-1-anti-coagulation use active cervicitis allergy to tamoxifen history of venous thromboembolism personal history of breast or uterine malignancy use of medication contraindicated with use of tamoxifen (coumadin, letrozole, bromocriptine, rifampicin, aminoglutethimide, phenobarbital)

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

70

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

Severe/critical disease at enrollment

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

7: Severe/critical disease at enrollment

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

160

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": "0.5mg/kg/day;PO", "treatment_id": 1596, "treatment_name": "Isotretinoin+tamoxifen", "treatment_type": "Others pharmacological treatment+antimalarials", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "0.2mg/kg/day to 4mg/kg/day;aerosol", "treatment_id": 1596, "treatment_name": "Isotretinoin+tamoxifen", "treatment_type": "Others pharmacological treatment+antimalarials", "pharmacological_treatment": "Pharmacological treatment"}]