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Trial - NCT04530409


Column Value
Trial registration number NCT04530409
Full text link
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

First author
Last imported at : Jan. 20, 2022, 11:30 a.m.
Source : ClinicalTrials.gov

Emad R Issak, MD

Contact
Last imported at : Jan. 20, 2022, 11:30 a.m.
Source : ClinicalTrials.gov

dr.emad.r.h.issak@gmail.com

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

2020-08-28

Recruitment status
Last imported at : Nov. 3, 2022, 4 a.m.
Source : ClinicalTrials.gov

Not recruiting

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 : March 15, 2023, 4 a.m.
Source : ClinicalTrials.gov

single-center

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: - any case with covid-19 more than or equal to 18 years - mild and moderate severity

Exclusion criteria
Last imported at : Jan. 20, 2022, 11:30 a.m.
Source : ClinicalTrials.gov

severe to critical covid-19 any contra-indication for the interventional drug mentally disabled cases

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

ClinAmygate

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

100

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

Egypt

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

Mild/moderate disease at enrollment

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

2: Mild/moderate disease at enrollment

Total sample size
Last imported at : Jan. 20, 2022, 11:30 a.m.
Source : ClinicalTrials.gov

752

primary outcome
Last imported at : Jan. 20, 2022, 11:30 a.m.
Source : ClinicalTrials.gov

28-days mortality;Percentage of cases that will need hospitalization;Percentage of cases that will need oxygen supplementation

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 4

Arms
Last imported at : Jan. 20, 2022, 11:30 a.m.
Source : ClinicalTrials.gov

[{"arm_notes": "Early-Dexamethasone:\nearly use of dexamethasone as early as laboratory evidence of high inflammatory markers\nOther Name: Dexamethasone", "treatment_id": 400, "treatment_name": "Dexamethasone", "treatment_type": "Corticosteroids", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "Late-Dexamethasone:\nUse of dexamethasone on deterioration of the cases with increased severity\nOther Name: Dexamethasone", "treatment_id": 400, "treatment_name": "Dexamethasone", "treatment_type": "Corticosteroids", "pharmacological_treatment": "Pharmacological treatment"}]