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Trial - NCT04959786


Column Value
Trial registration number NCT04959786
Full text link
Last imported at : July 14, 2021, 6 a.m.
Source : ClinicalTrials.gov

First author
Last imported at : July 14, 2021, 6 a.m.
Source : ClinicalTrials.gov

Hatem elalfy, MD

Contact
Last imported at : July 14, 2021, 6 a.m.
Source : ClinicalTrials.gov

ELALFY2004@MANS.EDU.EG

Registration date
Last imported at : July 14, 2021, 6 a.m.
Source : ClinicalTrials.gov

2021-07-13

Recruitment status
Last imported at : July 6, 2023, midnight
Source : ClinicalTrials.gov

Unknown

Study design
Last imported at : July 14, 2021, 6 a.m.
Source : ClinicalTrials.gov

RCT

Allocation
Last imported at : July 14, 2021, 6 a.m.
Source : ClinicalTrials.gov

Randomized

Design
Last imported at : July 14, 2021, 6 a.m.
Source : ClinicalTrials.gov

Parallel

Masking
Last imported at : July 14, 2021, 6 a.m.
Source : ClinicalTrials.gov

Blind label

Center
Last imported at : March 15, 2023, 4 a.m.
Source : ClinicalTrials.gov

single-center

Study aim
Last imported at : July 14, 2021, 6 a.m.
Source : ClinicalTrials.gov

Treatment

Inclusion criteria
Last imported at : July 14, 2021, 6 a.m.
Source : ClinicalTrials.gov

inclusion criteria: - aged ≥18 years - laboratory-confirmed sars-cov- 2 infection - hospitalized patients - need reservoir mask for oxygen support - need hfnc for oxygen support

Exclusion criteria
Last imported at : July 14, 2021, 6 a.m.
Source : ClinicalTrials.gov

- mechanical ventilations for oxygen support - inability to take oral medications - pregnancy or breastfeeding

Number of arms
Last imported at : July 14, 2021, 6 a.m.
Source : ClinicalTrials.gov

2

Funding
Last imported at : July 14, 2021, 6 a.m.
Source : ClinicalTrials.gov

Mansoura University

Inclusion age min
Last imported at : July 14, 2021, 6 a.m.
Source : ClinicalTrials.gov

18

Inclusion age max
Last imported at : July 14, 2021, 6 a.m.
Source : ClinicalTrials.gov

100

Countries
Last imported at : July 14, 2021, 6 a.m.
Source : ClinicalTrials.gov

Egypt

Type of patients
Last imported at : July 14, 2021, 6 a.m.
Source : ClinicalTrials.gov

Moderate/severe disease at enrollment

Severity scale
Last imported at : July 14, 2021, 6 a.m.
Source : ClinicalTrials.gov

4: Moderate/severe disease at enrollment

Total sample size
Last imported at : July 14, 2021, 6 a.m.
Source : ClinicalTrials.gov

100

primary outcome
Last imported at : July 14, 2021, 6 a.m.
Source : ClinicalTrials.gov

In-hospital and 28-day mortality;Stabilization of oxygen

Notes
Last imported at : July 14, 2021, 6 a.m.
Source : ClinicalTrials.gov

None

Phase
Last imported at : July 14, 2021, 6 a.m.
Source : ClinicalTrials.gov

Phase 2/Phase 3

Arms
Last imported at : July 14, 2021, 6 a.m.
Source : ClinicalTrials.gov

[{"arm_notes": "", "treatment_id": 2302, "treatment_name": "Ivermectin+nitazoxanide+ribavirin+zinc", "treatment_type": "Antiparasitics+antivirals+vitamins and dietary supplements", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2188, "treatment_name": "Standard of care", "treatment_type": "Standard of care", "pharmacological_treatment": "Standard of care"}]