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Trial - NCT04871828


Column Value
Trial registration number NCT04871828
Full text link
Last imported at : May 5, 2021, 11:25 a.m.
Source : ClinicalTrials.gov

https://clinicaltrials.gov/show/NCT04871828

First author
Last imported at : May 5, 2021, 11:25 a.m.
Source : ClinicalTrials.gov

Mohammed Al Ghobain, MD

Contact
Last imported at : May 5, 2021, 11:25 a.m.
Source : ClinicalTrials.gov

alghobainmo@NGHA.MED.SA   

Registration date
Last imported at : May 5, 2021, 11:25 a.m.
Source : ClinicalTrials.gov

2021-05-04

Recruitment status
Last imported at : May 6, 2023, 8 p.m.
Source : ClinicalTrials.gov

Unknown

Study design
Last imported at : May 5, 2021, 11:25 a.m.
Source : ClinicalTrials.gov

RCT

Allocation
Last imported at : May 5, 2021, 11:25 a.m.
Source : ClinicalTrials.gov

Randomized

Design
Last imported at : May 5, 2021, 11:25 a.m.
Source : ClinicalTrials.gov

Parallel

Masking
Last imported at : May 5, 2021, 11:25 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 : May 5, 2021, 11:25 a.m.
Source : ClinicalTrials.gov

Treatment

Inclusion criteria
Last imported at : Nov. 16, 2021, 6:30 p.m.
Source : ClinicalTrials.gov

inclusion criteria: age of 18 years or above diagnosed with covid-19 by pcr confirmed sars-cov-2 viral infection. able to sign the consent form and agree to clinical samples collection moderate symptomatic covid-19 patients, (any or all of the followings: fever or cough or sob) admitted to the hospital (outside the icu) patients had to be enrolled within 10 days of symptoms onset. willingness to comply with all study procedures and availability for the duration of the study

Exclusion criteria
Last imported at : Nov. 16, 2021, 6:30 p.m.
Source : ClinicalTrials.gov

asthmatic patient using antiasthma medications being in the hospital or in home isolation for more than 72 hours before the start of the study drug. known sensitivity/allergy to the study drug pregnancy patient refused chronic liver disease severe mental disorder unstable patients requiring icu admission participating in other clinical trial

Number of arms
Last imported at : May 5, 2021, 11:25 a.m.
Source : ClinicalTrials.gov

2

Funding
Last imported at : May 5, 2021, 11:25 a.m.
Source : ClinicalTrials.gov

King Abdullah International Medical Research Center

Inclusion age min
Last imported at : May 5, 2021, 11:25 a.m.
Source : ClinicalTrials.gov

18

Inclusion age max
Last imported at : May 5, 2021, 11:25 a.m.
Source : ClinicalTrials.gov

100

Countries
Last imported at : May 5, 2021, 11:25 a.m.
Source : ClinicalTrials.gov

Saudi Arabia

Type of patients
Last imported at : May 5, 2021, 11:25 a.m.
Source : ClinicalTrials.gov

Moderate disease at enrollment

Severity scale
Last imported at : May 5, 2021, 11:25 a.m.
Source : ClinicalTrials.gov

3: Moderate disease at enrollment

Total sample size
Last imported at : May 5, 2021, 11:25 a.m.
Source : ClinicalTrials.gov

66

primary outcome
Last imported at : May 5, 2021, 11:25 a.m.
Source : ClinicalTrials.gov

Time to clinical improvement,

Notes
Last imported at : May 5, 2021, 11:25 a.m.
Source : ClinicalTrials.gov

None

Phase
Last imported at : May 5, 2021, 11:25 a.m.
Source : ClinicalTrials.gov

Phase 3

Arms
Last imported at : May 5, 2021, 11:25 a.m.
Source : ClinicalTrials.gov

[{"arm_notes": "", "treatment_id": 728, "treatment_name": "Leukotriene receptor antagonist", "treatment_type": "Respiratory agents", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]