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Trial - NCT04869579


Column Value
Trial registration number NCT04869579
Full text link
Last imported at : May 5, 2021, 11:25 a.m.
Source : ClinicalTrials.gov

https://clinicaltrials.gov/show/NCT04869579

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

Mohamed S Ghoweba, MD

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

mohamed.ghoweba@christushealth.org

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

2021-05-03

Recruitment status
Last imported at : July 4, 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: willing and able to provide written informed consent, or with a legal representative who can provide informed consent, or enrolled under international conference on harmonization (ich) e6(r2) 4.8.15 emergency use provisions as deemed necessary by the investigator (age ≥18) prior to performing study procedure. aged ≥ 18 years. severe acute respiratory syndrome coronavirus (sars-cov)-2 infection confirmed by polymerase chain reaction (pcr) test ≤ 4 days before randomization. currently hospitalized. peripheral capillary oxygen saturation (spo2) ≤ 94% or requiring supplemental oxygen on screening.

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

participation in any other clinical trial of an experimental treatment for covid-19. evidence of multiorgan failure. mechanically ventilated for > 5 days. alanine aminotransferase (alt) or aspartate aminotransferase (ast) > 5 x upper limit of normal (uln). creatinine clearance < 50 ml/min.

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

CHRISTUS Health

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

United States

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

Severe disease at enrollment

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

6: Severe disease at enrollment

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

100

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

Mean change in the ordinal scale;Rate of hospital discharges or deaths

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 2

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

[{"arm_notes": "", "treatment_id": 1178, "treatment_name": "Selenium", "treatment_type": "Vitamins and dietary supplements", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]