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Trial - NCT04703036


Column Value
Trial registration number NCT04703036
Full text link
Last imported at : Jan. 13, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

First author
Last imported at : May 11, 2023, 8 a.m.
Source : ClinicalTrials.gov

Rajagopal V Sekhar

Contact
Last imported at : May 11, 2023, 8 a.m.
Source : ClinicalTrials.gov

Not reported

Registration date
Last imported at : Jan. 13, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

2021-01-11

Recruitment status
Last imported at : May 11, 2023, 8 a.m.
Source : ClinicalTrials.gov

Not recruiting

Study design
Last imported at : Jan. 13, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

RCT

Allocation
Last imported at : Jan. 13, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

Randomized

Design
Last imported at : Jan. 13, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

Parallel

Masking
Last imported at : Jan. 13, 2021, 12:31 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 : Jan. 13, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

Treatment

Inclusion criteria
Last imported at : Jan. 13, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

inclusion criteria: - age 55-85y; - diagnosis of covid-19; - hospitalized patients.

Exclusion criteria
Last imported at : Jan. 13, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

- active heart disease or active cancer at time of recruitment; - patients in intensive care unit at the time of recruitment; - patents with alanine transaminase and aspartate transaminase greater than 5 times the upper limit of normal at any time; - patients requiring >4l per minute of oxygen support at the time of recruitment.

Number of arms
Last imported at : Jan. 13, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

2

Funding
Last imported at : Jan. 13, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

Baylor College of Medicine

Inclusion age min
Last imported at : Jan. 13, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

55

Inclusion age max
Last imported at : Jan. 13, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

85

Countries
Last imported at : Jan. 13, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

United States

Type of patients
Last imported at : Jan. 13, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

Moderate/severe disease at enrollment

Severity scale
Last imported at : Jan. 13, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

4: Moderate/severe disease at enrollment

Total sample size
Last imported at : Jan. 13, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

64

primary outcome
Last imported at : Jan. 13, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

Change in Glutathione concentrations;Change in Interleukein 6 concentrations;Change in Ordinal scale

Notes
Last imported at : Jan. 13, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

None

Phase
Last imported at : Feb. 25, 2021, 7:58 p.m.
Source : ClinicalTrials.gov

Phase 1

Arms
Last imported at : Jan. 13, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

[{"arm_notes": "", "treatment_id": 1525, "treatment_name": "Glycine+n-acetylcysteine", "treatment_type": "Vitamins and dietary supplements+respiratory agents", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]