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Trial - NCT04329832


Column Value
Trial registration number NCT04329832
Full text link
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

https://clinicaltrials.gov/show/NCT04329832

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

Samuel M Brown, MD MS

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

Valerie T Aston, Valerie.Aston@imail.org (PI email not reported)

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

2020-04-01

Recruitment status
Last imported at : April 21, 2022, 1 a.m.
Source : ClinicalTrials.gov

Completed

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

multi-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: - adult (age ≥ 18 years) - confirmed or suspected covid-19, - confirmed: positive assay for covid-19 within the last 10 days - suspected: pending assay for covid-19 with high clinical suspicion - scheduled for admission or already admitted to an inpatient bed

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

- allergy to hydroxychloroquine or azithromycin - history of bone marrow transplant - known g6pd deficiency - chronic hemodialysis or glomerular filtration rate < 20ml/min - psoriasis - porphyria - concomitant use of digitalis, flecainide, amiodarone, procainamide, propafenone, cimetidine, dofetilide, phenobarbital, phenytoin, or sotalol - known history of long qt syndrome - current known qtc>500 msec - pregnant or nursing - prisoner - weight < 35kg - seizure disorder - severe liver disease - outpatient use of hydroxychloroquine for treatment of a disease other than covid-19 or has received more than 2 days of hydroxychloroquine or azithromycin for suspected or confirmed covid-19 - patient has recovered from covid-19 and/or is being discharged from the hospital on day of enrollment. - treating physician refuses to allow patient participation in the study - unable to obtain informed consent - prior enrollment in this study

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

2

Funding
Last imported at : Dec. 12, 2022, 8 a.m.
Source : ClinicalTrials.gov

Intermountain Health Care, Inc.

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

None

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

United States

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 : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

85

primary outcome
Last imported at : Dec. 12, 2022, 8 a.m.
Source : ClinicalTrials.gov

COVID Ordinal Outcomes Scale at 14 Days

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 2

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

[{"arm_notes": "", "treatment_id": 607, "treatment_name": "Hydroxychloroquine", "treatment_type": "Antimalarials", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 165, "treatment_name": "Azithromycin", "treatment_type": "Antibiotics", "pharmacological_treatment": "Pharmacological treatment"}]