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Trial - NCT04334148


Column Value
Trial registration number NCT04334148
Full text link
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

https://clinicaltrials.gov/show/NCT04334148

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

Adrian Hernandez, MD

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

Rachel Olson, rachel.e.olson@duke.edu (PI email not reported)

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

2020-04-06

Recruitment status
Last imported at : Feb. 23, 2021, 12:31 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

Blind 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

Prevention

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

inclusion: - completed informed consent - age ≥ 18 years old - currently working in any environment in which there is a risk of exposure to patients with covid-19 infections ("healthcare worker")

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

- prior diagnosis of covid-19 infection - participation in another covid-19 prophylaxis trial within 30 days of consent - respiratory illness with new-onset fever (temperature > 100°f) or ongoing cough or dyspnea within 14 days - known allergy to hcq or chloroquine - congenital prolonged qt syndrome - current or planned use of qt prolonging drugs (e.g. procainamide, disopyramide, mexiletine, flecainide, propafenone, amiodarone, sotalol, cimetidine, dronedarone, dofetilide, levofloxacin, ciprofloxacin, moxifloxacin) and other contraindicated medications - end stage renal disease - pre-existing retinopathy - current or planned use of hydroxychloroquine (study drug) for any indication current or planned use of the following for treatment or prevention of covid-19 infection: - chloroquine - azithromycin - known cirrhosis or severe liver disease - history of severe skin reactions such as steven-johnson syndrome, toxic epidermal necrolysis - history of psoriasis or porphyria - ventricular arrhythmias requiring medical treatment - severe coronary artery disease or heart failure/cardiomyopathy with ongoing symptoms - current or planned use of use of anti-seizure drugs - history of glucose-6-phosphate dehydrogenase deficiency

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

2

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

Adrian Hernandez

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

Close contacts to covid patients

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

N/A

Total sample size
Last imported at : Oct. 8, 2021, 12:30 p.m.
Source : ClinicalTrials.gov

1360

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

Number of participants with clinical infection with COVID-19 infection

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 3

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": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]