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Trial - NCT04371523


Column Value
Trial registration number NCT04371523
Full text link
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

https://clinicaltrials.gov/show/NCT04371523

First author
Last imported at : Sept. 28, 2021, 8 a.m.
Source : ClinicalTrials.gov

Kimberley Lewis

Contact
Last imported at : Sept. 28, 2021, 8 a.m.
Source : ClinicalTrials.gov

kimberley.lewis@medportal.ca

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

2020-05-01

Recruitment status
Last imported at : Sept. 28, 2021, 8 a.m.
Source : ClinicalTrials.gov

Withdrawn

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

single-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 criteria: - 18 years of age or older to participate. - healthcare workers with primary practice in intensive care unit, general internal medicine, - covid-19 testing centres, emergency rooms, and nursing homes. - covid_19 symptom free at the time of randomization and have a negative diagnostic swab.

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

- known covid-19 positivity defined as: a laboratory confirmed case as defined by the local public health institutes - suspected covid-19 positivity defined as possessing symptoms consistent with covid-19 infections such as: headache, fever, nausea, vomiting, diarrhea, dyspnea, dry cough - healthcare workers with pre-existing retinopathy or serious visual problems - healthcare workers with known malignancies receiving active chemotherapy or immune modifying medications - healthcare workers with known autoimmune disorders - healthcare workers with known qt prolongation - history of ventricular arrhythmias - participants at risk of malignant arrythmias ○ at risk defined as: a sudden loss of consciousness with injury; anyone in their immediate family, under the age of 45year, with sudden cardiac death; anyone family history of long qt syndrome - known sensitivity/allergy to hydroxychloroquine - healthcare workers that are currently pregnant - healthcare workers that are already taking chloroquine or hydroxychloroquine - healthcare workers on colchicine or any other anti-viral medication - healthcare workers taking a medication that may interact with hydroxychloroquine (see table below - inability to take oral medications - inability to provide written consent - known g6pd 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

St. Joseph's Healthcare Hamilton

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

Canada

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

Health workers

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

N/A

Total sample size
Last imported at : Sept. 28, 2021, 8 a.m.
Source : ClinicalTrials.gov

0

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

Positive for SARS-CoV-2

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"}]