Hydroxychloroquine to Prevent COVID-19 Disease Amongst Healthcare Workers (PROVIDE)

St. Joseph's Healthcare Hamilton

Status and phase: Withdrawn; Phase 3

Conditions: Corona Virus Infection

Treatments: Drug: Matched Placebo; Drug: Apo-Hydroxychloroquine

Study type: Interventional

Funder types: Other

Identifiers

NCT04371523

3190

Details and patient eligibility

About

The objectives of PROVIDE are to:

1. Determine if prophylactic once weekly hydroxychloroquine reduces the incidence of conversion from SARS-2-CoVnasopharyngeal swab negative to positive
2. To determine if weekly prophylactic hydroxychloroquine reduced the severity of COVID-19 symptoms
3. To determine the safety of taking weekly prophylactic hydroxychloroquine

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

• 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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0 participants in 2 patient groups, including a placebo group

Intervention - Hydroxychloroquine

Experimental group

Treatment:

Drug: Apo-Hydroxychloroquine

Control

Placebo Comparator group

Treatment:

Drug: Matched Placebo