Hydroxychloroquine to Prevent COVID-19 Disease Amongst Healthcare Workers

Corona Virus Infection Clinical Trial

— PROVIDE  

Official title:

Hydroxychloroquine to Prevent COVID-19 Disease Amongst Healthcare Workers (PROVIDE): A Parallel Randomized Controlled Trial

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04371523
• Other study ID #: 3190
• Status: Withdrawn
• Phase: Phase 3
• Start date: May 1, 2020
• Est. completion date: August 30, 2020

Study information

• Verified date: September 2021
• Source: St. Joseph's Healthcare Hamilton
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: August 30, 2020
• Est. primary completion date: July 31, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Corona Virus Infection
• Coronavirus Infections

Intervention

Drug:
• Apo-Hydroxychloroquine
Hydroxychloroquine sulfate 400mg PO BID on day one, then 400mg PO weekly, to be taken with meals for two months total.
• Matched Placebo
Matching Placebo

Locations

Country	Name	City	State
Canada	St. Joseph's Healthcare Hamilton	Hamilton	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
St. Joseph's Healthcare Hamilton

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Positive for SARS-CoV-2	The number of HCW that tested positive for SARS-CoV-2	8 weeks
Secondary	Hospital admissions	The number of HCW that required hospital admission secondary to SARS-CoV-2	at any time after first dose to hospital discharge, truncated at 60 days
Secondary	Intensive care unit admissions	The number of HCW that required intensive care unit admission	at any time after first dose to hospital discharge, truncated at 60 days
Secondary	Intubation and mechanical ventilation	The number of HCW that required intubation and mechanical ventilation	at any time after first dose, truncated at 60 days
Secondary	ICU length of stay	number of days admitted to the ICU	from randomization to hospital discharge, truncated at 60 days
Secondary	Hospital length of stay	number of days admitted to the hospital	from randomization to hospital discharge, truncated at 60 days
Secondary	Mortality	Death	from randomization to 60 days
Secondary	Incidence of adverse events	Gastrointestinal symptoms (abdominal pain, diarrhea, nausea, vomiting), Hypoglycemia, Abdominal LFTs, Angioedema, Opthalmic (corneal changes, decreased visual acuity, macular degeneration, retinal changes), Bronchospasm	from randomization to 60 days