Corona Virus InfectionPhase 3PROVIDENCT04371523
Hydroxychloroquine to Prevent COVID-19 Disease Amongst Healthcare Workers
A Phase 3 study testing Apo-Hydroxychloroquine in people with Corona Virus Infection, run by St. Joseph's Healthcare Hamilton at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Corona Virus Infection
- What is being tested?
- Apo-Hydroxychloroquine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteCanada
- Study dates
- 1 May 2020to 30 Aug 2020
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 16Show fewer
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: Hydroxychloroquine to Prevent COVID-19 Disease Amongst Healthcare Workers (PROVIDE): A Parallel Randomized Controlled Trial
The objectives of PROVIDE are to:
- Determine if prophylactic once weekly hydroxychloroquine reduces the incidence of conversion from SARS-2-CoVnasopharyngeal swab negative to positive
- To determine if weekly prophylactic hydroxychloroquine reduced the severity of COVID-19 symptoms
- To determine the safety of taking weekly prophylactic hydroxychloroquine
- Conditions
- Corona Virus Infection
- Being tested
- Apo-Hydroxychloroquine, Matched Placebo
- Medical subject headings
- Coronavirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Apo-HydroxychloroquineDrug
Hydroxychloroquine sulfate 400mg PO BID on day one, then 400mg PO weekly, to be taken with meals for two months total.
Matched PlaceboDrug
Matching Placebo
| Study group | Role | What they receive |
|---|---|---|
| Intervention - Hydroxychloroquine | Experimental | Not described Receives: Drug: Apo-Hydroxychloroquine |
| Control | Placebo comparator | Not described Receives: Drug: Matched Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Positive for SARS-CoV-2
The number of HCW that tested positive for SARS-CoV-2
Measured: 8 weeks
Secondary outcomes (7)
Hospital admissions
The number of HCW that required hospital admission secondary to SARS-CoV-2
Measured: at any time after first dose to hospital discharge, truncated at 60 days
Intensive care unit admissions
The number of HCW that required intensive care unit admission
Measured: at any time after first dose to hospital discharge, truncated at 60 days
Intubation and mechanical ventilation
The number of HCW that required intubation and mechanical ventilation
Measured: at any time after first dose, truncated at 60 days
ICU length of stay
number of days admitted to the ICU
Measured: from randomization to hospital discharge, truncated at 60 days
Hospital length of stay
number of days admitted to the hospital
Measured: from randomization to hospital discharge, truncated at 60 days
Mortality
Death
Measured: from randomization to 60 days
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
Measured: from randomization to 60 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2020
- Study start1 May 2020 (estimated)
- Primary completion31 Jul 2020 (estimated)
- Study completion30 Aug 2020 (estimated)
Why it stopped: Study was not initiated due to evidence becoming available that did not support the use of hydroxychloroquine in this population, with potential risk of added harm
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Corona Virus InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Parallel two-armed, multi-centred, blinded, stratified, superiority, randomized controlled trial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Joseph's Healthcare Hamilton
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Waleed Al-Hazzani, St. Joseph's Healthcare Hamilton
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04371523
- Sponsor's protocol ID
- 3190
- Acronym
- PROVIDE
- Status last verified
- Sep 2021
- First submitted
- 28 Apr 2020
- Last updated
- 27 Sep 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hydroxychloroquine to Prevent COVID-19 Disease Amongst Healthcare Workers (PROVIDE): A Parallel Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04371523
- Acronym / sponsor ID
- PROVIDE / 3190
- Conditions
- Corona Virus Infection
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study was not initiated due to evidence becoming available that did not support the use of hydroxychloroquine in this population, with potential risk of added harm
- Enrolment
- 0 participants (actual)
- Lead sponsor
- St. Joseph's Healthcare HamiltonUniversity, hospital or other
- Study start
- 1 May 2020 (estimated)
- Primary completion
- 31 Jul 2020 (estimated)
- Study completion
- 30 Aug 2020 (estimated)
- First posted
- 1 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objectives of PROVIDE are to:
- Determine if prophylactic once weekly hydroxychloroquine reduces the incidence of conversion from SARS-2-CoVnasopharyngeal swab negative to positive
- To determine if weekly prophylactic hydroxychloroquine reduced the severity of COVID-19 symptoms
- To determine the safety of taking weekly prophylactic hydroxychloroquine
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Parallel two-armed, multi-centred, blinded, stratified, superiority, randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Intervention - Hydroxychloroquine | Experimental | Drug: Apo-Hydroxychloroquine |
| Control | Placebo comparator | Drug: Matched Placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (16 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Apo-HydroxychloroquineHydroxychloroquine sulfate 400mg PO BID on day one, then 400mg PO weekly, to be taken with meals for two months total. | Drug | Intervention - Hydroxychloroquine |
| Matched PlaceboMatching Placebo | Drug | Control |
Primary outcome
Positive for SARS-CoV-2
Time frame: 8 weeks
The number of HCW that tested positive for SARS-CoV-2
7 secondary outcomes
Hospital admissions
Time frame: at any time after first dose to hospital discharge, truncated at 60 days
Intensive care unit admissions
Time frame: at any time after first dose to hospital discharge, truncated at 60 days
Intubation and mechanical ventilation
Time frame: at any time after first dose, truncated at 60 days
ICU length of stay
Time frame: from randomization to hospital discharge, truncated at 60 days
Hospital length of stay
Time frame: from randomization to hospital discharge, truncated at 60 days
Mortality
Time frame: from randomization to 60 days
Incidence of adverse events
Time frame: from randomization to 60 days
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Sep 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Apo-Hydroxychloroquine in people with Corona Virus Infection, run by St. Joseph's Healthcare Hamilton at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 27 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Positive for SARS-CoV-2 (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Sep 2021.