COVID-19Phase 2NCT04333225

Hydroxychloroquine in the Prevention of COVID-19 Infection in Healthcare Workers

A Phase 2 study testing Hydroxychloroquine in people with COVID-19, run by Baylor Research Institute at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 75 yearsHealthy volunteers can take part
Conditions the study is for: COVID-19
What is being tested?: Hydroxychloroquine
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 221 participants
Where: 1 siteUnited States
Study dates: 3 Apr 2020to 30 Jun 2020
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 to 75 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Adult male and female healthcare workers ≥ 18 to ≤ 75 years of age upon study consent
Healthcare workers with
One day or more of exposure to suspect and/or positive COVID-19 patients, including but not limited to those working in the Emergency Department or Intensive Care Unit.
OR
Unprotected exposure to a known positive COVID-19 patient within 72 hours of screening.
Afebrile with no constitutional symptoms
Willing and able to comply with scheduled visits, treatment plan, and other study procedures
Evidence of a personally signed and dated informed consent document indicating that the subject (or a legally acceptable representative) has been informed of all pertinent aspects of the study prior to initiation of any subject-mandated procedures

Who cannot join

Participation in other investigational clinical trials for the treatment or prevention of SARS-COV-2 infection within 30days
Unwilling to practice acceptable methods of birth control (both males who have partners of childbearing potential and females of childbearing potential) during Screening, while taking study drug, and for at least 30 days after the last dose of study drug is ingested Note: the following criteria follow standard clinical practice for FDA approved indications of this medication
Having a prior history of blood disorders such as aplastic anemia, agranulocytosis, leukopenia, or thrombocytopenia
Having a prior history of glucose-6-phosphate dehydrogenase (G-6-PD) deficiency
Having dermatitis, psoriasis or porphyria
Taking Digoxin, Mefloquine, methotrexate, cyclosporine, praziquantel, antacids and kaolin, cimetidine, ampicillin, Insulin or antidiabetic drugs, arrhythmogenic drugs, antiepileptic drugs, loop, thiazide, and related diuretics, laxatives and enemas, amphotericin B, high dose corticosteroids, and proton pump inhibitors, neostigmine, praziquantel, Pyridostigmine, tamoxifen citrate

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Allergies: 4-Aminoquinolines
Pre-existing retinopathy of the eye
Has a chronic liver disease or cirrhosis, including hepatitis B and/or untreated hepatitis
Untreated or uncontrolled active bacterial, fungal infection
Known or suspected active drug or alcohol abuse, per investigator judgment
Women who are pregnant or breastfeeding
Known hypersensitivity to any component of the study drug
A known history of prolonged QT syndrome or history of additional risk factors for torsades de pointe (e.g., heart failure, requires a lab test , family history of Long QT Syndrome), or the use of concomitant medications that prolong the QT/QTc interval

Trial locations and contacts

1 site in 1 country.

United States1 site

Baylor University Medical Center
Dallas, Texas, 75226

Other trials in United States

About this study

Official title: A Prospective Clinical Study of Hydroxychloroquine in the Prevention of SARS- CoV-2 (COVID-19) Infection in Healthcare Workers After High-risk Exposures

In order to assess the efficacy of hydroxychloroquine treatment weekly for a total of 7 weeks in the prevention of COVID-19 infection, three hundred sixty (360) Healthcare workers with high risk exposure to patients infected with COVID-19 will be tested for COVID-19 infection via nasopharyngeal (NP) swab once weekly for 7 weeks. Of those, one hundred eighty (180) will receive weekly doses of hydroxychloroquine for the duration of the study. Subjects who opt not to receive the study drug will form the control group.

Conditions: COVID-19
Being tested: Hydroxychloroquine
Keywords: hydroxychloroquine
Medical subject headings: COVID-19

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

HydroxychloroquineDrug
Also called Plaquenil, HCQ
Weekly treatment in individuals at high risk

Study groups in NCT04333225
Study group	Role	What they receive
Hydroxychloroquine	Experimental	Subjects who chose to enter the HCQ arm received a loading dose of 800 mg HCQ on day 1 followed by two 200 mg tablets once a week for a total of 7 weeks Receives: Drug: Hydroxychloroquine
Control	No intervention	Subjects who declined taking HCQ were considered as controls

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Participants Infected With COVID-19 or COVID-19 Like Illness During the Trial
Number of participants infected with COVID-19 or identified as having COVID-19 like illness during the trial
Measured: Up to 7 weeks after study initiation

Secondary outcomes (1)

Time From Study Initiation Until the Occurrence of COVID-19 or COVID-19 Like Illness or Being Censored
Time-to-first clinical event consisting of a persistent change for any of the following:
- diagnosis of COVID-19
- clinical characteristics of COVID-19 like illness
- being censored
Measured: Up to 7 weeks after study initiation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

3 Apr 202030 Jun 2020

First posted3 Apr 2020
Study start3 Apr 2020
Primary completion30 Jun 2020
Study completion30 Jun 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for COVID-19Studies of the same condition, open and under way.
More trials run by Baylor Research InstituteThe sponsor's other registered studies.
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 2
Primary purpose: Prevention
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 221 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04333225
Sponsor's protocol ID: 020-132
Status last verified: May 2020
First submitted: 1 Apr 2020
Last updated: 20 Aug 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 20 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Prospective Clinical Study of Hydroxychloroquine in the Prevention of SARS- CoV-2 (COVID-19) Infection in Healthcare Workers After High-risk Exposures
ClinicalTrials.gov ID: NCT04333225
Acronym / sponsor ID: 020-132
Conditions: COVID-19
Keywords: hydroxychloroquine
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 221 participants (actual)
Lead sponsor: Baylor Research InstituteUniversity, hospital or other
Study start: 3 Apr 2020 (actual)
Primary completion: 30 Jun 2020 (actual)
Study completion: 30 Jun 2020 (actual)
First posted: 3 Apr 2020 (actual)
Results: Posted 20 Aug 2021

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Prevention
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Hydroxychloroquine	Experimental	Drug: HydroxychloroquineSubjects who chose to enter the HCQ arm received a loading dose of 800 mg HCQ on day 1 followed by two 200 mg tablets once a week for a total of 7 weeks
Control	No intervention	–Subjects who declined taking HCQ were considered as controls

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (8 listed)

Adult male and female healthcare workers ≥ 18 to ≤ 75 years of age upon study consent
Healthcare workers with
OR
Afebrile with no constitutional symptoms
Willing and able to comply with scheduled visits, treatment plan, and other study procedures

Key exclusion criteria (14 listed)

Participation in other investigational clinical trials for the treatment or prevention of SARS-COV-2 infection within 30days
Unwilling to practice acceptable methods of birth control (both males who have partners of childbearing potential and females of childbearing potential) during Screening, while taking study drug, and for at least 30 days after the last dose of study drug is ingested Note: the following criteria follow standard clinical practice for FDA approved indications of this medication
Having a prior history of blood disorders such as aplastic anemia, agranulocytosis, leukopenia, or thrombocytopenia
Having a prior history of glucose-6-phosphate dehydrogenase (G-6-PD) deficiency
Having dermatitis, psoriasis or porphyria

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
HydroxychloroquineAlso: Plaquenil, HCQWeekly treatment in individuals at high risk	Drug	Hydroxychloroquine

Primary outcome

Number of Participants Infected With COVID-19 or COVID-19 Like Illness During the Trial
Time frame: Up to 7 weeks after study initiation
Number of participants infected with COVID-19 or identified as having COVID-19 like illness during the trial

1 secondary outcome

Time From Study Initiation Until the Occurrence of COVID-19 or COVID-19 Like Illness or Being Censored
Time frame: Up to 7 weeks after study initiation

Results and safety

Results posted to the registry on 20 Aug 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Hydroxychloroquine	101	98
Control	120	115

Primary outcome: Number of Participants Infected With COVID-19 or COVID-19 Like Illness During the Trial

Time frame: Up to 7 weeks after study initiation. Count of participants. Unit: Participants

Measure	Hydroxychloroquine n = 101	Control n = 120
Value	13	32

Hydroxychloroquine vs Control: Risk Ratio (RR): 2.0718 (95% CI 1.15 to 3.72), p = 0.0112, Chi-squared

1 secondary outcome is reported in the full results.

Adverse events

Time frame: 7 weeks. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Hydroxychloroquine	1 of 101 (1%)	21 of 101 (20.8%)	0 of 101
Control	0 of 120 (0%)	0 of 120 (0%)	0 of 120

Limitations and caveats (from the sponsor): * Due to the off-label use of HCQ, we were not able to incorporate randomization in our design. * The outcome of CLI was based on self-reported symptoms, which is prone to bias. * The trial may be under-powered as recruitment was forced to stop early at 221 instead of 360 because of the demand for and subsequent shortage of HCQ in March 2020. * Our study participants were young and healthy compared to other prophylaxis trials, which may partially explain the low rates of COVID-19.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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.

Peter A McCullough, MD, MPH principal investigator

Baylor Health Care System

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Hydroxychloroquine in people with COVID-19, run by Baylor Research Institute at 1 site in United States.

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 8 inclusion and 14 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: finished, as of the sponsor's last update on 20 Aug 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 United States. 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. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 20 Aug 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Number of Participants Infected With COVID-19 or COVID-19 Like Illness During the Trial (time frame: Up to 7 weeks after study initiation). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04333225.

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 20 Aug 2021.