SARS-CoV-2Phase 3NCT04414241

Hydroxychloroquine to Prevent SARS-CoV-2 Infection/COVID-19

A Phase 3 study testing Hydroxychloroquine in people with SARS-CoV-2, run by Universidad Peruana Cayetano Heredia at 3 sites in Peru.

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 years and olderHealthy volunteers can take part
Conditions the study is for: SARS-CoV-2
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: 68 participants
Where: 3 sitesPeru
Study dates: 25 Jun 2020to 23 Nov 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

Healthcare workers in service during the COVID-19 outbreak including medical, nurse, technical, and auxiliary staff.
Negative rapid serologic and molecular testing for SARS-CoV-2.
Written informed consent.

Who cannot join

Presents COVID-19 symptoms including cough, fever, myalgias, headaches, loss of smell, and taste.
Prior (last 30 days), current or planned use (during study period) of hydroxychloroquine, chloroquine sulfate, or azithromycin.
Known cardiac disease or a history of prolonged QT syndrome.
Known allergy or intolerance to hydroxychloroquine and/or chloroquine sulfate.
Use of concomitant medications that are contraindicated with the use of hydroxychloroquine.
Other reported medical conditions, such as glucose-6-phosphate dehydrogenase deficiency, hepatic or renal insufficiency, or visual acuity or field disturbances, that make study participation not in the individual's best interest.

Trial locations and contacts

3 sites in 1 country.

Peru3 sites

Centro Médico Naval "Cirujano Mayor Santiago Távara"
Callao, 07006
Hospital Nacional Arzobispo Loayza
Lima, 15082
Hospital Cayetano Heredia
Lima, 15102

Other trials in Peru

About this study

Official title: Hydroxychloroquine to Prevent SARS-CoV-2 Infection Among Healthcare Workers: Randomized Controlled, Open-label, Phase 3 Clinical Trial

The purpose of this study is to determine whether hydroxychloroquine is an effective prophylactic regimen to prevent SARS-CoV-2 infection among healthcare workers. Participants will be randomized into two parallel groups. The first arm will evaluate the use of hydroxychloroquine every-other-day plus standard measures of protection for the prevention of SARS-CoV-2. The second arm will evaluate the use of standard measures of protection for the prevention of SARS-CoV-2. The target enrollment is 320 participants. Each study participant will be monitored for SARS-CoV-2 seroconversion in weekly visits or for the development of COVID-19 symptoms for 8 weeks.

Conditions: SARS-CoV-2
Being tested: Hydroxychloroquine
Keywords: SARS-CoV-2 infection, 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
A loading dose of 600mg of hydroxychloroquine orally on the first day, followed by 400mg of hydroxychloroquine orally every-other-day and use of standard measures of personal protection provided from the hospital for 8 weeks.

Study groups in NCT04414241
Study group	Role	What they receive
Hydroxychloroquine	Experimental	Hydroxychloroquine prophylaxis plus standard measures of personal protection. Receives: Drug: Hydroxychloroquine
Control	No intervention	Standard measures of personal protection.

What is being measured

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

Efficacy: Proportion of participants with positive molecular or serologic testing for SARS-CoV-2
Measured: Eight weeks
Safety: Proportion of participants with grade 3 or more adverse events
Measured: Eight weeks

Secondary outcomes (1)

Tolerability: Proportion of participants that discontinue prophylactic treatment due to grade 1 or 2 adverse events
Measured: Eight weeks

Timeline

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

25 Jun 202023 Nov 2020

First posted4 Jun 2020
Study start25 Jun 2020
Primary completion23 Nov 2020
Study completion23 Nov 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for SARS-CoV-2Studies 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
Masking: None (open label)
Enrolment: 68 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04414241
Sponsor's protocol ID: 202087
Other IDs: 20923
Status last verified: Jun 2020
First submitted: 1 Jun 2020
Last updated: 28 Oct 2021
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Llanos-Cuentas A, Schwalb A, Quintana JL, Delfin B, Alvarez F, Ugarte-Gil C, Guerra Gronerth RI, Lucchetti A, Grogl M, Gotuzzo E. Hydroxychloroquine to prevent SARS-CoV-2 infection among healthcare workers: early termination of a phase 3, randomised, open-label, controlled clinical trial. BMC Res Notes. 2023 Feb 28;16(1):22. doi: 10.1186/s13104-023-06281-7.
PubMed 36849996

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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All SARS-CoV-2 trials

Study at a glance

From the registry record, last updated by the sponsor on 28 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Hydroxychloroquine to Prevent SARS-CoV-2 Infection Among Healthcare Workers: Randomized Controlled, Open-label, Phase 3 Clinical Trial
ClinicalTrials.gov ID: NCT04414241
Acronym / sponsor ID: 202087
Conditions: SARS-CoV-2
Keywords: SARS-CoV-2 infection, Hydroxychloroquine
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 68 participants (actual)
Lead sponsor: Universidad Peruana Cayetano HerediaUniversity, hospital or other
Study start: 25 Jun 2020 (actual)
Primary completion: 23 Nov 2020 (actual)
Study completion: 23 Nov 2020 (actual)
First posted: 4 Jun 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.

Study design

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

Arm	Type	Receives
Hydroxychloroquine	Experimental	Drug: HydroxychloroquineHydroxychloroquine prophylaxis plus standard measures of personal protection.
Control	No intervention	–Standard measures of personal protection.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

Healthcare workers in service during the COVID-19 outbreak including medical, nurse, technical, and auxiliary staff.
Negative rapid serologic and molecular testing for SARS-CoV-2.
Written informed consent.

Key exclusion criteria (6 listed)

Presents COVID-19 symptoms including cough, fever, myalgias, headaches, loss of smell, and taste.
Prior (last 30 days), current or planned use (during study period) of hydroxychloroquine, chloroquine sulfate, or azithromycin.
Known cardiac disease or a history of prolonged QT syndrome.
Known allergy or intolerance to hydroxychloroquine and/or chloroquine sulfate.
Use of concomitant medications that are contraindicated with the use of hydroxychloroquine.

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
HydroxychloroquineA loading dose of 600mg of hydroxychloroquine orally on the first day, followed by 400mg of hydroxychloroquine orally every-other-day and use of standard measures of personal protection provided from the hospital for 8 weeks.	Drug	Hydroxychloroquine

Primary outcome

Efficacy: Proportion of participants with positive molecular or serologic testing for SARS-CoV-2
Time frame: Eight weeks
Safety: Proportion of participants with grade 3 or more adverse events
Time frame: Eight weeks

1 secondary outcome

Tolerability: Proportion of participants that discontinue prophylactic treatment due to grade 1 or 2 adverse events
Time frame: Eight weeks

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2021.
Derived from this study: PubMed 36849996Llanos-Cuentas A, Schwalb A, Quintana JL, Delfin B, Alvarez F, Ugarte-Gil C, Guerra Gronerth RI, Lucchetti A, Grogl M, Gotuzzo E. Hydroxychloroquine to prevent SARS-CoV-2 infection among healthcare workers: early termination of a phase 3, randomised, open-label, controlled clinical trial. BMC Res Notes. 2023 Feb 28;16(1):22. doi: 10.1186/s13104-023-06281-7.
Individual participant dataSharing planned: No

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Phase I Open-Label Safety Trial of Pembrolizumab for Neurological Post- Acute Sequelae of SARS-CoV-2 (PD1-PASC I)
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Active, not recruitingPhase 1
A Safety and Immunogenicity Trial of OCU500, ChAd36 Vector Encoding SARS-CoV-2 Spike Vaccine Via Intranasal and Inhalational Routes in Previously Vaccinated Adults
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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.

Alejandro Llanos, MD, PhD principal investigator

Universidad Peruana Cayetano Heredia

Eduardo Gotuzzo, MD study chair

Universidad Peruana Cayetano Heredia

Max Grogl, PhD study chair

U.S. Naval Medical Research Unit Six

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

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Hydroxychloroquine in people with SARS-CoV-2, run by Universidad Peruana Cayetano Heredia at 3 sites in Peru.

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 3 inclusion and 6 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 28 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Peru. 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 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Efficacy: Proportion of participants with positive molecular or serologic testing for SARS-CoV-2 (time frame: Eight weeks). The study lists 2 primary outcomes in all. 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 NCT04414241, which also lists 1 linked publication.

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 28 Oct 2021.