COVID-19Phase 3PrEP_COVIDNCT04331834
Pre-Exposure Prophylaxis With Hydroxychloroquine for High-Risk Healthcare Workers During the COVID-19 Pandemic
A Phase 3 study testing Hydroxychloroquine in people with COVID-19, run by Barcelona Institute for Global Health at 1 site in Spain.
Trial summary
The investigators aim to evaluate the efficacy of pre-exposure prophylaxis with hydroxychloroquine in healthcare workers with high-risk of SARS-CoV-2 infection. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy 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?
- Yes, some participants may receive a placebo
- How many people
- 275 participants
- Where
- 1 siteSpain
- Study dates
- 3 Apr 2020to 31 Dec 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
- Age ≥ 18 years
- Negative PCR and negative serology on day 0
- Healthcare worker at any of the trial sites
- Female participants: negative for pregnancy test
- Willing to participate in the study
- Able to sign the informed consent form
Who cannot join
- Age <18 years
- Pregnancy or breastfeeding
- Ongoing antiviral or antiretroviral treatment or HIV positive
- Ongoing anti-inflammatory treatment (corticosteroids)
- Ongoing or previous (1 month) chloroquine or hydroxychloroquine treatment
- Confirmed case of SARS-CoV-2 infection (positive PCR) at day 0
Show all 21Show fewer
- Positive serology for SARS-CoV-1 infection at day 0
- Impossibility of signing the informed consent form
- Rejection of participation
- Working less than 3 days a week in the Hospital Clinic of Barcelona.
- Any contraindication for hydroxychloroquine treatment:
- Hydroxychloroquine hypersensitivity or 4-aminoquinoline hypersensitivity
- Retinopathy, visual field or visual acuity disturbances
- QT prolongation, bradycardia (<50bpm), ventricular tachycardia, other arrhythmias, as determined on day 0 ECG or medical history
- Potassium < 3 mEq/L or AST or ALT > 5 upper normal limit, as determined on day 0 blood test
- Previous myocardial infarction
- Myasthenia gravis
- Porphyria
- Glomerular clearance < 10ml/min
- Previous history of severe hypoglycaemia
- Ongoing treatment with antimalarials, antiarrhythmic, tricyclic antidepressants, selective serotonin reuptake inhibitors, natalizumab, quinolones, macrolides, agalsidase alfa and beta.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pre-Exposure Prophylaxis With Hydroxychloroquine for High-Risk Healthcare Workers During the COVID-19 Pandemic: A Multicentre, Double-Blinded Randomized Controlled Trial
The investigators aim to evaluate the efficacy of pre-exposure prophylaxis with hydroxychloroquine in healthcare workers with high-risk of SARS-CoV-2 infection.
- Conditions
- COVID-19
- Being tested
- Hydroxychloroquine, Placebos
- Keywords
- PrEP, hydroxychloroquine, prophylaxis, pre-exposure, healthcare workers
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hydroxychloroquine with the following dosage:
- day 0: 400 mg (2 tablets)
- day 1: 400 mg (2 tablets)
- day 2: 400 mg (2 tablets)
- day 3: 400 mg (2 tablets)
- weekly: 400 mg (2 tablets) for a period of six months
PlacebosDrug
Placebo with the following dosage:
- day 0: 400 mg (2 tablets)
- day 1: 400 mg (2 tablets)
- day 2: 400 mg (2 tablets)
- day 3: 400 mg (2 tablets)
- weekly: 400 mg (2 tablets) for a period of six months
| Study group | Role | What they receive |
|---|---|---|
| Pre-exposure prophylaxis of SARS-CoV-2 | Experimental | Participants will receive hydroxychloroquine 400 mg daily during the first 4 days, followed by 400 mg weekly during 6 months Receives: Drug: Hydroxychloroquine |
| Control group with placebo | Placebo comparator | Participants will receive placebo 400 mg daily during the first 4 days, followed by 400 mg weekly during 6 months Receives: Drug: Placebos |
What is being measured
The primary outcome is the main question the study is designed to answer.
Confirmed cases of a COVID-19
Confirmed cases of a COVID-19 (defined by a positive PCR for SARS-CoV-2 or symptoms compatible with COVID-19 with seroconversion) in the PrEP group compared to the placebo group at any time during the 6 months of the follow-up in healthcare workers with negative PCR for SARS-CoV-2 on day 0 and negative serology for SARS-CoV-2 on day 0.
Measured: Up to 6 months after start of treatment
Secondary outcomes (5)
SARS-CoV-2 seroconversion
SARS-CoV-2 seroconversion in the PrEP group compared to placebo in during 6 months of follow-up in healthcare workers with negative serology at day 0.
Measured: Up to 6 months after start of treatment
Occurrence of any adverse event related with hydroxychloroquine treatment
Incidence of clinical and/or laboratory adverse events will be compared in the PrEP group and in the placebo arm.
Measured: Up to 6 months after start of treatment
Incidence of SARS-CoV-2 infection and COVID-19 among healthcare workers
Incidence of SARS-CoV-2 infection and COVID-19 among healthcare workers will be estimated by the number of healthcare workers diagnosed with COVID-19 in the placebo group, among the total of healthcare workers included in the non-PrEP group during the study period.
Measured: Up to 6 months after start of treatment
Risk ratio for the different clinical, analytical and microbiological conditions to develop COVID-19
Measured: Up to 6 months after start of treatment
COVID-19 Biobank
A repository (biobank) of serum samples obtained from healthcare workers confirmed COVID-19 cases for future research on blood markers to predict SARS-CoV-2 infection.
Measured: Up to 6 months after start of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2020
- Study start3 Apr 2020
- Primary completion25 Jun 2020
- Study completion31 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for COVID-19Studies 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 275 participants (actual)
Sponsor and investigators
- Lead sponsor
- Barcelona Institute for Global Health
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital Clinic of Barcelona, Laboratorios Rubió, Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau, Hospital Plató, Hospital de Granollers
- Responsible party
- Sponsor
- Investigators
- Jose Muñoz Gutiérrez, MD, PhD, Principal investigator, Barcelona Institute for Global Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04331834
- Sponsor's protocol ID
- PrEP_COVID
- Acronym
- PrEP_COVID
- Status last verified
- Apr 2023
- First submitted
- 1 Apr 2020
- Last updated
- 1 May 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Grau-Pujol B, Camprubi-Ferrer D, Marti-Soler H, Fernandez-Pardos M, Carreras-Abad C, Andres MV, Ferrer E, Muelas-Fernandez M, Jullien S, Barilaro G, Ajanovic S, Vera I, Moreno L, Gonzalez-Redondo E, Cortes-Serra N, Roldan M, Arcos AA, Mur I, Domingo P, Garcia F, Guinovart C, Munoz J. Pre-exposure prophylaxis with hydroxychloroquine for COVID-19: a double-blind, placebo-controlled randomized clinical trial. Trials. 2021 Nov 15;22(1):808. doi: 10.1186/s13063-021-05758-9.
PubMed 34781981Grau-Pujol B, Camprubi D, Marti-Soler H, Fernandez-Pardos M, Guinovart C, Munoz J. Pre-exposure prophylaxis with hydroxychloroquine for high-risk healthcare workers during the COVID-19 pandemic: A structured summary of a study protocol for a multicentre, double-blind randomized controlled trial. Trials. 2020 Jul 29;21(1):688. doi: 10.1186/s13063-020-04621-7.
PubMed 32727613
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pre-Exposure Prophylaxis With Hydroxychloroquine for High-Risk Healthcare Workers During the COVID-19 Pandemic: A Multicentre, Double-Blinded Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04331834
- Acronym / sponsor ID
- PrEP_COVID / PrEP_COVID
- Conditions
- COVID-19
- Keywords
- PrEP, hydroxychloroquine, prophylaxis, pre-exposure, healthcare workers
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 275 participants (actual)
- Lead sponsor
- Barcelona Institute for Global HealthUniversity, hospital or other
- Collaborators
- Hospital Clinic of Barcelona, Laboratorios Rubió, Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau, Hospital Plató, Hospital de Granollers
- Study start
- 3 Apr 2020 (actual)
- Primary completion
- 25 Jun 2020 (actual)
- Study completion
- 31 Dec 2020 (actual)
- First posted
- 2 Apr 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 investigators aim to evaluate the efficacy of pre-exposure prophylaxis with hydroxychloroquine in healthcare workers with high-risk of SARS-CoV-2 infection.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pre-exposure prophylaxis of SARS-CoV-2 | Experimental | Drug: HydroxychloroquineParticipants will receive hydroxychloroquine 400 mg daily during the first 4 days, followed by 400 mg weekly during 6 months |
| Control group with placebo | Placebo comparator | Drug: PlacebosParticipants will receive placebo 400 mg daily during the first 4 days, followed by 400 mg weekly during 6 months |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age ≥ 18 years
- Negative PCR and negative serology on day 0
- Healthcare worker at any of the trial sites
- Female participants: negative for pregnancy test
- Willing to participate in the study
Key exclusion criteria (21 listed)
- Age <18 years
- Pregnancy or breastfeeding
- Ongoing antiviral or antiretroviral treatment or HIV positive
- Ongoing anti-inflammatory treatment (corticosteroids)
- Ongoing or previous (1 month) chloroquine or hydroxychloroquine treatment
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 |
|---|---|---|
| HydroxychloroquineHydroxychloroquine with the following dosage: * day 0: 400 mg (2 tablets) * day 1: 400 mg (2 tablets) * day 2: 400 mg (2 tablets) * day 3: 400 mg (2 tablets) * weekly: 400 mg (2 tablets) for a period of six months | Drug | Pre-exposure prophylaxis of SARS-CoV-2 |
| PlacebosPlacebo with the following dosage: * day 0: 400 mg (2 tablets) * day 1: 400 mg (2 tablets) * day 2: 400 mg (2 tablets) * day 3: 400 mg (2 tablets) * weekly: 400 mg (2 tablets) for a period of six months | Drug | Control group with placebo |
Primary outcome
Confirmed cases of a COVID-19
Time frame: Up to 6 months after start of treatment
Confirmed cases of a COVID-19 (defined by a positive PCR for SARS-CoV-2 or symptoms compatible with COVID-19 with seroconversion) in the PrEP group compared to the placebo group at any time during the 6 months of the follow-up in healthcare workers with negative PCR for SARS-CoV-2 on day 0 and negative serology for SARS-CoV-2 on day 0.
5 secondary outcomes
SARS-CoV-2 seroconversion
Time frame: Up to 6 months after start of treatment
Occurrence of any adverse event related with hydroxychloroquine treatment
Time frame: Up to 6 months after start of treatment
Incidence of SARS-CoV-2 infection and COVID-19 among healthcare workers
Time frame: Up to 6 months after start of treatment
Risk ratio for the different clinical, analytical and microbiological conditions to develop COVID-19
Time frame: Up to 6 months after start of treatment
COVID-19 Biobank
Time frame: Up to 6 months after start of treatment
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 1 May 2023.
- Derived from this study: PubMed 34781981Grau-Pujol B, Camprubi-Ferrer D, Marti-Soler H, Fernandez-Pardos M, Carreras-Abad C, Andres MV, Ferrer E, Muelas-Fernandez M, Jullien S, Barilaro G, Ajanovic S, Vera I, Moreno L, Gonzalez-Redondo E, Cortes-Serra N, Roldan M, Arcos AA, Mur I, Domingo P, Garcia F, Guinovart C, Munoz J. Pre-exposure prophylaxis with hydroxychloroquine for COVID-19: a double-blind, placebo-controlled randomized clinical trial. Trials. 2021 Nov 15;22(1):808. doi: 10.1186/s13063-021-05758-9.
- Derived from this study: PubMed 32727613Grau-Pujol B, Camprubi D, Marti-Soler H, Fernandez-Pardos M, Guinovart C, Munoz J. Pre-exposure prophylaxis with hydroxychloroquine for high-risk healthcare workers during the COVID-19 pandemic: A structured summary of a study protocol for a multicentre, double-blind randomized controlled trial. Trials. 2020 Jul 29;21(1):688. doi: 10.1186/s13063-020-04621-7.
- 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.
Jose Muñoz Gutiérrez, MD, PhD principal investigator
Barcelona Institute for Global Health
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 Hydroxychloroquine in people with COVID-19, run by Barcelona Institute for Global Health at 1 site in Spain.
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 6 inclusion and 21 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 1 May 2023. 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 Spain. 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 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?
Confirmed cases of a COVID-19 (time frame: Up to 6 months after start of treatment). 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 NCT04331834, which also lists 2 linked publications.
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 1 May 2023.