COVID-19Phase 3HCQ4COV19NCT04304053

Treatment of COVID-19 Cases and Chemoprophylaxis of Contacts as Prevention

A Phase 3 study testing Treatment and prophylaxis and Standard Public Health measures in people with COVID-19, run by Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia at 1 site in Spain.

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

This study is a research project to evaluate the efficacy of hydroxychloroquine for post-exposure prophylaxis and early treatment of Covid-19. The intervention entails administering prophylactic hydroxychloroquine to all contacts (Study 1) and treating non severe confirmed cases with hydroxychloroquine (Study 2). 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?: Treatment and prophylaxis and Standard Public Health measures
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 2,300 participants
Where: 1 siteSpain
Study dates: 18 Mar 2020to 15 Jun 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

Asymptomatic individuals exposed to a PCR confirmed COVID19 case within 7 days as either a healthcare worker or household contact
Aged ≥18 years male or female;
In women of childbearing potential, negative pregnancy test and commitment to use contraceptive method throughout the study.
Willing to take study medication;
Willing to comply with all study procedures;
Able to provide oral, informed consent and/or assent.

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Patients who meet the requirements of the New Coronavirus Infection Diagnosis (Acute <5 days respiratory infection symptoms, or fever alone, or acute cough alone and positive PCR)
Aged ≥18 years male or female;
In women of childbearing potential, negative pregnancy test and commitment to use contraceptive method throughout the study.
Willing to take study medication
Willing to comply with all study procedures, including repeat nasal swab at day 3
Able to provide oral and written informed consent

Who cannot join

With known history of cardiac arrhythmia (or QT prolongation syndrome);
Unable to take drugs by mouth;
With significantly abnormal liver function (Child Pugh C)
Need of dialysis treatment, or GFR≤30 mL/min/1.73 m2;
Participants with psoriasis, myasthenia, haematopoietic and retinal diseases,CNS-related hearing loss or glucose-6-phosphate dehydrogenase deficit;
Persons already treated with any of the study drugs during the last 30 days;

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Pregnant or lactating women;
Any contraindications as per the Data Sheet of Hydroxychloroquine.
Study 2:
Hospital admission
Serious condition meeting one of the following: (1) respiratory distress with respiratory rate >=30 breaths/min; (2) oxygen saturation<=93% on quiet status; (3) Arterial partial pressure of oxygen (PaO2)/oxygen concentration<=300mmHg;
Critically ill patients meeting one of the following: (1) Experience respiratory failure and need to receive mechanical ventilation; (2) Experience shock; (3) Complicated with other organs failure and need intensive care and therapy in ICU;
Participants under treatment with medications likely to interfere with experimental drugs
Unable to take drugs by mouth;
With significantly abnormal liver function (Child Pugh C)
Need of dialysis treatment, or GFR≤30 mL/min/1.73 m2;
Participants with psoriasis, myasthenia, haematopoietic and retinal diseases,CNS-related hearing loss or glucose-6-phosphate dehydrogenase deficit
Participants with severe neurological and mental illness;
Pregnant or lactating women;
Inability to consent and/or comply with study protocol;
Individuals with known hypersensitivity to the study drugs.
Persons already treated with any of the study drugs during the last 30 days.
Any contraindications as per the Data Sheet of Hydroxychloroquine.

Trial locations and contacts

1 site in 1 country.

Spain1 site

Departament de Salut
Barcelona

Other trials in Spain

About this study

Official title: Treatment of Non-severe Confirmed Cases of COVID-19 and Chemoprophylaxis of Their Contacts as Prevention Strategy: a Cluster Randomized Clinical Trial (PEP CoV-2 Study)

Read the detailed description

Hydroxychloroquine (HCQ) is a drug that has been extensively used for the prevention of malaria. HCQ showed excellent in vitro results and strong antiviral effects on SARS-CoV-2 infection of primate cells at low concentration. Empirical data for the efficacy of HCQ in hospitalized Covid-19 patients became available after the start of this study; HCQ administration did not result in a significantly higher PCR negative conversion in a RCT including 150 patients and there was no reduction in the risk of death/intubation in two large observational studies.

Study 1 -We investigated the efficacy and safety of HCQ to prevent secondary SARS-CoV-2 infection and Covid-19 disease in contacts exposed to a PCR-positive Covid-19 case during.

Study 2- We also conducted a study to test the hypothesis that HCQ treatment would be more efficacious than no-treatment for patients with mild Covid-19.

Initially, the protocol included the use of combined treatment with a HIV protease inhibidor (cobicistat-boosted darunavir) for cases (study 2), but it was adapted to HCQ alone after the recommendation of the pharmaceutical company not to use DRVc for the treatment of Covid-19 due to lack of activity in-vitro.

Conditions: COVID-19
Being tested: Treatment and prophylaxis, Standard Public Health measures
Medical subject headings: COVID-19

What participants receive

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

Treatment and prophylaxisDrug
Cases will be offered a therapeutic regimen hydroxychloroquine (200mg tablets) 800mg on day 1, and 400mg on days 2-7
Contacts will be offered a prophylactic regimen of hydroxychloroquine (200mg tablets) 800mg on day 1, and 400mg on days 2-7.
Standard Public Health measuresOther
Isolation of patient and contact tracing as per national guidelines.

Study groups in NCT04304053
Study group	Role	What they receive
No Intervention- SARS-CoV-2 surveillance	Active comparator	Study 1- Contacts will complete a survey collecting demographic, epidemiological and clinical data and provides a swab for RT-PCR testing at baseline and day 14. Study 2- Index case completes a survey collecting demographic, epidemiological and clinical data and provides a swab for RT-PCR testing at baseline and on days 3 and 7. Isolation of patient and contact tracing as per national guidelines. Receives: Other: Standard Public Health measures
Testing, treatment and prophylaxis of SARS-CoV-2	Experimental	Study 1- Contacts receive Hydroxychloroquine prophylaxis. Contacts will complete a survey collecting demographic, epidemiological and clinical and provides a swab for RT-PCR testing at baseline and day 14. Study 2- Index case receives Hydroxychloroquine. Index case completes a survey collecting demographic, epidemiological and clinical data and provides a swab for RT-PCR testing at baseline and on days 3, and 7. Isolation of patient and contact tracing as per national guidelines. Receives: Drug: Treatment and prophylaxis; Other: Standard Public Health measures

What is being measured

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

Study 1- Clinical and virological outcome in exposed contacts
Incidence of secondary PCR confirmed symptomatic Covid-19 episodes among contacts after high risk PCR+ exposure
Measured: Up to 14 days after start of treatment
Study 1- Transmission of SARS-CoV-2 in exposed contacts
Incidence of symptomatically compatible or a PCR-positive result regardless of symptoms
Measured: Up to 14 days after start of treatment
Study 2- Virological outcome in index cases
Reduction of viral RNA load in nasopharyngeal swabs at days 3, and 7 after treatment start.
Measured: Up to 7 days after start of treatment
Study 2- Clinical outcome in index cases
Time from randomization to complete resolution of symptoms at an extended 28-days follow-
Measured: Up to 28 days 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.

18 Mar 202015 Jun 2020

First posted11 Mar 2020
Study start18 Mar 2020
Primary completion15 Jun 2020
Study completion15 Jun 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
Model description: Primary study: Cluster-randomized clinical trial of Covid-19 contacts Secondary study: Randomized clinical trial of Covid-19 cases
Masking: None (open label)
Enrolment: 2,300 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04304053
Sponsor's protocol ID: HCQ4COV19
Other IDs: 2020-001031-27
Acronym: HCQ4COV19
Status last verified: Jun 2020
First submitted: 5 Mar 2020
Last updated: 30 Jun 2020
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: Open access

Publications

Akhtar S, Das JK, Ismail T, Wahid M, Saeed W, Bhutta ZA. Nutritional perspectives for the prevention and mitigation of COVID-19. Nutr Rev. 2021 Feb 11;79(3):289-300. doi: 10.1093/nutrit/nuaa063.
PubMed 33570583
Mitja O, Corbacho-Monne M, Ubals M, Alemany A, Suner C, Tebe C, Tobias A, Penafiel J, Ballana E, Perez CA, Admella P, Riera-Marti N, Laporte P, Mitja J, Clua M, Bertran L, Sarquella M, Gavilan S, Ara J, Argimon JM, Cuatrecasas G, Canadas P, Elizalde-Torrent A, Fabregat R, Farre M, Forcada A, Flores-Mateo G, Lopez C, Muntada E, Nadal N, Narejos S, Nieto A, Prat N, Puig J, Quinones C, Ramirez-Viaplana F, Reyes-Uruena J, Riveira-Munoz E, Ruiz L, Sanz S, Sentis A, Sierra A, Velasco C, Vivanco-Hidalgo RM, Zamora J, Casabona J, Vall-Mayans M, Gonzalez-Beiras C, Clotet B; BCN-PEP-CoV2 Research Group. A Cluster-Randomized Trial of Hydroxychloroquine for Prevention of Covid-19. N Engl J Med. 2021 Feb 4;384(5):417-427. doi: 10.1056/NEJMoa2021801. Epub 2020 Nov 24.
PubMed 33289973

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?

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Study at a glance

From the registry record, last updated by the sponsor on 30 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Treatment of Non-severe Confirmed Cases of COVID-19 and Chemoprophylaxis of Their Contacts as Prevention Strategy: a Cluster Randomized Clinical Trial (PEP CoV-2 Study)
ClinicalTrials.gov ID: NCT04304053
Acronym / sponsor ID: HCQ4COV19 / HCQ4COV19
Conditions: COVID-19
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 2,300 participants (actual)
Lead sponsor: Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la CienciaUniversity, hospital or other
Collaborators: Germans Trias i Pujol Hospital, Department of Health, Generalitat de Catalunya, Laboratorios Gebro Pharma SA, Laboratorios Rubió, Institut Catala de Salut
Study start: 18 Mar 2020 (actual)
Primary completion: 15 Jun 2020 (actual)
Study completion: 15 Jun 2020 (actual)
First posted: 11 Mar 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.

Detailed description

Study 1 -We investigated the efficacy and safety of HCQ to prevent secondary SARS-CoV-2 infection and Covid-19 disease in contacts exposed to a PCR-positive Covid-19 case during.

Study 2- We also conducted a study to test the hypothesis that HCQ treatment would be more efficacious than no-treatment for patients with mild Covid-19.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2
Model description: Primary study: Cluster-randomized clinical trial of Covid-19 contacts Secondary study: Randomized clinical trial of Covid-19 cases

Arm	Type	Receives
No Intervention- SARS-CoV-2 surveillance	Active comparator	Other: Standard Public Health measuresStudy 1- Contacts will complete a survey collecting demographic, epidemiological and clinical data and provides a swab for RT-PCR testing at baseline and day 14. Study 2- Index case completes a survey collecting demographic, epidemiological and clinical data and provides a swab for RT-PCR testing at baseline and on days 3 and 7. Isolation of patient and contact tracing as per national guidelines.
Testing, treatment and prophylaxis of SARS-CoV-2	Experimental	Drug: Treatment and prophylaxis, Other: Standard Public Health measuresStudy 1- Contacts receive Hydroxychloroquine prophylaxis. Contacts will complete a survey collecting demographic, epidemiological and clinical and provides a swab for RT-PCR testing at baseline and day 14. Study 2- Index case receives Hydroxychloroquine. Index case completes a survey collecting demographic, epidemiological and clinical data and provides a swab for RT-PCR testing at baseline and on days 3, and 7. Isolation of patient and contact tracing as per national guidelines.

Who may qualify

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

Key inclusion criteria (12 listed)

Asymptomatic individuals exposed to a PCR confirmed COVID19 case within 7 days as either a healthcare worker or household contact
Aged ≥18 years male or female;
In women of childbearing potential, negative pregnancy test and commitment to use contraceptive method throughout the study.
Willing to take study medication;
Willing to comply with all study procedures;

Key exclusion criteria (23 listed)

With known history of cardiac arrhythmia (or QT prolongation syndrome);
Unable to take drugs by mouth;
With significantly abnormal liver function (Child Pugh C)
Need of dialysis treatment, or GFR≤30 mL/min/1.73 m2;
Participants with psoriasis, myasthenia, haematopoietic and retinal diseases,CNS-related hearing loss or glucose-6-phosphate dehydrogenase deficit;

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
Treatment and prophylaxisCases will be offered a therapeutic regimen hydroxychloroquine (200mg tablets) 800mg on day 1, and 400mg on days 2-7 Contacts will be offered a prophylactic regimen of hydroxychloroquine (200mg tablets) 800mg on day 1, and 400mg on days 2-7.	Drug	Testing, treatment and prophylaxis of SARS-CoV-2
Standard Public Health measuresIsolation of patient and contact tracing as per national guidelines.	Other	No Intervention- SARS-CoV-2 surveillance, Testing, treatment and prophylaxis of SARS-CoV-2

Primary outcome

Study 1- Clinical and virological outcome in exposed contacts
Time frame: Up to 14 days after start of treatment
Incidence of secondary PCR confirmed symptomatic Covid-19 episodes among contacts after high risk PCR+ exposure
Study 1- Transmission of SARS-CoV-2 in exposed contacts
Time frame: Up to 14 days after start of treatment
Incidence of symptomatically compatible or a PCR-positive result regardless of symptoms
Study 2- Virological outcome in index cases
Time frame: Up to 7 days after start of treatment
Reduction of viral RNA load in nasopharyngeal swabs at days 3, and 7 after treatment start.
Study 2- Clinical outcome in index cases
Time frame: Up to 28 days after start of treatment
Time from randomization to complete resolution of symptoms at an extended 28-days follow-

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 30 Jun 2020.
Derived from this study: PubMed 33570583Akhtar S, Das JK, Ismail T, Wahid M, Saeed W, Bhutta ZA. Nutritional perspectives for the prevention and mitigation of COVID-19. Nutr Rev. 2021 Feb 11;79(3):289-300. doi: 10.1093/nutrit/nuaa063.
Derived from this study: PubMed 33289973Mitja O, Corbacho-Monne M, Ubals M, Alemany A, Suner C, Tebe C, Tobias A, Penafiel J, Ballana E, Perez CA, Admella P, Riera-Marti N, Laporte P, Mitja J, Clua M, Bertran L, Sarquella M, Gavilan S, Ara J, Argimon JM, Cuatrecasas G, Canadas P, Elizalde-Torrent A, Fabregat R, Farre M, Forcada A, Flores-Mateo G, Lopez C, Muntada E, Nadal N, Narejos S, Nieto A, Prat N, Puig J, Quinones C, Ramirez-Viaplana F, Reyes-Uruena J, Riveira-Munoz E, Ruiz L, Sanz S, Sentis A, Sierra A, Velasco C, Vivanco-Hidalgo RM, Zamora J, Casabona J, Vall-Mayans M, Gonzalez-Beiras C, Clotet B; BCN-PEP-CoV2 Research Group. A Cluster-Randomized Trial of Hydroxychloroquine for Prevention of Covid-19. N Engl J Med. 2021 Feb 4;384(5):417-427. doi: 10.1056/NEJMoa2021801. Epub 2020 Nov 24.
Individual participant dataSharing planned: Yes. Open access

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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?

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 12 inclusion and 23 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 30 Jun 2020. 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. 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?

Study 1- Clinical and virological outcome in exposed contacts (time frame: Up to 14 days after start of treatment). The study lists 4 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 NCT04304053, 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 30 Jun 2020.