Treatment of COVID-19 Cases and Chemoprophylaxis of Contacts as Prevention (HCQ4COV19)
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ClinicalTrials.gov Identifier: NCT04304053 |
Recruitment Status :
Completed
First Posted : March 11, 2020
Last Update Posted : June 30, 2020
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Tracking Information | |||||||||||||||||||||
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First Submitted Date ICMJE | March 5, 2020 | ||||||||||||||||||||
First Posted Date ICMJE | March 11, 2020 | ||||||||||||||||||||
Last Update Posted Date | June 30, 2020 | ||||||||||||||||||||
Actual Study Start Date ICMJE | March 18, 2020 | ||||||||||||||||||||
Actual Primary Completion Date | June 15, 2020 (Final data collection date for primary outcome measure) | ||||||||||||||||||||
Current Primary Outcome Measures ICMJE |
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Original Primary Outcome Measures ICMJE |
Effectiveness of chemoprophylaxis assessed by incidence of secondary COVID-19 cases [ Time Frame: Up to 14 days after start of treatment ] Incidence of secondary cases among contacts of a case and contacts of contacts
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Change History | |||||||||||||||||||||
Current Secondary Outcome Measures ICMJE | Not Provided | ||||||||||||||||||||
Original Secondary Outcome Measures ICMJE |
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Current Other Pre-specified Outcome Measures | Not Provided | ||||||||||||||||||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||||||||||||||||||
Descriptive Information | |||||||||||||||||||||
Brief Title ICMJE | Treatment of COVID-19 Cases and Chemoprophylaxis of Contacts as Prevention | ||||||||||||||||||||
Official Title ICMJE | 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) | ||||||||||||||||||||
Brief 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). | ||||||||||||||||||||
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. |
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Study Type ICMJE | Interventional | ||||||||||||||||||||
Study Phase ICMJE | Phase 3 | ||||||||||||||||||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Intervention Model Description: Primary study: Cluster-randomized clinical trial of Covid-19 contacts Secondary study: Randomized clinical trial of Covid-19 cases Masking Description: Open label Primary Purpose: Prevention
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Condition ICMJE | COVID-19 | ||||||||||||||||||||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||||||||||||||||
Recruitment Status ICMJE | Completed | ||||||||||||||||||||
Actual Enrollment ICMJE |
2300 | ||||||||||||||||||||
Original Estimated Enrollment ICMJE |
2900 | ||||||||||||||||||||
Actual Study Completion Date ICMJE | June 15, 2020 | ||||||||||||||||||||
Actual Primary Completion Date | June 15, 2020 (Final data collection date for primary outcome measure) | ||||||||||||||||||||
Eligibility Criteria ICMJE | Study 1: Inclusion Criteria for a contact:
Exclusion Criteria for a contact:
Study 2: Inclusion Criteria for a case:
Exclusion Criteria for a case:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||||||||||||||||||
Accepts Healthy Volunteers ICMJE | Yes | ||||||||||||||||||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||||||||||||||||
Listed Location Countries ICMJE | Spain | ||||||||||||||||||||
Removed Location Countries | |||||||||||||||||||||
Administrative Information | |||||||||||||||||||||
NCT Number ICMJE | NCT04304053 | ||||||||||||||||||||
Other Study ID Numbers ICMJE | HCQ4COV19 2020-001031-27 ( EudraCT Number ) |
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Has Data Monitoring Committee | Yes | ||||||||||||||||||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Current Responsible Party | Oriol Mitja, Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia | ||||||||||||||||||||
Original Responsible Party | Oriol Mitja, Germans Trias i Pujol Hospital, Prof (Ass) Infectious Disease and Global Health | ||||||||||||||||||||
Current Study Sponsor ICMJE | Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia | ||||||||||||||||||||
Original Study Sponsor ICMJE | Lihir Medical Centre | ||||||||||||||||||||
Collaborators ICMJE |
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Investigators ICMJE | Not Provided | ||||||||||||||||||||
PRS Account | Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia | ||||||||||||||||||||
Verification Date | June 2020 | ||||||||||||||||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |