HCQ4COV19: Treatment of COVID-19 Cases and Chemoprophylaxis of Contacts as Prevention
Study Details
Study Description
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).
Condition or Disease | Intervention/Treatment | Phase |
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Phase 3 |
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.
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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Active Comparator: No Intervention- SARS-CoV-2 surveillance 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. |
Other: Standard Public Health measures
Isolation of patient and contact tracing as per national guidelines.
|
Experimental: Testing, treatment and prophylaxis of SARS-CoV-2 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. |
Drug: Treatment and prophylaxis
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.
Other: Standard Public Health measures
Isolation of patient and contact tracing as per national guidelines.
|
Outcome Measures
Primary Outcome Measures
- Study 1- Clinical and virological outcome in exposed contacts [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 [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 [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 [Up to 28 days after start of treatment]
Time from randomization to complete resolution of symptoms at an extended 28-days follow-
Eligibility Criteria
Criteria
Study 1:
Inclusion Criteria for a contact:
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Asymptomatic individuals exposed to a PCR confirmed COVID19 case within 7 days as either a healthcare worker or household contact
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Aged ≥18 years male or female;
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In women of childbearing potential, negative pregnancy test and commitment to use contraceptive method throughout the study.
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Willing to take study medication;
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Willing to comply with all study procedures;
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Able to provide oral, informed consent and/or assent.
Exclusion Criteria for a contact:
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With known history of cardiac arrhythmia (or QT prolongation syndrome);
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Unable to take drugs by mouth;
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With significantly abnormal liver function (Child Pugh C)
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Need of dialysis treatment, or GFR≤30 mL/min/1.73 m2;
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Participants with psoriasis, myasthenia, haematopoietic and retinal diseases,CNS-related hearing loss or glucose-6-phosphate dehydrogenase deficit;
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Persons already treated with any of the study drugs during the last 30 days;
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Pregnant or lactating women;
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Any contraindications as per the Data Sheet of Hydroxychloroquine.
Study 2:
Inclusion Criteria for a case:
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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)
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Aged ≥18 years male or female;
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In women of childbearing potential, negative pregnancy test and commitment to use contraceptive method throughout the study.
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Willing to take study medication
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Willing to comply with all study procedures, including repeat nasal swab at day 3
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Able to provide oral and written informed consent
Exclusion Criteria for a case:
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Hospital admission
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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;
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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;
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Participants under treatment with medications likely to interfere with experimental drugs
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Unable to take drugs by mouth;
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With significantly abnormal liver function (Child Pugh C)
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Need of dialysis treatment, or GFR≤30 mL/min/1.73 m2;
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Participants with psoriasis, myasthenia, haematopoietic and retinal diseases,CNS-related hearing loss or glucose-6-phosphate dehydrogenase deficit
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Participants with severe neurological and mental illness;
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Pregnant or lactating women;
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Inability to consent and/or comply with study protocol;
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Individuals with known hypersensitivity to the study drugs.
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Persons already treated with any of the study drugs during the last 30 days.
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Any contraindications as per the Data Sheet of Hydroxychloroquine.
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Departament de Salut | Barcelona | Spain |
Sponsors and Collaborators
- Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia
- Germans Trias i Pujol Hospital
- Department of Health, Generalitat de Catalunya
- Laboratorios Gebro Pharma SA
- Laboratorios Rubió
- Institut Catala de Salut
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- HCQ4COV19
- 2020-001031-27