Treatment of COVID-19 Cases and Chemoprophylaxis of Contacts as Prevention (HCQ4COV19)
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| ClinicalTrials.gov Identifier: NCT04304053 |
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Recruitment Status :
Completed
First Posted : March 11, 2020
Last Update Posted : June 30, 2020
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| COVID-19 | Drug: Treatment and prophylaxis Other: Standard Public Health measures | Phase 3 |
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 Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 2300 participants |
| 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: | None (Open Label) |
| Masking Description: | Open label |
| Primary Purpose: | Prevention |
| 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) |
| Actual Study Start Date : | March 18, 2020 |
| Actual Primary Completion Date : | June 15, 2020 |
| Actual Study Completion Date : | June 15, 2020 |
| 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. |
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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. |
- 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-
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Yes |
Study 1:
Inclusion Criteria for a contact:
- 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.
Exclusion Criteria for a contact:
- 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;
- Pregnant or lactating women;
- Any contraindications as per the Data Sheet of Hydroxychloroquine.
Study 2:
Inclusion Criteria for a case:
- 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
Exclusion Criteria for a case:
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04304053
| Spain | |
| Departament de Salut | |
| Barcelona, Spain | |
| Responsible Party: | Oriol Mitja, Prof (Ass) Infectious Disease and Global Health, Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia |
| ClinicalTrials.gov Identifier: | NCT04304053 |
| Other Study ID Numbers: |
HCQ4COV19 2020-001031-27 ( EudraCT Number ) |
| First Posted: | March 11, 2020 Key Record Dates |
| Last Update Posted: | June 30, 2020 |
| Last Verified: | June 2020 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | Yes |
| Plan Description: | Open access |
| Supporting Materials: |
Study Protocol Statistical Analysis Plan (SAP) Informed Consent Form (ICF) Clinical Study Report (CSR) Analytic Code |
| Time Frame: | 30 days after start of treatment |
| Access Criteria: | Open access for everybody |
| URL: | http://www.estudicovid19.org |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
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COVID-19 Coronavirus Infections Coronaviridae Infections Pneumonia, Viral Pneumonia Respiratory Tract Infections |
Infections Virus Diseases Nidovirales Infections RNA Virus Infections Lung Diseases Respiratory Tract Diseases |