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Treatment of COVID-19 Cases and Chemoprophylaxis of Contacts as Prevention (HCQ4COV19)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04304053
Recruitment Status : Completed
First Posted : March 11, 2020
Last Update Posted : June 30, 2020
Sponsor:
Collaborators:
Germans Trias i Pujol Hospital
Department of Health, Generalitat de Catalunya
Laboratorios Gebro Pharma SA
Laboratorios Rubió
Institut Catala de Salut
Information provided by (Responsible Party):
Oriol Mitja, Fundacio Lluita Contra la SIDA

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
COVID-19 Drug: Treatment and prophylaxis Other: Standard Public Health measures 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.

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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
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.




Primary Outcome Measures :
  1. 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

  2. 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

  3. 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.

  4. 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-



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Study 1:

Inclusion Criteria for a contact:

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

Exclusion Criteria for a contact:

  1. With known history of cardiac arrhythmia (or QT prolongation syndrome);
  2. Unable to take drugs by mouth;
  3. With significantly abnormal liver function (Child Pugh C)
  4. Need of dialysis treatment, or GFR≤30 mL/min/1.73 m2;
  5. Participants with psoriasis, myasthenia, haematopoietic and retinal diseases,CNS-related hearing loss or glucose-6-phosphate dehydrogenase deficit;
  6. Persons already treated with any of the study drugs during the last 30 days;
  7. Pregnant or lactating women;
  8. Any contraindications as per the Data Sheet of Hydroxychloroquine.

Study 2:

Inclusion Criteria for a case:

  1. 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)
  2. Aged ≥18 years male or female;
  3. In women of childbearing potential, negative pregnancy test and commitment to use contraceptive method throughout the study.
  4. Willing to take study medication
  5. Willing to comply with all study procedures, including repeat nasal swab at day 3
  6. Able to provide oral and written informed consent

Exclusion Criteria for a case:

  1. Hospital admission
  2. 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;
  3. 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;
  4. Participants under treatment with medications likely to interfere with experimental drugs
  5. Unable to take drugs by mouth;
  6. With significantly abnormal liver function (Child Pugh C)
  7. Need of dialysis treatment, or GFR≤30 mL/min/1.73 m2;
  8. Participants with psoriasis, myasthenia, haematopoietic and retinal diseases,CNS-related hearing loss or glucose-6-phosphate dehydrogenase deficit
  9. Participants with severe neurological and mental illness;
  10. Pregnant or lactating women;
  11. Inability to consent and/or comply with study protocol;
  12. Individuals with known hypersensitivity to the study drugs.
  13. Persons already treated with any of the study drugs during the last 30 days.
  14. Any contraindications as per the Data Sheet of Hydroxychloroquine.

Information from the National Library of Medicine

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


Locations
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Spain
Departament de Salut
Barcelona, Spain
Sponsors and Collaborators
Fundacio Lluita Contra la SIDA
Germans Trias i Pujol Hospital
Department of Health, Generalitat de Catalunya
Laboratorios Gebro Pharma SA
Laboratorios Rubió
Institut Catala de Salut
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Responsible Party: Oriol Mitja, Prof (Ass) Infectious Disease and Global Health, Fundacio Lluita Contra la SIDA
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

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No