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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

Tracking Information
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
 (submitted: June 26, 2020)
  • 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-
Original Primary Outcome Measures  ICMJE
 (submitted: March 7, 2020)
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
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE
 (submitted: March 7, 2020)
  • The virological clearance rate of throat swabs, sputum, or lower respiratory tract secretions at days 3 [ Time Frame: 3 days after start of treatment ]
  • The mortality rate of subjects at weeks 2 [ Time Frame: Up to 14 days after start of treatment ]
  • Proportion of participants that drop out of study [ Time Frame: Up to 14 days after start of treatment ]
  • Proportion of participants that show non-compliance with study drug [ Time Frame: Up to 14 days after start of treatment ]
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.

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: None (Open Label)
Masking Description:
Open label
Primary Purpose: Prevention
Condition  ICMJE COVID-19
Intervention  ICMJE
  • 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 Arms  ICMJE
  • 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.

    Intervention: Other: Standard Public Health measures
  • 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.

    Interventions:
    • Drug: Treatment and prophylaxis
    • Other: Standard Public Health measures
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 26, 2020)
2300
Original Estimated Enrollment  ICMJE
 (submitted: March 7, 2020)
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:

  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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
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 )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: Open access
Supporting Materials: Study Protocol
Supporting Materials: Statistical Analysis Plan (SAP)
Supporting Materials: Informed Consent Form (ICF)
Supporting Materials: Clinical Study Report (CSR)
Supporting Materials: Analytic Code
Time Frame: 30 days after start of treatment
Access Criteria: Open access for everybody
URL: http://www.estudicovid19.org
Responsible Party Oriol Mitja, Fundacio Lluita Contra la SIDA
Study Sponsor  ICMJE Fundacio Lluita Contra la SIDA
Collaborators  ICMJE
  • Germans Trias i Pujol Hospital
  • Department of Health, Generalitat de Catalunya
  • Laboratorios Gebro Pharma SA
  • Laboratorios Rubió
  • Institut Catala de Salut
Investigators  ICMJE Not Provided
PRS Account Fundacio Lluita Contra la SIDA
Verification Date June 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP