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

Primary Purpose

COVID-19

Status
Completed
Phase
Phase 3
Locations
Spain
Study Type
Interventional
Intervention
Treatment and prophylaxis
Standard Public Health measures
Sponsored by
Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for COVID-19

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Departament de Salut

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

No Intervention- SARS-CoV-2 surveillance

Testing, treatment and prophylaxis of SARS-CoV-2

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Study 1- Clinical and virological outcome in exposed contacts
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
Incidence of symptomatically compatible or a PCR-positive result regardless of symptoms
Study 2- Virological outcome in index cases
Reduction of viral RNA load in nasopharyngeal swabs at days 3, and 7 after treatment start.
Study 2- Clinical outcome in index cases
Time from randomization to complete resolution of symptoms at an extended 28-days follow-

Secondary Outcome Measures

Full Information

First Posted
March 5, 2020
Last Updated
June 26, 2020
Sponsor
Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia
Collaborators
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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1. Study Identification

Unique Protocol Identification Number
NCT04304053
Brief Title
Treatment of COVID-19 Cases and Chemoprophylaxis of Contacts as Prevention
Acronym
HCQ4COV19
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)
Study Type
Interventional

2. Study Status

Record Verification Date
June 2020
Overall Recruitment Status
Completed
Study Start Date
March 18, 2020 (Actual)
Primary Completion Date
June 15, 2020 (Actual)
Study Completion Date
June 15, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia
Collaborators
Germans Trias i Pujol Hospital, Department of Health, Generalitat de Catalunya, Laboratorios Gebro Pharma SA, Laboratorios Rubió, Institut Catala de Salut

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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).
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
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
Allocation
Randomized
Enrollment
2300 (Actual)

8. Arms, Groups, and Interventions

Arm Title
No Intervention- SARS-CoV-2 surveillance
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Testing, treatment and prophylaxis of SARS-CoV-2
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Treatment and prophylaxis
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Standard Public Health measures
Intervention Description
Isolation of patient and contact tracing as per national guidelines.
Primary Outcome Measure Information:
Title
Study 1- Clinical and virological outcome in exposed contacts
Description
Incidence of secondary PCR confirmed symptomatic Covid-19 episodes among contacts after high risk PCR+ exposure
Time Frame
Up to 14 days after start of treatment
Title
Study 1- Transmission of SARS-CoV-2 in exposed contacts
Description
Incidence of symptomatically compatible or a PCR-positive result regardless of symptoms
Time Frame
Up to 14 days after start of treatment
Title
Study 2- Virological outcome in index cases
Description
Reduction of viral RNA load in nasopharyngeal swabs at days 3, and 7 after treatment start.
Time Frame
Up to 7 days after start of treatment
Title
Study 2- Clinical outcome in index cases
Description
Time from randomization to complete resolution of symptoms at an extended 28-days follow-
Time Frame
Up to 28 days after start of treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Facility Information:
Facility Name
Departament de Salut
City
Barcelona
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Open access
IPD Sharing Time Frame
30 days after start of treatment
IPD Sharing Access Criteria
Open access for everybody
IPD Sharing URL
http://www.estudicovid19.org
Citations:
PubMed Identifier
33570583
Citation
Akhtar S, Das JK, Ismail T, Wahid M, Saeed W, Bhutta ZA. Nutritional perspectives for the prevention and mitigation of COVID-19. Nutr Rev. 2021 Feb 11;79(3):289-300. doi: 10.1093/nutrit/nuaa063.
Results Reference
derived
PubMed Identifier
33289973
Citation
Mitja O, Corbacho-Monne M, Ubals M, Alemany A, Suner C, Tebe C, Tobias A, Penafiel J, Ballana E, Perez CA, Admella P, Riera-Marti N, Laporte P, Mitja J, Clua M, Bertran L, Sarquella M, Gavilan S, Ara J, Argimon JM, Cuatrecasas G, Canadas P, Elizalde-Torrent A, Fabregat R, Farre M, Forcada A, Flores-Mateo G, Lopez C, Muntada E, Nadal N, Narejos S, Nieto A, Prat N, Puig J, Quinones C, Ramirez-Viaplana F, Reyes-Uruena J, Riveira-Munoz E, Ruiz L, Sanz S, Sentis A, Sierra A, Velasco C, Vivanco-Hidalgo RM, Zamora J, Casabona J, Vall-Mayans M, Gonzalez-Beiras C, Clotet B; BCN-PEP-CoV2 Research Group. A Cluster-Randomized Trial of Hydroxychloroquine for Prevention of Covid-19. N Engl J Med. 2021 Feb 4;384(5):417-427. doi: 10.1056/NEJMoa2021801. Epub 2020 Nov 24.
Results Reference
derived

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Treatment of COVID-19 Cases and Chemoprophylaxis of Contacts as Prevention

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