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

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ClinicalTrials.gov Identifier: NCT04304053
Recruitment Status : Recruiting
First Posted : March 11, 2020
Last Update Posted : March 24, 2020
Sponsor:
Collaborators:
Germans Trias i Pujol Hospital
Department of Health, Generalitat de Catalunya
FUNDACIÓN FLS DE LUCHA CONTRA EL SIDA, LAS ENFERMEDADES INFECCIOSAS Y LA PROMOCIÓN DE LA SALUD Y LA CIENCIA
Laboratorios Gebro Pharma SA
Laboratorios Rubió
Institut Catala de Salut
Information provided by (Responsible Party):
Oriol Mitja, Germans Trias i Pujol Hospital

Brief Summary:

The investigators plan to evaluate the efficacy of the 'test and treat' strategy of infected patients and prophylactic chloroquine treatment to all contacts. The strategy entails decentralized COVID-19 testing and starting antiviral darunavir/cobicistat plus chloroquine treatment immediately in all who are found to be infected. As viral loads decline to undetectable levels, the probability of onward transmission is reduced to very low levels. Such evaluation will require prospective surveillance to assess the population-level effect of transmission prevention.

Drug interventions in this protocol will follow the Spanish law about off-label use of medicines.


Condition or disease Intervention/treatment Phase
COVID-19 Drug: Antiviral treatment and prophylaxis Other: Standard Public Health measures Phase 3

Detailed Description:

Previous research on influenza has indicated that antiviral drugs administered before o short after symptom onset can reduce infectiousness to others by reducing viral loads in the respiratory secretions of patients.

Lopinavir/ritonavir, a protease inhibitor used to treat HIV/AIDS, was found to block COVID-19 infection in vitro at low-micromolar concentration, with a half-maximal effective concentration (EC50) of 8.5 μM. China's guidelines were set up in January 2020 and treated hospitalized patients with lopinavir/ritonavir, either alone or with various combinations. Darunavir (DRV)/Cobicistat, is also a protease inhibitor used to treat and prevent HIV/AIDS. Its as effective as lopinavir/ritonavir for the treatment of HIV/AIDS and better tolerated because the adverse effects rate is lower (diarrhea 2% vs 27%).

Another promising drug is chloroquine, that showed excellent in vitro results and strong antiviral effects on SARS-CoV infection of primate cells. Results from n=100 patients have shown superiority to the control treatment in improving lung imaging findings, promoting virus reversion to negative and shortening the disease.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 3040 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Cluster-randomized clinical trial
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
Estimated Primary Completion Date : June 15, 2020
Estimated Study Completion Date : June 15, 2020

Arm Intervention/treatment
Active Comparator: No Intervention- SARS-CoV-2 surveillance
Subjects exhibiting Acute Respiratory Infection (ARI) symptoms at a participating health care services complete a survey collecting demographic and clinical data and provide a swab for RT-PCR testing. Isolation of patient and contact tracing as per 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
Subjects exhibiting ARI symptoms at a participating hospital complete a survey collecting demographic and clinical data and provide a swab to be tested on-site with a molecular assay. Isolation of patient and contact tracing as per guidelines. Case receive an antiviral if tested positive (Chloroquine and darunavir/cobicistat). Contacts receive Chloroquine prophylaxis
Drug: Antiviral treatment and prophylaxis

darunavir 800 mg / cobicistat 150 mg tablets (oral, 1 tablet q24h, taking for 7 days) and hydroxychloroquine (200mg tablets) 800mg on day 1, and 400mg on days 2,3,4, 5, 6 and 7.

Contacts will be offered a prophylactic regimen of hydroxychloroquine (200mg tablets) 800mg on day 1, and 400mg on days 2,3,4.


Other: Standard Public Health measures
Isolation of patient and contact tracing as per national guidelines.




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. The virological clearance rate of throat swabs, sputum, or lower respiratory tract secretions at days 3 [ Time Frame: 3 days after start of treatment ]
  2. The mortality rate of subjects at weeks 2 [ Time Frame: Up to 14 days after start of treatment ]
  3. Proportion of participants that drop out of study [ Time Frame: Up to 14 days after start of treatment ]
  4. Proportion of participants that show non-compliance with study drug [ Time Frame: Up to 14 days after start of treatment ]


Information from the National Library of Medicine

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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

Inclusion Criteria for a case:

  1. Patients who meet the requirements of the New Coronavirus Infection Diagnosis (Acute respiratory infection symptoms 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. 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;
  2. 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;
  3. Participants under treatment with medications likely to interfere with experimental drugs
  4. Unable to take drugs by mouth;
  5. With significantly abnormal liver function (Child Pugh C)
  6. Need of dialysis treatment, or GFR≤30 mL/min/1.73 m2;
  7. Participants with psoriasis, myasthenia, haematopoietic and retinal diseases,CNS-related hearing loss or glucose-6-phosphate dehydrogenase deficit
  8. Participants with severe neurological and mental illness;
  9. Pregnant or lactating women;
  10. Inability to consent and/or comply with study protocol;
  11. Individuals with known hypersensitivity to the study drugs.
  12. Persons already treated with any of the study drugs during the last 30 days.
  13. Concomitant administration of enzyme inducers (such as carbamazepine) which could lead to ineffectiveness of darunavir; and those who receive CYP3A4 substrates (such as statins) because of the risk of increased toxicity.
  14. HIV patients (because these are already on antiretroviral treatment)
  15. Any contraindications as per the Data Sheet of Rezolsta or Hydroxychloroquine.

Inclusion Criteria for a contact:

  1. Patients who meet the definition of a contact according to the Catalan Public Health Department Guidelines
  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.

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


Contacts
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Contact: oriol Mitja, PhD 0034 934651072 oriolmitja@hotmail.com
Contact: Laia Bertran 0034 934651072

Locations
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Spain
CAP II Sant Fèlix Recruiting
Sabadell, Barcelona, Spain, 08204
Gerència Territorial Catalunya Central Recruiting
Sant Fruitós De Bages, Barcelona, Spain, 08272
Centre de Salut Isabel Roig-Casernes de Sant Andreu Recruiting
Barcelona, Spain, 08030
Sponsors and Collaborators
Fundacio Lluita Contra la SIDA
Germans Trias i Pujol Hospital
Department of Health, Generalitat de Catalunya
FUNDACIÓN FLS DE LUCHA CONTRA EL SIDA, LAS ENFERMEDADES INFECCIOSAS Y LA PROMOCIÓN DE LA SALUD Y LA CIENCIA
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, Germans Trias i Pujol Hospital
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: March 24, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Antiviral Agents
Anti-Infective Agents