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History of Changes for Study: NCT04304053
Treatment of Mild Cases and Chemoprophylaxis of Contacts as Prevention of the COVID-19 Epidemic (CQ4COV19)
Latest version (submitted June 26, 2020) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 March 7, 2020 None (earliest Version on record)
2 March 11, 2020 Study Design, Eligibility, Sponsor/Collaborators and Study Status
3 March 13, 2020 Study Identification, Arms and Interventions, Sponsor/Collaborators and Study Status
4 March 22, 2020 Recruitment Status, Study Status, Sponsor/Collaborators, Study Identification, Contacts/Locations, Eligibility, Arms and Interventions and Oversight
5 April 6, 2020 IPDSharing, Contacts/Locations and Study Status
6 April 14, 2020 Arms and Interventions, Study Description, Eligibility, Outcome Measures and Study Status
7 June 7, 2020 Recruitment Status, Outcome Measures, Study Status, Contacts/Locations, Study Description and Arms and Interventions
8 June 10, 2020 Outcome Measures, Arms and Interventions, Study Design, Study Description and Study Status
9 June 22, 2020 Outcome Measures, Arms and Interventions, Study Design, Study Description and Study Status
10 June 26, 2020 Recruitment Status, Study Status, Arms and Interventions, Study Design, Study Description, Eligibility, Outcome Measures and Sponsor/Collaborators
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Study NCT04304053
Submitted Date:  March 7, 2020 (v1)

Open or close this module Study Identification
Unique Protocol ID: CQ4COV19
Brief Title: Treatment of Mild Cases and Chemoprophylaxis of Contacts as Prevention of the COVID-19 Epidemic (CQ4COV19)
Official Title: Antiviral Treatment of COVID-19 Confirmed Cases and Ring Chloroquine Chemoprevention in Close Contacts: a Cluster Randomized Clinical Trial
Secondary IDs:
Open or close this module Study Status
Record Verification: March 2020
Overall Status: Not yet recruiting
Study Start: March 15, 2020
Primary Completion: July 15, 2020 [Anticipated]
Study Completion: July 15, 2020 [Anticipated]
First Submitted: March 5, 2020
First Submitted that
Met QC Criteria:
March 7, 2020
First Posted: March 11, 2020 [Actual]
Last Update Submitted that
Met QC Criteria:
March 7, 2020
Last Update Posted: March 11, 2020 [Actual]
Open or close this module Sponsor/Collaborators
Sponsor: Lihir Medical Centre
Responsible Party: Principal Investigator
Investigator: Oriol Mitja
Official Title: Prof (Ass) Infectious Disease and Global Health
Affiliation: Germans Trias i Pujol Hospital
Collaborators: Germans Trias i Pujol Hospital
Department of Health, Generalitat de Catalunya
Open or close this module Oversight
U.S. FDA-regulated Drug: No
U.S. FDA-regulated Device: No
Data Monitoring: Yes
Open or close this module Study Description
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.

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.

Open or close this module Conditions
Conditions: COVID-19
Keywords:
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Prevention
Study Phase: Phase 2/Phase 3
Interventional Study Model: Parallel Assignment
Cluster-randomized clinical trial
Number of Arms: 2
Masking: None (Open Label)
Allocation: Randomized
Enrollment: 2900 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
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.
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 chloroquine (ResochinR chloroquine phosphate 250mg tablets, equivalent to 155mg chloroquine base) 1 g of chloroquine phosphate on days 1 and 2 and 0,5 g on day 3.

Contacts will be offered a prophylactic regimen of chloroquine (ResochinR chloroquine phosphate 250mg tablets, equivalent to 155mg chloroquine base;) 1 g of chloroquine phosphate on days 1 and 2 and 0,5 g on day 3.

Standard Public Health measures
Isolation of patient and contact tracing as per national guidelines.
Open or close this module Outcome Measures
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 ]

Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age:
Sex: All
Gender Based:
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. Willing to take study medication
  4. Willing to comply with all study procedures, including repeat nasal swab at day 3
  5. Able to provide written, informed consent and/or assent

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. With known history of cardiac arrhythmia (or QT prolongation syndrome);
  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 retinal disease, hearing loss;
  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.

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. Willing to take study medication;
  4. Willing to comply with all study procedures;
  5. 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 retinal disease, hearing loss.
Open or close this module Contacts/Locations
Central Contact Person: oriol Mitja, PhD
Telephone: 0034 934651072
Email: oriolmitja@hotmail.com
Central Contact Backup: Laia Bertran
Telephone: 0034 934651072
Locations:
Open or close this module IPDSharing
Plan to Share IPD: No
Open or close this module References
Links:
Available IPD/Information:

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