Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Efficacy of Pragmatic Same-day COVID-19 Ring Prophylaxis for Adult Individuals Exposed to SARS-CoV-2 in Switzerland (COPEP)

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04364022
Recruitment Status : Recruiting
First Posted : April 27, 2020
Last Update Posted : April 27, 2020
Sponsor:
Information provided by (Responsible Party):
Calmy Alexandra, University Hospital, Geneva

Brief Summary:
A study to assess, in a three-arm open-label cluster randomized clinical trial, the efficacy of a single-dose of HCQ treatment and of a 5-day course of LPV/r treatment in preventing COVID-19 in asymptomatic individuals exposed to a SARS-CoV-2 documented index patient, compared to surveillance alone.

Condition or disease Intervention/treatment Phase
Prevention of COVID-19 Drug: Hydroxychloroquine Sulfate 200 MG [Plaquenil] Drug: Lopinavir/ritonavir Phase 3

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 420 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Efficacy of Pragmatic Same-day Ring COVID-19 Prophylaxis for Adult Individuals Exposed to SARS-CoV-2 in Switzerland: an Open-label Cluster Randomized Trial
Estimated Study Start Date : April 2020
Estimated Primary Completion Date : October 2020
Estimated Study Completion Date : October 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Hydroxychloroquine Sulfate 200 MG [Plaquenil] Drug: Hydroxychloroquine Sulfate 200 MG [Plaquenil]
Single dose (PO) of 800 mg

Active Comparator: Lopinavir/Ritonavir Drug: Lopinavir/ritonavir
2x 200mg/50mg, twice daily for 5 days (bid, PO)

No Intervention: Active surveillance



Primary Outcome Measures :
  1. 21-day incidence of COVID-19 in individuals exposed to SARS-CoV- 2 who are asymptomatic at baseline (intent-to-treat (ITT) analysis). [ Time Frame: 21-day ]

Secondary Outcome Measures :
  1. 21-day incidence of COVID-19 in individuals exposed to SARS-CoV- 2 who are asymptomatic, PCR-confirmed SARS-CoV-2 negative and have negative SARS-CoV-2 serology at baseline (modified ITT) [ Time Frame: 21-day ]
  2. 21-day incidence of SARS-CoV-2 infection in individuals exposed to SARS-CoV-2 who are asymptomatic, PCR-confirmed SARS-CoV-2 negative and have negative SARS-CoV-2 serology at baseline (modified ITT) [ Time Frame: 21-day ]
  3. Severity of clinical COVID-19 on a 7-point ordinal scale [ Time Frame: 21-day ]
    (1: not hospitalized, no limitations on activities, 2: not hospitalized, limitation on activities, 3: hospitalized, not requiring supplemental oxygen, 4: hospitalized, requiring supplemental oxygen, 5: hospitalized, on non- invasive mechanical ventilation 6: hospitalized, on invasive mechanical ventilation or ECMO and 7: death)



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.


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

Inclusion Criteria:

  1. Documented close contact with a PCR-confirmed SARS-CoV-2 positive individual within the last 48 hours;
  2. ≥ 18 years of age;
  3. Informed consent as documented by signature;

Exclusion Criteria:

  1. Fever (temperature >38.0°) and/or respiratory symptoms (cough, dyspnoea) and/or new anosmia/ageusia;
  2. Individuals with previous confirmed SARS-CoV-2 infection;
  3. Known impairment of liver function;
  4. Haemolytic anaemia, porphyria, haemophilia and G6PD deficit; known retinopathy, epilepsy or visual field impairment;
  5. Individuals with known severe renal impairment (creatinine clearance <30mL/min) or undergoing dialysis;
  6. Known hypersensitivity to any of the study medications;
  7. Known long QT syndrome (LQTS)
  8. Use of QT interval prolonging medications (https://crediblemeds.org), anti-arrhythmic drugs, or any other medications that are contraindicated with lopinavir/ritonavir and hydroxychloroquine using the website www.covid19-druginteractions.org
  9. Individuals on either HQC or a boosted protease inhibitor as part of an antiretroviral therapy
  10. Inability to be followed-up for the trial period

    • Where necessary, additional biological and clinical assessment will be performed, based on clinical judgement.

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): NCT04364022


Contacts
Layout table for location contacts
Contact: Alexandra Calmy, Prof 223729811 ext 41 alexandra.calmy@hcuge.ch

Locations
Layout table for location information
Switzerland
Universitätsspital Basel and SwissTPH Recruiting
Basel, Switzerland
Hôpitaux Universitaires de Genève Recruiting
Geneva, Switzerland
Contact: Alexandra Calmy, Prof         
Principal Investigator: Alexandra Calmy, Prof         
Sponsors and Collaborators
Calmy Alexandra
Investigators
Layout table for investigator information
Principal Investigator: Alexandra Calmy, Prof Hôpitaux Universitaires de Genève
Principal Investigator: Niklaus Labhardt, Prof Universitätsspital Basel
Layout table for additonal information
Responsible Party: Calmy Alexandra, Prof. Alexandra Calmy, University Hospital, Geneva
ClinicalTrials.gov Identifier: NCT04364022    
Other Study ID Numbers: CCER 2020-00864
First Posted: April 27, 2020    Key Record Dates
Last Update Posted: April 27, 2020
Last Verified: April 2020

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Calmy Alexandra, University Hospital, Geneva:
COVID-19
Additional relevant MeSH terms:
Layout table for MeSH terms
Ritonavir
Lopinavir
Hydroxychloroquine
HIV Protease Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Cytochrome P-450 CYP3A Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents
Antirheumatic Agents