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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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04364022
Recruitment Status : Completed
First Posted : April 27, 2020
Last Update Posted : April 12, 2021
Sponsor:
Information provided by (Responsible Party):
Calmy Alexandra, University Hospital, Geneva

Study Description
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Brief Summary:
A study to assess, in a two-arm open-label cluster randomized clinical trial, the efficacy 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: Lopinavir/ritonavir Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 326 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
Actual Study Start Date : April 23, 2020
Actual Primary Completion Date : March 24, 2021
Actual Study Completion Date : March 24, 2021

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Lopinavir/Ritonavir Drug: Lopinavir/ritonavir
2x 200mg/50mg, twice daily for 5 days (bid, PO)
No Intervention: Active surveillance


Outcome Measures
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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)


Eligibility Criteria
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Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion criteria:

  1. Documented close contact with a person with either a PCR-confirmed SARS-CoV-2 or a positive rapid SARS-CoV-2 antigen test (as per standard of care).
  2. Enrolment of the participant no more than 7 days since last contact with index case;
  3. ≥ 16 years of age;
  4. Informed consent as documented by signature (including parent's or legal guardian's signature if the participant is between 16 and 18 y.o.).

Exclusion criteria*:

  1. Fever (temperature >38.0°C) and/or respiratory symptoms (cough, dyspnea) and/or new anosmia/ageusia;
  2. Individuals with previous confirmed SARS-CoV-2 infection, dating within the last six months ;
  3. Known impairment of liver function;
  4. Known hypersensitivity to the study medications;
  5. Use of any medications that are contraindicated with lopinavir/ritonavir using the website www.hiv-druginteractions.org/checker
  6. Individuals on boosted protease inhibitor (other than LPV) or boosted elvitegravir as part of an antiretroviral therapy
  7. Inability to be followed-up for the trial period

  8. Documented vaccination against SARS-CoV-2

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


Locations
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Brazil
Instituto Nacional de Infectiologia Evandro Chagas, Fiocruz
Rio De Janeiro, Brazil
Switzerland
Universitätsspital Basel and SwissTPH
Basel, Switzerland
Hôpitaux Universitaires de Genève
Geneva, Switzerland
Ospedale Regionale di Lugano
Lugano, Switzerland
Sponsors and Collaborators
Calmy Alexandra
Investigators
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Principal Investigator: Alexandra Calmy, Prof Hôpitaux Universitaires de Genève
Principal Investigator: Niklaus Labhardt, Prof Universitätsspital Basel
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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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 12, 2021
Last Verified: April 2021

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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:
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COVID-19
Antiviral Agents
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases
 Ritonavir
Lopinavir
HIV Protease Inhibitors
Viral Protease Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-HIV Agents
Anti-Retroviral Agents
Anti-Infective Agents
Cytochrome P-450 CYP3A Inhibitors
Cytochrome P-450 Enzyme Inhibitors