search
Back to results

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

Primary Purpose

Prevention of COVID-19

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Lopinavir/ritonavir
Sponsored by
Calmy Alexandra
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Prevention of COVID-19 focused on measuring COVID-19

Eligibility Criteria

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

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.

Sites / Locations

  • Instituto Nacional de Infectiologia Evandro Chagas, Fiocruz
  • Universitätsspital Basel and SwissTPH
  • Hôpitaux Universitaires de Genève
  • Ospedale Regionale di Lugano

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Lopinavir/Ritonavir

Active surveillance

Arm Description

Outcomes

Primary Outcome Measures

21-day incidence of COVID-19 in individuals exposed to SARS-CoV- 2 who are asymptomatic at baseline (intent-to-treat (ITT) analysis).

Secondary Outcome Measures

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)
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)
Severity of clinical COVID-19 on a 7-point ordinal scale
(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)

Full Information

First Posted
April 23, 2020
Last Updated
April 9, 2021
Sponsor
Calmy Alexandra
search

1. Study Identification

Unique Protocol Identification Number
NCT04364022
Brief Title
Efficacy of Pragmatic Same-day COVID-19 Ring Prophylaxis for Adult Individuals Exposed to SARS-CoV-2 in Switzerland
Acronym
COPEP
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2021
Overall Recruitment Status
Completed
Study Start Date
April 23, 2020 (Actual)
Primary Completion Date
March 24, 2021 (Actual)
Study Completion Date
March 24, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Calmy Alexandra

4. Oversight

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

5. Study Description

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.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
326 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Lopinavir/Ritonavir
Arm Type
Active Comparator
Arm Title
Active surveillance
Arm Type
No Intervention
Intervention Type
Drug
Intervention Name(s)
Lopinavir/ritonavir
Intervention Description
2x 200mg/50mg, twice daily for 5 days (bid, PO)
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
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
Title
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
Title
Severity of clinical COVID-19 on a 7-point ordinal scale
Description
(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)
Time Frame
21-day

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion criteria: 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). Enrolment of the participant no more than 7 days since last contact with index case; ≥ 16 years of age; 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*: Fever (temperature >38.0°C) and/or respiratory symptoms (cough, dyspnea) and/or new anosmia/ageusia; Individuals with previous confirmed SARS-CoV-2 infection, dating within the last six months ; Known impairment of liver function; Known hypersensitivity to the study medications; Use of any medications that are contraindicated with lopinavir/ritonavir using the website www.hiv-druginteractions.org/checker Individuals on boosted protease inhibitor (other than LPV) or boosted elvitegravir as part of an antiretroviral therapy Inability to be followed-up for the trial period Documented vaccination against SARS-CoV-2 Where necessary, additional biological and clinical assessment will be performed, based on clinical judgement.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alexandra Calmy, Prof
Organizational Affiliation
Hôpitaux universitaires de Genève
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Niklaus Labhardt, Prof
Organizational Affiliation
Universitätsspital Basel
Official's Role
Principal Investigator
Facility Information:
Facility Name
Instituto Nacional de Infectiologia Evandro Chagas, Fiocruz
City
Rio De Janeiro
Country
Brazil
Facility Name
Universitätsspital Basel and SwissTPH
City
Basel
Country
Switzerland
Facility Name
Hôpitaux Universitaires de Genève
City
Geneva
Country
Switzerland
Facility Name
Ospedale Regionale di Lugano
City
Lugano
Country
Switzerland

12. IPD Sharing Statement

Citations:
PubMed Identifier
34778734
Citation
Labhardt ND, Smit M, Petignat I, Perneger T, Marinosci A, Ustero P, Diniz Ribeiro MP, Ragozzino S, Nicoletti GJ, Fare PB, Andrey DO, Jacquerioz F, Lebowitz D, Agoritsas T, Meyer B, Spechbach H, Salamun J, Guessous I, Chappuis F, Kaiser L, Decosterd LA, Grinsztejn B, Bernasconi E, Cardoso SW, Calmy A, Team FTCS. Post-exposure Lopinavir-Ritonavir Prophylaxis versus Surveillance for Individuals Exposed to SARS-CoV-2: The COPEP Pragmatic Open-Label, Cluster Randomized Trial. EClinicalMedicine. 2021 Dec;42:101188. doi: 10.1016/j.eclinm.2021.101188. Epub 2021 Nov 6.
Results Reference
derived
PubMed Identifier
33184083
Citation
Smit M, Marinosci A, Nicoletti GJ, Perneger T, Ragozzino S, Andrey DO, Stoeckle M, Jacquerioz F, Lebowitz D, Agoritsas T, Meyer B, Spechbach H, Salamun J, Back M, Schaubhut C, Fuchs S, Decosterd L, Battegay M, Guessous I, Chappuis F, Kaiser L, Labhardt ND, Calmy A. Efficacy of pragmatic same-day ring prophylaxis for adult individuals exposed to SARS-CoV-2 in Switzerland (COPEP): protocol of an open-label cluster randomised trial. BMJ Open. 2020 Nov 12;10(11):e040110. doi: 10.1136/bmjopen-2020-040110.
Results Reference
derived

Learn more about this trial

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

We'll reach out to this number within 24 hrs