Clinical trial NCT04364022: Efficacy of Pragmatic Same-day COVID-19 Ring Prophylaxis for Adult Individuals Exposed to SARS-CoV-2 in Switzerland
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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Prevention of COVID-19
Keywords: COVID-19
Lead sponsor: University Hospital, Geneva
Sponsor class: OTHER
First posted: 2020-04-27
Enrollment: 326
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility 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.

Primary outcomes:
measure: 21-day incidence of COVID-19 in individuals exposed to SARS-CoV- 2 who are asymptomatic at baseline (intent-to-treat (ITT) analysis).
timeFrame: 21-day
Secondary outcomes:
measure: 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)
timeFrame: 21-day
measure: 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)
timeFrame: 21-day
measure: Severity of clinical COVID-19 on a 7-point ordinal scale
timeFrame: 21-day
Other outcomes:
Locations:
city: Rio De Janeiro
country: Brazil
facility: Instituto Nacional de Infectiologia Evandro Chagas, Fiocruz
city: Basel
country: Switzerland
facility: Universitätsspital Basel and SwissTPH
city: Geneva
country: Switzerland
facility: Hôpitaux Universitaires de Genève
city: Lugano
country: Switzerland
facility: Ospedale Regionale di Lugano
Study officials:
affiliation: University Hospital, Geneva
name: Alexandra Calmy, Prof
role: PRINCIPAL_INVESTIGATOR
affiliation: Universitätsspital Basel
name: Niklaus Labhardt, Prof
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.