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

NCT04364022 | Completed Phase 3

• 1 other identifier: CCER 2020-00864
• Study Type: interventional
• Target: 326
• Locations: 2 countries
• Sites: 4

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.

Conditions

Prevention of COVID-19

Keywords

COVID-19

Outcome Measures

Primary Outcomes (1)

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

  21-day

Secondary Outcomes (3)

• 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

• 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)

  21-day

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

  21-day

Study Arms (2)

Lopinavir/Ritonavir

ACTIVE COMPARATOR

Drug: Lopinavir/ritonavir

Active surveillance

NO INTERVENTION

Interventions

Lopinavir/ritonavir DRUG

2x 200mg/50mg, twice daily for 5 days (bid, PO)

Lopinavir/Ritonavir

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Calmy Alexandra: lead

Study Sites (4)

Instituto Nacional de Infectiologia Evandro Chagas, Fiocruz

Rio de Janeiro, Brazil

Location

Universitätsspital Basel and SwissTPH

Basel, Switzerland

Location

Hôpitaux Universitaires de Genève

Geneva, Switzerland

Location

Ospedale Regionale di Lugano

Lugano, Switzerland

Location

Related Publications (2)

• 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.

  PMID: 34778734 DERIVED

• 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.

  PMID: 33184083 DERIVED

MeSH Terms

Conditions

COVID-19

Interventions

Lopinavir

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Alexandra Calmy, Prof

  University Hospital, Geneva

  PRINCIPAL INVESTIGATOR

• Niklaus Labhardt, Prof

  Universitätsspital Basel

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Prof. Alexandra Calmy

Study Record Dates

• First Submitted: April 23, 2020
• First Posted: April 27, 2020
• Study Start: April 23, 2020
• Primary Completion: March 24, 2021
• Study Completion: March 24, 2021
• Last Updated: April 12, 2021

Record last verified: 2021-04

Locations

CH (3); BR (1)