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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lopinavir/Ritonavir | Active Comparator |
| |
| Active surveillance | No Intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lopinavir/ritonavir | Drug | 2x 200mg/50mg, twice daily for 5 days (bid, PO) |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
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Inclusion criteria:
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
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| Name | Affiliation | Role |
|---|---|---|
| Alexandra Calmy, Prof | University Hospital, Geneva | Principal Investigator |
| Niklaus Labhardt, Prof | Universitätsspital Basel | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Instituto Nacional de Infectiologia Evandro Chagas, Fiocruz | Rio de Janeiro | Brazil | ||||
| Universitätsspital Basel and SwissTPH |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34778734 | Derived | 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. | |
| 33184083 |
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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| ID | Term |
|---|---|
| D061466 | Lopinavir |
| ID | Term |
|---|---|
| D011744 | Pyrimidinones |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| 21-day |
| 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) | 21-day |
| Basel |
| Switzerland |
| Hôpitaux Universitaires de Genève | Geneva | Switzerland |
| Ospedale Regionale di Lugano | Lugano | Switzerland |
| 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. |
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |