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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Prevention of COVID-19

Intervention / Treatment
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* Drug: Lopinavir/ritonavir


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 16 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Lopinavir/Ritonavir<br> | Drug: Lopinavir/ritonavir<br>* 2x 200mg/50mg, twice daily for 5 days (bid, PO)<br>|
| No Intervention: Active surveillance<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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) |  | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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COVID-19