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

Phase 3

Completed

• Conditions: Prevention of COVID-19
• Interventions: Drug: Lopinavir/ritonavir

• Registration Number: NCT04364022
• Lead Sponsor: Calmy Alexandra

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-04-23
• Study First Submitted: 2020-04-23
• Study First Submitted QC: 2020-04-24
• Study First Posted: 2020-04-27
• Primary Completion: 2021-03-24
• Study Completion: 2021-03-24
• Status Verified: 2021-04
• Last Update Submitted: 2021-04-09
• Last Update Posted: 2021-04-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 326

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Lopinavir/Ritonavir	Lopinavir/ritonavir	-

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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
Severity of clinical COVID-19 on a 7-point ordinal scale	21-day	(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 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

Trial Locations

Locations (4)

Hôpitaux Universitaires de Genève; 🇨🇭 Geneva, Switzerland

Ospedale Regionale di Lugano; 🇨🇭 Lugano, Switzerland

Universitätsspital Basel and SwissTPH; 🇨🇭 Basel, Switzerland

Instituto Nacional de Infectiologia Evandro Chagas, Fiocruz; 🇧🇷 Rio De Janeiro, Brazil