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
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.

Completed
Prevention of COVID-19

Drug: Lopinavir/ritonavir

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

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.

Eligibility Gender
All
Eligibility Age
Minimum: 16 Years ~ Maximum: N/A
Countries
Brazil
Switzerland
Locations

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

Universitätsspital Basel and SwissTPH
Basel, Switzerland

Hôpitaux Universitaires de Genève
Geneva, Switzerland

Ospedale Regionale di Lugano
Lugano, Switzerland

Calmy Alexandra
NCT Number
Keywords
Covid-19
MeSH Terms
COVID-19
Ritonavir
Lopinavir