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

Calmy Alexandra

Status and phase

Completed

Phase 3

Conditions

Prevention of COVID-19

Treatments

Drug: Lopinavir/ritonavir

Study type

Interventional

Funder types

Other

Identifiers

NCT04364022

CCER 2020-00864

Details and patient eligibility

About

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.

Enrollment

326 patients

Sex

All

Ages

16+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion criteria

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.