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Status:

COMPLETED

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

Lead Sponsor:

Calmy Alexandra

Conditions:

Prevention of COVID-19

Eligibility:

All Genders

16+ years

Phase:

PHASE3

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...

Eligibility Criteria

Inclusion

  • 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.

Exclusion

    Key Trial Info

    Start Date :

    April 23 2020

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    March 24 2021

    Estimated Enrollment :

    326 Patients enrolled

    Trial Details

    Trial ID

    NCT04364022

    Start Date

    April 23 2020

    End Date

    March 24 2021

    Last Update

    April 12 2021

    Active Locations (4)

    Enter a location and click search to find clinical trials sorted by distance.

    Page 1 of 1 (4 locations)

    1

    Instituto Nacional de Infectiologia Evandro Chagas, Fiocruz

    Rio de Janeiro, Brazil

    2

    Universitätsspital Basel and SwissTPH

    Basel, Switzerland

    3

    Hôpitaux Universitaires de Genève

    Geneva, Switzerland

    4

    Ospedale Regionale di Lugano

    Lugano, Switzerland