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Efficacy of same day chemoprophylaxis for exposed asymptomatic individuals exposed to SARS-CoV-2 in Switzerland: a pragmatic open-label cluster randomized trial (COPEP-trial)

Applicant Calmy Alexandra
Number 196251
Funding scheme Special Call on Coronaviruses
Research institution Service de Maladies Infectieuses HUG
Institution of higher education University of Geneva - GE
Main discipline Infectious Diseases
Start/End 01.06.2020 - 31.10.2022
Approved amount 299'399.00
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All Disciplines (2)

Discipline
Infectious Diseases
Respiratory Diseases

Keywords (9)

same-day postexposure prophylaxis; pragmatic; open-label cluster randomized control trial; SARS-CoV-2; category B trial; COVID-19; novel coronavirus; ring prophylaxis; chemoprophylaxis

Lay Summary (French)

Lead
La Suisse a été très affectée par l’épidémie COVID-19. Pour assurer le contrôle de l’épidémie, des stratégies de prévention efficaces sont essentielles, non seulement pour interrompre les chaines de transmission, mais également pour protéger les personnes les plus vulnérables dans notre société.
Lay summary

Contenu et objectifs du projet de recherche :

Il s’agit d’un essai clinique multicentrique visant à tester l’efficacité de traitements préventifs chez des individus asymptomatiques avec un contact étroit avec une personne porteuse du SARS-CoV-2. La molécule qui sera testée est le lopinavir/ritonavir, un antirétroviral connu depuis le début des années 2000 dans le traitement du  VIH. L’objectif est de démontrer que ce traitement préventif fonctionne pour limiter la propagation du  virus au sein d’un même environnement (familial ou professionnel).

300 participants seront recrutés dans différents sites hospitaliers en Suisse: à Genève, Bâle, et à Lugano. Les participants devront être asymptomatiques et avoir été en contact rapproché avec une personne testée positive pour le SARS-CoV-2. Ils seront attribués de manière aléatoire à l’un des 2 groupes (lopinavir/ritonavir ; groupe sur surveillance clinique). Les participants de l’étude auront également un suivi médical rapproché avec deux visites, au cours desquelles un frottis SARS-CoV-2 et une sérologie seront effectués, ainsi qu’un suivi quotidien de leur état de santé via un questionnaire en ligne.

Contexte scientifique et social du projet de recherche :

Avec cet essai, nous souhaitons prouver qu’un traitement préventif serait efficace pour limiter la propagation du virus, et si tel est le cas, nous pourrions généraliser cet essai à l'ensemble de la population. Cela permettrait également de faciliter un retour à une vie sociale et économique normale dans les pays atteints par le SARS-CoV-2.

Direct link to Lay Summary Last update: 04.06.2020

Responsible applicant and co-applicants

Employees

Project partner

Associated projects

Number Title Start Funding scheme
205053 Assessing the feasibility, safety and effectiveness of offering same-day antiretroviral therapy to persons with HIV and presumptive tuberculosis: A collaborative multi-country research project in sub-Sahara Africa 01.01.2022 Project funding (Div. I-III)
181355 Evidence-based Differentiated Care for HIV in South-Eastern Africa: Shaping the post 2020 agenda 01.01.2019 Eccellenza

Abstract

Background: Severe Acute Respiratory Coronavirus 2 (SARS-CoV-2) is a novel coronavirus strain that was declared a pandemic by the World Health Organization on 11th March 2020. The world is now scrambling to identify effective pharmacological candidates for its prevention and treatment. The availability of simple and effective post-exposure prophylaxis (PEP) to prevent either SARS-CoV-2 infection and/or resulting clinical Coronavirus Disease (COVID-19) will play a crucial role both for the rapid containment and to protect at risk individuals including front-line health care workers now and in future outbreaks. Objectives We propose to assess the efficacy, safety and acceptability of same-day LPV/r-based and HCQ-based PEP compared to standard of care for asymptomatic individuals exposed to individuals diagnosed with SARS-CoV-2 in a category B open-label cluster randomized clinical trial. The study has two co-primary endpoints; 14-day incidence of clinical COVID-19 and 14-day incidence of PCR-confirmed SARS-CoV-2. Method: Participants will be screened if they had a close contact of newly diagnosed SARS-CoV-2 index cases as early as possible and randomized no later than 48 hours after the document contact. Adults without fever or respiratory symptoms will be enrolled across two sites, Geneva and Basel. During baseline visit, naso-pharyngeal swab, SARS-CoV-2 serology (rapid test) and a clinical assessment will be performed and individuals will be randomized by household 1:1:1 to either LPV/r 400/100 mg twice daily for 5 days versus a single dose of 800mg HCQ versus no treatment. Individuals will be asked to record daily their temperature and complete a online symptoms and adverse events questionnaire during the 14 days of follow-up. Participants who record COVID-19 symptoms will undergo clinical assessment and a naso-pharyngeal swab to confirm/exclude SARS-CoV-2 infection, and if found positive will be provided with appropriate care. Follow-up visit at Day 14 will include a naso-pharyngeal swab and completion of questionnaires on adherence and acceptability of the PEP intervention.Endpoints: This trial has two co-primary endpoints: a) 14-day incidence of COVID-19 in individuals exposed to SARS-CoV-2 who are asymptomatic at baseline (intention-to-treat (ITT) analysis)b) 14-day incidence of SARS-CoV-2 in individuals exposed to SARS-CoV-2 who are asymptomatic and PCR-confirmed SARS-CoV-2 negative at baseline (modified ITT)Secondary endpoints:a) severity of clinical COVID-19 (0- asymptomatic or with mild disease; 1 - hospitalized or died)b) adverse events c) adherence to and acceptance of PEPStudy impact and importance: COVID-19 generates intense pressure on health systems across the world, with the sudden and uncontrolled influx of severe cases causing depletion of all hospital-based resources. Meanwhile, asymptomatic SARS-CoV-2 infections fuel the pandemic. A simple and effective PEP strategy, that can be prescribed the same day with limited laboratory exams, will help contain both the current pandemic and future COVID-19 outbreaks. Even if effective vaccination and treatment become available, PEP will play an important role in safeguarding individuals at highest risk, including front-line health care workers, and will be crucial for rapid containment of future outbreaks. The PEP candidates we are proposing to investigate are cheap, safe and globally available, including in Switzerland. This makes them particularly attractive PEP candidates worldwide, including settings where health systems are fragile and the scarcity of tertiary care facilities, intensive care bed and ventilators cause concern in face of COVID-19.
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