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

Prevention of COVID-19 Clinical Trial

— COPEP  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04364022
• Other study ID #: CCER 2020-00864
• Status: Completed
• Phase: Phase 3
• Start date: April 23, 2020
• Est. completion date: March 24, 2021

Study information

• Verified date: April 2021
• Source: University Hospital, Geneva
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 326
• Est. completion date: March 24, 2021
• Est. primary completion date: March 24, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 16 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Prevention of COVID-19

Intervention

Drug:
• Lopinavir/ritonavir
2x 200mg/50mg, twice daily for 5 days (bid, PO)

Locations

Country	Name	City	State
Brazil	Instituto Nacional de Infectiologia Evandro Chagas, Fiocruz	Rio De Janeiro
Switzerland	Universitätsspital Basel and SwissTPH	Basel
Switzerland	Hôpitaux Universitaires de Genève	Geneva
Switzerland	Ospedale Regionale di Lugano	Lugano

Sponsors (1)

Lead Sponsor	Collaborator
Calmy Alexandra

Countries where clinical trial is conducted

Brazil,  Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	Severity of clinical COVID-19 on a 7-point ordinal scale	(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