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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

326 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-04-23

Study Completion Date

2021-03-24

Brief Summary

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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.

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Detailed Description

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Conditions

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Prevention of COVID-19

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Lopinavir/Ritonavir

Group Type ACTIVE_COMPARATOR

Lopinavir/ritonavir

Intervention Type DRUG

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

Active surveillance

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Lopinavir/ritonavir

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

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes