Prevention of COVID-19
Conditions
Keywords
COVID-19
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-2 documented index patient, compared to surveillance alone.
Interventions
DRUGLopinavir/ritonavir
2x 200mg/50mg, twice daily for 5 days (bid, PO)
Sponsors
Calmy Alexandra
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
16 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 | — |
| 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 | — |
| Severity of clinical COVID-19 on a 7-point ordinal scale | 21-day | (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) |
Countries
Brazil, Switzerland
Outcome results
None listed