Trial NCT04364022; SNCTP 000003732
Publication Labhardt N, COPEP, 2021 (No COI)
Dates: 4/23/2020 to 2/26/2021
Funding: Public/nonprofit (Fondation privée des HUG (Edmond Rothschild (Suisse) SA, Union Bancaire Privée and Fondation pour la recherche et le traitement médical), Swiss National Fund )
Conflict of interest:
| Methods | |
| RCT Blinding: | |
| Location :
Multicenter / Brazil, Switzerland Follow-up duration (days): 21 | |
| Inclusion criteria | Asymptomatic individuals; ?16 years; documented close contact with a person with a confirmed SARS-CoV-2 infection (index case), defined as having spent >15 minutes in <2 meters distance or having shared closed space for ?2 hours; index cases had to be diagnosed by either a PCR oro- or nasopharyngeal swab test, or a validated rapid antigen test at an authorized SARS-CoV-2 test center; contact occurred 48 hours before onset of symptoms in the index case and within 7 days of enrollment, but no more than 72 hours after diagnosis of the index case; written informed consent |
| Exclusion criteria | Symptoms compatible with COVID-19 (tympanic body temperature >38.0°, cough, dyspnea, new anosmia or ageusia, sore throat, myalgia, fatigue); known previous SARS-CoV-2 infection; previous vaccination against SARS-CoV-2; contraindications to LPV/r (impaired liver function, hypersensitivity to LPV/r, drug-drug interactions with the participants usual medication, persons already taking protease inhibitors) |
| Interventions | |
| Treatment
Lopinavir-Ritonavir (*) Duration : 5 days |
|
| Control
Standard care Definition of Standard care: * | |
| Participants | |
| Randomized 321 participants (n1=212 / n2= 109) | |
| Characteristics of participants N=321 Mean age : 39.7 161 males | |
| Primary outcome | |
| In the register 21-day incidence of COVID-19 in individuals exposed to SARS-CoV- 2 who are asymptomatic at baseline (intent-to-treat (ITT) analysis). [ Time Frame: 21-day ] | |
| In the report 21-day incidence of COVID-19 (PCRs/rapid antigen test) | |
| Documents available |
Protocol Yes. In English Statistical plan Yes Data-sharing stated Yes |
| Risk of bias Overall The overall risk of bias reported in the table corresponds to the highest risk of bias for the outcomes assessed for the systematic review |
Some concerns |
| General comment | In addition to the pre-print article, the prospective registry (27 April 2020) and study protocol (including statistical analysis plan) were used in data extraction and assessment of risk of bias. The primary outcome in the report reflects that in the registry. The two secondary efficacy outcomes in the report (incidence in seronegative participants and severity scale) also reflect those in the registry. The reported safety outcome adverse events was not included in the registry or protocol. During the course of the trial, the protocol underwent several critical amendments: a third arm (800 mg single dose hydroxychloroquine) was stopped after 7 weeks due to concerns of harm, a third Swiss site and a Brazilian site were added, the definition of SARS-CoV-2 infection and COVID-19 was broadened to include rapid antigen tests as well as PCR, and being vaccinated against SARS-CoV-2 was introduced as an exclusion criterion. The study achieved its target sample size. |