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Post-exposure Lopinavir-Ritonavir Prophylaxis versus Surveillance for Individuals Exposed to SARS-CoV-2: The COPEP Pragmatic Open-Label, Cluster Randomized Trial

Labhardt et al., eClinicalMedicine, doi:10.1016/j.eclinm.2021.101188, COPEP, NCT04364022, Dec 2021
https://c19early.org/labhardt.html
Progression, level 2-4 -630% Improvement Relative Risk Symp. case 40% Lopinavir/r..  COPEP  Prophylaxis  RCT Is prophylaxis with lopinavir/ritonavir beneficial for COVID-19? RCT 318 patients in multiple countries (March 2020 - March 2021) Fewer symptomatic cases with lopinavir/ritonavir (not stat. sig., p=0.17) c19early.org Labhardt et al., eClinicalMedicine, Dec 2021 Favorslopinavir/ritonavir Favorscontrol 0 0.5 1 1.5 2+
Open-label, cluster-randomized RCT 318 asymptomatic close contacts in Switzerland and Brazil showing no statistically significant difference in symptomatic COVID-19 at 21 days with LPV/r prophylaxis. The mid-trial changes in allocation and 10-month recruitment window introduces potential calendar-time confounding - e.g., if community incidence fell over time, this may over-represent lower-risk weeks in the LPV/r arm, thereby overestimating efficacy. Authors reports 2 hospitalizations but do not specify which group the patients were in.
This study is excluded in the after exclusion results of meta analysis: significant confounding by time possible.
risk of progression, 630.1% higher, RR 7.30, p = 0.02, treatment 14 of 209 (6.7%), control 1 of 109 (0.9%), level 2-4.
risk of symptomatic case, 40.0% lower, HR 0.60, p = 0.17, treatment 35 of 209 (16.7%), control 13 of 109 (11.9%), adjusted per study.
Effect extraction follows pre-specified rules prioritizing more serious outcomes. Submit updates
Labhardt et al., 31 Dec 2021, Randomized Controlled Trial, multiple countries, peer-reviewed, mean age 39.7, 26 authors, study period March 2020 - March 2021, trial NCT04364022 (history) (COPEP). Contact: Alexandra.Calmy@hcuge.ch.
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