Efficacy and safety of lopinavir/ritonavir or arbidol in adult patients with mild/moderate COVID-19: an exploratory randomized controlled trial
clinical drug discovery/repurposing therapeutics
Authors: Li et al.
Journal/ Pre-Print: Med (CellPress)
Tags: Clinical, Drug discovery/Drug repurpose, Therapeutics
1. No benefit of lopinavir/ritonavir or arbidol monotherapies over supportive treatment for patients with mild to moderate COVID-19.
This study builds on recent clinical trials (199 patients in Wuhan and 134 in Shanghai) for the use of lopinavir/ritonavir (LPV/r) as an antiviral therapy for COVID-19 patients. Consistent with these trials, no clinical benefit was observed. Benefit was defined as time to SARS-CoV-2 negativity in pharyngeal swabs and improved clinical parameters including fever, cough, chest CT imaging. In a controlled randomised trial, 86 patients with mild to moderate COVID-19 were assigned at a 2:2:1 ratio to LPV/r, arbidol and no antiviral. All patients received supportive care. Curiously, the LPV/r had the highest proportion of clinical deterioration and adverse events, but this was not statistically significant.
Impact for SARS-CoV2/COVID19 research efforts
Treatment of SARS-CoV2/COVID19 positive individuals. LPV/r and arbidol monotherapies had no clinical benefit from control groups not given anti-viral treatment.
· Clinical Cohort study
Strengths and limitations of the paper
Novelty: This paper indicates no clinical benefit for the use of LPV/r and arbidol anti-viral treatments for COVID-19, although this has already been observed in two previous clinical trials.
Standing in the field: Supports similar clinical trials in severe COVID-19 patients.
Appropriate statistics: Appropriate statistics were used for comparisons. As pointed out by the authors, calculating an appropriate sample size is made difficult due to the novelty of the disease. Only 86 patients could be recruited, which may affect statistical power.
Viral model used: SARS-CoV-2 (COVID-19 patients) between 1st February to 28th March in Guangzhou, China.
Translatability: Clinical study
Main limitations: Constrained by trial size of 86 patients.
Only recruitment of patients with mild/moderate COVID-19.
No patients with serious underlying disease (high risk populations)