Current best evidence for clinical care (more info)
Background: Antiviral therapies against the novel coronavirus SARS-CoV-2, which has caused a global pandemic of respiratory illness called COVID-19, are still lacking.
Methods: Our study (ClinicalTrials.gov: NCT04252885, named ELACOI), was an exploratory randomized (2:2:1) controlled trial assessing the efficacy and safety of lopinavir/ritonavir (LPV/r) or arbidol monotherapy for treating patients with mild/moderate COVID-19.
Findings: This study successfully enrolled 86 patients with mild/moderate COVID-19, with 34 randomly assigned to receive LPV/r, 35 to arbidol, and 17 with no antiviral medication as control. Baseline characteristics of the three groups were comparable. The primary endpoint, the rate of positive-to-negative conversion of SARS-CoV-2 nucleic acid, was similar between groups (all p > 0.05). There were no differences between groups in the secondary endpoints, the rates of antipyresis, cough alleviation, or improvement of chest computed tomography (CT) at days 7 or 14 (all p > 0.05). At day 7, 8 (23.5%) patients in the LPV/r group, 3 (8.6%) in the arbidol group, and 2 (11.8%) in the control group showed a deterioration in clinical status from moderate to severe/critical (p = 0.206). Overall, 12 (35.3%) patients in the LPV/r group and 5 (14.3%) in the arbidol group experienced adverse events during the follow-up period. No apparent adverse event occurred in the control group.
Conclusions: LPV/r or arbidol monotherapy present little benefit for improving the clinical outcome of patients hospitalized with mild/moderate COVID-19 over supportive care.
Funding: This study was supported by project 2018ZX10302103-002, 2017ZX10202102-003-004, and Infectious Disease Specialty of Guangzhou High-level Clinical Key Specialty (2019-2021).
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Arbidol therapy didn't prove to be a successful therapy for COVID treatment based on this randomized controlled trial.
With so many observations about what might work in COVID-19, these randomized studies of anti-viral therapies are critically important, even with short term end-points and even if most treatment locations are unlikely to prescribe these agents at this point in the pandemic.
This article is an RCT whose objective is to evaluate the efficacy and safety of Lopinavir/Ritonavir (LPV-r) and Arbidol in the treatment of mild/moderate COVID-19 infection. Despite the relevance of discussing new therapeutic possibilities during the pandemic, the study has important methodological limitations, according to CONSORT guidelines. The doses administered to the patients, as well as the choice of the start day of the medications were not explained in the text. It was also unclear how the sample size was calculated and who were responsible for randomization. The number of participants in the 3 groups was insufficient to allow the performance of statistical analysis to control confounding factors (comorbidities, use of other medications), not allowing to conclude to what extent the adverse effects can be attributed to the drugs tested.
This is very timely research during these times.
The small sample of patients is not enough to predict if the antivirals in question were effective.