An exploratory randomized, controlled study on the efficacy and safety of lopinavir/ritonavir or arbidol treating adult patients hospitalized with mild/moderate COVID-19 (ELACOI)

Background: The novel coronavirus pneumonia (COVID-19) outbreak has caused a global pandemic, however, effective antiviral therapeutics are still unavailable. Methods: Our study ( NCT04252885 ), designated as ELACOI, was an exploratory randomized (2:2:1) and controlled one, exploring the efficacy and safety of lopinavir/ritonavir (LPV/r) or arbidol monotherapy treating mild/moderate COVID-19 patients. Results: This study successful enrolled 44 patients with mild/moderate COVID-19, with 21 randomly assigned to receive LPV/r, 16 to arbidol and 7 to no antiviral medication as control. Baseline characteristics of three groups were comparable. The median time of positive-to-negative conversion of SARS-CoV-2 nucleic acid was 8.5 (IQR 3, 13) days in the LPV/r group, 7 (IQR 3, 10.5) days in the arbidol group and 4 (IQR 3, 10.5) days in the control group (P=0.751). The positive-to-negative conversion rates of SARS-CoV-2 nucleic acid at day 7 and 14 did not show significant differences in the LPV/r group (42.9%, 76.2%), the arbidol group (62.5%, 87.5%) and the control group (71.4%, 71.4%) (all P>0.53). No statistical differences were found among three groups in the rates of antipyresis, cough alleviation, improvement of chest CT or the deterioration rate of clinical status (all P > 0.05). Overall, 5 (23.8%) patients in the LPV/r group experienced adverse events during the follow-up period. No apparent adverse events occurred in the arbidol or control group. Conclusion: LPV/r or arbidol monotherapy seems little benefit for improving the clinical outcome of mild/moderate COVID-19. LPV/r might lead to more adverse events. Due to the limitation of small sample size, further verification is needed in the future.