Abstract
BackgroundThe outbreak of COVID-19 (caused by SARS-Cov-2) is very serious, and no effective antiviral treatment has yet been confirmed. The adage “old drug, new trick” in this context may suggest the important therapeutic potential of existing drugs. We found that the lopinavir/ritonavir treatment recommended in the fifth edition of the Treatment Plan of China can only help to improve a minority of throat-swab nucleic-acid results (3/15) in hospitals. Our previous use of chloroquine to treat patients with COVID-19 infection showed an improvement in more throat-swab nucleic-acid results (5/10) than the use of lopinavir/ritonavir.Methods/designThis is a prospective, open-label, randomized controlled, multicenter clinical study. The study consists of three phases: a screening period, a treatment period of no more than 10 days, and a follow-up period for each participant. Participants with COVID-19 infection who are eligible for selection for the study will be randomly allocated to the trial group or the control group. The control group will be given lopinavir/ritonavir treatment for no more than 10 days. The trial group will be given chloroquine phosphate treatment for no more than 10 days. The primary outcome is the clinical recovery time at no more than 28 days after the completion of therapy and follow-up. The secondary outcomes include the rate of treatment success after the completion of therapy and follow-up, the time of treatment success after no more than 28 days, the rate of serious adverse events during the completion of therapy and follow-up, and the time to return to normal temperature (calculated from the onset of illness) during the completion of therapy and follow-up. Comparisons will be performed using two-sided tests with a statistical significance level of 5%.DiscussionThis experiment should reveal the efficacy and safety of using chloroquine versus lopinavir/ritonavir for patients with mild/general COVID-19 infection. If the new treatment including chloroquine shows a higher rate of throat-swab SARS-CoV-2 real-time fluorescent reverse transcription polymerase chain reaction (RT-PCR) negativity and is safe, it could be tested as a future COVID-19 treatment.Trial registrationChinese Clinical Trial Registry, ID: ChiCTR2000029741. Registered on 11 February 2020.
Highlights
In December 2019, patients with unexplained pneumonia appeared in Wuhan, China, and were subsequently identified as a having a novel type of coronavirus
If the new treatment including chloroquine shows a higher rate of throat-swab SARS-CoV-2 real-time fluorescent reverse transcription polymerase chain reaction (RT-PCR) negativity and is safe, it could be tested as a future COVID-19 treatment
The National Health Commission of China announced a new coronavirus-infectionrelated pneumonia diagnosis and treatment program, which proposed the trial of lopinavir/ritonavir for its antivirus effect [2,3,4]
Summary
As of 10 April 2020, the total number of COVID-19 infection diagnoses in the world was more than 1.3 million, with more than 80,000 deaths (https://www.who. int/dg/speeches/detail/the-cooperation-council-of-theturkic-speaking-states%2D%2D-10-april-2020). In the seventh edition of the Chinese version of the COVID-19 Diagnosis and Treatment Plan (http://www.nhc.gov.cn/ yzygj/s7653p/202003/46c9294a7dfe4cef80dc7f5912eb1 989/files/ce3e6945832a438eaae415350a8ce964.pdf), the recommended antiviral drugs are lopinavir/ritonavir, chloroquine phosphate and other drugs. The trial will be conducted in a clinical outpatient and inpatient setting by experienced clinicians, and participants will be recruited from the patient base of the other three hospitals participating in the trial. The purpose of this prospective, open-label, multicenter randomized controlled, comprehensive clinical study is to evaluate the efficacy and safety of chloroquine phosphate and lopinavir/ritonavir in patients with mild/general COVID-19 infection. The results of this study should provide meaningful information and evidence for clinical practice and should help to design a proven and reasonable RCT soon
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