Trial NCT04252885
Publication Yueping L, CellPress (2020) (published paper)
Dates: 01feb2020 to 28mar2020
Funding: Public/non profit (Project 2018ZX10302103-002, 2017ZX10202102-003-004 and Infectious Disease Specialty of Guangzhou High-level Clinical Key Specialty (2019-2021) )
Conflict of interest: No

Methods
RCT
Blinding: Participants
Location : Single center / China
Follow-up duration (days): 21
Inclusion criteria
  • 1) Age between 18 and 80 years old

  • 2) SARS-CoV-2 infection confirmed by real-time PCR (RT-PCR) from pharyngeal swab

  • 3) Mild clinical status, defined as having mild clinical symptoms but no signs of pneumonia on imaging or moderate clinical status, defined as having fever, respiratory symptoms and pneumonia on imaging

  • 4) The following lab findings: creatinine ?110?mol/L, creatinine clearance rate (eGFR) ?60 ml/min/1.73m2, aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ?5 × ULN, and total bilirubin (TBIL) ?2 × ULN
  • 5) willing to participate the study and sign the informed consent
Exclusion criteria
  • 1) Known or suspected to be allergic to LPV/r or Umifenovir

  • 2) Having severe nausea, vomiting, diarrhea or other complaints affecting oral intake or absorption in the digestive tract

  • 3) Taking other drugs that may interact with LPV/r or Umifenovir

  • 4) Having serious underlying diseases, including but not limited to heart, lung, or kidney disease, liver malfunction, or mental diseases affecting treatment compliance

  • 5) Complicating with pancreatitis or hemophilia prior to the trial

  • 6) Pregnant or lactating women

  • 7) Having the suspected or confirmed history of alcohol or substance use disorder

  • 8) Having participated in other drug trials in the past month

  • 9) Deemed otherwise unsuitable for the study by the researchers.
Interventions
Treatment
Lopinavir-Ritonavir
LPV/r: 200/50 mg orally twice a day for 7-14 days

Umifenovir
200 mg orally 3 times a day for 7-14 days
Control
Standard care

Participants
Randomized
participants :
Lopinavir-Ritonavir=34
Umifenovir=35
Standard care=17
Characteristics of participants
N= 86
Mean age : NR
40 males
Severity : Mild: n=11 / Moderate: n=75 / Severe: n=0 Critical: n=0
Number of vaccinated participants: NR
Primary outcome
In the register
The rate of virus inhibition [ Time Frame: Day 0, 2, 4, 7, 10, 14 and 21 ]
In the report
Time of positive-to-negative conversion of SARS-CoV-2 nucleic acid from initiating treatment to day 21, with the enrollment day as the first day of treatment
Documents
available

Protocol

NR

Statistical plan

NR

Data-sharing willing stated in the publication:

No
Risk of bias
Overall
The overall risk of bias reported in the table corresponds to the highest risk of bias for the outcomes assessed for the systematic review
Some concerns
General comment In addition to all available versions of the published/pre-print article, the study registry and the reply provided by authors were used in data extraction and risk of bias assessment.The study did not achieve the target sample size specified in the trial registry. There is no change from the trial registration in the intervention and control treatments. The primary outcome indicated in the registry is measured at multiple time points, some of which are not reported in the paper. Some outcomes are reported in the paper, but were not pre-specified in the trial registry/protocol (e.g., adverse events).