Trial NCT04252885
Publication Yueping L, 2020 (published paper)
Dates: 1-Feb-20 to 28-Mar-20
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: single blinding | |
| 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 Ã ULN, and total bilirubin (TBIL) ?2 Ã 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 1 Lopinavir-Ritonavir (500 mg) Co-Intervention: Standard care Duration : 7-14 days | |
| Control Standard care | |
| Control Umifenovir (200 mg ) Co-Intervention: Standard care Duration : 7-14 days | |
| Participants | |
| Randomized 86 participants n1=34/ n2=17/ n3=35 | |
| Characteristics of participants N=86 Mean age : 49.4 40 males Severity : Mild: n=11 / Moderate: n=75/ Severe: n=0 Critical: n=0 | |
| 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 stated Unclear |
| 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). |