The study explores the efficacy of lopinavir plus ritonavir and arbidol in treating with novel coronavirus infection. As a result this study would provide evidence for the clinical usage of these drugs in the future .
This is a phase IV, open-labelled, randomized controlled clinical trial. A total of 125 cases
who are novel coronavirus positive are planned to be recruited. These cases are randomized
into 3 groups: in group A（Standard treatment+lopinavir/ritonavir）, 50 cases are given
ordinary treatment plus a regimen of lopinavir (200mg) and ritonavir (50mg) (oral, q12h,
every time 2 tablets of each, taking for 7-14 days). In group B（Standard treatment+arbidol） ,
50 cases are given ordinary treatment plus a regimen of arbidol (100mg) (oral, tid, 200mg
each time, taking for 7-14 days). In group C（Standard treatment）, 25 cases are only given
ordinary treatment. The observation duration is 21 days. Patients will be followed up at
baseline (day 0) and day 2, 4, 7, 10,14, 21 after receiving indicated treatment. The primary
observed indicators include viral nucleic in acid nose / throat swab, body temperature,
respiratory rate, oxygen saturation of blood, chest imaging. The secondary observed
indicators include but not limited to blood pressure, heart rate, blood routine test, liver
and kidney function, myocardial enzyme, flow cytometry classification and counting,
cytokines, other infection indicators, conditions and parameters of auxiliary respiration,
the total days in hospital, exacerbation and mortality.
Drug: Lopinavir and Ritonavir Tablets
As indicated in arm/group descriptions
Other Name: Kletra
Drug: Arbidol
As indicated in arm/group descriptions
Inclusion Criteria:
- In sputum, throat swab, lower respiratory tract secretion, blood and other samples,
the nucleic acid of the novel coronavirus was positive, or the sequencing of the virus
gene was highly homologous with the known novel coronavirus
- Age is between 18-80 years old, the weight is more than 30kg, and there is no limit
for men and women
- The following conditions were met: creatinine ≤ 110 umol / L, creatinine clearance
rate (EGFR) ≥ 60 ml / min / 1.73m2, AST and ALT ≤ 5 × ULN, TBIL ≤ 2 × ULN;
- The subjects should fully understand the purpose, nature, method and possible reaction
of the study, voluntarily participate in the study and sign the informed consent.
Exclusion Criteria:
- Have a clear history of lopinavir or ritonavir or arbidol allergy
- Severe nausea, vomiting, diarrhea and other clinical manifestations affect the oral or
absorption of the drugs
- At the same time, take drugs that may interact with lopinavir or ritonavir or arbidol
- Patients with serious underlying diseases, including but not limited to heart disease
(including history of angina pectoris or coronary heart disease or myocardial
infarction, atrioventricular block), lung, kidney, liver malfunction and mental
diseases that cannot be treated together
- ancreatitis or hemophilia
- Pregnant and lactating women
- Suspected or confirmed history of alcohol and drug abuse
- Participated in other drug trials in the past month
- The researchers judged that patients were not suitable for the study
Guangzhou Eighth People's Hospital
Guangzhou, Guangdong, China