Clinical trial NCT04252885: The Efficacy of Lopinavir Plus Ritonavir and Arbidol Against Novel Coronavirus Infection
Official title: A Randomized, Open-label, Controlled Study of the Efficacy of Lopinavir Plus Ritonavir and Arbidol for Treating With Patients With Novel Coronavirus Infection
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Coronavirus Infections
Keywords: Coronavirus infection
Lopinarvir plus ritonavir
Arbidol
Efficacy
Lead sponsor: Guangzhou 8th People's Hospital
Sponsor class: OTHER
First posted: 2020-02-05
Enrollment: 86
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 125 patients are randomized in 3 groups (2:2:1). 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.
Primary purpose: TREATMENT

Brief summary: 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 .

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: The rate of virus inhibition
timeFrame: Day 0, 2, 4, 7, 10, 14 and 21
Secondary outcomes:
measure: The disease prorogation-temperature
timeFrame: Day 0 till day 21
measure: The disease prorogation-respiratory function 1
timeFrame: Day 0 till day 21
measure: The disease prorogation-respiratory function 2
timeFrame: Day 0 till day 21
measure: The disease prorogation-respiratory function 3
timeFrame: Day 0, 4, 7, 10, 14 and 21
Other outcomes:
measure: Patients health condition-routine test
timeFrame: Day 0 till day 21
measure: Patients health condition-liver function
timeFrame: Day 0, 4, 7, 10, 14 and 21
measure: Patients health condition-kidney function
timeFrame: Day 0, 4, 7, 10, 14 and 21
measure: Patients health condition-other blood routine test
timeFrame: Day 0, 4, 7, 10, 14 and 21
measure: Patients health condition-blood routine test
timeFrame: Day 0, 4, 7, 10, 14 and 21
Locations:
city: Guangzhou
country: China
facility: Guangzhou Eighth People's Hospital
state: Guangdong
Study officials:
References:
citation: Li Y, Xie Z, Lin W, Cai W, Wen C, Guan Y, Mo X, Wang J, Wang Y, Peng P, Chen X, Hong W, Xiao G, Liu J, Zhang L, Hu F, Li F, Zhang F, Deng X, Li L. Efficacy and Safety of Lopinavir/Ritonavir or Arbidol in Adult Patients with Mild/Moderate COVID-19: An Exploratory Randomized Controlled Trial. Med. 2020 Dec 18;1(1):105-113.e4. doi: 10.1016/j.medj.2020.04.001. Epub 2020 May 19.