The Efficacy of Lopinavir Plus Ritonavir and Arbidol Against Novel Coronavirus Infection

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Randomized, Open-label, Controlled Study of the Efficacy of Lopinavir Plus Ritonavir and Arbidol for Treating With Patients With Novel Coronavirus Infection

Conditions
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Coronavirus Infections

Intervention / Treatment
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* Drug: Lopinavir and Ritonavir Tablets
* Drug: Arbidol


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group A-Standard treatment+lopinavir/ritonavir<br>In group A, 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). | Drug: Lopinavir and Ritonavir Tablets<br>* As indicated in arm/group descriptions<br>* Other names: Kletra;|
| Active Comparator: Group B-Standard treatment+arbidol<br>In group B, 50 cases are given ordinary treatment plus a regimen of arbidol (100mg) (oral, tid, 200mg each time, taking for 7-14 days). | Drug: Arbidol<br>* As indicated in arm/group descriptions<br>|
| No Intervention: Group C-Standard treatment<br>In group C, 25 cases are only given ordinary treatment. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The rate of virus inhibition | Novel coronaviral nucleic acid is measured in nose / throat swab at each time point. | Day 0, 2, 4, 7, 10, 14 and 21 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The disease prorogation-temperature | Body temperature will be followed everyday during time frame. | Day 0 till day 21 | 
| The disease prorogation-respiratory function 1 | Respiratory rate will be followed everyday during time frame. | Day 0 till day 21 | 
| The disease prorogation-respiratory function 2 | Oxygen saturation of blood will be followed everyday during time frame. | Day 0 till day 21 | 
| The disease prorogation-respiratory function 3 | Chest imaging will be taken at each time point. | Day 0, 4, 7, 10, 14 and 21 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Coronavirus infection, Lopinarvir plus ritonavir, Arbidol, Efficacy