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

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

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 .

Study Overview

• Status: Completed
• Conditions: Coronavirus Infections
• Intervention / Treatment: Drug: Lopinavir and Ritonavir Tablets; Drug: Arbidol

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.

• Study Type: Interventional
• Enrollment (Actual): 86
• Phase: Phase 4

Contacts and Locations

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510060
      • Guangzhou Eighth People's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group A-Standard treatment+lopinavir/ritonavir; 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; As indicated in arm/group descriptions; Other Names: Kletra
Active Comparator: Group B-Standard treatment+arbidol; 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; As indicated in arm/group descriptions
No Intervention: Group C-Standard treatment; In group C, 25 cases are only given ordinary treatment.

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patients health condition-routine test	Blood pressure and heart rate will be followed everyday during time frame.	Day 0 till day 21
Patients health condition-liver function	Liver function will be assessed as AST, ALT and TBIL at each time point.	Day 0, 4, 7, 10, 14 and 21
Patients health condition-kidney function	Kidney function will be assessed as eGFR and creatine clearance rate at each time point.	Day 0, 4, 7, 10, 14 and 21
Patients health condition-other blood routine test	Blood routine and myocardial enzyme will be measured at each time point.	Day 0, 4, 7, 10, 14 and 21
Patients health condition-blood routine test	Flow cytometry classification and counting and cytokines will be measured at each time point.	Day 0, 4, 7, 10, 14 and 21

Collaborators and Investigators

• Sponsor: Guangzhou 8th People's Hospital

Publications and helpful links

General Publications

• 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 (N Y). 2020 Dec 18;1(1):105-113.e4. doi: 10.1016/j.medj.2020.04.001. Epub 2020 May 19.

Study record dates

Study Major Dates

• Study Start (Actual): January 28, 2020
• Primary Completion (Actual): April 30, 2020
• Study Completion (Actual): May 31, 2020

Study Registration Dates

• First Submitted: January 30, 2020
• First Submitted That Met QC Criteria: January 31, 2020
• First Posted (Actual): February 5, 2020

Study Record Updates

• Last Update Posted (Actual): July 1, 2020
• Last Update Submitted That Met QC Criteria: June 29, 2020
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Keywords: Efficacy; Coronavirus infection; Arbidol; Lopinarvir plus ritonavir
• Additional Relevant MeSH Terms: Pathologic Processes; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Disease Attributes; Coronavirus Infections; Infections; Communicable Diseases; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Antiviral Agents; Enzyme Inhibitors; Anti-HIV Agents; Anti-Retroviral Agents; Protease Inhibitors; Cytochrome P-450 CYP3A Inhibitors; Cytochrome P-450 Enzyme Inhibitors; HIV Protease Inhibitors; Viral Protease Inhibitors; Ritonavir; Lopinavir
• Other Study ID Numbers: GZ8H-V1.0 20200122

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No