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

• ClinicalTrials.gov Identifier: NCT04252885
• Recruitment Status: Completed
• First Posted: February 5, 2020
• Last Update Posted: July 1, 2020
• Sponsor: Guangzhou 8th People's Hospital
• Information provided by (Responsible Party): Linghua LI, Guangzhou 8th People's Hospital

Study Description

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 .

Condition or disease	Intervention/treatment	Phase
Coronavirus Infections	Drug: Lopinavir and Ritonavir Tablets; Drug: Arbidol	Phase 4

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 86 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• 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.
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: January 28, 2020
• Actual Primary Completion Date: April 30, 2020
• Actual Study Completion Date: May 31, 2020

Arms and Interventions

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 Name: 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.

Outcome Measures

Primary Outcome Measures :

1. The rate of virus inhibition [ Time Frame: Day 0, 2, 4, 7, 10, 14 and 21 ]
   Novel coronaviral nucleic acid is measured in nose / throat swab at each time point.

Secondary Outcome Measures :

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

Other Outcome Measures:

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

Eligibility Criteria

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

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

Contacts and Locations

Locations

China, Guangdong

Guangzhou Eighth People's Hospital

Guangzhou, Guangdong, China, 510060

Sponsors and Collaborators

Guangzhou 8th People's Hospital

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: Linghua LI, Vice chief of Infectious Disease Center, Guangzhou 8th People's Hospital
• ClinicalTrials.gov Identifier: NCT04252885
• Other Study ID Numbers: GZ8H-V1.0 20200122
• First Posted: February 5, 2020
• Last Update Posted: July 1, 2020
• Last Verified: June 2020

• 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

Keywords provided by Linghua LI, Guangzhou 8th People's Hospital:

Coronavirus infection; Lopinarvir plus ritonavir; Arbidol; Efficacy

Additional relevant MeSH terms:

Infections; Communicable Diseases; Coronavirus Infections; Disease Attributes; Pathologic Processes; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Ritonavir; Lopinavir; HIV Protease Inhibitors; Viral Protease Inhibitors; Protease Inhibitors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action; Anti-HIV Agents; Anti-Retroviral Agents; Antiviral Agents; Anti-Infective Agents; Cytochrome P-450 CYP3A Inhibitors; Cytochrome P-450 Enzyme Inhibitors