Back to results

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

Primary Purpose

Coronavirus Infections

Status

Completed

Phase

Phase 4

Locations

China

Study Type

Interventional

Intervention

Lopinavir and Ritonavir Tablets

Arbidol

About this trial

This is an interventional treatment trial for Coronavirus Infections focused on measuring Coronavirus infection, Lopinarvir plus ritonavir, Arbidol, Efficacy

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Guangzhou Eighth People's Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

No Intervention

Arm Label

Group A-Standard treatment+lopinavir/ritonavir

Group B-Standard treatment+arbidol

Group C-Standard treatment

Arm Description

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).

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).

In group C, 25 cases are only given ordinary treatment.

Outcomes

Primary Outcome Measures

The rate of virus inhibition

Novel coronaviral nucleic acid is measured in nose / throat swab at each time point.

Secondary Outcome Measures

The disease prorogation-temperature

Body temperature will be followed everyday during time frame.

The disease prorogation-respiratory function 1

Respiratory rate will be followed everyday during time frame.

The disease prorogation-respiratory function 2

Oxygen saturation of blood will be followed everyday during time frame.

The disease prorogation-respiratory function 3

Chest imaging will be taken at each time point.

Full Information

NCT ID

NCT04252885

First Posted

January 30, 2020

Last Updated

June 29, 2020

Sponsor

Guangzhou 8th People's Hospital

1. Study Identification

Unique Protocol Identification Number

NCT04252885

Brief Title

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

Acronym

ELACOI

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

2. Study Status

Record Verification Date

June 2020

Overall Recruitment Status

Completed

Study Start Date

January 28, 2020 (Actual)

Primary Completion Date

April 30, 2020 (Actual)

Study Completion Date

May 31, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Guangzhou 8th People's Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

5. 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 .

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Coronavirus Infections

Keywords

Coronavirus infection, Lopinarvir plus ritonavir, Arbidol, Efficacy

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

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)

Allocation

Randomized

Enrollment

86 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Group A-Standard treatment+lopinavir/ritonavir

Arm Type

Experimental

Arm Description

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).

Arm Title

Group B-Standard treatment+arbidol

Arm Type

Active Comparator

Arm Description

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).

Arm Title

Group C-Standard treatment

Arm Type

No Intervention

Arm Description

In group C, 25 cases are only given ordinary treatment.

Intervention Type

Drug

Intervention Name(s)

Lopinavir and Ritonavir Tablets

Other Intervention Name(s)

Kletra

Intervention Description

As indicated in arm/group descriptions

Intervention Type

Drug

Intervention Name(s)

Arbidol

Intervention Description

As indicated in arm/group descriptions

Primary Outcome Measure Information:

Title

The rate of virus inhibition

Description

Novel coronaviral nucleic acid is measured in nose / throat swab at each time point.

Time Frame

Day 0, 2, 4, 7, 10, 14 and 21

Secondary Outcome Measure Information:

Title

The disease prorogation-temperature

Description

Body temperature will be followed everyday during time frame.

Time Frame

Day 0 till day 21

Title

The disease prorogation-respiratory function 1

Description

Respiratory rate will be followed everyday during time frame.

Time Frame

Day 0 till day 21

Title

The disease prorogation-respiratory function 2

Description

Oxygen saturation of blood will be followed everyday during time frame.

Time Frame

Day 0 till day 21

Title

The disease prorogation-respiratory function 3

Description

Chest imaging will be taken at each time point.

Time Frame

Day 0, 4, 7, 10, 14 and 21

Other Pre-specified Outcome Measures:

Title

Patients health condition-routine test

Description

Blood pressure and heart rate will be followed everyday during time frame.

Time Frame

Day 0 till day 21

Title

Patients health condition-liver function

Description

Liver function will be assessed as AST, ALT and TBIL at each time point.

Time Frame

Day 0, 4, 7, 10, 14 and 21

Title

Patients health condition-kidney function

Description

Kidney function will be assessed as eGFR and creatine clearance rate at each time point.

Time Frame

Day 0, 4, 7, 10, 14 and 21

Title

Patients health condition-other blood routine test

Description

Blood routine and myocardial enzyme will be measured at each time point.

Time Frame

Day 0, 4, 7, 10, 14 and 21

Title

Patients health condition-blood routine test

Description

Flow cytometry classification and counting and cytokines will be measured at each time point.

Time Frame

Day 0, 4, 7, 10, 14 and 21

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

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

Facility Information:

Facility Name

Guangzhou Eighth People's Hospital

City

Guangzhou

State/Province

Guangdong

ZIP/Postal Code

510060

Country

China

12. IPD Sharing Statement

Citations:

PubMed Identifier

32838353

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.

Results Reference

derived

Learn more about this trial

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

We'll reach out to this number within 24 hrs