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

Coronavirus Infections Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04252885
• Other study ID #: GZ8H-V1.0 20200122
• Status: Completed
• Phase: Phase 4
• Start date: January 28, 2020
• Est. completion date: May 31, 2020

Study information

• Verified date: June 2020
• Source: Guangzhou 8th People's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 .

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 86
• Est. completion date: May 31, 2020
• Est. primary completion date: April 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Communicable Diseases
• Coronavirus Infections
• Infection
• Severe Acute Respiratory Syndrome

Intervention

Drug:
• Lopinavir and Ritonavir Tablets
As indicated in arm/group descriptions
• Arbidol
As indicated in arm/group descriptions

Locations

Country	Name	City	State
China	Guangzhou Eighth People's Hospital	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Guangzhou 8th People's Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Patients health condition-routine test	Blood pressure and heart rate will be followed everyday during time frame.	Day 0 till day 21
Other	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
Other	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
Other	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
Other	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
Primary	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	The disease prorogation-temperature	Body temperature will be followed everyday during time frame.	Day 0 till day 21
Secondary	The disease prorogation-respiratory function 1	Respiratory rate will be followed everyday during time frame.	Day 0 till day 21
Secondary	The disease prorogation-respiratory function 2	Oxygen saturation of blood will be followed everyday during time frame.	Day 0 till day 21
Secondary	The disease prorogation-respiratory function 3	Chest imaging will be taken at each time point.	Day 0, 4, 7, 10, 14 and 21