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

NCT04252885 | Completed Phase 4

• 1 other identifier: GZ8H-V1.0 20200122
• Study Type: interventional
• Target: 86
• Locations: 1 country
• Sites: 1

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 .

Conditions

Coronavirus Infections

Keywords

Coronavirus infection; Lopinarvir plus ritonavir; Arbidol; Efficacy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• The disease prorogation-temperature

  Day 0 till day 21

• The disease prorogation-respiratory function 1

  Day 0 till day 21

• The disease prorogation-respiratory function 2

  Day 0 till day 21

• The disease prorogation-respiratory function 3

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

Other Outcomes (5)

• Patients health condition-routine test

  Day 0 till day 21

• Patients health condition-liver function

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

• Patients health condition-kidney function

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

Study Arms (3)

Group A-Standard treatment+lopinavir/ritonavir

EXPERIMENTAL

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

Group B-Standard treatment+arbidol

ACTIVE COMPARATOR

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

Group C-Standard treatment

NO INTERVENTION

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

Interventions

Lopinavir and Ritonavir Tablets DRUG

As indicated in arm/group descriptions

Also known as: Kletra

Group A-Standard treatment+lopinavir/ritonavir

Arbidol DRUG

As indicated in arm/group descriptions

Group B-Standard treatment+arbidol

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Guangzhou 8th People's Hospital: lead

Study Sites (1)

Guangzhou Eighth People's Hospital

Guangzhou, Guangdong, 510060, China

Location

Related Publications (1)

• 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.

  PMID: 32838353 DERIVED

MeSH Terms

Conditions

Coronavirus Infections

Interventions

Lopinavir; Ritonavir; umifenovir

Condition Hierarchy (Ancestors)

Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections

Intervention Hierarchy (Ancestors)

Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Thiazoles; Sulfur Compounds; Organic Chemicals; Azoles

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Vice chief of Infectious Disease Center

Model Details: 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.

Study Record Dates

• First Submitted: January 30, 2020
• First Posted: February 5, 2020
• Study Start: January 28, 2020
• Primary Completion: April 30, 2020
• Study Completion: May 31, 2020
• Last Updated: July 1, 2020

Record last verified: 2020-06

Locations

CN (1)