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

NCT ID: NCT04252885

Last Updated: 2020-07-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 86 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-01-28
• Study Completion Date: 2020-05-31

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.

Conditions

Coronavirus Infections

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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).

Group Type: EXPERIMENTAL

Lopinavir and Ritonavir Tablets

Intervention Type: DRUG

As indicated in arm/group descriptions

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).

Group Type: ACTIVE_COMPARATOR

Arbidol

Intervention Type: DRUG

As indicated in arm/group descriptions

Group C-Standard treatment

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Lopinavir and Ritonavir Tablets

As indicated in arm/group descriptions

Intervention Type: DRUG

Arbidol

As indicated in arm/group descriptions

Intervention Type: DRUG

Other Intervention Names

Kletra

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Guangzhou 8th People's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Linghua LI

Vice chief of Infectious Disease Center

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Guangzhou Eighth People's Hospital

Guangzhou, Guangdong, China

Countries

China

References

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.

Reference Type: DERIVED

PMID: 32838353 (View on PubMed)

Other Identifiers

GZ8H-V1.0 20200122

Identifier Type: -

Identifier Source: org_study_id