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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04252885
Recruitment Status : Completed
First Posted : February 5, 2020
Last Update Posted : July 1, 2020
Sponsor:
Information provided by (Responsible Party):
Linghua LI, Guangzhou 8th People's Hospital

Tracking Information
First Submitted Date  ICMJE January 30, 2020
First Posted Date  ICMJE February 5, 2020
Last Update Posted Date July 1, 2020
Actual Study Start Date  ICMJE January 28, 2020
Actual Primary Completion Date April 30, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 31, 2020)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 31, 2020)
  • The disease prorogation-temperature [ Time Frame: Day 0 till day 21 ]
    Body temperature will be followed everyday during time frame.
  • The disease prorogation-respiratory function 1 [ Time Frame: Day 0 till day 21 ]
    Respiratory rate will be followed everyday during time frame.
  • The disease prorogation-respiratory function 2 [ Time Frame: Day 0 till day 21 ]
    Oxygen saturation of blood will be followed everyday during time frame.
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: January 31, 2020)
  • Patients health condition-routine test [ Time Frame: Day 0 till day 21 ]
    Blood pressure and heart rate will be followed everyday during time frame.
  • 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.
  • 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.
  • 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.
  • 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.
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE The Efficacy of Lopinavir Plus Ritonavir and Arbidol Against Novel Coronavirus Infection
Official Title  ICMJE A Randomized, Open-label, Controlled Study of the Efficacy of Lopinavir Plus Ritonavir and Arbidol for Treating With Patients With Novel Coronavirus Infection
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE 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
Condition  ICMJE Coronavirus Infections
Intervention  ICMJE
  • Drug: Lopinavir and Ritonavir Tablets
    As indicated in arm/group descriptions
    Other Name: Kletra
  • Drug: Arbidol
    As indicated in arm/group descriptions
Study Arms  ICMJE
  • 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).
    Intervention: Drug: Lopinavir and Ritonavir Tablets
  • 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).
    Intervention: Drug: Arbidol
  • No Intervention: Group C-Standard treatment
    In group C, 25 cases are only given ordinary treatment.
Publications * 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 (N Y). 2020 May 19. doi: 10.1016/j.medj.2020.04.001. [Epub ahead of print]

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 29, 2020)
86
Original Estimated Enrollment  ICMJE
 (submitted: January 31, 2020)
125
Actual Study Completion Date  ICMJE May 31, 2020
Actual Primary Completion Date April 30, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04252885
Other Study ID Numbers  ICMJE GZ8H-V1.0 20200122
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Linghua LI, Guangzhou 8th People's Hospital
Study Sponsor  ICMJE Guangzhou 8th People's Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Guangzhou 8th People's Hospital
Verification Date June 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP