Trial record 1 of 1 for:
The Efficacy of Lopinavir Plus Ritonavir and Arbidol Against Novel Coronavirus Infection
The Efficacy of Lopinavir Plus Ritonavir and Arbidol Against Novel Coronavirus Infection (ELACOI)
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ClinicalTrials.gov Identifier: NCT04252885 |
Recruitment Status :
Completed
First Posted : February 5, 2020
Last Update Posted : July 1, 2020
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Sponsor:
Guangzhou 8th People's Hospital
Information provided by (Responsible Party):
Linghua LI, Guangzhou 8th People's Hospital
Tracking Information | |||||||
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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 |
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.
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Original Primary Outcome Measures ICMJE | Same as current | ||||||
Change History | |||||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | ||||||
Current Other Pre-specified Outcome Measures |
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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 |
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Condition ICMJE | Coronavirus Infections | ||||||
Intervention ICMJE |
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Study Arms ICMJE |
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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 Dec 18;1(1):105-113.e4. doi: 10.1016/j.medj.2020.04.001. Epub 2020 May 19. | ||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||
Recruitment Status ICMJE | Completed | ||||||
Actual Enrollment ICMJE |
86 | ||||||
Original Estimated Enrollment ICMJE |
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:
Exclusion Criteria:
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Sex/Gender ICMJE |
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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 |
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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 |