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Coronavirus InfectionsPhase 4ELACOINCT04252885

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

A Phase 4 study testing Lopinavir and Ritonavir Tablets and Arbidol in people with Coronavirus Infections, run by Guangzhou 8th People's Hospital at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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 . Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Coronavirus Infections
What is being tested?
Lopinavir and Ritonavir Tablets and Arbidol
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
86 participants
Where
1 siteChina
Study dates
28 Jan 2020to 31 May 2020
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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
Show all 9Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

China1 site

  • Guangzhou Eighth People's Hospital

    Guangzhou, Guangdong, 510060

Other trials in China

About this study

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

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 .

Read the 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.

Being tested
Lopinavir and Ritonavir Tablets, Arbidol
Keywords
Coronavirus infection, Lopinarvir plus ritonavir, Arbidol, Efficacy
Medical subject headings
Coronavirus Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Lopinavir and Ritonavir TabletsDrug

    Also called Kletra

    As indicated in arm/group descriptions

  • ArbidolDrug

    As indicated in arm/group descriptions

Study groups in NCT04252885
Study groupRoleWhat they receive
Group A-Standard treatment+lopinavir/ritonavirExperimentalIn 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).
Receives: Drug: Lopinavir and Ritonavir Tablets
Group B-Standard treatment+arbidolActive comparatorIn group B, 50 cases are given ordinary treatment plus a regimen of arbidol (100mg) (oral, tid, 200mg each time, taking for 7-14 days).
Receives: Drug: Arbidol
Group C-Standard treatmentNo interventionIn group C, 25 cases are only given ordinary treatment.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The rate of virus inhibition

    Novel coronaviral nucleic acid is measured in nose / throat swab at each time point.

    Measured: Day 0, 2, 4, 7, 10, 14 and 21

Secondary outcomes (4)

  1. The disease prorogation-temperature

    Body temperature will be followed everyday during time frame.

    Measured: Day 0 till day 21

  2. The disease prorogation-respiratory function 1

    Respiratory rate will be followed everyday during time frame.

    Measured: Day 0 till day 21

  3. The disease prorogation-respiratory function 2

    Oxygen saturation of blood will be followed everyday during time frame.

    Measured: Day 0 till day 21

  4. The disease prorogation-respiratory function 3

    Chest imaging will be taken at each time point.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Feb 2020
  2. Study start28 Jan 2020
  3. Primary completion30 Apr 2020
  4. Study completion31 May 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
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)
Enrolment
86 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04252885
Sponsor's protocol ID
GZ8H-V1.0 20200122
Acronym
ELACOI
Status last verified
Jun 2020
First submitted
30 Jan 2020
Last updated
1 Jul 2020
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

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. 2020 Dec 18;1(1):105-113.e4. doi: 10.1016/j.medj.2020.04.001. Epub 2020 May 19.

    PubMed 32838353

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Lopinavir and Ritonavir Tablets and Arbidol in people with Coronavirus Infections, run by Guangzhou 8th People's Hospital at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The rate of virus inhibition (time frame: Day 0, 2, 4, 7, 10, 14 and 21). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04252885, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jul 2020.

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