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Novel Coronavirus InfectionPhase 2NCT04276688

Lopinavir/ Ritonavir, Ribavirin and IFN-beta Combination for nCoV Treatment

A Phase 2 study testing Lopinavir/ritonavir, Ribavirin and Interferon Beta-1B in people with Novel Coronavirus Infection, run by The University of Hong Kong at 1 site in Hong Kong.

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

A combination of lopinavir/ ritonavir, ribavirin and interferon beta-1b will expedite the recovery, suppress the viral load, shorten hospitalisation and reduce mortality in patients with 2019-n-CoV infection compared with to lopinavir/ ritonavir Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Novel Coronavirus Infection
What is being tested?
Lopinavir/ritonavir, Ribavirin and Interferon Beta-1B
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
127 participants
Where
1 siteHong Kong
Study dates
10 Feb 2020to 31 Mar 2020
Phase
Phase 2
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Recruited subjects include all adult patients ≥18 years hospitalised for virologically confirmed 2019-n-CoV infection.
  • NEWS of ≥1 upon recruitment
  • Auditory temperature ≥38°C with at least one of the following symptoms (cough, sputum production, sore-throat, nasal discharge, myalgia, headache or fatigue) upon admission
  • Symptom duration ≤10 days
  • All subjects give written informed consent.
  • Subjects must be available to complete the study and comply with study procedures. Willingness to allow for serum samples to be stored beyond the study period, for potential additional future testing to better characterize immune response.

Who cannot join

  • Inability to comprehend and to follow all required study procedures.
  • Allergy or severe reactions to the study drugs
  • Patients with known prolonged QT or PR interval, second- or third-degree heart block, or ventricular cardiac arrhythmias, including torsade de pointes
  • Patients taking medication that will potentially interact with lopinavir/ ritonavir, ribavirin or interferon-beta1b
  • Patients with known history of severe depression
  • Pregnant or lactation women
Show all 10Show fewer
  • Inability to comprehend and to follow all required study procedures
  • Received an experimental agent (vaccine, drug, biologic, device, blood product, or medication) within 1 month prior to recruitment in this study or expect to receive an experimental agent during this study. Unwilling to refuse participation in another clinical study through the end of this study.
  • Have a history of alcohol or drug abuse in the last 5 years.
  • Have any condition that the investigator believes may interfere with successful completion of the study.

Trial locations and contacts

1 site in 1 country.

Hong Kong1 site

  • University of Hong Kong, Queen Mary Hospital

    Hong Kong

Other trials in Hong Kong

About this study

Official title: An Open-label Randomized Controlled Trial on Lopinavir/ Ritonavir, Ribavirin and Interferon Beta 1b Combination Versus Lopinavir/ Ritonavir Alone, as Treatment for 2019 Novel Coronavirus Infection

A combination of lopinavir/ ritonavir, ribavirin and interferon beta-1b will expedite the recovery, suppress the viral load, shorten hospitalisation and reduce mortality in patients with 2019-n-CoV infection compared with to lopinavir/ ritonavir

Read the detailed description

Hypothesis A combination of lopinavir/ ritonavir, ribavirin and interferon beta-1b will expedite the recovery, suppress the viral load, shorten hospitalisation and reduce mortality in patients with 2019-n-CoV infection compared with to lopinavir/ ritonavir alone

Primary objective: To evaluate the safety and efficacy in mortality reduction with a combination of lopinavir/ ritonavir, ribavirin and interferon beta-1b in the treatment of patient hospitalised for 2019-n-CoV infection and compare this to lopinavir/ ritonavir alone

Subject/patient definition: Recruited subjects include adult patients ≥18 years of age, admitted to the HA Hospitals from February 2020 onwards, with laboratory confirmed 2019-n-CoV infection. All subjects give written informed consent. Subjects must be available to complete the study and comply with study procedures.

Study design: This is a prospective open-label randomised controlled trial among adult patients hospitalised after February 2020 for virologically confirmed 2019-n-CoV infection. Patients will be randomly assigned to either a 14-day course of lopinavir/ ritonavir 400mg/100mg twice daily, ribavirin 400mg bd and zero to three doses of subcutaneous injection of interferon beta-1b 1mL (0.25mg; 8 million IU) on day 1, 3 and 5 (depending on day of admission from symptoms onset) plus standard care, or a 14-day course of lopinavir/ ritonavir 400mg/100mg twice daily plus standard care alone (2:1).

Intervention/study article: lopinavir/ ritonavir, ribavirin and interferon beta-1b

Primary outcome: Time to negative nasopharyngeal swab (NPS) 2019-n-CoV coronavirus viral RT-PCR

Secondary outcome:

  1. Time to negative saliva 2019-n-CoV coronavirus viral RT-PCR
  2. Time to clinical improvement of NEWS2 (National Early Warning Score 2) of 0 maintained for 24 hours
  3. Length of hospitalisation
  4. Adverse events during treatment
  5. 30-day mortality
  6. Cytokine/ chemokine changes
Being tested
Lopinavir/ritonavir, Ribavirin, Interferon Beta-1B
Keywords
nCoV, lopinavir/ ritonavir, IFN-beta

What participants receive

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

  • Lopinavir/ritonavirDrug

    400mg/100mg twice daily for 14 days

  • RibavirinDrug

    400mg twice daily for 14 days

  • Interferon Beta-1BDrug

    0.25mg subcutaneous injection alternate day for 3 days

Study groups in NCT04276688
Study groupRoleWhat they receive
Study groupActive comparatortriple combination
Receives: Drug: Lopinavir/ritonavir; Drug: Ribavirin; Drug: Interferon Beta-1B
Control groupActive comparatorsingle
Receives: Drug: Lopinavir/ritonavir

What is being measured

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

  1. Time to negative NPS

    Time to negative NPS 2019-n-CoV RT-PCR

    Measured: Up to 1 month

Secondary outcomes (7)

  1. Time to negative saliva

    Time to negative saliva 2019-n-CoV RT-PCR

    Measured: Up to 1 month

  2. Time to clinical improvement

    Time to NEWS of 0

    Measured: Up to 1 month

  3. Hospitalisation

    Length of hospitalisation

    Measured: Up to 1 month

  4. Mortality

    30-day mortality

    Measured: Up to 1 month

  5. Immune reaction

    Cytokine/ chemokine changes

    Measured: up to 1 month

  6. Adverse events

    Adverse events during treatment

    Measured: up to 1 month

  7. Time to negative all clinical specimens

    Time to negative NPS, saliva, urine and stool 2019-n-CoV RT-PCR

    Measured: up to 1 month

Timeline

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

  1. First posted19 Feb 2020
  2. Study start10 Feb 2020
  3. Primary completion30 Mar 2020
  4. Study completion31 Mar 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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
open-label randomised controlled trial
Masking
None (open label)
Enrolment
127 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04276688
Sponsor's protocol ID
UW-20-074
Status last verified
Apr 2020
First submitted
11 Feb 2020
Last updated
15 Apr 2020
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Moschen AR. IBD in the time of corona - vigilance for immune-mediated diseases. Nat Rev Gastroenterol Hepatol. 2020 Sep;17(9):529-530. doi: 10.1038/s41575-020-0333-5.

    PubMed 32555385

  • Hung IF, Lung KC, Tso EY, Liu R, Chung TW, Chu MY, Ng YY, Lo J, Chan J, Tam AR, Shum HP, Chan V, Wu AK, Sin KM, Leung WS, Law WL, Lung DC, Sin S, Yeung P, Yip CC, Zhang RR, Fung AY, Yan EY, Leung KH, Ip JD, Chu AW, Chan WM, Ng AC, Lee R, Fung K, Yeung A, Wu TC, Chan JW, Yan WW, Chan WM, Chan JF, Lie AK, Tsang OT, Cheng VC, Que TL, Lau CS, Chan KH, To KK, Yuen KY. Triple combination of interferon beta-1b, lopinavir-ritonavir, and ribavirin in the treatment of patients admitted to hospital with COVID-19: an open-label, randomised, phase 2 trial. Lancet. 2020 May 30;395(10238):1695-1704. doi: 10.1016/S0140-6736(20)31042-4. Epub 2020 May 10.

    PubMed 32401715

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Lopinavir/ritonavir, Ribavirin and Interferon Beta-1B in people with Novel Coronavirus Infection, run by The University of Hong Kong at 1 site in Hong Kong.

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 6 inclusion and 10 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 15 Apr 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 Hong Kong. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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?

Time to negative NPS (time frame: Up to 1 month). 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 NCT04276688, which also lists 2 linked publications.

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 15 Apr 2020.

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