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

NCT04276688 | Completed Phase 2 DMC

• 1 other identifier: UW-20-074
• Study Type: interventional
• Target: 127
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Novel Coronavirus Infection

Keywords

nCoV; lopinavir/ ritonavir; IFN-beta

Outcome Measures

Primary Outcomes (1)

• Time to negative NPS

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

  Up to 1 month

Secondary Outcomes (7)

• Time to negative saliva

  Up to 1 month

• Time to clinical improvement

  Up to 1 month

• Hospitalisation

  Up to 1 month

• Mortality

  Up to 1 month

• Immune reaction

  up to 1 month

Study Arms (2)

Study group

ACTIVE COMPARATOR

triple combination

Drug: Lopinavir/ritonavir; Drug: Ribavirin; Drug: Interferon Beta-1B

Control group

ACTIVE COMPARATOR

single

Drug: Lopinavir/ritonavir

Interventions

Lopinavir/ritonavir DRUG

400mg/100mg twice daily for 14 days

Control group; Study group

Ribavirin DRUG

400mg twice daily for 14 days

Study group

Interferon Beta-1B DRUG

0.25mg subcutaneous injection alternate day for 3 days

Study group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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
• 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.

Sponsors & Collaborators

• The University of Hong Kong: lead
• Hospital Authority, Hong Kong: collaborator

Study Sites (1)

University of Hong Kong, Queen Mary Hospital

Hong Kong, Hong Kong

Location

Related Publications (2)

• 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.

  PMID: 32555385 DERIVED

• 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.

  PMID: 32401715 DERIVED

MeSH Terms

Interventions

Lopinavir; Ribavirin; Interferon beta-1b

Intervention Hierarchy (Ancestors)

Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Ribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Interferon-beta; Interferon Type I; Interferons; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors

Study Officials

• Ivan FN Hung, MD FRCP

  The University of Hong Kong

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: open-label randomised controlled trial

Study Record Dates

• First Submitted: February 11, 2020
• First Posted: February 19, 2020
• Study Start: February 10, 2020
• Primary Completion: March 30, 2020
• Study Completion: March 31, 2020
• Last Updated: April 15, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)