Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 4 for:    lopinavir-ritonavir ribavirin | COVID
Previous Study | Return to List | Next Study

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

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: NCT04276688
Recruitment Status : Completed
First Posted : February 19, 2020
Last Update Posted : April 15, 2020
Sponsor:
Collaborator:
Hospital Authority, Hong Kong
Information provided by (Responsible Party):
The University of Hong Kong

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

Condition or disease Intervention/treatment Phase
Novel Coronavirus Infection Drug: Lopinavir/ritonavir Drug: Ribavirin Drug: Interferon Beta-1B Phase 2

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

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 127 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: open-label randomised controlled trial
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : February 10, 2020
Actual Primary Completion Date : March 30, 2020
Actual Study Completion Date : March 31, 2020


Arm Intervention/treatment
Active Comparator: Study group
triple combination
Drug: Lopinavir/ritonavir
400mg/100mg twice daily for 14 days

Drug: Ribavirin
400mg twice daily for 14 days

Drug: Interferon Beta-1B
0.25mg subcutaneous injection alternate day for 3 days

Active Comparator: Control group
single
Drug: Lopinavir/ritonavir
400mg/100mg twice daily for 14 days




Primary Outcome Measures :
  1. Time to negative NPS [ Time Frame: Up to 1 month ]
    Time to negative NPS 2019-n-CoV RT-PCR


Secondary Outcome Measures :
  1. Time to negative saliva [ Time Frame: Up to 1 month ]
    Time to negative saliva 2019-n-CoV RT-PCR

  2. Time to clinical improvement [ Time Frame: Up to 1 month ]
    Time to NEWS of 0

  3. Hospitalisation [ Time Frame: Up to 1 month ]
    Length of hospitalisation

  4. Mortality [ Time Frame: Up to 1 month ]
    30-day mortality

  5. Immune reaction [ Time Frame: up to 1 month ]
    Cytokine/ chemokine changes

  6. Adverse events [ Time Frame: up to 1 month ]
    Adverse events during treatment

  7. Time to negative all clinical specimens [ Time Frame: up to 1 month ]
    Time to negative NPS, saliva, urine and stool 2019-n-CoV RT-PCR



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Recruited subjects include all adult patients ≥18 years hospitalised for virologically confirmed 2019-n-CoV infection.
  2. NEWS of ≥1 upon recruitment
  3. 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
  4. Symptom duration ≤10 days
  5. All subjects give written informed consent.
  6. 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.

Exclusion Criteria:

  1. Inability to comprehend and to follow all required study procedures.
  2. Allergy or severe reactions to the study drugs
  3. Patients with known prolonged QT or PR interval, second- or third-degree heart block, or ventricular cardiac arrhythmias, including torsade de pointes
  4. Patients taking medication that will potentially interact with lopinavir/ ritonavir, ribavirin or interferon-beta1b
  5. Patients with known history of severe depression
  6. Pregnant or lactation women
  7. Inability to comprehend and to follow all required study procedures
  8. 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.
  9. Have a history of alcohol or drug abuse in the last 5 years.
  10. Have any condition that the investigator believes may interfere with successful completion of the study.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04276688


Locations
Layout table for location information
Hong Kong
University of Hong Kong, Queen Mary Hospital
Hong Kong, Hong Kong
Sponsors and Collaborators
The University of Hong Kong
Hospital Authority, Hong Kong
Investigators
Layout table for investigator information
Principal Investigator: Ivan FN Hung, MD FRCP The University of Hong Kong
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: The University of Hong Kong
ClinicalTrials.gov Identifier: NCT04276688    
Other Study ID Numbers: UW-20-074
First Posted: February 19, 2020    Key Record Dates
Last Update Posted: April 15, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by The University of Hong Kong:
nCoV
lopinavir/ ritonavir
IFN-beta
Additional relevant MeSH terms:
Layout table for MeSH terms
Ribavirin
Lopinavir
Infection
Coronavirus Infections
Severe Acute Respiratory Syndrome
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Interferons
Ritonavir
Interferon-beta
Interferon beta-1b
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
HIV Protease Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-HIV Agents
Anti-Retroviral Agents
Cytochrome P-450 CYP3A Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Antimetabolites
Immunologic Factors
Physiological Effects of Drugs
Adjuvants, Immunologic