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

• Status: Completed
• Trial end date: 2020-03-31
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: The University of Hong Kong
• Collaborator: Hospital Authority, Hong Kong
• Treatments: Interferon beta-1b; Interferon-beta; Interferons; Lopinavir; Ribavirin; Ritonavir

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.