Status:
COMPLETED
Lopinavir/ Ritonavir, Ribavirin and IFN-beta Combination for nCoV Treatment
Lead Sponsor:
The University of Hong Kong
Collaborating Sponsors:
Hospital Authority, Hong Kong
Conditions:
Novel Coronavirus Infection
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 in...
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 20...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
February 10 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 31 2020
Estimated Enrollment :
127 Patients enrolled
Trial Details
Trial ID
NCT04276688
Start Date
February 10 2020
End Date
March 31 2020
Last Update
April 15 2020
Active Locations (1)
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1
University of Hong Kong, Queen Mary Hospital
Hong Kong, Hong Kong