Status:
COMPLETED
Double Therapy With IFN-beta 1b and Hydroxychloroquine
Lead Sponsor:
The University of Hong Kong
Conditions:
COVID
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The novel coronavirus (SARS-CoV-2), is a single-stranded RNA coronavirus. The virus was first isolated from patients presented with pneumonia in Wuhan in December 2019. Sequences of the Wuhan betacoro...
Detailed Description
This is a prospective open-label randomised controlled trial among adult patients hospitalised after April 2020 for virologically confirmed SARS-CoV-2 infection. Patients will be randomly assigned to...
Eligibility Criteria
Inclusion
- Recruited subjects include all adult patients ≥18 years hospitalized for virologic confirmed SARS-CoV-2 infection.
- All subjects give written informed consent. For patients who are critically ill, requiring ICU, ventilation or confused, informed consent will be obtained from spouse, next-of-kin or legal guardians.
- 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 QTc syndrome, ventricular cardiac arrhythmias, including torsade de pointes, second or third degree heart block, QTc interval \>480ms
- Patients taking medication that will potentially interact with l interferon beta-1b or hydroxychloroquine
- Patients with known underlying retinopathy
- Patients with G6PD deficiency
- Patients with known history of severe depression
- 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.
- To participate in an unrelated trial during the current clinical trial. Nevertheless, the patients have the right to withdraw from the current clinical trial to join another clinical trial.
- 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 :
April 9 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 7 2020
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT04350281
Start Date
April 9 2020
End Date
July 7 2020
Last Update
July 28 2020
Active Locations (1)
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1
The University of Hong Kong, Queen Mary Hospital
Hong Kong, Hong Kong, 852