Overview

Dual Therapy With Interferon Beta-1b and Clofazimine for COVID-19

Status:
Recruiting
Trial end date:
2021-09-30
Target enrollment:
0
Participant gender:
All
Summary
To conduct an open-label randomized controlled trial on a short course of interferon β-1b and clofazimine combination treatment for patients hospitalized for COVID-19 infection. To assess its safety and clinical efficacy.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
The University of Hong Kong
Treatments:
Clofazimine
Interferon beta-1b
Interferon-beta
Interferons
Criteria
Inclusion Criteria:

1. Recruited subjects include all adult patients 18 years or above hospitalized for
virologic confirmed SARS-CoV-2 infection.

2. 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.

3. 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 taking medication that will potentially interact with l interferon beta-1b or
clofazimine

4. Patients with known history of severe depression

5. 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.

6. 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.

7. Have a history of alcohol or drug abuse in the last 5 years.

8. Have any condition that the investigator believes may interfere with successful
completion of the study