Overview

IFN-beta 1b and Remdesivir for COVID19

Status:
Recruiting
Trial end date:
2021-09-30
Target enrollment:
0
Participant gender:
All
Summary
A 5-day combination of interferon β-1b and remdesivir will expedite the recovery, suppress the viral load and shorten hospitalisation in patients with SARS-CoV-2 infection compare to the control arm
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
The University of Hong Kong
Treatments:
Interferon beta-1b
Interferon-beta
Interferons
Remdesivir
Criteria
Inclusion Criteria:

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

2. Fulfilling one of the following criteria associated with high risk of clinical
deterioration: age 65 years or above, radiological evidence of pneumonia, oxygen
desaturation <94% on room air, comorbidity including hypertension, diabetes,
cardiovascular diseases, chronic obstructive lung disease, chronic liver diseases,
chronic kidney diseases, malignancy, haematological diseases, rheumatological
diseases, immunocompromised hosts and obesity (BMI > 30)

3. 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.

4. 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
and remdesivir

4. Patients with known history of severe depression

5. Estimated glomerular filtration rate <30 mL/min

6. 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.

7. 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.

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

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