Double Therapy With IFN-beta 1b and Hydroxychloroquine
Keywords
Abstract
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 either the treatment group: a 3-day course of 3 doses of subcutaneous injection of interferon β-1b 1mL (0.25mg; 8 million IU) consecutively on day 1 to day 3 and hydroxychloroquine 800mg on day 1, then 400mg daily for 2 days plus standard care, or the control group: a 3-day course of hydroxycholoroquine 800mg on day 1, then 400mg daily for 2 days plus standard care alone (1:1).
For the control group, if the day 4 nasopharyngeal swab (NPS) viral load remains positive, then patients will receive another 3 days of subcutaneous injection of interferon β-1b 1mL (0.25mg; 8 million IU) and hydroxychloroquine 400mg daily.
Dates
| Last Verified: | 06/30/2020 |
| First Submitted: | 04/12/2020 |
| Estimated Enrollment Submitted: | 04/12/2020 |
| First Posted: | 04/16/2020 |
| Last Update Submitted: | 07/26/2020 |
| Last Update Posted: | 07/27/2020 |
| Actual Study Start Date: | 04/08/2020 |
| Estimated Primary Completion Date: | 06/30/2020 |
| Estimated Study Completion Date: | 07/06/2020 |
Condition or disease
Intervention/treatment
Drug: Treatment group
Drug: Hydroxychloroquine
Phase
Arm Groups
| Arm | Intervention/treatment |
|---|---|
| Active Comparator: Treatment group Subcutaneous injection of interferon β-1b 1mL (0.25mg; 8 million IU) consecutively on day 1 to day 3 and hydroxychloroquine 800mg on day 1, then 400mg daily for 2 days plus standard care | Drug: Treatment group Daily subcutaneous injection of interferon β-1b 1mL (0.25mg; 8 million IU) consecutively on day 1 to day 3 |
| Active Comparator: Control group Hydroxychloroquine 800mg on day 1, then 400mg daily for 2 days plus standard care alone. |
Eligibility Criteria
| Ages Eligible for Study | 18 Years To 18 Years |
| Sexes Eligible for Study | All |
| Accepts Healthy Volunteers | Yes |
| Criteria | Inclusion Criteria: 1. Recruited subjects include all adult patients ≥18 years 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 with known prolonged QTc syndrome, ventricular cardiac arrhythmias, including torsade de pointes, second or third degree heart block, QTc interval >480ms 4. Patients taking medication that will potentially interact with l interferon beta-1b or hydroxychloroquine 5. Patients with known underlying retinopathy 6. Patients with G6PD deficiency 7. Patients with known history of severe depression 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. 9. 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. 10. Have a history of alcohol or drug abuse in the last 5 years. 11. Have any condition that the investigator believes may interfere with successful completion of the study. |
Outcome
Primary Outcome Measures
1. Time to negative NPS viral load [4 weeks]
Secondary Outcome Measures
1. Time to NEWS 0 [4 weeks]
2. Length of Hospitalisation [4 weeks]
3. Time to negative viral load in all clinical samples [4 weeks]
4. Adverse events [4 weeks]
5. Mortality [30 days]
6. Inflammatory markers changes [4 weeks from diagnosis]
