A Multicenter, Adaptive, Randomized Blinded Controlled Trial of the Safety and Efficacy of Investigational Therapeutics for the Treatment of COVID-19 in Hospitalized Adults

Phase 3

• Conditions: ovel Coronavirus Infectious Disease (COVID-19)

• Registration Number: JPRN-jRCT2031200092
• Lead Sponsor: Ohmagari Norio

Brief Summary

Interferon B-1 a in addition to remdesivir showed no clinical benefit compared with remdesivir alone in adult inpatients with COVID-19. The time to recovery, the primary endpoint, was five days in both treatment groups. Furthermore, there were no differences in treatment efficacy at any of the secondary endpoints, nor were there any overall differences in efficacy or significant safety between the treatment and control groups, which is not recommended for patients hospitalized with COVID-19.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-08-21
• Study Completion: 2020-12-21
• Results First Posted: 2021-10-18
• Last Update Posted: 20 November 2023

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 969

Inclusion Criteria

1.Admitted to a hospital with symptoms suggestive of COVID-19.
2.Subject(or legally authorizedrepresentative) provides informed consent prior to initiation of any study procedures.
3.Subject(or legally authorized representative) understands and agrees to comply with planned study procedures.
4.Male or non-pregnant female adults => 18 years of age at time of enrollment.
5.Has laboratory-confirmed SARS-CoV-2 infection as determined by PCR or other commercial or public health assay(e.g., NAAT and antigen tests)in any respiratoryspecimen, as documented by either of the following:
_PCR or other assay positive in sample collected < 72 hours prior to randomization; OR
_PCR or other assay positive in sample collected =>72 hours but < 7 daysprior to randomizationAND progressive disease suggestive of ongoing SARS-CoV-2 infection.
Note: if written documentation of the positive test result is not available at the time of enrollment(e.g., report came from other institution), the subjectmay be enrolled but the PCR should be repeatedat the time of enrollment.
6.Illness of any duration, and at least one of the following:
_Radiographic infiltrates by imaging (chest x-ray, CT scan, etc.), OR
_SpO2=< 94% on room air, OR
_Requiring supplemental oxygen, OR
_Requiring mechanical ventilation.
7.Women of childbearing potential must agree to either abstinence or use at least one primary form of contraception not including hormonal contraception from the time of screening through Day 29.
8.Agrees to not participate in another clinical trial (both pharmacologic and other types of interventions) for the treatment of COVID-19 through Day29.

Exclusion Criteria

1.Anticipated discharge from the hospital or transfer to another hospital which is not a study site within 72 hours.
2.Subject is on or being prepared to go on ECMO at the time of screening.
3.Subjects with an estimated glomerular filtration rate (eGFR) < 30 mL/min are excluded unless in the opinion of the PI, the potential benefit of receiving remdesivir outweighs the potential risk of study participation.
4.ALT or AST > 5 timesthe upper limitsof normal.
5.Total white cell blood cell count (WBC) <1500 cells/microL.
6.Plateletcount<50,000/microL.
7.History of chronic liver disease (e.g., jaundice, ascites, hepatic encephalopathy, history of bleeding esophageal or gastric varices). No laboratory testing is needed.
8.Pregnancy or breast feeding (lactating women who agree to discard breast milkfrom Day 1 to two weeks after the last study product is givenare not excluded).
9.Allergy to any study medication including history of hypersensitivity to natural or recombinant interferon beta or human albumin.
10.Patient has a chronic or acute medical condition or is taking a medication that cannot be discontinued at enrollment, that in the judgement of the PI, places them at unacceptable risk for a poor clinical outcome if they were to participate in the study.
11.Received three or more doses of remdesivir,including the loading dose, outside of the study for COVID-19.
12.Received convalescent plasma or intravenous immunoglobulin [IVIg] for the treatment of COVID-19.
13.Received any interferon product within two weeks of screening,either for the treatment of COVID-19 or for a chronic medicalcondition (e.g., multiple sclerosis, HCV infection).
14.Received any of the following in the two weeks prior to screeningas treatment of COVID-19:
_small molecule tyrosine kinase inhibitors (e.g.,baricitinib, imatinib, gefitinib, acalabrutinib, etc.);
_monoclonal antibodies targeting cytokines (e.g., TNF inhibitors, anti-interleukin-1 [IL-1], anti-IL-6 [tocilizumab or sarilumab], etc.);
_monoclonal antibodies targeting T-cells or B-cells as treatment for COVID-19.
15. Suject with severe depression or suicidal ideation, or a history of severe depression or suicidal ideation
16. Subject with autoimmune hepatitis
17. Subject with epilepsy who are not adequately managed by treatment
18. Subject who is receiving the treatment of Shosaikoto

Study & Design

• Study Type: Interventional
• Study Design: Not specified