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Clinical Study for the Treatment With Interferon-ß-1a (IFNß-1a) of COVID-19 Patients

NCT04449380 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 56

Last updated 2021-05-03

No results posted yet for this study

Summary

Pharmacological therapies of proven efficacy in coronavirus disease 2019 (COVID-19) are still lacking.

Since two clinical stages of COVID-19 are emerging, an early one with typical clinical characteristics of a viral infection (fever, malaise, cough) and a later one with pneumonia leading to progressive respiratory failure, associated with heavy, cytokine-mediated, inflammation, an intervention by a compound possessing both antiviral activity and immunomodulatory effects would be most effective at the earliest possible stage.

The purpose of this clinical trial is to test the efficacy of Interferon-β-1a (IFNβ-1a), in COVID-19 patients in an open label, randomized clinical trial.

The design of the study is to test IFNβ-1a in addition to standard of care compared with standard of care alone.

The primary outcome is the time to negative conversion of Severe Acute Respiratory Syndrome-CoronaVirus-2 (SARS-CoV-2) nasopharyngeal swabs.

Conditions

  • COVID-19 Virus Infection

Interventions

DRUG

Interferon-ß-1a

IFNβ-1a will be administered subcutaneously at a dose of 44 mcg (equivalent to 12 million international units), three times per week at least 48 hours apart, for a total of two weeks. All patients will receive a total dose of 264 mcg (72 million international units) under physician control

COMBINATION_PRODUCT

Standard of Care (SOC)

Any pharmacological (e.g. antibiotics, etc.) and non-pharmacological (e.g. oxygen, ventilation, etc.) treatments prescribed on clinical grounds

Sponsors & Collaborators

  • Emanuele Bosi

    lead OTHER

Principal Investigators

  • Emanuele Bosi, Professor · IRCCS Ospedale San Raffaele

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-11-02
Primary Completion
2021-03-30
Completion
2021-03-30

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04449380 on ClinicalTrials.gov