Clinical study for the treatment with Interferon-ß-1a (IFNß-1a) of COVID-19 patients: randomized, controlled, open label

Phase 1

• Conditions: SARS-Cov-2 infection (COVID-19); MedDRA version: 23.0Level: PTClassification code 10051905Term: Coronavirus infectionSystem Organ Class: 10021881 - Infections and infestations; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2020-002458-25-IT
• Lead Sponsor: OSPEDALE SAN RAFFAELE

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-08-10
• Last Update Posted: 26 October 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 126

Inclusion Criteria

a.Informed consent signed
b.Patients hospitalized with confirmed swab RT-PCR detection of SARS-CoV-2
c.X-ray and/or TC diagnosed pneumonia
d.Age >=18 years
e.Clinical status defined as 3, 4 or 5 on the 7-point ordinal scale
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 63
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 63

Exclusion Criteria

a.Known allergy or hypersensitivity to IFNß-1a or IFNß-1b
b.Presence of severe concomitant illnesses/medical conditions that in the physician opinion do not allow participation to the stud
c.Pregnant or lactating females
d.History of major depression disorder or suicidal attempt or suicidal ideation
e.Spontaneous blood ALT/AST levels > 5 times the upper limit of normal
f.Clinical status defined as 1, 2, or 6 on the 7-point ordinal scale

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To determine the efficacy of IFNß-1a as time to negative conversion of SARS-Cov-2 nasopharyngeal swab in hospitalized COVID-19 patients;Secondary Objective: I.To determine the efficacy of IFNß-1a to improve the clinical status and respiratory functions in hospitalized COVID-19 patients.<br>II.To determine the efficacy of IFNß-1a to reduce mortality in COVID-19 patients<br>III.To determine the efficacy of IFNß-1a to improve the chest CT scan picture in hospitalized COVID-19 patients.<br>IV.To determine the efficacy of IFNß-1a to reduce the time of hospitalization in hospitalized COVID-19 patients.<br>V.To determine the efficacy of IFNß-1a to reduce the viral load of SARS-CoV-2 measured on plasma<br>VI.To determine the safety of the use of IFNß-1a in hospitalized COVID-19 patients.;Primary end point(s): Time to negative conversion of SARS-CoV-2 nasopharyngeal swab. Viral load will be measured by RT-PCR.;Timepoint(s) of evaluation of this end point: Baseline, days 3, 5, 7, 9, 11, 13, 15, 21, 29