SARS-Cov-2 infection (COVID-19) MedDRA version: 23.0 Level: PT Classification code 10051905 Term: Coronavirus infection System Organ Class: 10021881 - Infections and infestations
Conditions
Interventions
Trade Name: REBIF - 44 MCG(12 MILIONI UI) -SOLUZ INIETTABILE- USO SOTTOCUTANEO-PENNA PRERIEMPITA 0.5 ML (24 MILIONI UI/ML) 1 PENNA PRERIEMPITA
Product Name: Interferone-ß-1a
Product Code: [IFNß-1a]
Sponsors
OSPEDALE SAN RAFFAELE
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. II. To determine the efficacy of IFNß-1a to reduce mortality in COVID-19 patients III. To determine the efficacy of IFNß-1a to improve the chest CT scan picture in hospitalized COVID-19 patients. IV. To determine the efficacy of IFNß-1a to reduce the time of hospitalization in hospitalized COVID-19 patients. V. To determine the efficacy of IFNß-1a to reduce the viral load of SARS-CoV-2 measured on plasma 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 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Changes from baseline in pulmonary TC; a. Improvement in clinical severity score, defined as percentage of subjects reporting each severity rating on a 7-point ordinal scale b. Improvement in clinical severity score, defined as the time to clinical improvement of two points from the time of randomization on a 7-category ordinal scale or live discharge from the hospital c. Incidence of new oxygen use, non-invasive ventilation, or high flow oxygen devices d. Oxygenation free days e. Ventilator free days f. Incidence of new mechanical ventilation use g. Number of patients transferred to Intensive Care Unit; Mortality rate; Duration of hospital stay expressed in days; Viral load measured on plasma with RT-PCR; a. Number of Serious adverse events and Adverse Drug Reaction (expected and un-expected) b. Changes from baseline in Hematological and biochemical blood parameters;Timepoint(s) of evaluation of this end point: Baseline, day 21; extra follow up at 90 days; From baseline to day 29; From baseline to day 29; From baseline to day 29; Baseline, days 3, 5, 7, 9, 11, 13, 15, 21, 29; From baseline to day 29 | — |
Countries
Italy
Contacts
Public ContactUnità di Medicina Generale, Diabete
IRCCS Ospedale San Raffaele
Outcome results
None listed