SARS-CoV 2 infection characterized by a National Early Warning Score lower or equal to 2 and symptoms present for less than 7 days MedDRA version: 23.0 Level: LLT Classification code 10053983 Term: Corona virus infection System Organ Class: 100000004862 MedDRA version: 20.0 Level: PT Classification code 10070255 Term: Coronavirus test positive System Organ Class: 10022891 - Investigations
Conditions
Interventions
Trade Name: REBIF - 22 MCG/0.5 ML - SOLUZIONE INIETTABILE - USO SOTTOCUTANEO - CARTUCCIA (VETRO) - 1.5 ML (12 MILIONI UI/ML) 4 CARTUCCE
Product Name: Interferon beta-1a
Product Code: [IFNb]
Pharmaceut
Sponsors
Istituto di Farmacologia Traslazionale - CNR
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: •>= 65 years of age at time of enrolment; •Laboratory-confirmed SARS-CoV 2 infection as determined by PCR, in any specimen =65 years) yes F.1.3.1 Number of subjects for this age range 60
Exclusion criteria
Exclusion criteria: •Hospitalized patients with illness of any duration, and at least one of the following: -Clinical assessment (evidence of rales/crackles on exam) AND SpO2 = 94% on room air at rest or after walking test, OR -Acute respiratory failure requiring mechanical ventilation and/or supplemental oxygen. •Patients currently using interferon-beta (e.g., multiple sclerosis patients); •Patients treated with chemotherapy and/or immunosuppressive agents; •Patients with chronic kidney diseases •Known allergy or hypersensitivity to interferon (including asthma); •Any autoimmune disease (resulting from patient anamnesis) •Patients with signs of dementia or neurocognitive disorders •Patients with current severe depression and/or suicidal ideations •Being concurrently involved in another trial •HIV infection (based on the anamnesis) •Use of any antiretroviral medication •Impaired renal function (eGFR calculated by CKD-EPI Creatinine equation < 30 ml/min); •Presence of other severe diseases impairing life expectancy (e.g. patients are not expected to survive 28 days given their pre-existing medical condition); •Any physical or psychological impediment in a patient that could let the investigator to suspect his/her poor compliance; •Lack or withdrawal of informed consent
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: 28 days after randomization; 28 days after randomization; 28 days after randomization; 28 days after randomization; 14 days after randomization; 28 days after randomization;Secondary end point(s): Incidence of adverse events; Change from Baseline in SARS-CoV 2-Specific Binding Antibody Titers at day 28; ICU-free days at 28 days will be calculated as the number of days a patient is not in an ICU; All-cause mortality (Day 1 through Day 28); Negative SARS-CoV 2 RT-PCR at day 14 post-randomization; Negative SARS-CoV 2 RT-PCR at day 28 post-randomization | — |
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Primary Objective of the study is to evaluate the reduction in disease progression in patients treated with Interferon Beta versus control group within 28 days.;Secondary Objective: Secondary Objectives of the study are: 1) to assess the reduction in ICU admission in patients treated with IFN versus control group; 2) to assess the reduction in number of deaths in IFN compared to control group; 3) to evaluate the increase in proportion of participants returning to negative SARS-CoV 2 RT-PCR in IFN-treated versus control group at Day 14 and Day 28; 4) To assess the increase in SARS-CoV 2-Specific Antibody Titers in IFN-treated compared to control group; 5) to assess the safety of IFN-treated patients.;Primary end point(s): Primary endpoint of the study is the proportion of patients experiencing a disease progression, during at least 5 days, according to the National Early Warning Score (NEWS). The NEWS score is a standardized approach aimed at promptly detecting signs of clinical deterioration in acutely ill patients and establishing the potential need for higher level of care. It is based on the evaluation of vital signs including respiratory rate, oxygen saturation, temperature, blood pressure, pulse/heart rate, AVPU response. The resulting observations, compared to a normal range, are combined in a single composite “alarm” score. Any other clinical sign clearly indicating a disease worsening will be considered as disease progression.;Timepoint(s) of evaluation of this end point: 28 days after enrollment | — |
Countries
Italy
Contacts
Public ContactSteering committee dello studio ANT
Istituto di Farmacologia Traslazionale - CNR
Outcome results
None listed