Status:
TERMINATED
Clinical Study for the Treatment With Interferon-ß-1a (IFNß-1a) of COVID-19 Patients
Lead Sponsor:
Emanuele Bosi
Conditions:
COVID-19 Virus Infection
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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 character...
Eligibility Criteria
Inclusion
- Informed consent signed
- Patients hospitalized with confirmed swab RT-PCR detection of SARS-CoV-2
- X-ray and/or CT diagnosed pneumonia
- Age \>=18 years
- Clinical status defined as 3, 4 or 5 on the 7-point ordinal scale
Exclusion
- Known allergy or hypersensitivity to IFNß-1a or IFNß-1b
- Presence of severe concomitant illnesses/medical conditions that in the physician opinion do not allow participation to the study
- Pregnant or lactating females
- History of major depression disorder or suicidal attempt or suicidal ideation
- Spontaneous blood alanine aminotransferase/aspartate aminotransferase (ALT/AST) levels \> 5 times the upper limit of normal
- Clinical status defined as 1, 2, or 6 on the 7-point ordinal scale
Key Trial Info
Start Date :
November 2 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 30 2021
Estimated Enrollment :
56 Patients enrolled
Trial Details
Trial ID
NCT04449380
Start Date
November 2 2020
End Date
March 30 2021
Last Update
May 3 2021
Active Locations (1)
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1
IRCCS Ospedale San Raffaele
Milan, Italy, 20132