This study is a randomized, double-blind, multicenter, placebo-controlled trial to evaluate the safety and efficacy of a novel therapeutic agent, Novaferon, in hospitalized adult patients diagnosed with COVID-19. The study is comprised of two cohorts: * Cohort A: This is a blinded safety lead-in comprising two arms. 40 patients will be randomized on a 1:1 basis to receive either Novaferon or matched placebo via a commercial nebulizer, plus Standard of Care (SOC) * Cohort B: This is the main portion of the study, which comprises two arms. Up to 874 patients will be randomized on a 1:1 basis to receive either Novaferon or matched placebo via a commercial nebulizer, plus SOC
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
914
a novel recombinant antiviral protein drug
Formulation vehicle
Hospital Interzonal General de Agudos Dr Jose Penna
Bahía Blanca, Argentina
RECRUITINGClinica Zabala
Buenos Aires, Argentina
RECRUITINGCEMIC
Ciudad Autonoma Buenos Aires, Argentina
RECRUITINGClinica Adventista Belgrano
Ciudad Autonoma Buenos Aires, Argentina
Rate of clinical deterioration
Proportion of patients requiring mechanical ventilation or that die (defined as WHO categories 6, 7, or 8)
Time frame: From enrollment to Day 28
Rate of recovery
Proportion of patients demonstrating clinical improvement (defined as WHO categories 0, 1, 2, or 3)
Time frame: From enrollment to Day 28
Hospital discharge rate
Rate of non-hospitalized alive patients
Time frame: At Day 28
Mortality rate
Mortality rate
Time frame: At Day 28
Duration of hospitalization
Number of days hospitalized
Time frame: Up to Day 28
Adverse events
Adverse event incidence, type and severity
Time frame: From first dose to Day 56
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Hospital San Roque
Córdoba, Argentina
RECRUITINGSanatorio del Salvador Privado S.A.
Córdoba, Argentina
RECRUITINGSanatorio Privado Duarte Quiroz De Clinica Colombo SA
Córdoba, Argentina
RECRUITINGInstituto Medico Rio Cuarto
Río Cuarto, Argentina
RECRUITINGClinica Central S.A.
Villa Regina, Argentina
RECRUITINGHCPA- Hospital de Clínicas de Porto Alegre
Alegre, Brazil
RECRUITING...and 78 more locations