It appears interesting to use nivolumab in severe patients infected with SARS-CoV-2 requiring hospitalization in conventional unit or in ICU. This protocol CORIMUNO19-NIVO therefore, will evaluate the efficacy and safety of OPTIVO® (nivolumab) COVID-19 patients hospitalized in conventional unit. The purpose of this study is to show the efficacy of nivolumab in patients with COVID-19 in combination with standard treatments. A phase 2 randomized open trial will evaluate the efficacy and safety of optivo® (nivolumab) alone versus standard of care (SoC) in patients hospitalized in conventional units. Patients will be randomly allocated 1:1 to either nivolumab or SoC.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
92
Treatment consists of an infusion of OPDIVO® 3mg/kg on day 1 (D1).
Pneumologie hôpital Tenon
Paris, France
Time to clinical improvement
the time required for clinical improvement, defined as the time elapsed between randomization and a two-point improvement on an ordinal scale with seven categories (WHO scale), or the discharge alive from hospital, whatever occurred first
Time frame: day 14
Overall survival
Time frame: day 28
Overall survival
Time frame: day 90
Cumulative incidence of ICU admission
Time frame: day 28
Length of hospital stay
Time frame: day 90
Positive nasal PCR
Time frame: day 7
Incidence of adverse events
Time frame: day 28
Incidence of grade 3-4 adverse events
according to CTC AE-4.03
Time frame: day 28
World Health Organisation (WHO) progression scale
range, from 0 (healthy) to 10 (death)
Time frame: day 4, 7 and 14
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.