Efficiency and Security of NIVOLUMAB Therapy in Obese Individuals With COVID-19(COrona VIrus Disease) Infection (NIVISCO)
Obesity, COVID-19 Infection
About this trial
This is an interventional treatment trial for Obesity, COVID-19 Infection focused on measuring COVID-19, Obesity, Nivolumab, Immunotherapy, Anti-PD1
Eligibility Criteria
Inclusion Criteria:
- Patients between 18 and 70 years old
- COVID-19+ patients diagnosed upon biological testing (PCR Coronavirus SARS-CoV2)
- Hospitalized patients
- Obese individuals (BMI≥30kg/m²)
- Lymphocyte counts between 500 and 1500/mm3.
- Patients upon oxygen (either using mask or nasal cannula).
- Patients within their first 7 days after the beginning of symptoms.
- Women of childbearing potential: effective contraception for the duration of the study and 5 months after the administration of treatment.
- Patient who understands and accepts the need for a long term follow-up,
- Patients who agrees to be included in the study and who signs the informed consent form,
- Patients affiliated to a healthcare insurance plan.
Exclusion Criteria:
CRITERIA LINKED TO THE DISEASE SEVERITY :
- Patients hospitalized in ICU or constant care unit.
- Patients with clinical symptoms requiring ICU admission (respiratory rate>30/min, oxygen requirement> 4Liters/min (using high concentration mask) to reach and maintain O2saturation>90%, qSOFA≥ 2(quick score of Sepsis-related Organ Failure Assessment), or associated multi-visceral failure.
- Patients with high biological probability of macrophage activation syndrome (hemoglobin < 9.2 g/dl AND a blood platelets < 110000/mm3 AND AST > 30 U/l AND ferritin > 600 mg/l).
CRITERIA LINKED TO THE TREATMENT TOXICITY :
- Patients currently treated for cancer or with personal history of cancer within the last 3 years.
- Patients with Chronic Obstructive Pulmonary Disease (COPD) (GOLD 3 and 4 stages).
- Chronic respiratory insufficiency treated with oxygen.
- Patients aged above 70 years old.
- Active smoking.
- Personal history of thoracic radiotherapy.
- Patients with known sensibility to NIVOLUMAB or one of its component.
- Patients upon immunosuppressive dosage of corticoids.
- Patients upon immunosuppressive therapy or immunosuppressed patients.
- Patients already presenting severe autoimmune disease, for whom additional immunologic activation response would potentially precipitate lethal prognosis
GENERAL CRITERIA:
- Minor Patients
- Mentally unbalanced patients, under supervision or guardianship,
- Patient deprived of liberty,
- Patient who does not understand French/ is unable to give consent,
- Patient already included in a trial who may interfere with the study or in a period of exclusion following participation in a previous study.
- Pregnant (controlled by a pregnancy test) or lactating woman
Sites / Locations
- Hôpital Lyon Sud Service Endocrinologie, Diabète et Nutrition
Arms of the Study
Arm 1
Arm 2
Experimental
Other
NIVOLUMAB on top of routine standard of care
Standard of care for COVID-19 infection
This correspond to COVID-19+ patients diagnosed upon biological testing (PCR Coronavirus SARS-CoV2), hospitalized, obese (BMI≥30kg/m²), with low lymphocyte counts, without high biological probability of macrophage activation syndrome (hemoglobin < 9.2 g/dl AND a blood platelets < 110000/mm3 AND aspartate aminotransferase (AST) > 30 U/l AND ferritin > 600 mg/l) and upon oxygen (either using mask or nasal cannula) but without criteria for ICU admission benefiting from a NIVOLUMAB treatment and routine standard of care for COVID-19 infection at the time of study inclusion
This correspond to COVID-19+ patients diagnosed upon biological testing (PCR Coronavirus SARS-CoV2), hospitalized, obese (BMI≥30kg/m²), with low lymphocyte counts, without high biological probability of macrophage activation syndrome (hemoglobin < 9.2 g/dl AND a blood platelets < 110000/mm3 AND AST > 30 U/l AND ferritin > 600 mg/l) and upon oxygen (either using mask or nasal cannula) but without criteria for ICU admission benefiting from a routine standard of care for COVID-19 infection at the time of study inclusion