Status:
UNKNOWN
Efficiency and Security of NIVOLUMAB Therapy in Obese Individuals With COVID-19(COrona VIrus Disease) Infection
Lead Sponsor:
Hospices Civils de Lyon
Conditions:
Obesity, COVID-19 Infection
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
Brief Summary
Although SARS-CoV-2 (Severe Acute Respiratory Syndrome-associated coronavirus) due to COVID-19 evolves poorly towards ARDS (Acute Respiratory Distress Syndrome) and death, there is to date no validate...
Eligibility Criteria
Inclusion
- 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 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
Key Trial Info
Start Date :
June 15 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 15 2021
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT04413838
Start Date
June 15 2020
End Date
September 15 2021
Last Update
June 4 2020
Active Locations (1)
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1
Hôpital Lyon Sud Service Endocrinologie, Diabète et Nutrition
Pierre-Bénite, France, 69495