Patients aged 75 years and older with confirmed infection Covid19 and saturation SaO2= under 95% O2> 5 L / min disqualified from a care in the ICU MedDRA version: 20.0 Level: LLT Classification code 10051905 Term: Coronavirus infection System Organ Class: 100000004862
Conditions
Interventions
Trade Name: Immunoglobulines Humaines Normales
Pharmaceutical Form: Solution for injection/infusion
Sponsors
CH Versailles
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Man or woman aged 75 and over - SARS-coV2 infection confirmed by RT-PCR or thoraco-pulmonary CT - Hospitalized in the acute general geriatrics unit of the Versailles Hospital Center - Patient rejected from resuscitation - Saturation = 95% under oxygen therapy> 5 L / min (i.e. PaO2 / FiO2=200mmHg according to the Berlin definition of ARDS) by means of a nasal cannula, a high concentration facial mask or another device similar oxygen distribution Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 39
Exclusion criteria
Exclusion criteria: - Patient under palliative care - Patient with contraindication to IV polyvalent Ig at. Hypersensitivity to the active substance or to any of the excipients (L-proline) b. Hypersensitivity to human immunoglobulins, especially when the patient has anti-IgA antibodies, vs. Patients with type I or II hyperprolinemia - Patient under guardianship or curatorship - Patient receiving another experimental treatment as part of an interventional study - Moderate to severe dementia known: it must have been diagnosed before hospitalization and is defined by an MMSE <20/30 or a neuropsychological assessment with a diagnosis made. - Patient not affiliated with a social security system in France - ADL patients <4/6 and / or IADL <6/8
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Evaluation of the efficacy of polyvalent IVIg in combination with the standard management of patients aged 75 and over with SARSCov2 infection with acute respiratory failure (saturation = 95%) requiring oxygen therapy> 5 L / min (i.e. patients considered as moderate to severe ARDS according to the Berlin definition, Pa02 / Fi02=200) and disqualified from a care in the ICU.;Secondary Objective: Evaluate the consequences of treatment with immunoglobulins on - The length of hospital stay - The duration of oxygen therapy (oxygen dependence) - The evolution of the parameters of inflammation - Lung function and overall physical condition at 3 and 6 months - The quality of life at 3 and 6 months - The rate of death and re-hospitalization at 3 and 6 months;Primary end point(s): Mortality;Timepoint(s) of evaluation of this end point: On D14 of treatment D1 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Total number of days of full hospitalization, - Duration of oxygen therapy - Ferritin, CRP, LDH, lymphocyte, PNN, and platelet levels in the blood - WHO performance index, WHOQOL-OLD questionnaire at 3 and 6 months - Lung function by pulmonary computed tomography and EFR at 3 and 6 months - Mortality and re-hospitalization rates at 3 months and 6 months;Timepoint(s) of evaluation of this end point: 3 and 6 months | — |
Countries
France
Contacts
Public ContactMélody FORT
CH de Versailles
Outcome results
None listed