STUDY OF THE EFFICIENCY OF NORMAL HUMAN IMMUNOGLOBULINS (IVIG) IN PATIENTS AGED 75 YEARS AND OVER COVID-19 WITH SEVERE ACUTE RESPIRATORY FAILURE GERONIMO 19

Phase 1

• Conditions: 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: 20.0Level: LLTClassification code 10051905Term: Coronavirus infectionSystem Organ Class: 100000004862; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2020-001768-27-FR
• Lead Sponsor: CH Versailles

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-04-16
• Last Update Posted: 24 January 2022

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 39

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

- 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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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)<br>and disqualified from a care in the ICU.;Secondary Objective: Evaluate the consequences of treatment with immunoglobulins on<br>- The length of hospital stay<br>- The duration of oxygen therapy (oxygen dependence)<br>- The evolution of the parameters of inflammation<br>- Lung function and overall physical condition at 3 and 6 months<br>- The quality of life at 3 and 6 months<br>- 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 Outcome Measures

Name	Time	Method
Secondary end point(s): - Total number of days of full hospitalization,<br>- Duration of oxygen therapy<br>- Ferritin, CRP, LDH, lymphocyte, PNN, and platelet levels in the blood<br>- WHO performance index, WHOQOL-OLD questionnaire at 3 and 6 months<br>- Lung function by pulmonary computed tomography and EFR at 3 and 6 months<br>- Mortality and re-hospitalization rates at 3 months and 6 months;Timepoint(s) of evaluation of this end point: 3 and 6 months