EUCTR2020-001768-27-FR
Active, not recruiting
Phase 1
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 - GERONIMO19
CH Versailles0 sites39 target enrollmentApril 16, 2020
ConditionsPatients aged 75 years and older with confirmed infection Covid19 and saturation SaO2= under 95% O2> 5 L / min disqualified from a care in the ICUMedDRA version: 20.0Level: LLTClassification code 10051905Term: Coronavirus infectionSystem Organ Class: 100000004862Therapeutic area: Diseases [C] - Virus Diseases [C02]
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- 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
- Sponsor
- CH Versailles
- Enrollment
- 39
- Status
- Active, not recruiting
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility 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
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
Outcomes
Primary Outcomes
Not specified
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