Status:
UNKNOWN
NORMAL HUMAN IMMUNOGLOBULINS (IVIG) IN PATIENTS AGED 75 YEARS AND OVER, COVID-19 WITH SEVERE ACUTE RESPIRATORY FAILURE
Lead Sponsor:
Versailles Hospital
Conditions:
Sars-CoV2
Eligibility:
All Genders
75+ years
Phase:
PHASE2
Brief Summary
According to recent data, death rate is more than 20% for 75 years old hospitalized patients and older. In case of aggravation, according to the latest observations, if they are refused for mechanica...
Eligibility Criteria
Inclusion
- 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
Exclusion
- Patient under palliative care
- Patient with contraindication to IV polyvalent Ig
- . Hypersensitivity to the active substance or to any of the excipients (L-proline)
- . Hypersensitivity to human immunoglobulins, especially when the patient has anti-IgA antibodies,
- . 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
Key Trial Info
Start Date :
May 5 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 5 2021
Estimated Enrollment :
35 Patients enrolled
Trial Details
Trial ID
NCT04403269
Start Date
May 5 2020
End Date
May 5 2021
Last Update
May 27 2020
Active Locations (1)
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1
Centre Hospitalier de Versailles
Le Chesnay, France, 78150