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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04403269
Other study ID # P20/07 GERONIMO 19
Secondary ID
Status Recruiting
Phase Phase 2
First received
Last updated
Start date May 5, 2020
Est. completion date May 5, 2021

Study information

Verified date May 2020
Source Versailles Hospital
Contact Mélody FORT
Phone +33139239776
Email mfort@ch-versailles.fr
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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 mechanical ventilation in intensive care, their death rate could reach 60% even for patients without comorbidity.

Apart from an increase in oxygen therapy, no specific treatment is currently proposed.

The control of the inflammatory component seems to be a key element to be able to influence the patients' health evolution.

Polyvalent intravenous immunoglobilins have immunomodulatory and anti-inflammatory properties with a favorable safety profile for these elderly patients and several clinical cases lead to positive impact in the caring for Covid patients.

This study objective is 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 35
Est. completion date May 5, 2021
Est. primary completion date May 5, 2021
Accepts healthy volunteers No
Gender All
Age group 75 Years and older
Eligibility 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

Exclusion Criteria:

- Patient under palliative care

- Patient with contraindication to IV polyvalent Ig

1. . Hypersensitivity to the active substance or to any of the excipients (L-proline)

2. . Hypersensitivity to human immunoglobulins, especially when the patient has anti-IgA antibodies,

3. . 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


Related Conditions & MeSH terms


Intervention

Drug:
IgIV
2 infusion at D1 and D2 (0.8 g / kg by IV infusion)

Locations

Country Name City State
France Centre Hospitalier de Versailles Le Chesnay

Sponsors (1)

Lead Sponsor Collaborator
Versailles Hospital

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Mortality Day 14
Secondary Total number of days of full hospitalization 3 and 6 months
Secondary Duration of oxygen therapy 3 and 6 months
Secondary Ferritin level in the blood 3 and 6 months
Secondary CRP level in the blood 3 and 6 months
Secondary LDH level in the blood 3 and 6 months
Secondary Lymphocyte level in the blood 3 and 6 months
Secondary PNN level in the blood 3 and 6 months
Secondary platelet level in the blood 3 and 6 months
Secondary WHO performance index 3 and 6 months
Secondary WHOQOL-OLD questionnaire 3 and 6 months
Secondary Lung function by pulmonary computed tomography 3 and 6 months
Secondary Lung function by EFR 3 and 6 months
Secondary Mortality 3 and 6 months
Secondary Readmission Rates 3 and 6 months
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