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

Primary Purpose

Sars-CoV2

Status

Unknown status

Phase

Phase 2

Locations

France

Study Type

Interventional

Intervention

IgIV

About this trial

This is an interventional treatment trial for Sars-CoV2

Eligibility Criteria

75 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Centre Hospitalier de VersaillesRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

IgIV

Arm Description

The experimental arm is human immunoglobulins. 2 infusion at D1 and D2. (0.8 g / kg by IV infusion)

Outcomes

Primary Outcome Measures

Mortality

Secondary Outcome Measures

Total number of days of full hospitalization

Duration of oxygen therapy

Ferritin level in the blood

CRP level in the blood

LDH level in the blood

Lymphocyte level in the blood

PNN level in the blood

platelet level in the blood

WHO performance index

WHOQOL-OLD questionnaire

Lung function by pulmonary computed tomography

Lung function by EFR

Mortality

Readmission Rates

Full Information

NCT ID

NCT04403269

First Posted

May 18, 2020

Last Updated

May 22, 2020

Sponsor

Versailles Hospital

1. Study Identification

Unique Protocol Identification Number

NCT04403269

Brief Title

NORMAL HUMAN IMMUNOGLOBULINS (IVIG) IN PATIENTS AGED 75 YEARS AND OVER, COVID-19 WITH SEVERE ACUTE RESPIRATORY FAILURE

Acronym

GERONIMO 19

Official Title

"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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2020

Overall Recruitment Status

Unknown status

Study Start Date

May 5, 2020 (Actual)

Primary Completion Date

May 5, 2021 (Anticipated)

Study Completion Date

May 5, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Versailles Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Sars-CoV2

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

35 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

IgIV

Arm Type

Experimental

Arm Description

The experimental arm is human immunoglobulins. 2 infusion at D1 and D2. (0.8 g / kg by IV infusion)

Intervention Type

Drug

Intervention Name(s)

IgIV

Intervention Description

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

Primary Outcome Measure Information:

Title

Mortality

Time Frame

Day 14

Secondary Outcome Measure Information:

Title

Total number of days of full hospitalization

Time Frame

3 and 6 months

Title

Duration of oxygen therapy

Time Frame

3 and 6 months

Title

Ferritin level in the blood

Time Frame

3 and 6 months

Title

CRP level in the blood

Time Frame

3 and 6 months

Title

LDH level in the blood

Time Frame

3 and 6 months

Title

Lymphocyte level in the blood

Time Frame

3 and 6 months

Title

PNN level in the blood

Time Frame

3 and 6 months

Title

platelet level in the blood

Time Frame

3 and 6 months

Title

WHO performance index

Time Frame

3 and 6 months

Title

WHOQOL-OLD questionnaire

Time Frame

3 and 6 months

Title

Lung function by pulmonary computed tomography

Time Frame

3 and 6 months

Title

Lung function by EFR

Time Frame

3 and 6 months

Title

Mortality

Time Frame

3 and 6 months

Title

Readmission Rates

Time Frame

3 and 6 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

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 Exclusion Criteria: 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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Mélody FORT

Phone

+33139239776

mfort@ch-versailles.fr

Facility Information:

Facility Name

Centre Hospitalier de Versailles

City

Le Chesnay

ZIP/Postal Code

78150

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Laure PARNET

12. IPD Sharing Statement

Learn more about this trial

NORMAL HUMAN IMMUNOGLOBULINS (IVIG) IN PATIENTS AGED 75 YEARS AND OVER, COVID-19 WITH SEVERE ACUTE RESPIRATORY FAILURE

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