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

NCT ID: NCT04403269

Last Updated: 2020-05-27

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 35 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-05-05
• Study Completion Date: 2021-05-05

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.

Conditions

Sars-CoV2

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

IgIV

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

Group Type: EXPERIMENTAL

IgIV

Intervention Type: DRUG

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

Interventions

IgIV

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

Intervention Type: DRUG

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

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

• Minimum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Versailles Hospital

OTHER

Sponsor Role: lead

Responsible Party

Dr Laure PARNET

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Centre Hospitalier de Versailles

Le Chesnay, , France

Site Status: RECRUITING

Countries

France

Central Contacts

Mélody FORT

Role: CONTACT

mfort@ch-versailles.fr

+33139239776

Facility Contacts

Laure PARNET

Role: primary

Other Identifiers

P20/07 GERONIMO 19

Identifier Type: -

Identifier Source: org_study_id