NCT04403269

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
35

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started May 2020

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 5, 2020

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

May 18, 2020

Completed
9 days until next milestone

First Posted

Study publicly available on registry

May 27, 2020

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 5, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 5, 2021

Completed
Last Updated

May 27, 2020

Status Verified

May 1, 2020

Enrollment Period

1 year

First QC Date

May 18, 2020

Last Update Submit

May 22, 2020

Conditions

Sars-CoV2

Outcome Measures

Primary Outcomes (1)

  • Mortality

    Day 14

Secondary Outcomes (14)

  • Total number of days of full hospitalization

    3 and 6 months

  • Duration of oxygen therapy

    3 and 6 months

  • Ferritin level in the blood

    3 and 6 months

  • CRP level in the blood

    3 and 6 months

  • LDH level in the blood

    3 and 6 months

  • +9 more secondary outcomes

Study Arms (1)

IgIV

EXPERIMENTAL

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

Drug: IgIV

Interventions

IgIVDRUG

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

IgIV

Eligibility Criteria

Age75 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre Hospitalier de Versailles

Le Chesnay, 78150, France

RECRUITING

Central Study Contacts

Mélody FORT

CONTACT

+33139239776mfort@ch-versailles.fr

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

May 18, 2020

First Posted

May 27, 2020

Study Start

May 5, 2020

Primary Completion

May 5, 2021

Study Completion

May 5, 2021

Last Updated

May 27, 2020

Record last verified: 2020-05

Locations

FR(1)