drugset / Trial / NCT04403269

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

NCT04403269

Phase 2 Unknown 35 enrolled Versailles Hospital
NaSingle-groupOpen-labelTreatment

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.

Timeline

Start
2020-05-05
Primary completion
2021-05-05
Completion
2021-05-05

Drugs

EvaluationDrugModalityDoseRoute
Subject Immune Globulin Intravenous (Human) Protein / enzyme biologic 0.8 g/kg Intravenous

Indications