Intravenous Immunoglobulin (IVIG, Bioven) Efficacy Assess for COVID-19 / SARS-CoV-2 Severe Pneumonia Complex Treatment
Status:
Completed
Trial end date:
2020-09-15
Target enrollment:
Participant gender:
Summary
Pneumonia caused by coronavirus infection COVID-19 is characterized by a combination of
several dangerous factors that consistently worsen the patient's condition: viral lung damage
early in the disease; a sharp increase in inflammation on the background of an unbalanced
immune response ("cytokine storm"); joining a bacterial infection.
The condition of patients deteriorates significantly mostly at cytokine storm development.
The damaging of a large volume of lung tissue leads to develops of respiratory failure,
respiratory distress syndrome, or shock. Ventilatory support becomes ineffective and patients
die.
There are reports of the effectiveness of Human Normal Immunoglobulin for Intravenous
Administration (IVIG) high doses when used as part of complex therapy in patients with
pneumonia caused by coronavirus COVID-19. In particular, IVIG has a positive effect on
survival rates, overall disease course, duration of stay in the intensive care unit, and
ventilatory support duration.
The probable mechanism of action of high-dose IVIG therapy is considered to be a regulatory
effect on the immune system. Similar is the known and confirmed effectiveness of IVIG for
autoimmune diseases (Kavasaky disease, Guillain Barre syndrome, Chronic inflammatory
demyelinating polyradiculoneuropathy, Multifocal motor neuropathy).
This trial to assesses the Efficacy of IVIG (medication trade name - Bioven, manufactured by
Biopharma Plasma LLC) in the High Immunomodulatory Dose in Complex Treatment of Severe
Pneumonia Caused by COVID-19 / SARS-CoV-2
Phase:
Phase 3
Details
Lead Sponsor:
Biopharma Plasma LLC
Collaborators:
Lviv National Medical University Vinnitsa National Medical University