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: 0
• Participant gender: All

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
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Biopharma Plasma LLC
• Collaborators: Lviv National Medical University; Vinnitsa National Medical University
• Treatments: Immunoglobulins

Criteria

Inclusion Criteria:

• Men and women 18 years of age and older;

• COVID-19 documentary confirmed by PCR lab test;

• severe pneumonia caused by COVID-19 according to the criteria below:

• - fever or suspicion of respiratory infection;

• - the number of respiratory movements 30 per 1 min and above;

• - severe respiratory failure or SpO2 <90% with spontaneous breathing indoors;

• - the presence of foci of inflammation in the lungs according to the results of computed tomography, which is documented.

• or if any of the conditions listed below have developed on the background of previously diagnosed coronavirus pneumonia:

• - severe respiratory failure required mechanical ventilation (ALV);

• - acute respiratory distress syndrome according to WHO diagnostic criteria (development within one week after the manifestation of disease clinical symptoms or emergence of new ones or deterioration of respiratory syndromes. Chest visualization (lung X-ray, CT or ultrasound); bilateral opacities not fully explaining the gravity of condition or lung collapse or nodules);

• - sepsis according to WHO diagnostic criteria (life-threatening organ dysfunction caused by disturbance of host reaction to suspected or proven infection. The features of organ dysfunction include the following: mental change, labored or shallow breathing, low oxygenation, oliguria or anuria, rapid heart palpitation, weak pulse, cold extremities or low blood pressure, skin blotching or lab-proven coagulopathy, thrombocytopenia, acidosis, high level of lactic acid or hyperbilirubinemia);

• - endotoxic shock according to WHO diagnostic criteria (persisting hypotension despite extensive resuscitation requiring vasoconstrictors for maintaining mean arterial pressure ≥ 65 mmHg and serum lactate level > 2 mmol/l);

• the signed patient's informed consent to participation in the trial;

• the negative pregnancy test (for female patients of reproductive age), readiness to use reliable contraception methods during the whole duration of the trial.

• the ability, according to the researcher, to follow all requirements of the research protocol.

• this study allows you to take into account the results of examinations related to the disease, conducted within 10 days before signing the Informed Consent. Such data are transferred from the primary documentation to the CRF.

Exclusion Criteria:

• known intolerance to plasma or immunoglobulin drugs;

• drug allergy or hypersensitization to immunoglobulin drugs;

• any known counter-indication to immunoglobulin drugs according to the instruction for medical application of the tested drug;

• pneumonia not associated with COVID-19 infection;

• pregnancy, lactation period;

• any clinically significant impairment of liver function (elevation of serum transaminase levels more than 3 times the upper limit of normal);

• serum creatinine levels more than 2 times the upper limit of normal for a given age and gender;

• established diagnosis of primary immunodeficiency;

• verified HIV-infection;

• immune diseases (blood immune diseases, rheumatic diseases, nephritis, etc.)

• severe cardiovascular failure (Stage III);

• mental illness in anamnesis;

• the need for prescribing medicines or procedures that are incompatible with the administration of the drug within the scope of this study: monoclonal antybodies;

• known drug addiction;

• participation in any other clinical trial presently or within the last 30 days.