Covid 19 Clinical Trials

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

NCT04500067 Covid19 Pneumonia Drug: IVIG

MeSH:Pneumonia

HPO:Pneumonia

Primary Outcomes

Description: Number of days post-onset of severe pneumonia to the moment of normalization at least two from following primary outcomes: O2 saturation with self-breathing, respiratory movements rate with self-breathing, body temperature without antipyretics use, lymphocyte count (targeted levels set in the description each of these primary outcomes)

Measure: Period duration (in days) to clinical improvement

Time: From date post-onset of severe pneumonia to date of patient discharge or date of death, whichever came first, assessed up to 28 days

Description: The target level of SPO2 percentage - 95% and above with self-breathing, is used as one of the clinical improvement criteria

Measure: O2 saturation (SPO2 percentage), with self-breathing

Time: From date post-onset of severe pneumonia to date of patient discharge or date of death, whichever came first, assessed up to 28 days

Description: The target level of respiratory movements - 28 per minute or less with self-breathing, is used as one of the clinical improvement criteria

Measure: Respiratory movements rate (amount per minute), with self-breathing

Time: From date post-onset of severe pneumonia to date of patient discharge or date of death, whichever came first, assessed up to 28 days

Description: Measured in degrees Celsius. Fever absence (body temperature no more 37 degrees Celsius) during at least 24 hours without antipyretics, is used as one of the clinical improvement criteria.

Measure: Body temperature without antipyretics use

Time: From date post-onset of severe pneumonia to date of patient discharge or date of death, whichever came first, assessed up to 28 days

Description: The target level 1000 cells / mm3 and above is used as one of the clinical improvement criteria (applicable for patients with lymphocytes count lower 1000 cells / mm3 at screening moment)

Measure: Lymphocyte count

Time: From date post-onset of severe pneumonia to date of patient discharge or date of death, whichever came first, assessed up to 28 days

Secondary Outcomes

Description: Period duration (in days)

Measure: Time from the onset of the disease to discharge, in days

Time: 28 days

Description: Number of days with ventilatory support

Measure: Duration of the need for ventilatory support, in days

Time: 28 days

Description: Number of days in the intensive care unit

Measure: Duration of the need for intensive care, in days

Time: 28 days

Description: Number of days with necessery of oxygenation support

Measure: Duration of need for oxygenation in days (SPO2 ≤ 93% with self-breathing)

Time: 28 days

Description: Measuring the analyte concentration in plasma (mg/L)

Measure: The C-reactive protein (CRP) level