Intravenous Immunoglobulin (IVIG, Bioven) Efficacy Assess for COVID-19 / SARS-CoV-2 Severe Pneumonia Complex Treatment

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT04500067
• Date of registration: 15/07/2020
• Prospective Registration: No
• Primary sponsor: Biopharma Plasma LLC
• Public title: Intravenous Immunoglobulin (IVIG, Bioven) Efficacy Assess for COVID-19 / SARS-CoV-2 Severe Pneumonia Complex Treatment
• Scientific title: An Open-label Multicenter Randomized Trial to Evaluate the Efficacy of Bioven, Manufactured by Biopharma Plasma, LLC, in Complex Therapy of Patients With Pneumonia Induced by COVID-19 / SARS-CoV-2
• Date of first enrolment: May 7, 2020
• Target sample size: 76
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT04500067
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 3

Countries of recruitment

Ukraine

Key inclusion & exclusion 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.



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Covid19

Pneumonia

Intervention(s)

Drug: IVIG

Primary Outcome(s)

O2 saturation (SPO2 percentage), with self-breathing [Time Frame: From date post-onset of severe pneumonia to date of patient discharge or date of death, whichever came first, assessed up to 28 days]

Body temperature without antipyretics use [Time Frame: From date post-onset of severe pneumonia to date of patient discharge or date of death, whichever came first, assessed up to 28 days]

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

Period duration (in days) to clinical improvement [Time Frame: From date post-onset of severe pneumonia to date of patient discharge or date of death, whichever came first, assessed up to 28 days]

Respiratory movements rate (amount per minute), with self-breathing [Time Frame: 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 Outcome(s)

Duration of the need for ventilatory support, in days [Time Frame: 28 days]

The tumor necrozis factor alpha (TNF-a) level [Time Frame: Day 0 (screening), day 5, day 14, day 28]

The D-dimer level [Time Frame: Day 0 (screening), day 5, day 14, day 28]

The interleukin-6 (IL-6) level [Time Frame: Day 0 (screening), day 5, day 14, day 28]

The C-reactive protein (CRP) level [Time Frame: Day 0 (screening), day 5, day 14, day 28]

The Circulating immune complexes level [Time Frame: Day 0 (screening), day 5, day 14, day 28]

The procalcitonin level [Time Frame: Day 0 (screening), day 5, day 14, day 28]

Time from the onset of the disease to discharge, in days [Time Frame: 28 days]

Duration of the need for intensive care, in days [Time Frame: 28 days]

IgG subtypes [Time Frame: Day 0 (screening), day 5, day 14, day 28]

The Complement (C3 component) level [Time Frame: Day 0 (screening), day 5, day 14, day 28]

The ferritin level [Time Frame: Day 0 (screening), day 5, day 14, day 28]

Survival assessment for a 28-day follow-up period since the onset of severe pneumonia [Time Frame: 28 days]

The interleukin-1ß (IL-1ß) level [Time Frame: Day 0 (screening), day 5, day 14, day 28]

Duration of need for oxygenation in days (SPO2 = 93% with self-breathing) [Time Frame: 28 days]

Secondary ID(s)

2020-BV-BP

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Vinnitsa National Medical University

Lviv National Medical University