COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT04500067

Andrii R Rybakov, MD

a.rybakov@biopharma.ua

2020-08-05

Completed

RCT

Randomized

Parallel

Open label

multi-center

Treatment

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.

- 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.

2

Biopharma Plasma LLC

18

100

Ukraine

Moderate/severe disease at enrollment

4: Moderate/severe disease at enrollment

76

Respiratory movements rate (amount per minute), with self-breathing;Body temperature without antipyretics use;Lymphocyte count;O2 saturation (SPO2 percentage), with self-breathing;Period duration (in days) to clinical improvement

None

Phase 3

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