The research began in May 2020 and ended in October this year. The aim is to evaluate the effectiveness of Bioven in the complex therapy of patients with pneumonia caused by coronavirus infection COVID-19/SARS-CoV-2.
An open multicenter randomized controlled trial to evaluate the effectiveness of Bioven was conducted at 9 clinical bases: in Kyiv, Bila Tserkva, Lviv, Odesa, Vinnytsia, Ternopil, Ivano-Frankivsk, and Lutsk.
The number of patients in the study was approved by the SEC of Ukraine and involved 76 participants.
Of all participants, 10 patients were screened and indicators were found that exclude their participation (including unacceptable abnormalities in kidney, liver, etc.). 66 patients were successfully screened and randomized. The study group included 32, and the control group – 34. All patients were hospitalized. The study included only patients with confirmed severe coronavirus pneumonia – according to national criteria of the Ministry of Health of Ukraine.
The use of Bioven in the treatment of pneumonia caused by SARS-CoV-2 (Covid19), compared with standard therapy, allows to achieve statistically significant advantages in the following parameters:
– reduction of mortality in comparison with the control group by four times (control group – 23.6%, study – 6.25%);
– reduction of the average time to improvement – from 9 to 5 days;
– reduction of time of staying in the hospital by need – for 3-5 days.
Detailed results of the study are presented in a report that has been validated and carefully analyzed by regulatory authorities. Based on the analysis, the procedure for making changes to the registration documents was carried out. The updated instruction for medical use includes the indications, key results of clinical trials, and provide recommendations on how to administer the drug to patients with severe coronavirus pneumonia.
The study design can be found in the Data Registry at the link https://clinicaltrials.gov/ct2/show/NCT04500067
The results of the research in scientific journals are expected to be published in the near future.
Biopharma also continues to work on the development of hyperimmune immunoglobulin. In this project, the company cooperates with the world’s leading plasma manufacturers in the framework of the International Alliance CoVIg-19. “Our team has high hopes for this product. We expect that it will be more effective than conventional immunoglobulin and the dose will be much lower. It requires the plasma of people who have recovered from COVID-19. If you have recovered from disease, please donate plasma! It will save someone’s life!” – the president of Biopharma Konstantin Efymenko said.
LLC “Biopharma Plasma” (Biopharma)- Ukrainian biopharmaceutical company specializing in the development and production of innovative high-tech drugs from human donor blood plasma. The company is also actively involved in the development of plasma centers and donor movement in Ukraine.