Biopharma Plasma head announces world's first completion of clinical trials of immunoglobulin used COVID-19 treatment
The biopharmaceutical company Biopharma Plasma (Bila Tserkva, Kyiv region) has completed clinical trials of the drug used the the therapy of COVID-19, Bioven (immunoglobulin), head and co-owner of the company Kostiantyn Yefymenko has said.
"Today, 18 clinical trials of immunoglobulin are ongoing in the world ... However, Biopharma is the first company to start clinical trials, and the first to complete them. Yesterday, Bioven was included in the COVID-19 treatment protocol," he wrote, thanking the Ministry of Health for support in the study.
The co-owner of Biopharma clarified that clinical trials began in May, "66 patients with a severe course of the disease were randomized, nine bases were involved in the study. The study was completed in October." According to him, the use of Bioven in the complex therapy for pneumonia caused by SARS-CoV-2, COVID-19 in comparison with standard therapy allows achieving statistically significant advantages in the following parameters. In particular, this is a fourfold reduction in mortality from 23.6% to 6.25%, the reduction in the average time to improvement from nine to five days, and a reduction in the time required for hospitalization by 3-5 days.
"Biopharma continues to work on the creation of hyperimmune immunoglobulin. There will be news in the near future," Yefymenko said.
According to the information on the website clinicaltrials.gov of the U.S. National Library of Medicine, there are six clinical trials in Ukraine in the fight against COVID-19, of which only Bioven has the status of "completed." The results of the study, which was conducted jointly with the Lviv and Vinnytsia Medical Universities, are not yet available on the website, but it is indicated that there were 76 participants in it. They were equally divided into groups, one of which received basic therapy with Bioven, and the other received only basic therapy.
The studies were carried out on the basis of seven hospitals in Ivano-Frankivsk, Bila Tserkva, Lviv, Odesa, Ternopil, Vinnytsia, Lutsk and two in Kyiv.