Briefing at the Ministry of health
LONDON (Reuters) – A global trial designed to test whether the anti-malaria drugs hydroxychloroquine and chloroquine can prevent infection with COVID-19 is to restart after being approved by British regulators.
The Medicines and Healthcare Products Regulatory Agency (MHRA) took its decision on what is known as the COPCOV trial after hydroxychloroquine was found in another British trial to have no benefit as a treatment for patients already infected with COVID-19, the disease caused by the new coronavirus.
The COPCOV study was paused pending review after the treatment trial results.
It is a randomised, placebo-controlled trial that is aiming to enrol 40,000 healthcare workers and other at-risk staff around the world, and is being led by the Oxford University’s Mahidol Oxford Tropical Medicine Research Unit (MORU) in the Thai capital, Bangkok.
U.S. President Donald Trump said in March hydroxychloroquine could be a game-changer and then said he was taking it himself, even after the U.S. regulator, the Food and Drug Administration (FDA), advised that its efficacy and safety were unproven.
The FDA later revoked emergency use authorisation for the drugs to treat COVID-19, after trials showed they were of no benefit as treatments.
But Oxford University’s Professor Nicholas White, who is co-leading the COPCOV trial, said studies of the drugs as a potential preventative medicine had not yet given a conclusive answer.
“Hydroxychloroquine could still prevent infections, and this needs to be determined in a randomised controlled trial,” he said in a statement. “The question whether (it) can prevent COVID-19 or not remains as pertinent as ever.”
White’s team said recruitment of British health workers would resume this week, and said plans were under way for new sites in Thailand and Southeast Asia, Africa and South America. Results are expected by the end of this year.
The death toll from COVID-19 surpassed half a million people on Sunday, according to a Reuters tally, with the number of cases reported globally now more than 10 million.
More information: Vimeo
MoriVid (hydroxychloroquine sulfate) 200 mg, 30 tablets, expected by thousands of Bulgarian patients, is now available in the pharmacies countrywide. The distributor of the medicinal product is Commercial League – Global Pharma Center.
Prof. Toni Vekov – Director of the scientific board of Tchaikapharma, prof. Rasho Rashkov – Chairman of the Bulgarian Rheumatology Society and Boryana Boteva – Chairman of the Rheumatology Patients Organisation took part in the broadcasting “Ask BNT” related to the matters of efficiency and safety of the treatment with Hydroxychloroquine (HCQ) for rheumatology-related diseases and as therapy for COVID-19.
Prof. Toni Vekov: The product is already registered in Bulgaria, we have been assured by the National Organization of prices and re-imbursement of pharmaceutical products, that the price will be discussed on Thursday (18th of June). I hope MoriVid to be available in all pharmacies as of next week.
A representative epidemiological study leaded by our research team, which included 56 countries, showed that in countries where 5 times more HCQ is used, mortality is 2 times lower.
Prof. Rasho Rashkov: I work with Hydroxychloroquine for 36 years. The Chloroquine and the Hydroxychloroquine have a good effect [if the right dosage is applied] and are safe to a significant extent. The product is efficient in cases of COVID-19 infections as well.
B. Boteva: The registration of the Hydroxychloroquine is Bulgaria is an immense achievement. Many thanks to the pharmaceutical company!
Watch the full interview here /in Bulgarian/.
(updated on 5 June, 14:30 )
In response to numerous inquiries from doctors, journalists and especially from patients suffering from autoimmune diseases, we confirm inform that Tchaikapharma High Quality Medicines Inc. has developed, produced and registered for use in Bulgaria hydroxychloroquine sulfate in one galenic form. The regulatory approval is highly anticipated and very welcomed. So far, more than 4,000 people have been forced to seek the medicine from abroad or to stop their treatment, which dramatically worsens their quality of life and compromises their further treatment.
We recall that after the stark opposition and widespred reaction of the international scientific community against the publication of May 22, 2020 with fabricated data in the otherwise authoritative medical scientific journal Lancet, yesterday, June 3, 2020, the World Health Organization resumed all clinical trials of hydroxychloroquine for treatment of COVID-19. The researchers from Harvard and authors of the Lancet article were forced to wear sackloth and ashes and retracted it against the disclosure of data fabrication. Just an hour later, a second article published in another legendary scientific forum, the New England Journal of Medicine, was retracted for the acknowledged use of inaccurate data collected in compromised ways and without probative value.
MoriVid will be available in hospitals and in all pharmacies within days.
MoriVid will be registered in 10 European countries by the end of the year.
International Press Center
Leading cardiac surgeon Prof. Vladimir Danov to the press:
“Tchaikapharma” developed a production technology for a period so short that is worthy of a record and registered in Bulgaria Hydroxychloroquine Sulfate, which is wonderful news for more than four thousand Bulgarians, suffering from autoimmune diseases.
You can read the whole interview here in Bulgarian.