Doctors from subordinate medical institutions in Moscow have been offered to participate in a study of a drug for COVID-19 prevention. The drug, called hydroxychloroquine, is used for rheumatoid arthritis and malaria, but its effectiveness against the new coronavirus has not been confirmed. Doctors warn of the risk of numerous side effects.
Moscow health workers are offered to participate in a research study on hydroxychloroquine for coronavirus prevention on the website doc-covid.ru. It was created on the orders of the head of the Moscow Health Department, Alexei Kripun. A signed order from him was obtained by an employee of one of the Moscow hospitals and verified by the BBC Russian Service. A source close to the Ministry of Health has confirmed that under the decree of Sergei Sobyanin, doctors will receive free drugs for the prevention of coronavirus. Resource workers respond to messages from the e-mail on the domain name of the Moscow Department of Health. For additional information, they recommended contacting the press service of the Moscow Department of Health. The Russian service of the BBC sent questions and is waiting for a response.
To participate in the experiment, physicians must register on the website by providing personal information and a phone number. “The aim of this study is to determine the effectiveness of hydroxychloroquine as a prophylactic measure against the development of COVID-19 symptoms in healthcare workers who have direct contact with COVID-19 positive patients,” as stated on doc-covid.ru. The drug is produced under the brand names “Imard”, “Plaquenil”, “Hydroxychloroquine”. It is indicated for rheumatoid arthritis, malaria and lupus erythematosus. Earlier, information about its effectiveness in the treatment and prevention of COVID-19 appeared in the media – as a result, there was a frantic demand, and the drug disappeared from many pharmacies. Moscow authorities announced a tender for its supply.
We explain quickly, simply, and clearly what happened, why it matters, and what happens next. The number of episodes should remain the same. End of story Podcast advertising The Web site lists 23 clinical trials of hydroxychloroquine against coronaviruses that are currently being conducted in various countries. Of these, 11 are investigating the preventive effect of the drug. Official public data on the start of clinical trials in Moscow could not be found on the website clinicaltrials.gov by the Russian service of the BBC. In the documents and on doc-covid.ru it is not positioned as a clinical trial. Only the phrase “off-label use” is used. Physicians who agree to participate in the trial will receive free hydroxychloroquine (200 mg morning and evening for 14 days, followed by 200 mg once daily for three months). The drugs will be distributed to the doctors at their place of work, which is in the hospital. “There is an option to refuse such prevention, but departments require their employees to register compulsorily,” says the letter on the situation in the infectious hospital, which was familiarized by the Russian service of the BBC. The requirement to provide medication to patients and those working with coronavirus patients was included in Sobyanin’s decree on the introduction of an enhanced preparedness regime. Drugs will also be provided free of charge to patients receiving treatment at home.
According to the order of Moscow Health Minister Alexey Kripun, the experiment will be conducted in 10 hospitals in Moscow, including the Kommunarka hospital, the largest hospital receiving coronavirus patients. Using the phone number indicated on doc-covid.ru, they advised to call the press service, providing the number listed in SPARK in the contacts of one of the subordinate organizations of Moscow (Scientific Research Institute of Health Organization and Medical Management of DZM). On April 2, the Moscow Health Department announced the purchase of hydroxychloroquine drugs for 2.6 million rubles. The tender does not specify for whom the drug is intended – doctors or patients – and for what disease. Currently, there are no drugs with proven efficacy for the treatment and prevention of coronavirus.
According to the recommendations of the Ministry of Health of Russia, hydroxychloroquine, along with several other drugs, can be used for patients diagnosed with coronavirus. However, the document includes the disclaimer: “The available information on the results of treatment with these drugs does not allow a definitive conclusion on their effectiveness/ineffectiveness, therefore their use is allowed at the discretion of the medical committee in accordance with established procedures, in cases where the potential benefit to the patient outweighs the risk of their use”. In the consent form for use of the drug posted on doc-covid.ru, it is also stated that the effectiveness of the drug “for prevention and treatment of mild forms of coronavirus is currently not confirmed by objective data” and “its use in severe forms of the new coronavirus infection COVID-19 has not been proven effective”. The website lists the drug’s side effects, including nausea and vomiting, ringing in the ears, hearing loss, blurred vision, dizziness and diarrhea. “I don’t know how they’re going to combine a chemical suit with diarrhea, probably their performance will decrease,” said a BBC employee of a medical organization familiar with the drug’s side effects.
In Russia, hydroxychloroquine drugs are registered by four manufacturers: French company “Sanofi”, Canadian company “New Pharm Inc”, Indian company “Ipka Laboratories” and Stavropol company “Biokom”. The Russian service of the BBC managed to contact one of them – “Sanofi”. According to Yuri Mochalin, director of corporate relations for Sanofi in Eurasia, there has been a recent increase in demand for hydroxychloroquine from both the pharmaceutical sector and government customers. “It can be prompted by numerous publications demonstrating the potential antiviral activity of this drug in the case of COVID-19 coronavirus infection,” reads the written response from Mochalin, BBC. According to him, these publications are based on preliminary results of small studies. Hydroxychloroquine is not currently recommended for the treatment of coronavirus. Due to the increased demand, it has become more difficult for those who need the medication for medical reasons to obtain it. “Vedomosti reported that on March 27, most pharmacies in Moscow did not have antimalarial drugs containing hydroxychloroquine. Mochalin explained that the company is taking steps to provide patients with hydroxychloroquine to continue prescribed therapy for registered indications. “For our part, we are implementing strict monitoring of orders and shipments to contractors to ensure patients with registered indications,” he said. The company asked market players to tighten control over the distribution of the drug according to prescriptions and registered indications. “Sanofi” also appealed to the Russian Ministry of Health with a request to “express a clear position regarding the use of this drug for unregistered indications”, as there are currently no reliable clinical studies on the effectiveness of the drug against coronavirus. With the participation of Andrey Soshnikov and Andrey Zakharov