The University of Washington is one of the research facilities that investigate the effect of hydroxychloroquine on COVID-19-patients and patients who are exposed to the Virus. (CatherineL-Prod photo via Bigstock)
The Food and Drug Administration has today, call your emergency approval for two related to malaria medications, chloroquine and hydroxychloroquine, for the treatment of COVID-19.
Relying on new and emerging scientific data, the FDA said that it was unlikely that the drugs used in the treatment of COVID-19 are effective, and that the potential Benefits do not outweigh the known risks, including the occurrence of serious cardiac events. For these reasons, the statutory criteria for granting are no longer fulfilled, a permit for the event of an emergency, said the FDA.
The two drugs have been used for decades, with FDA approval for the treatment of Malaria, as well as auto-immune diseases such as Lupus and rheumatoid Arthritis. The FDA noted that Doctors can prescribe approved products for Off-Label applications, if you find that you are suitable for the treatment of patients.
In a separate report, the FDA warned that the antiviral effect of the other medicine may be reduced by means of, Remdesivir, if the same patient is given chloroquine or hydroxychloroquine. In April, researchers said, showed preliminary results that Remdesivir seemed to shorten the time required to recover from COVID-19.
The FDA said its warning of possible interaction with other drugs is based on a recently completed non-clinical study.
Hydroxychloroquine partly due to the high-profile recommendations from President Donald Trump in the spotlight. Last month, he told reporters that he take the drug for two weeks, a COVID-19-to ward off infection, and asked: “What have you got to lose? “
In clinical studies, the potential Benefit of the drug was reviewed under the strict Monitoring and strict conditions. Medical researchers at the University of Washington were involved in several of these studies, and in a written statement UW Medicine said that the studies will be continued in spite of difficulties in recruitment. Here is the full statement is:
“Researchers from UW Medicine to put hydroxychloroquine studies carried out with ambulatory patients. These studies provide protective measures, such as Monitoring the heart rhythm and also include people with underlying heart, kidney or liver disease. In contrast to many previous hydroxychloroquine studies, our researchers recruit participants, while they are good enough to be at home.
“These studies do not involve the use of hydroxychloroquine for emergency use in the treatment of COVID-19-patients.
“A clinical study at a plurality of locations, conducted by the University of Washington School of Medicine in collaboration with the Grossman School of Medicine of New York University, aims to determine definitively whether hydroxychloroquine may prevent the Transmission in persons exposed to the Virus. The Team registered 1.650 outpatient participants who are referred by Physicians in seven locations and close contacts with persons with confirmed or pending COVID-19-diagnoses have. So far, the study is enrolled to 30%. Ruanne Barnabas, associate Professor of global health at the medical and public health schools of the University of Washington, is the main researcher.
“The researchers are part of two studies, where 2.625 outpatient participants took part in order to determine whether a treatment combining a low dose of hydroxychloroquine and Azithromycin, hospital stays and deaths among people with COVID-19 can be prevented. The study with 625 outpatients enrolled to 15%. Christine Johnston, associate Professor of medicine in the division of Allergy and infectious diseases, School of Medicine of the University of Washington, is the main researcher.
“In a larger study of 2,000 out-patients, however only two people on the spot and 17 were set at the national level. Ann Collier, a Professor of Allergy and infectious diseases in the Department of medicine at the Medical faculty of the University of Washington, is the local Principal investigator. She said the negative advertising of hydroxychloroquine and the declining epidemic would have made it difficult to register.
“The scientific consensus is that strictly conducted clinical studies that monitor the safety, are the most reliable way to determine the effectiveness of hydroxychloroquine for the prevention and treatment of COVID-19. “
Update 14.45 PT 15. June: This report has been updated with the warning from the FDA regarding the interaction of medicines with Remdesivir and with the Declaration of UW clinical studies.