Researchers from Intermountain Healthcare and the University of Utah in Salt Lake City have initiated two important clinical trials to test the effectiveness and safety of two drugs-hydroxychloroquine (HCQ) and azithromycin-for patients with COVID-19. Researchers from these two health systems plan to recruit nearly 2,300 COVID-19-positive or suspected patients.
Research by the principal investigator and Intermountain Healthcare emergency care researcher, Samuel Brown, MD, said: "These findings will help us understand the value of hydroxychloroquine (HCQ) treatment of COVID-19 in our efforts to fight the virus and may help To reduce pandemics. "
Hydroxychloroquine is an antimalarial drug commonly used to treat some autoimmune diseases; azithromycin is an antibiotic commonly used to treat sinusitis or pneumonia.
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In addition, these drugs can also cause significant side effects. In some cases, hydroxychloroquine can increase the content of another virus in the blood or cause heart rhythm problems. In addition, the surge in interest in hydroxychloroquine puts patients taking the drug in order to control persistent chronic diseases at risk of losing conventional treatment.
"Because COVID-19 is a new disease, we all start from scratch," said Adam M. Spivak, MD, a principal investigator of one of the clinical trials and an infectious disease doctor at the University of Utah Health. "To answer 'Is this drug effective?' Is to conduct an impartial clinical trial and study its effects."
In the first trial, patients hospitalized with suspected or confirmed COVID-19 will be given hydroxychloroquine or azithromycin to determine whether these two drugs affect the severity of COVID-19 and save lives.
The researchers plan to recruit 300 patients to participate in clinical trials from all Intermountain Healthcare and the University of Utah Health Hospital, which are treating patients with COVID-19.
Dr. Brown said: "The main question we will answer in this trial is whether hydroxychloroquine can improve the severity of the disease and save the lives of patients hospitalized with COVID-19?"
In the second set of trials, patients receiving COVID-19 as an outpatient will be given hydroxychloroquine or azithromycin to determine whether these two drugs can prevent hospitalization. The trial will also determine whether hydroxychloroquine affects virus shedding and prevents infection by household contacts compared to placebo.
In these outpatient trials, the researchers will recruit 2,000 patients from all Utah Intermountain Healthcare institutions and the University of Utah Medical System Hospital, which are treating COVID-19 patients. Patients will receive treatment and pass remote health monitoring.
Brandon Webb MD is the principal investigator of this outpatient trial and an infectious disease physician at Intermountain Healthcare. He said that there is a strong global interest in these two clinical trials.
"These drugs are of interest all over the world, but the available clinical data has not shown any benefit," he added. "These clinical trials allow us to protect the safety of patients, but also answer the really important questions of benefit and harm."
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Clinical trials usually take months or years to start. Researchers from Intermountain Healthcare, the University of Utah Institute of Health, the Utah Department of Health, and the Utah Medical Association were able to initiate these COVID-19 clinical trials within two weeks.
"To achieve this goal, everyone in our research team works 18 hours a day," Dr. Brown said. "We are able to meet the strict clinical trial standards while remaining agile and flexible because the demand for this knowledge is so great. We appreciate the cooperation of all these organizations to make these clinical trials a reality and do the right thing for our patients Thing. "
The researchers admit that clinicians may have pressure on COVID-19 patients to use hydroxychloroquine outside of clinical trials. They said that while prescribing this medicine during a pandemic may be reassuring, it may be counterproductive or even harmful until doctors better understand their effects.
Two weeks ago, the heads of research at Intermountain Healthcare and the University of Utah agreed to work together to help solve this problem.
"Although some institutions will choose to prescribe hydroxychloroquine for their patients, Intermountain Healthcare, the University of Utah Health, and the Utah Department of Health have used the safest way to treat this drug with COVID-19 within the framework of a clinical trial. （from Bioon.com)