研究ers from 大发娱乐 and 山间医疗 in Salt Lake City have launched two vital 临床试验s to test the effectiveness and safety of two drugs – hydroxychloroquine (HCQ) 和阿奇霉素 – to treat patients with COVID-19 (infection with the novel 冠状病毒).
研究ers from the two health systems plan to enroll nearly 2,300 patients who are COVID-19 positive or suspected of being positive for the virus.
"Results from these studies will help us to understand the value of hydroxychloroquine (HCQ) in treatment of COVID-19 as we seek ways to fight the virus effectively and reduce the human cost of this pandemic,塞缪尔·布朗说, MD, principal investigator of one of the studies and a critical care researcher at 山间医疗.
羟氯喹, an anti-malarial drug typically used to treat some autoimmune diseases, 和阿奇霉素, 一种抗生素，通常用于鼻窦炎或肺炎, 被建议作为COVID-19的潜在治疗方法, 但它们是否真的有大发娱乐还不得而知.
此外，这些药物还会产生严重的副作用. 在某些情况下, hydroxychloroquine has increased the levels of a different virus present in the blood or caused problems with heart rhythm. 进一步, a surge in interest in hydroxychloroquine has left patients who take the drug to manage ongoing chronic illnesses at risk of losing access to their regular course of treatment.
"The only way to answer the key question of ‘does this drug work?' is to perform an unbiased 临床试验 where we study its effects."
"Because COVID-19 is a new disease, we're all starting from scratch," said 亚当M. 斯博士, a principal investigator of one of the 临床试验s and an 传染性疾病 犹他健康大学的内科医生. "The only way to answer the key question of ‘does this drug work?' is to perform an unbiased 临床试验 where we study its effects."
在第一次试验中, patients hospitalized with suspected or confirmed COVID-19 will be given either hydroxychloroquine or azithromycin to determine whether either drug affects the severity of COVID-19 and saves lives.
研究ers plan to enroll 300 patients in the 临床试验 from across all 山间医疗 hospitals and 大发娱乐 hospitals that are treating COVID-19 patients.
“大发娱乐在这个试验中想要回答的主要问题是, does HCQ improve the severity of illness and save lives for patients hospitalized with COVID-19?”医生说。. 棕色（的）.
在第二组试验中, patients with confirmed COVID-19 who are being treated as outpatients will be given hydroxychloroquine or azithromycin to determine if either drug can prevent hospitalization. The trials will also determine whether hydroxychlorquine impacts viral shedding and prevents infection of household contacts as compared to placebo.
对于这些门诊试验, 研究人员将招收2名,000 patients across Utah from all 山间医疗 and 大发娱乐 System hospitals that are treating COVID-19 patients. 病人 will receive treatment and be monitored via telehealth.
布兰登·韦伯, MD, a principal investigator of the first trial and an 传染性疾病s physician at 山间医疗, said there's significant global interest in both 临床试验s to provide scientific evidence as to whether these drugs are effective in treating COVID-19 patients.
“全世界都对这些药物感兴趣, but the available clinical data have not yet shown any benefit. These 临床试验s allow us to protect the safety of patients but also answer the really important question of benefit versus harm,他补充道.
临床试验通常需要数月或数年才能启动. 山间医疗的研究人员, 大发娱乐, 犹他州卫生部, and the Utah Medical Association were able to launch these COVID-19 临床试验s in two weeks.
Everyone on our research team has been working 18-hour days to make this happen,”医生说。. 棕色（的）. "We've been able to be nimble and flexible while still meeting the rigorous standards of a 临床试验 because the need for this knowledge is so great. We applaud all of these organizations for working collaboratively to make these 临床试验s a reality and to do the right thing for our patients."
研究ers acknowledge there may be pressure on clinicians to use hydroxychloroquine for COVID-19 patients outside of a 临床试验. While it may feel reassuring to prescribe this medication in the midst of a pandemic, it may be counter-productive or even harmful until physicians better understand their impact, 他们说.
Two weeks ago, research leaders at 山间医疗 and 大发娱乐 同意共同努力大发娱乐解决这个问题.
"Although some providers will choose to prescribe HCQ to their patients, 山间医疗, 大发娱乐, 犹他州卫生部, and the UMA recognize the safest way to use this medication to treat COVID-19 is within the framework of 临床试验s,拉杰·斯里瓦斯塔瓦说, MD, assistant vice president of research at 山间医疗.
"These trials will ensure patients are provided information about potential associated risks and have consented to participate so their progress can be closely monitored by healthcare providers and research staff,” 雷切尔·赫斯，医学博士，硕士, a principal investigator of the outpatient trial and co-director for the 临床与转化科学中心 犹他大学的教授.