{"id":31642,"date":"2020-05-06T16:14:02","date_gmt":"2020-05-06T22:14:02","guid":{"rendered":"https:\/\/www.uchealth.org\/today\/?p=31642"},"modified":"2024-12-24T08:48:24","modified_gmt":"2024-12-24T15:48:24","slug":"coronavirus-clinical-trials-focus-on-remdesivir-sarilumab-hydroxychloroquine-convalescent-plasma-more","status":"publish","type":"post","link":"https:\/\/www.uchealth.org\/today\/coronavirus-clinical-trials-focus-on-remdesivir-sarilumab-hydroxychloroquine-convalescent-plasma-more\/","title":{"rendered":"Several coronavirus clinical trials, same key questions: \u2018Is it safe?\u2019 \u2018Does it work?\u2019"},"content":{"rendered":"
<\/div>
\"University
UCHealth University of Colorado Hospital (UCH) on the Anschutz Medical Campus has been fueling medical advances for more than a century. Photo by UCHealth.<\/figcaption><\/figure>\n

The tight relationship between University of Colorado School of Medicine faculty researchers and UCHealth University of Colorado Hospital<\/a> (UCH) on the Anschutz Medical Campus<\/a> has been fueling medical advances for more than a century. Now these institutions are working together to bring experimental therapies to patients and, they hope, beat back the coronavirus in a matter of weeks or months.<\/p>\n

Coronavirus clinical trials<\/strong><\/h3>\n

As of this writing, four coronavirus clinical trials are already happening at UCH, with more on tap. (Clinical trials, as opposed to laboratory research, involve actual patients.) If that doesn\u2019t sound like many, consider that Colorado\u2019s first COVID-19 case was reported to the state on March 5 \u2013 just two months ago \u2013 and that clinical trials typically take three or more months to initiate before the first patient is enrolled.<\/p>\n

The Anschutz Medical Campus\u2019s $500-million-a-year research enterprise has mobilized to take on the coronavirus at an unprecedented pace. That has meant compressing the timelines of study design, regulatory considerations and approvals, and many other factors \u2013 all while ensuring patient safety and maximizing the medical knowledge reaped from a study.<\/p>\n

\u201cI know that the research and administrative teams have stayed very, very late into the night and addressed things in days which would normally take weeks,\u201d said Dr. Thomas Flaig<\/a>, vice chancellor of research on the Anschutz Medical Campus.<\/p>\n

\"Dr.
Dr. Thomas Flaig<\/figcaption><\/figure>\n

These thorough checks are necessary for many reasons. Drugs tested in a clinical trial can be new to medicine or, as is the case with the therapies being rushed to coronavirus patients, they can be existing drugs such as the antiviral remdesivir and the antimalarial hydroxychloroquine.<\/p>\n

In either case, Flaig says, responsible medical science demands that clinical trials proceed in structured ways that produce solid data which can help answer three questions: \u201cIs it safe?\u201d \u201cDoes it work?\u201d and \u201cIf it works, what\u2019s the right dose?\u201d<\/p>\n

Even amid a global pandemic starved for medical breakthroughs, there\u2019s only so much one can rush this process. You might ask why, given the enormous human and economic costs of the coronavirus, we don\u2019t just throw bowl after bowl of proverbial spaghetti at the wall and just see what sticks?<\/p>\n

Because we wouldn\u2019t know what actually sticks and what doesn\u2019t. The vast majority of clinical trials fail (86% of them, by one count), either because the drugs aren\u2019t safe or they\u2019re not effective. Without a clinical trial, and drugs that do no good \u2013 or, worse, outright harm \u2013 would continue to endanger patients as surely as did charms and bloodletting back before empirical medicine.<\/p>\n

\u201cWe have to balance between going fast and still having high-quality data that\u2019s going to answer a question for us,\u201d Flaig said. \u201cI see researchers balancing that very, very well in a way that we really haven\u2019t had to do before.\u201d<\/p>\n

Promising antiviral<\/strong><\/h3>\n

Flaig and other CU School of Medicine research leaders have established a committee to quickly review and prioritize COVID-19-related clinical-trial proposals.<\/p>\n

\u201cThe tricky part is deciding which ones we can open and should open,\u201d he said. \u201cWe want to make sure there\u2019s not so many trials that we sort of trip over each other.\u201d<\/p>\n

\"Dr.
Dr. Thomas Campbell<\/figcaption><\/figure>\n

The group has reviewed perhaps three dozen proposals; as of this writing, four are underway, with more coming soon.<\/p>\n

Dr. Thomas Campbell<\/a>, a University of Colorado School of Medicine and UCHealth infectious-disease specialist, is leading three of these studies on the Anschutz Medical Campus. Two involve Gilead Sciences\u2019 antiviral drug remdesivir, a drug originally developed for \u2013 and found to less effective than other medicines for \u2013 Ebola. But lab studies showed remdesivir to impede replication of the SARS-CoV-2 coronavirus, so two trials, each involving dozens of medical centers, quickly ramped up.<\/p>\n

One<\/a> considered hospitalized patients with severe cases of COVID-19; the other<\/a> hospitalized patients with moderate (still very sick, but not on a ventilator) disease. Campbell says 40 UCH patients have been on one or the other of these clinical trials, and that both trials are now in what\u2019s called the extension phase. That means the randomized arms are gone, and every patient is getting the drug. That\u2019s because of\u00a0preliminary results<\/a> of another trial involving the severe patients. The study shows that the hundreds of patients at 68 sites who received remdesivir infusions and ultimately recovered did so in 11 days; those who received the placebo recovered in 15 days.<\/p>\n

The results from the remdesivir trial involving moderately-ill patients have yet to be posted, Campbell says.<\/p>\n

Campbell, a virologist, and his CU School of Medicine laboratory focused on clinical trials of HIV antivirals for 15 years before he pivoted the team to studying the coronavirus two months ago.<\/p>\n

\u201cI realized we were going to be hit with a tidal wave,\u201d he said.<\/p>\n

His research group was poised to ride it. Remdesivir\u2019s mechanism \u2013 it\u2019s a nucleotide<\/a> analog that inhibits viral RNA replication and, by extension, viral replication \u2013 is similar to that of HIV antivirals. But there were marked differences, too: HIV-drug trials usually happen with outpatients who are still reasonably healthy; COVID-19 trials involve hospitalized, very sick patients.<\/p>\n

\u201cSo it\u2019s not like you could evaluate them on Monday and start them in the trial in the next week or two weeks later,\u201d Campbell said. \u201cIf they\u2019re evaluated on Monday, we try to get them treated on Monday. So it\u2019s a much faster pace of research.\u201d<\/p>\n

Campbell believes remdesivir will turn out to be a good first step in developing COVID-19 treatments.<\/p>\n

\u201cIt\u2019s probably not the last step, and maybe it\u2019s not going to turn out to be the best. But it\u2019s the first, so it gives us a foothold against the virus, and it will allow us to design and build better treatments in the future,\u201d he said.<\/p>\n

The pace of research, he says, has been remarkable. It took four years from the discovery of the AIDS virus to the first AIDS antiviral, AZT. Remdesivir was approved within about four months of the SARS-CoV-2 coronavirus being described.<\/p>\n

Quelling the storm<\/strong><\/h3>\n

The third study Campbell is leading at UCHealth is part of a 63-center<\/a> clinical trial of sarilumab, a drug developed by Regeneron Pharmaceuticals and Sanofi. Sarilumab blocks a cell receptor (IL-6) involved in the immune system\u2019s inflammatory response to infection. Many COVID-19 deaths have been caused not by the virus alone, but by collateral damage wrought by an overzealous immune response that attacks cells in the lungs and other organs. Sarilumab shows promise in quelling this \u201ccytokine storm\u201d and reducing the damage of this friendly-fire assault. Roughly equal numbers of patients have been enrolled in the sarilumab and \u00a0remdesivir trials at UCHealth, Campbell says.<\/p>\n

\"machine
A nurse from Poudre Valley Hospital who has recovered from COVID-19 gives convalescent plasma at Garth England Blood Donation Center in Fort Collins recently. Photo: Kati Blocker, UCHealth.<\/figcaption><\/figure>\n

The fourth clinical trial, led by Dr. David Beckham<\/a>, a CU School of Medicine virologist and infectious-disease specialist, is underway at multiple sites in UCHealth. That trial is testing the effects of infusing blood plasma<\/a> from someone who has recovered from the coronavirus into a current coronavirus patient. The hope is that the healed patient\u2019s antibodies will help the patient still fighting the virus. Convalescent plasma has shown to have an effect with Ebola and MERS<\/a> patients, and a small Chinese study showed promise<\/a> vis-a-vis coronavirus. At least one critically ill patient who received convalescent plasma has recovered<\/a> \u2013 anecdotal evidence, but good news nonetheless.<\/p>\n

Hydroxychloroquine is also a potential COVID-19 treatment, Campbell says. Apparent success with the antimalarial drug in a small COVID-19 trial in France elevated the drug<\/a> to political darling; subsequent studies have cast doubt on its effectiveness and raised alarm about possible heart issues<\/a> associated with its use in coronavirus patients. However, hydroxychloroquine has shown to slow coronavirus replication in the laboratory, and given the urgent need to find working COVID-19 therapies, the drug remains a research focus.<\/p>\n

Dr. Marc Moss<\/a>, a critical-care and lung specialist, is leading the UCH arm of the 43-center ORCHID<\/a> trial. The trial will monitor the drug\u2019s antiviral potency and its effects on the heart of hospitalized coronavirus patients. Dr. Adit Ginde<\/a>, emergency medicine and critical care physician, is leading the UCH arm of a multicenter trial designed to test hydroxychloroquine<\/a> on patients who aren\u2019t sick enough to be hospitalized. The ORCHID trial will start enrolling the week of May 11; Ginde\u2019s trial will soon follow..<\/p>\n

These efforts are among many laboratory- and observational-research efforts racing ahead on the Anschutz Medical Campus. They involve understanding the disease\u2019s progression in the lungs (particularly with ARDS, an area of particular expertise<\/a>), COVID-19\u2019s role in triggering dangerous blood clotting, its effect on the lungs, its impact on the heart (cardiologist Dr. Michael Bristow<\/a> is leading a major effort<\/a> here), its role in disrupting immune-system function, and more.<\/p>\n

Ambitious faculty physicians and their teams are at the heart of all these efforts, but the proximity UCH and Children\u2019s Hospital Colorado to the CU School of Medicine\u2019s research labs plays a role, too, Flaig says.<\/p>\n

\u201cIt\u2019s that back-and-forth, both intellectually and physically, that allows us to accelerate discoveries at an even faster rate,\u201d he said.<\/p>\n","protected":false},"excerpt":{"rendered":"

The tight relationship between University of Colorado School of Medicine faculty researchers and UCHealth University of Colorado Hospital (UCH) on the Anschutz Medical Campus has been fueling medical advances for more than a century. Now these institutions are working together to bring experimental therapies to patients and, they hope, beat back the coronavirus in a […]<\/p>\n","protected":false},"author":23,"featured_media":31441,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"_relevanssi_hide_post":"","_relevanssi_hide_content":"","_relevanssi_pin_for_all":"","_relevanssi_pin_keywords":"","_relevanssi_unpin_keywords":"","_relevanssi_related_keywords":"","_relevanssi_related_include_ids":"","_relevanssi_related_exclude_ids":"","_relevanssi_related_no_append":"","_relevanssi_related_not_related":"","_relevanssi_related_posts":"","_relevanssi_noindex_reason":"","footnotes":""},"categories":[5],"tags":[167,4859,4860,162,4781],"class_list":["post-31642","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-innovative-care","tag-clinical-trials","tag-coronavirus","tag-covid-19","tag-infectious-diseases","tag-research-in-health-care"],"acf":[],"yoast_head":"\nCoronavirus clinical trials focus on new treatments like convalescent 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