{"id":36409,"date":"2020-12-02T08:09:27","date_gmt":"2020-12-02T15:09:27","guid":{"rendered":"https:\/\/www.uchealth.org\/today\/?p=36409"},"modified":"2025-02-28T10:58:00","modified_gmt":"2025-02-28T17:58:00","slug":"coronavirus-drug-trials-answering-big-questions","status":"publish","type":"post","link":"https:\/\/www.uchealth.org\/today\/coronavirus-drug-trials-answering-big-questions\/","title":{"rendered":"Coronavirus drug trials: Answering big questions"},"content":{"rendered":"
<\/div>

Editor’s note: For the most up-to-date COVID-19 vaccine information, please click here<\/a>.<\/strong><\/em><\/p>\n

Great news<\/a> from coronavirus vaccine clinical trials have earned a deserved spotlight over the last couple of weeks. For good reason, too: The Pfizer and Moderna, and other COVID-19 vaccines, will do much to douse the COVID-19 pandemic.<\/p>\n

\"A
Coronavirus drug trials are underway at UCHealth, with investigators working across the spectrum to prevent the disease from getting worse and improve recovery. Photo: Getty Images.<\/figcaption><\/figure>\n

Meanwhile, though, the number of people infected with the virus that causes COVID-19 skyrockets during the holiday season, and we enter a pandemic phase that looks to be taking cues from the disastrous autumn of 1918. The hard truth is that months will pass before the slow drip of vaccines finally put out this fire. In the meantime, the fruits of a different variety of clinical trials \u2013 those that test therapies to help those who have already caught the coronavirus \u2013 hold the most medical promise in limiting the worst damage.<\/p>\n

UCHealth has been hosting coronavirus therapy trials since spring. They have come in three varieties: those for outpatients, those for inpatients, and those for inpatients sick enough to be in intensive-care units.<\/p>\n

Success, discovery from coronavirus drug trials<\/strong><\/h3>\n

Dr. Adit Ginde<\/a>, a UCHealth emergency physician and vice chair for research in the Department of Emergency Medicine at CU School of Medicine, has been leading coronavirus drug trials at UCHealth even as he has been a leader in the design and conduct of clinical trials on the international stage.<\/p>\n

\"Photo
Dr. Adit Ginde<\/figcaption><\/figure>\n

\u201cWe UCHealth investigators are doing work across the spectrum \u2013 prophylaxis, outpatient, and inpatient \u2013 to prevent the disease from getting worse and improve recovery,\u201d Ginde said. \u201cOver one-third of patients have prolonged symptoms for weeks and months even if not hospitalized.\u201d<\/p>\n

Sometimes, the results aren\u2019t promising. Ginde and Dr. Marc Moss<\/a>, head of the\u00a0Division of Pulmonary Sciences and Critical Care Medicine\u00a0at the\u00a0CU School of Medicine, led UCHealth efforts on a national trial studying the impact of hydroxychloroquine on hospital inpatients. The medical community had, despite heavy political support for the drug, already recognized that COVID-19 shrugs off the repurposed antimalarial; the ORCHID study\u2019s results, published<\/a> on Nov. 9, nailed the coffin shut.<\/p>\n

\u201cThe number of articles in the peer-reviewed literature over the last several months that have consistently and convincingly demonstrated the lack of efficacy of a highly hyped \u2018cure\u2019 for COVID-19 represent the consequence of the irresponsible infusion of politics into the world of scientific evidence and discourse,\u201d wrote Dr. Michael Saag of the University of Alabama School of Medicine. \u201cFor other potential therapies or interventions for COVID-19 (or any other diseases), this should not happen again.\u201d<\/p>\n

Ginde says the study\u2019s an example of a null result doing some good.<\/p>\n

\u201cIt is very clear that hydroxychloroquine does not work,\u201d Ginde said. \u201cGiven all the publicity over the spring and summer, it\u2019s also important to provide definitive proof when treatments don\u2019t work.\u201d<\/p>\n

\"Dr.
Dr. Marc Moss<\/figcaption><\/figure>\n

Lilly\u2019s coronavirus drug joins Regeneron\u2019s monoclonal antibody \u2013 also trialed<\/a> at UCHealth, in what Ginde and others hope will be a growing pool of such drugs available to coronavirus patients. Ginde is a leader of the international Operation Warp Speed<\/a> ACTIV-3 trial, which will test another two monoclonal antibodies in early December.<\/p>\n

Convalescent plasma \u2013 blood plasma from recovered COVID-19 patients \u2013 is another study focus at UCHealth. Convalescent plasma has already received emergency-use authorization from the FDA, but it has yet to prove itself in a major clinical trial. That\u2019s happening now in two national trials, one with Emergency Department outpatients<\/a>, one inpatient<\/a>. UCHealth is participating in both, with Ginde leading these efforts locally. The inpatient trial expected to wrap up in January and the ED outpatient trial soon thereafter.<\/p>\n

Ginde is the national lead investigator of the TREAT NOW<\/a> trial enrolling outpatients at UCHealth and five other hospitals across the country. The trial is testing the antiviral drugs lopinavir and ritonavir. These drugs appear to be ineffective<\/a> with inpatients with severe COVID-19, but there\u2019s hope that it might work better with patients who aren\u2019t sick enough to be hospitalized.<\/p>\n

Quick churn<\/strong><\/h3>\n
\"A
Dr. Ellen Burnham<\/figcaption><\/figure>\n

It\u2019s tempting to believe that, the earlier in the course of COVID-19 disease a drug is taken, the more effective the drug should be. In medicine, early intervention and better outcomes usually go hand-in-hand (think cancer). But from its confounding and hijacking<\/a> of the immune system to its tendency to induce blood clotting to its strange neurological impacts, the coronavirus has vexed medical intuition. Dr. Ellen Burnham<\/a>, a CU School of Medicine pulmonary sciences and critical care medicine specialist and medical director of the medical intensive care unit at UCHealth University of Colorado Hospital<\/a> on the Anschutz Medical Campus<\/a>, says all that makes doing coronavirus clinical trials for inpatients as well as outpatients all the more important.<\/p>\n

Burnham is leading the UCHealth site of a national trial testing a rolling list of therapies for effectiveness on those sick enough to land in the ICU. Called I-SPY COVID-19<\/a>, the UCHealth patients in the trial \u2013 30 so far \u2013 are given one of four drugs on top of a standard of care including the antiviral remdesivir<\/a> and the steroid dexamethasone<\/a>.<\/p>\n

The drugs include the anti-inflammatory apremilast (used for psoriasis), the anti-inflammatory and antifibrotic cenicriviroc (HIV and liver fibrosis), icatibant (hereditary angioedema<\/a>), and razuprotafib (inflammation and reduced capillary leakage).<\/p>\n

\u201cThey\u2019re all quite different from each other,\u201d Burnham said. But, she added, they all have been shown to target mechanisms implicated in acute respiratory distress syndrome (ARDS), COVID-19\u2019s most lethal manifestation.<\/p>\n

The coronavirus drug trial is built for speed: as soon as its leaders have enough data to see if a drug seems to be helping, the candidate will graduate from I-SPY COVID-19 for closer examination in a traditional, larger trial. If a drug doesn\u2019t seem to work, it will roll back to where it came from. Burnham says the trial has five additional candidates, each vetted by national ARDS experts, waiting in the wings to backfill departures.<\/p>\n

Patients who would like to participate but don\u2019t qualify for the I-SPY COVID-19 trial\u2019s drugs still contribute to science. They may participate in an observational study where their clinical data, outcomes, and specimens are collected during inpatient hospitalization. This project will help investigators better understand the relationships between demographic and clinical factors on outcomes in COVID-19-related respiratory failure.<\/p>\n

Burnham\u2019s is one of several observational studies that have happened or are underway at UCHealth. These have considered antibodies in health care workers<\/a>, the general course of disease<\/a>, and the impacts on COVID-19 and other viral diseases we may see as the winter progresses, among others.<\/p>\n

Neither Burnham nor Ginde nor anyone else expects a silver bullet therapy to emerge before coronavirus vaccines end the pandemic. But then, nobody quite expected the vaccines to be the silver bullets they look to be. Either way, medical researchers at UCHealth and around the world will press on with their studies of coronavirus therapies. The drugs may work, and they may not. Certain is this: when it\u2019s over, their efforts will have left homesteads of empirical proof where only empty expanses of conjecture and hope had been.<\/p>\n","protected":false},"excerpt":{"rendered":"

Editor’s note: For the most up-to-date COVID-19 vaccine information, please click here. Great news from coronavirus vaccine clinical trials have earned a deserved spotlight over the last couple of weeks. For good reason, too: The Pfizer and Moderna, and other COVID-19 vaccines, will do much to douse the COVID-19 pandemic. Meanwhile, though, the number of […]<\/p>\n","protected":false},"author":23,"featured_media":34845,"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":[8],"tags":[167,4859,4860],"class_list":["post-36409","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-news","tag-clinical-trials","tag-coronavirus","tag-covid-19"],"acf":[],"yoast_head":"\nCoronavirus drug trials: Answering big questions - UCHealth Today<\/title>\n<meta name=\"description\" content=\"Great news from coronavirus drug trials have earned a deserved spotlight over the last couple of weeks, and for good reason, too.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.uchealth.org\/today\/coronavirus-drug-trials-answering-big-questions\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Coronavirus drug trials: Answering big questions\" \/>\n<meta property=\"og:description\" content=\"Great news from coronavirus drug trials have earned a deserved spotlight over the last couple of weeks, and for good reason, too.\" \/>\n<meta property=\"og:url\" content=\"https:\/\/www.uchealth.org\/today\/coronavirus-drug-trials-answering-big-questions\/\" \/>\n<meta property=\"og:site_name\" content=\"UCHealth Today\" \/>\n<meta property=\"article:publisher\" content=\"https:\/\/www.facebook.com\/uchealthorg\/\" \/>\n<meta property=\"article:published_time\" content=\"2020-12-02T15:09:27+00:00\" \/>\n<meta property=\"article:modified_time\" content=\"2025-02-28T17:58:00+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/uchealth-wp-uploads.s3.amazonaws.com\/wp-content\/uploads\/sites\/6\/2020\/10\/05115153\/GettyImages-1266494637resize.jpg\" \/>\n\t<meta property=\"og:image:type\" content=\"image\/jpeg\" \/>\n<meta name=\"author\" content=\"Todd Neff, for UCHealth\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:creator\" content=\"@uchealth\" \/>\n<meta name=\"twitter:site\" content=\"@uchealth\" \/>\n<meta name=\"twitter:label1\" content=\"Written by\" \/>\n\t<meta name=\"twitter:data1\" content=\"Todd Neff, for UCHealth\" \/>\n\t<meta name=\"twitter:label2\" content=\"Est. reading time\" \/>\n\t<meta name=\"twitter:data2\" content=\"6 minutes\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\/\/schema.org\",\"@graph\":[{\"@type\":\"Article\",\"@id\":\"https:\/\/www.uchealth.org\/today\/coronavirus-drug-trials-answering-big-questions\/#article\",\"isPartOf\":{\"@id\":\"https:\/\/www.uchealth.org\/today\/coronavirus-drug-trials-answering-big-questions\/\"},\"author\":{\"name\":\"Todd Neff, for UCHealth\",\"@id\":\"https:\/\/www.uchealth.org\/today\/#\/schema\/person\/da7733ff5562e48e55c027d111ee5911\"},\"headline\":\"Coronavirus drug trials: Answering big questions\",\"datePublished\":\"2020-12-02T15:09:27+00:00\",\"dateModified\":\"2025-02-28T17:58:00+00:00\",\"mainEntityOfPage\":{\"@id\":\"https:\/\/www.uchealth.org\/today\/coronavirus-drug-trials-answering-big-questions\/\"},\"wordCount\":1243,\"publisher\":{\"@id\":\"https:\/\/www.uchealth.org\/today\/#organization\"},\"image\":{\"@id\":\"https:\/\/www.uchealth.org\/today\/coronavirus-drug-trials-answering-big-questions\/#primaryimage\"},\"thumbnailUrl\":\"https:\/\/uchealth-wp-uploads.s3.amazonaws.com\/wp-content\/uploads\/sites\/6\/2020\/10\/05115153\/GettyImages-1266494637resize.webp\",\"keywords\":[\"Clinical trials\",\"coronavirus\",\"COVID-19\"],\"articleSection\":[\"News\"],\"inLanguage\":\"en-US\"},{\"@type\":\"WebPage\",\"@id\":\"https:\/\/www.uchealth.org\/today\/coronavirus-drug-trials-answering-big-questions\/\",\"url\":\"https:\/\/www.uchealth.org\/today\/coronavirus-drug-trials-answering-big-questions\/\",\"name\":\"Coronavirus drug trials: Answering big questions - 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