438 lines
38 KiB
Text
438 lines
38 KiB
Text
<!DOCTYPE html>
|
||
<html lang="en" dir="ltr" prefix="og: https://ogp.me/ns#">
|
||
<head>
|
||
<meta charset="utf-8" />
|
||
<meta name="description" content="As part of the ACTIV initiative, NIH launched a clinical trial to evaluate the efficacy of three immune modulator drugs in hospitalized adults with COVID-19." />
|
||
<meta name="keywords" content="COVID-19, SARS-CoV-2, clinical trials, ACTIV, CTSA Program, immune modulator, drug development, ACTIV-1 Immune Modulators" />
|
||
<link rel="canonical" href="http://ncats.nih.gov/news-events/news/nih-begins-large-clinical-trial-to-test-immune-modulators-for-treatment-of-covid-19" />
|
||
<meta name="google" content="PROqkJCbtNawPO29xzL4ENjcb0_EckySw96i97QXx8s" />
|
||
<meta name="google-site-verification" content="PROqkJCbtNawPO29xzL4ENjcb0_EckySw96i97QXx8s" />
|
||
<meta name="Generator" content="Drupal 10 (https://www.drupal.org)" />
|
||
<meta name="MobileOptimized" content="width" />
|
||
<meta name="HandheldFriendly" content="true" />
|
||
<meta name="viewport" content="width=device-width, initial-scale=1.0" />
|
||
<link rel="icon" href="/themes/custom/d9_subtheme/assets/images/favicon.ico" type="image/vnd.microsoft.icon" />
|
||
|
||
<title>NIH Begins Large Clinical Trial to Test Immune Modulators for Treatment of COVID-19 | National Center for Advancing Translational Sciences</title>
|
||
<link rel="stylesheet" media="all" href="/libraries/drupal-superfish/css/superfish.css?srmo5o" />
|
||
<link rel="stylesheet" media="all" href="/core/modules/system/css/components/ajax-progress.module.css?srmo5o" />
|
||
<link rel="stylesheet" media="all" href="/core/modules/system/css/components/align.module.css?srmo5o" />
|
||
<link rel="stylesheet" media="all" href="/core/modules/system/css/components/autocomplete-loading.module.css?srmo5o" />
|
||
<link rel="stylesheet" media="all" href="/core/modules/system/css/components/fieldgroup.module.css?srmo5o" />
|
||
<link rel="stylesheet" media="all" href="/core/modules/system/css/components/container-inline.module.css?srmo5o" />
|
||
<link rel="stylesheet" media="all" href="/core/modules/system/css/components/clearfix.module.css?srmo5o" />
|
||
<link rel="stylesheet" media="all" href="/core/modules/system/css/components/details.module.css?srmo5o" />
|
||
<link rel="stylesheet" media="all" href="/core/modules/system/css/components/hidden.module.css?srmo5o" />
|
||
<link rel="stylesheet" media="all" href="/core/modules/system/css/components/item-list.module.css?srmo5o" />
|
||
<link rel="stylesheet" media="all" href="/core/modules/system/css/components/js.module.css?srmo5o" />
|
||
<link rel="stylesheet" media="all" href="/core/modules/system/css/components/nowrap.module.css?srmo5o" />
|
||
<link rel="stylesheet" media="all" href="/core/modules/system/css/components/position-container.module.css?srmo5o" />
|
||
<link rel="stylesheet" media="all" href="/core/modules/system/css/components/progress.module.css?srmo5o" />
|
||
<link rel="stylesheet" media="all" href="/core/modules/system/css/components/reset-appearance.module.css?srmo5o" />
|
||
<link rel="stylesheet" media="all" href="/core/modules/system/css/components/resize.module.css?srmo5o" />
|
||
<link rel="stylesheet" media="all" href="/core/modules/system/css/components/sticky-header.module.css?srmo5o" />
|
||
<link rel="stylesheet" media="all" href="/core/modules/system/css/components/system-status-counter.css?srmo5o" />
|
||
<link rel="stylesheet" media="all" href="/core/modules/system/css/components/system-status-report-counters.css?srmo5o" />
|
||
<link rel="stylesheet" media="all" href="/core/modules/system/css/components/system-status-report-general-info.css?srmo5o" />
|
||
<link rel="stylesheet" media="all" href="/core/modules/system/css/components/tabledrag.module.css?srmo5o" />
|
||
<link rel="stylesheet" media="all" href="/core/modules/system/css/components/tablesort.module.css?srmo5o" />
|
||
<link rel="stylesheet" media="all" href="/core/modules/system/css/components/tree-child.module.css?srmo5o" />
|
||
<link rel="stylesheet" media="all" href="/modules/contrib/extlink/extlink.css?srmo5o" />
|
||
<link rel="stylesheet" media="all" href="/core/modules/layout_discovery/layouts/onecol/onecol.css?srmo5o" />
|
||
<link rel="stylesheet" media="all" href="https://cdn.jsdelivr.net/npm/@uswds/uswds@3.3.0/dist/css/uswds.min.css" />
|
||
<link rel="stylesheet" media="all" href="https://cdn.jsdelivr.net/npm/bootstrap@5.0.2/dist/css/bootstrap.min.css" />
|
||
<link rel="stylesheet" media="all" href="https://cdn.jsdelivr.net/npm/bootstrap-icons@1.11.1/font/bootstrap-icons.css" />
|
||
<link rel="stylesheet" media="all" href="/themes/custom/d9_subtheme/css/styles.css?srmo5o" />
|
||
|
||
<script src="https://dap.digitalgov.gov/Universal-Federated-Analytics-Min.js?agency=HHS&subagency=NIH" id="_fed_an_ua_tag" async type="text/javascript"></script>
|
||
|
||
</head>
|
||
<body class="path-node page-node-type-level3">
|
||
<a href="#main-content" class="usa-sr-only focusable">
|
||
Skip to main content
|
||
</a>
|
||
<noscript><iframe src="https://www.googletagmanager.com/ns.html?id=GTM-55CGV66V"
|
||
height="0" width="0" style="display:none;visibility:hidden"></iframe></noscript>
|
||
|
||
<div class="dialog-off-canvas-main-canvas" data-off-canvas-main-canvas>
|
||
|
||
<section class="navigation-top">
|
||
<div class="container">
|
||
<div class="row">
|
||
<div class="col-12">
|
||
<div class="link-small d-flex">
|
||
|
||
<a href="http://www.hhs.gov/" title="Go to the hhs.gov" class="" target="_blank">
|
||
<img src="/sites/default/files/2023-10/hhs-white.png" alt="HHS Logo">
|
||
<span class="d-xl-inline d-lg-inline d-none small">U.S. Department of Health & Human Services</span>
|
||
</a>
|
||
|
||
<a href="http://www.nih.gov/" title="National Institutes of Health | Homepage" class="" target="_blank">
|
||
<img src="/sites/default/files/2023-10/nih-logo.png" alt="NIH Logo">
|
||
<span class="d-xl-inline d-lg-inline d-none small">National Institutes of Health</span>
|
||
</a>
|
||
|
||
</div>
|
||
</div>
|
||
</div>
|
||
</div>
|
||
</section>
|
||
|
||
|
||
<div class="usa-overlay"></div>
|
||
|
||
<header class="usa-header usa-header--extended usa-header--extended-megamenu" id="header" role="banner">
|
||
|
||
|
||
|
||
|
||
|
||
<div class="region region-header grid-container">
|
||
<div class="grid-row grid-gap-1"><div class="desktop:grid-col-3 header-first">
|
||
<div class="usa-logo site-logo" id="logo">
|
||
|
||
<em class="usa-logo__text">
|
||
<a class="logo-img" href="/" accesskey="1" title="Home" aria-label="Home">
|
||
<img src="/themes/custom/d9_subtheme/logo.png" alt="Home" />
|
||
</a>
|
||
|
||
|
||
</em>
|
||
|
||
</div>
|
||
<div class="search-icon d-md-none"><a class="toggle-search" href="#"><i class="bi bi-search"></i></a></div>
|
||
|
||
</div><div class="desktop:grid-col-7">
|
||
<div id="block-navigation" class="block block-superfish block-superfishnavigation">
|
||
|
||
|
||
|
||
<ul id="superfish-navigation" class="menu sf-menu sf-navigation sf-horizontal sf-style-none">
|
||
|
||
<li id="navigation-menu-link-contentaed842ec-f581-4cea-b0b0-4a85c50def86" class="sf-depth-1 menuparent"><a href="/research" class="sf-depth-1 menuparent">Research</a><ul><li id="navigation-menu-link-content5a3b6aac-7ae9-45d7-929f-fbf776db20f0" class="sf-depth-2 sf-no-children"><a href="/research/overview" class="sf-depth-2">Research Overview</a></li><li id="navigation-menu-link-contentd0507d8b-7b88-453c-908a-2b7e961c0479" class="sf-depth-2 sf-no-children"><a href="/research/our-impact" class="sf-depth-2">Our Impact</a></li><li id="navigation-menu-link-contented530d1e-2ec3-46db-a529-9029be3f3fb4" class="sf-depth-2 sf-no-children"><a href="/research/research-activities" class="sf-depth-2">Research Activities</a></li><li id="navigation-menu-link-content2dac8545-38f2-47c0-8993-ea0cae65e123" class="sf-depth-2 sf-no-children"><a href="/research/research-resources" class="sf-depth-2">Research Resources</a></li><li id="navigation-menu-link-content311ec98e-6232-4e22-9966-4a9ac796870a" class="sf-depth-2 sf-no-children"><a href="/research/training-education" class="sf-depth-2">Training & Education</a></li><li id="navigation-menu-link-content52b1ba41-94ea-4d84-9db7-7482b8f78f16" class="sf-depth-2 sf-no-children"><a href="/research/alliances" class="sf-depth-2">Alliances</a></li><li id="navigation-menu-link-contenta185af75-90a5-4cc4-813f-ef66f35e21ea" class="sf-depth-2 sf-no-children"><a href="/research/collaborate-with-ncats" class="sf-depth-2">Collaborate With NCATS</a></li></ul></li><li id="navigation-menu-link-content84a3cc1f-203d-4de6-ab26-d80c256b96dc" class="sf-depth-1 menuparent"><a href="/funding" class="sf-depth-1 menuparent">Funding</a><ul><li id="navigation-menu-link-content0a09bed2-3d99-4faf-b3c5-fc9a4878629a" class="sf-depth-2 sf-no-children"><a href="/funding/overview" class="sf-depth-2">Funding Overview</a></li><li id="navigation-menu-link-contentd85a1f38-7893-4e4a-8514-5b9e767983e2" class="sf-depth-2 sf-no-children"><a href="/funding/funding-opportunities" class="sf-depth-2">Open Funding Opportunities</a></li><li id="navigation-menu-link-content81e84c00-ef73-4aff-a15f-7728cc398801" class="sf-depth-2 sf-no-children"><a href="/funding/small-business-programs" class="sf-depth-2">Small Business Programs</a></li><li id="navigation-menu-link-content631a166b-650b-450f-97b4-9014d14935e9" class="sf-depth-2 sf-no-children"><a href="/funding/funding-policy-operating-guidelines" class="sf-depth-2">Funding Policy & Operating Guidelines</a></li><li id="navigation-menu-link-content5d56ebe7-b3e8-452a-bd30-df92b0deabef" class="sf-depth-2 sf-no-children"><a href="/funding/grant-information" class="sf-depth-2">Grant Information</a></li><li id="navigation-menu-link-content4429fdc9-e911-4022-b3dc-3f6a4980b9ff" class="sf-depth-2 sf-no-children"><a href="/funding/challenges" class="sf-depth-2">Challenges and Prize Competitions</a></li><li id="navigation-menu-link-content943fe682-94ff-4fcf-a6b0-32096d2b2d0e" class="sf-depth-2 sf-no-children"><a href="/funding/scientific-review" class="sf-depth-2">Scientific Review</a></li><li id="navigation-menu-link-content10496705-320e-4437-b2ba-ea2830b293d1" class="sf-depth-2 sf-no-children"><a href="/funding/conference-grant-information" class="sf-depth-2">Conference Grant Information</a></li></ul></li><li id="navigation-menu-link-contentea91f2ef-1b8d-4b1c-83e7-5830769dd505" class="sf-depth-1 menuparent"><a href="/resources" class="sf-depth-1 menuparent">Resources For You</a><ul><li id="navigation-menu-link-content567e64e3-685d-41bc-8bf4-130c7689d6a2" class="sf-depth-2 sf-no-children"><a href="/resources/overview" title="Resources for You" class="sf-depth-2">Resources for You</a></li><li id="navigation-menu-link-content786ce1f5-ff7a-463a-bb05-c01882062426" class="sf-depth-2 sf-no-children"><a href="/resources/for-researchers" title="Resources for Researchers" class="sf-depth-2">Resources for Researchers</a></li><li id="navigation-menu-link-contente737ec67-ecd0-4f18-915d-b61660cb524f" class="sf-depth-2 sf-no-children"><a href="/resources/for-trainees" title="Resources for Trainees" class="sf-depth-2">Resources for Trainees</a></li><li id="navigation-menu-link-content8812fdb6-0fb7-4b27-8401-2fc5b3f41ff1" class="sf-depth-2 sf-no-children"><a href="/resources/for-rare-disease-patients-and-advocates" title="Resources for Rare Disease Patients and Advocates" class="sf-depth-2">Resources for Rare Disease Patients and Advocates</a></li></ul></li><li id="navigation-menu-link-contenta8527040-df23-4117-a5a7-566bd83e2c7f" class="sf-depth-1 menuparent"><a href="/news-events" class="sf-depth-1 menuparent">News & Events</a><ul><li id="navigation-menu-link-contentf6836a81-a42a-4528-b569-18939d8451da" class="sf-depth-2 sf-no-children"><a href="/news-events/overview" class="sf-depth-2">News & Events Overview</a></li><li id="navigation-menu-link-content9f44edc6-e5b7-4a92-bcb3-c0a8777461f4" class="sf-depth-2 sf-no-children"><a href="/news-events/news" class="sf-depth-2">News</a></li><li id="navigation-menu-link-content402cff9f-12b7-459b-9f0f-56606930399c" class="sf-depth-2 sf-no-children"><a href="/news-events/newsletter" class="sf-depth-2">Newsletters</a></li><li id="navigation-menu-link-content6cd76cbe-053e-4e3b-8961-c9f5def57ba6" class="sf-depth-2 sf-no-children"><a href="/news-events/events" class="sf-depth-2">Events</a></li><li id="navigation-menu-link-content0a211675-2fb5-45cc-b443-c7946e7d9120" class="sf-depth-2 sf-no-children"><a href="/news-events/science-publications" class="sf-depth-2">Scientific Publications</a></li><li id="navigation-menu-link-contente6d4ed4f-826f-41b4-a9e2-728c2fb4ca62" class="sf-depth-2 sf-no-children"><a href="/news-events/multimedia" class="sf-depth-2">Multimedia</a></li></ul></li><li id="navigation-menu-link-contentf1eb1fa8-5813-433c-9bcc-dc56f2e258f3" class="sf-depth-1 menuparent"><a href="/about" class="sf-depth-1 menuparent">About NCATS</a><ul><li id="navigation-menu-link-contentada9a195-ae5a-446a-9014-c1232164e6db" class="sf-depth-2 sf-no-children"><a href="/about/ncats-overview" class="sf-depth-2">NCATS Overview</a></li><li id="navigation-menu-link-contentd5e0369a-aded-4348-84f7-463c64498447" class="sf-depth-2 sf-no-children"><a href="/about/about-translational-science" class="sf-depth-2">About Translational Science</a></li><li id="navigation-menu-link-contente298b7b2-724e-408b-9bb9-afcaac57a751" class="sf-depth-2 sf-no-children"><a href="/about/advisory-committees" class="sf-depth-2">Advisory Committees</a></li><li id="navigation-menu-link-contentbc9c91b7-8d3d-4d2c-af65-c25ef894d269" class="sf-depth-2 sf-no-children"><a href="/about/budget" class="sf-depth-2">Budget</a></li><li id="navigation-menu-link-contenta4ed4439-05db-4a41-9357-731c2ff74543" class="sf-depth-2 sf-no-children"><a href="/about/director" class="sf-depth-2">Director's Corner</a></li><li id="navigation-menu-link-contentb50f96af-3723-4634-8566-4e60c2639491" class="sf-depth-2 sf-no-children"><a href="/about/divisions-and-offices" class="sf-depth-2">Divisions & Offices</a></li><li id="navigation-menu-link-content41d11ad4-c576-46be-a326-1f8cf5059354" class="sf-depth-2 sf-no-children"><a href="/about/our-staff" class="sf-depth-2">Our Staff</a></li></ul></li>
|
||
</ul>
|
||
|
||
</div>
|
||
</div>
|
||
<div class="desktop:grid-col-2 search-block">
|
||
<form class="usa-search usa-search--small" action="/search/node" method="get" id="search-block-form" accept-charset="UTF-8">
|
||
<div role="search">
|
||
|
||
<input class="usa-input" id="extended-search-field-small" type="search" name="keys" />
|
||
<button class="usa-button" type="submit">
|
||
<img src="/themes/custom/d9_subtheme/node_modules/@uswds/uswds/dist/img/usa-icons-bg/search--white.svg" class="usa-search__submit-icon" alt="Search">
|
||
</button>
|
||
</div>
|
||
</form>
|
||
</div></div>
|
||
</div>
|
||
|
||
|
||
<nav class="usa-nav" role="navigation">
|
||
<div class="usa-nav__inner">
|
||
|
||
<button type="button" class="usa-nav__close">
|
||
<img src="/themes/custom/d9_subtheme/node_modules/@uswds/uswds/dist/img/usa-icons/close.svg" alt="close"/>
|
||
</button>
|
||
|
||
|
||
|
||
|
||
|
||
|
||
</div>
|
||
</nav>
|
||
|
||
|
||
</header>
|
||
|
||
<main class="main-content usa-layout-docs usa-section " role="main"
|
||
id="main-content">
|
||
|
||
<div class="grid-container-">
|
||
|
||
<div class="grid-row">
|
||
|
||
</div>
|
||
|
||
<div class="">
|
||
|
||
</div>
|
||
|
||
<div class="grid-row ">
|
||
|
||
</div>
|
||
|
||
<div class="grid-row grid-gap">
|
||
|
||
<div class="usa-layout-docs__main desktop:grid-col-fill">
|
||
<div class="">
|
||
<div data-drupal-messages-fallback class="hidden"></div>
|
||
<div id="block-d9-subtheme-content" class="block block-system block-system-main-block">
|
||
|
||
|
||
<article data-history-node-id="18078">
|
||
|
||
|
||
|
||
|
||
|
||
<div>
|
||
<div class="container layout layout--onecol">
|
||
<div class="layout__region layout__region--content">
|
||
<div class="block block-system block-system-breadcrumb-block">
|
||
|
||
|
||
<nav class="usa-breadcrumb" role="navigation" aria-labelledby="system-breadcrumb">
|
||
<h2 id="system-breadcrumb" class="usa-sr-only">Breadcrumb</h2>
|
||
<ol class="usa-breadcrumb__list">
|
||
<li class="usa-breadcrumb__list-item">
|
||
<a href="/" class="usa-breadcrumb__link"><span>Home</span></a>
|
||
</li>
|
||
<li class="usa-breadcrumb__list-item">
|
||
<a href="/news-events/overview" class="usa-breadcrumb__link"><span>News & Events</span></a>
|
||
</li>
|
||
<li class="usa-breadcrumb__list-item">
|
||
<a href="/news-events/news" class="usa-breadcrumb__link"><span>News</span></a>
|
||
</li>
|
||
<li class="usa-breadcrumb__list-item">
|
||
<span>NIH Begins Large Clinical Trial To Test Immune Modulators For Treatment of COVID-19</span>
|
||
</li>
|
||
</ol>
|
||
</nav>
|
||
|
||
</div>
|
||
<div class="block block-layout-builder block-extra-field-blocknodelevel3content-moderation-control">
|
||
|
||
|
||
|
||
</div>
|
||
|
||
</div>
|
||
</div>
|
||
<div class="container layout layout--onecol">
|
||
<div class="layout__region layout__region--content">
|
||
<div class="block block-layout-builder block-field-blocknodelevel3title">
|
||
|
||
|
||
|
||
<h1 class="page-title">NIH Begins Large Clinical Trial to Test Immune Modulators for Treatment of COVID-19</h1>
|
||
|
||
</div>
|
||
<div class="block block-layout-builder block-field-blocknodelevel3body">
|
||
|
||
|
||
|
||
|
||
<div style="background-color:#E3EBED;margin:12px 0;padding:20px;"><p style="margin:0;padding:0;"><strong>UPDATE:</strong> View the <a href="/news/releases/2022/Immune-Modulator-Drugs-Improved-Survival-for-People-Hospitalized-with-COVID-19" title="June 2022 release<">June 2022 release</a> to see preliminary results of the ACTIV-1 Immune Modulators trial. Read the preprints for <a href="https://www.medrxiv.org/content/10.1101/2022.09.22.22280247v1" title="abatacept">abatacept</a> and <a href="https://www.medrxiv.org/content/10.1101/2022.09.22.22280245v2" title="infliximab">infliximab</a>.</p></div><div class="caption-right-md"><img class="img-responsive" src="/sites/default/files/C0492806-Covid-19_cytokine_storm_illustration_BLUE_900x600.jpg" alt="Illustration of a cytokine storm response to infection with the new coronavirus SARS-CoV-2." width="900" height="600"><div class="caption-text"><p>Illustration of a cytokine storm response to infection with the new coronavirus SARS-CoV-2. A cytokine storm is a severe immune reaction that results in greatly elevated levels of inflammatory immune proteins (cytokines, purple) in the body. <em>(Fernando Da Cunha/Science Photo Library)</em></p></div></div><p>October 16, 2020 </p><p>The National Institutes of Health has launched an adaptive Phase 3 clinical trial to evaluate the safety and efficacy of three immune modulator drugs in hospitalized adults with COVID-19. Some COVID-19 patients experience an immune response in which the immune system unleashes excessive amounts of proteins that trigger inflammation — called a “cytokine storm” — that can lead to acute respiratory distress syndrome, multiple organ failure and other life-threatening complications. The clinical trial aims to determine if modulating that immune response can reduce the need for ventilators and shorten hospital stays. The trial, known as ACTIV-1 Immune Modulators (IM), will determine if the therapeutics are able to restore balance to an overactive immune system.</p><p>Part of the Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV) initiative, the trial expects to enroll approximately 2,100 hospitalized adults with moderate to severe COVID-19 at medical facilities in the United States and Latin America. The National Center for Advancing Translational Sciences (NCATS), part of NIH, will coordinate and oversee the trial with funding support from the Biomedical Advanced Research and Development Authority (BARDA) of the U.S. Department of Health and Human Services Office of the Assistant Secretary for Preparedness and Response, in support of the Trump administration’s <a href="https://www.hhs.gov/about/news/2020/06/16/fact-sheet-explaining-operation-warp-speed.html" rel="noopener" title="Operation Warp Speed">Operation Warp Speed</a> goals. BARDA’s Clinical Studies Network will be responsible for operationalizing the trial through a task order awarded to contract research organization Technical Resources International, Inc.</p><p>“This is the fifth master protocol to be launched under the ACTIV partnership in an unprecedented timeframe, and focuses efforts on therapies that hold the greatest promise for treating COVID-19,” said NIH Director Francis S. Collins, M.D., Ph.D. “Immune modulators provide another treatment modality in the ACTIV therapeutic toolkit to help manage the complex, multi-system conditions that can be caused by this very serious disease.”</p><p>ACTIV-1 IM is a randomized placebo-controlled trial that uses an adaptive master protocol. One of the hallmarks of master protocols is that they allow coordinated and efficient evaluation of multiple investigational agents as they become available. This enables maximum flexibility to swiftly weed out drugs that do not demonstrate effectiveness, identify those that do in a short time frame, and rapidly incorporate additional experimental agents into the trial.</p><p>The ACTIV public-private partnership selected three agents for the study from a pool of over 130 immune modulators initially reviewed based on several factors including their relevance to COVID-19, strong evidence for use against inflammatory reaction and cytokine storm and availability for large-scale clinical studies. The initial agents are infliximab (REMICADE), developed by Janssen Research & Development, LLC., one of the Janssen Pharmaceutical Companies of Johnson & Johnson; abatacept (ORENCIA), developed by Bristol Myers Squibb; and Cenicriviroc (CVC), an investigational late-stage agent developed by AbbVie.</p><p>All participants in the trial will receive remdesivir, which is the current standard of care treatment of hospitalized patients with COVID-19. Convalescent plasma and dexamethasone will be allowed at the discretion of the site investigator and in accordance with national guidelines. They will be randomly assigned to receive a placebo or one of the immune modulators as an add-on treatment. The trial will study the different combination treatment regimens with respect to illness severity, recovery speed, mortality and hospital resource utilization. Enrollment is now open, and the trial is expected to last approximately six months. Results will be available shortly after the trial is completed, or possibly sooner if analysis conducted during the trial indicates that one or more of the drugs is beneficial. To ensure that the trial is being conducted in a safe and effective manner, an independent data and safety monitoring board will oversee the trial and conduct periodic reviews of the accumulating data.</p><p>The protocol team chair is William G. Powderly, M.D., director of the Institute for Clinical and Translational Sciences and co-director of the Division of Infectious Diseases at Washington University School of Medicine in St. Louis. NCATS’ Clinical and Translational Science Awards (CTSA) Program and the Trial Innovation Network will play a key role in adding U.S. study sites and enrolling patients, including those from communities disproportionately affected by COVID-19.</p><p>“The CTSA Program’s nimbleness and innovation in conducting clinical trials — along with the network’s extensive capacity and broad geographical reach — have positioned it to rapidly implement this important trial,” said NCATS Director Christopher P. Austin, M.D. “The innovative trial design will allow efficient evaluation of three different potential COVID-19 treatments concurrently, delivering new possible treatments for patients more quickly and valuable insights into the science of clinical translation.”</p><p>NIH <a href="https://www.nih.gov/news-events/news-releases/nih-launch-public-private-partnership-speed-covid-19-vaccine-treatment-options" rel="noopener" title="announced">announced</a> the <a href="https://www.nih.gov/research-training/medical-research-initiatives/activ" rel="noopener" title="Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV) initiative">Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV) initiative</a> in April 2020 to develop a national research response to prioritize and speed the development of the most promising COVID-19 treatments and vaccines. Coordinated by the Foundation for the National Institutes of Health, ACTIV brings together partners from government, industry, academia and non-profit organizations. Visit the ACTIV Therapeutics page.</p><p>Media Contact: NCATS Information Officer, <a href="mailto:ncatsinfo@mail.nih.gov" title="ncatsinfo@mail.nih.gov">ncatsinfo@mail.nih.gov</a></p><p><strong>About the National Center for Advancing Translational Sciences (NCATS):</strong> NCATS conducts and supports research on the science and operation of translation — the process by which interventions to improve health are developed and implemented — to allow more treatments to get to more patients more quickly. For more information about how NCATS helps shorten the journey from scientific observation to clinical intervention, visit <a href="https://ncats.nih.gov" rel="noopener" title="https://ncats.nih.gov">https://ncats.nih.gov</a>.</p><p><strong>About the National Institutes of Health (NIH):</strong> NIH, the nation’s medical research agency, includes 27 Institutes and Centers and is a component of the U.S. Department of Health and Human Services. NIH is the primary federal agency conducting and supporting basic, clinical, and translational medical research, and is investigating the causes, treatments, and cures for both common and rare diseases. For more information about NIH and its programs, visit <a href="https://www.nih.gov/" rel="noopener" title="https://www.nih.gov">https://www.nih.gov</a>.</p><p><strong>About HHS, ASPR, and BARDA:</strong> HHS works to enhance and protect the health and well-being of all Americans, providing for effective health and human services and fostering advances in medicine, public health, and social services. The mission of ASPR is to save lives and protect Americans from 21st century health security threats. Within ASPR, BARDA invests in the innovation, advanced research and development, acquisition, and manufacturing of medical countermeasures — vaccines, drugs, therapeutics, diagnostic tools, and non-pharmaceutical products needed to combat health security threats. To date, 55 BARDA-supported products have achieved FDA approval, licensure or clearance. For more on BARDA’s development portfolios and on partnering with BARDA, visit <a href="https://www.medicalcountermeasures.gov/" rel="noopener" title="medicalcountermeasures.gov">medicalcountermeasures.gov</a>. To learn more about federal public health and medical preparedness and response, visit <a href="https://www.phe.gov/" rel="noopener" title="phe.gov">phe.gov</a>.</p><p align="center"><em><strong>NIH…Turning Discovery Into Health<sup>®</sup></strong></em></p><p> </p><div class="sharethis-inline-share-buttons"> </div><p> </p>
|
||
|
||
</div>
|
||
|
||
</div>
|
||
</div>
|
||
|
||
</div>
|
||
|
||
</article>
|
||
|
||
</div>
|
||
<div id="block-footercss" class="block block-block-content block-block-content2db33373-6fb7-49c5-be2f-83266eddea39">
|
||
|
||
|
||
|
||
|
||
<style type="text/css">
|
||
ul#superfish-navigation li { line-height:1.25; }
|
||
.region-header .block-superfish ul.sf-menu li a {padding-right:40px !important;}
|
||
@media (min-width: 1200px) {
|
||
ul.sf-menu.sf-navigation li.menuparent ul {width:280px !important;}
|
||
}
|
||
.main-content article .menu--navigation {
|
||
display:flex;
|
||
flex-wrap: nowrap;
|
||
justify-content: space-between;
|
||
align-items: stretch;
|
||
}
|
||
.main-content article .menu--navigation li {
|
||
flex: 1 1 0;
|
||
width: 0;
|
||
align-items: center;
|
||
display: flex;
|
||
justify-content: center;
|
||
}
|
||
.main-content article .menu--navigation li .dropdown-toggle {
|
||
white-space: unset;
|
||
}
|
||
.image-box img,
|
||
div.col-md-4.col-lg-2 img {
|
||
height: auto;
|
||
}
|
||
.caption-left-md {
|
||
float: left;
|
||
width: 50%;
|
||
margin: 0 1% 2% 0;
|
||
border: 1px solid #ddd;
|
||
}
|
||
.caption-left-md img {
|
||
width: 100%!important;
|
||
height: auto;
|
||
}
|
||
div.block.block-layout-builder.block-field-blocknodestafffield-divisions-office {
|
||
display: none
|
||
}
|
||
@media (max-width: 992px) {
|
||
.main-content article .menu--navigation {
|
||
flex-direction:column;
|
||
}
|
||
.main-content article .menu--navigation li {
|
||
display:inline-block;
|
||
margin:0;
|
||
padding:.25rem;
|
||
width: auto;
|
||
text-align:left;
|
||
}
|
||
.main-content article .menu--navigation li:hover, .main-content article .menu--navigation li.active {
|
||
border-bottom: 4px solid transparent !important;
|
||
}
|
||
.main-content article .menu--navigation li:hover a, .main-content article .menu--navigation li.active a {
|
||
border-bottom:4px solid #00626f !important;
|
||
padding-bottom:4px;
|
||
}
|
||
}
|
||
p.last-update-container {
|
||
font-size: 15px;
|
||
font-style: italic;
|
||
}
|
||
</style>
|
||
|
||
</div>
|
||
|
||
</div>
|
||
</div>
|
||
</div>
|
||
</div>
|
||
</main>
|
||
<div>
|
||
<div id="block-d9-subtheme-lastupdateblock" class="block block-ncats-common block-last-update-block">
|
||
|
||
|
||
<div class="container"><p class="last-update-container">Last updated on January 24, 2025</p></div>
|
||
</div>
|
||
|
||
</div>
|
||
|
||
<footer class="pt-4 footer mt-4">
|
||
<div class="container">
|
||
<div class="row">
|
||
<div class="col-12 py-4">
|
||
<img src="/sites/default/files/2023-10/ncats-logo-footer.png" class="img-fluid" alt="NCATS">
|
||
</div>
|
||
</div>
|
||
|
||
<div class="row">
|
||
<div class="container">
|
||
<div class="row justify-content-between">
|
||
<div class="col-xl-4">
|
||
<div class="pt-4">
|
||
<address>
|
||
9609 Medical Center Drive<br>
|
||
Rockville, MD 20850-9793<br>
|
||
301-594-8966<br>
|
||
<a href="mailto:ncatsinfo@nih.gov">ncatsinfo@nih.gov</a>
|
||
</address>
|
||
</div>
|
||
|
||
<div class="text-white social-links mt-4">
|
||
<h5>Connect with us</h5>
|
||
<ul id="social-media-icons" class="list-unstyled d-flex mb-4">
|
||
<li><a href="http://www.facebook.com/ncats.nih.gov" title="Visit us on Facebook" target="_blank"><i class="bi bi-facebook"></i></a></li>
|
||
<li><a href="https://www.linkedin.com/company/nih-ncats" title="Visit us on LinkedIn" target="_blank"><i class="bi bi-linkedin"></i></a></li>
|
||
<li><a href="http://www.twitter.com/ncats_nih_gov" title="Visit us on X" target="_blank"><i class="bi bi-twitter-x"></i></a></li>
|
||
<li><a href="http://www.youtube.com/user/ncatsmedia" title="View our videos on YouTube" target="_blank"><i class="bi bi-youtube"></i></a></li>
|
||
<li><a href="https://www.flickr.com/photos/64860478@N05/" target="_blank" title="View our photos on Flickr"><img src="/sites/default/files/2023-10/flickr.png" alt="View our photos on Flickr" style="height:24px;"></a></li>
|
||
</ul>
|
||
<p class="small">For <a href="http://edi.nih.gov/consulting/language-access-program/about" target="_blank">language access assistance</a>, contact the <a href="mailto:ncatsinfo@nih.gov">NCATS Public Information Officer</a></p>
|
||
</div>
|
||
|
||
</div>
|
||
<div class="col-xl-3 text-white mt-5 d-lg-none d-sm-none d-none d-xl-block">
|
||
<div id="mc_embed_shell">
|
||
|
||
<div id="mc_embed_signup">
|
||
<form action="https://nih.us5.list-manage.com/subscribe/post?u=e06bd55ccbb41f1a362306dff&id=d32fa404b4&f_id=0087b1edf0" method="post" id="mc-embedded-subscribe-form" name="mc-embedded-subscribe-form" class="validate" target="_blank">
|
||
<h5>Subscribe to NCATS News</h5>
|
||
<p>If you would like to stay up to date with the latest information from us, please sign up for NCATS News.</p>
|
||
<div id="mce-responses" class="clear">
|
||
<div class="response" id="mce-error-response" style="display: none;"></div>
|
||
<div class="response" id="mce-success-response" style="display: none;"></div>
|
||
</div>
|
||
<div class="input-group mb-3">
|
||
<input type="email" name="EMAIL" class="required email form-control" id="mce-EMAIL" required="" value="" placeholder="Enter Email" aria-label="Recipient's username" aria-describedby="button-addon2" tabindex="-1">
|
||
|
||
<div aria-hidden="true" style="position: absolute; left: -5000px;"><input type="text" name="b_e06bd55ccbb41f1a362306dff_d32fa404b4" tabindex="-1" value=""></div>
|
||
<button type="submit" name="subscribe" id="mc-embedded-subscribe" class="button btn" value="Subscribe">Submit</button>
|
||
</div>
|
||
|
||
</form>
|
||
</div>
|
||
<script type="text/javascript" src="//s3.amazonaws.com/downloads.mailchimp.com/js/mc-validate.js"></script><script type="text/javascript">(function($) {window.fnames = new Array(); window.ftypes = new Array();fnames[0]='EMAIL';ftypes[0]='email';fnames[1]='FNAME';ftypes[1]='text';fnames[2]='LNAME';ftypes[2]='text';fnames[3]='SIGNUP';ftypes[3]='text';}(jQuery));var $mcj = jQuery.noConflict(true);</script></div>
|
||
|
||
</div>
|
||
</div>
|
||
</div>
|
||
</div>
|
||
|
||
</div>
|
||
<!-- footer menu section -->
|
||
|
||
<section class="footer-menu py-3 mb-xl-0 mb-lg-0 mb-sm-5 mt-4">
|
||
<div class="container">
|
||
<div class="row">
|
||
<div class="col-12">
|
||
<ul class="list-unstyled d-xl-flex d-lg-flex d-sm-block d-block justify-content-center mb-0">
|
||
<li><a href="https://ncats.nih.gov/">NCATS Home</a></li>
|
||
<li><a href="/sitemap">Site Map</a></li>
|
||
<li><a href="/privacy">Privacy Notice</a></li>
|
||
<li><a href="/comments">Comment Policy</a></li>
|
||
<li><a href="/accessibility">Accessibility</a></li>
|
||
<li><a href="/foia">FOIA</a></li>
|
||
<li><a href="http://oig.hhs.gov/" target="_blank">OIG</a></li>
|
||
<li class="border-0"><a href="https://www.hhs.gov/vulnerability-disclosure-policy/index.html" target="_blank">HHS Vulnerability Disclosure</a></li>
|
||
</ul>
|
||
</div>
|
||
</div>
|
||
</div>
|
||
</section>
|
||
</footer>
|
||
|
||
</div>
|
||
|
||
|
||
<script type="application/json" data-drupal-selector="drupal-settings-json">{"path":{"baseUrl":"\/","pathPrefix":"","currentPath":"node\/18078","currentPathIsAdmin":false,"isFront":false,"currentLanguage":"en"},"pluralDelimiter":"\u0003","suppressDeprecationErrors":true,"ajaxPageState":{"libraries":"eJx1j8EOwjAMQ3-o0DNfU2Vt1pWlzdSkbPt7OgkhQONi2c_yweHmpA06YUYLIqhiwgfCTbEWoAt02TV5MR1RKrMNtS1A11c0kTkSOoVoY5fffIU7bN8wG4Kdm7qQxPMD6265oGcy0hasY5LJvt0Zc9OxSkWx6GkvGYjEV8Ry3h-uf5V_7cKSNHFf76KY7QCCpskaxB3WjhUyrlznJ5W4glk","theme":"d9_subtheme","theme_token":null},"ajaxTrustedUrl":[],"gtm":{"tagId":null,"settings":{"data_layer":"dataLayer","include_classes":false,"allowlist_classes":"","blocklist_classes":"","include_environment":false,"environment_id":"","environment_token":""},"tagIds":["GTM-55CGV66V"]},"gtag":{"tagId":"G-ZZQ8H5G8ZX","otherIds":[],"events":[],"additionalConfigInfo":[]},"data":{"extlink":{"extTarget":true,"extTargetNoOverride":false,"extNofollow":false,"extNoreferrer":true,"extFollowNoOverride":false,"extClass":"ext","extLabel":"(link is external)","extImgClass":false,"extSubdomains":true,"extExclude":"","extInclude":"","extCssExclude":"","extCssExplicit":"","extAlert":true,"extAlertText":"You are leaving the NIH website.\r\n\r\nThis external link provides additional information that is consistent with the intended purpose of this site. NIH cannot attest to the accuracy of a non-federal site.\r\n\r\nLinking to a non-federal site does not constitute an endorsement by NIH or any of its employees of the sponsors or the information and products presented on the site. You will be subject to the destination site\u0027s privacy policy when you follow the link.","mailtoClass":"mailto","mailtoLabel":"(link sends email)","extUseFontAwesome":false,"extIconPlacement":"append","extFaLinkClasses":"fa fa-external-link","extFaMailtoClasses":"fa fa-envelope-o","whitelistedDomains":[]}},"superfish":{"superfish-navigation":{"id":"superfish-navigation","sf":{"animation":{"opacity":"show","height":"show"},"speed":"fast"},"plugins":{"smallscreen":{"mode":"window_width","accordionButton":0,"title":"Navigation"},"supposition":true,"supersubs":true}}},"user":{"uid":0,"permissionsHash":"24b2a698a72e7a44d4f2d94d9880a6ba82bfbc8b8200dee23422144335254cbc"}}</script>
|
||
<script src="/core/assets/vendor/jquery/jquery.min.js?v=3.7.1"></script>
|
||
<script src="/core/assets/vendor/once/once.min.js?v=1.0.1"></script>
|
||
<script src="/core/misc/drupalSettingsLoader.js?v=10.2.3"></script>
|
||
<script src="/core/misc/drupal.js?v=10.2.3"></script>
|
||
<script src="/core/misc/drupal.init.js?v=10.2.3"></script>
|
||
<script src="/core/assets/vendor/tabbable/index.umd.min.js?v=6.2.0"></script>
|
||
<script src="https://cdn.jsdelivr.net/npm/@uswds/uswds@3.3.0/dist/js/uswds.min.js"></script>
|
||
<script src="/core/misc/progress.js?v=10.2.3"></script>
|
||
<script src="/core/assets/vendor/loadjs/loadjs.min.js?v=4.2.0"></script>
|
||
<script src="/core/misc/debounce.js?v=10.2.3"></script>
|
||
<script src="/core/misc/announce.js?v=10.2.3"></script>
|
||
<script src="/core/misc/message.js?v=10.2.3"></script>
|
||
<script src="/core/misc/ajax.js?v=10.2.3"></script>
|
||
<script src="/themes/custom/d9_subtheme/js/script.js?v=10.2.3"></script>
|
||
<script src="/modules/contrib/extlink/extlink.js?v=10.2.3"></script>
|
||
<script src="/modules/contrib/google_tag/js/gtm.js?srmo5o"></script>
|
||
<script src="/modules/contrib/google_tag/js/gtag.js?srmo5o"></script>
|
||
<script src="/modules/contrib/google_tag/js/gtag.ajax.js?srmo5o"></script>
|
||
<script src="/libraries/drupal-superfish/superfish.js?srmo5o"></script>
|
||
<script src="/libraries/drupal-superfish/jquery.hoverIntent.minified.js?srmo5o"></script>
|
||
<script src="/libraries/drupal-superfish/sfsmallscreen.js?srmo5o"></script>
|
||
<script src="/libraries/drupal-superfish/supposition.js?srmo5o"></script>
|
||
<script src="/libraries/drupal-superfish/supersubs.js?srmo5o"></script>
|
||
<script src="/modules/contrib/superfish/js/superfish.js?v=2.0"></script>
|
||
|
||
</body>
|
||
</html>
|