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NIH clinical trial of remdesivir to treat COVID-19 begins
NIH ^ | February 25, 2020

Posted on 02/26/2020 5:30:28 AM PST by nuconvert

Study enrolling hospitalized adults with COVID-19 in Nebraska

A randomized, controlled clinical trial to evaluate the safety and efficacy of the investigational antiviral remdesivir in hospitalized adults diagnosed with coronavirus disease 2019 (COVID-19) has begun at the University of Nebraska Medical Center (UNMC) in Omaha. The trial regulatory sponsor is the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health. This is the first clinical trial in the United States to evaluate an experimental treatment for COVID-19, the respiratory disease first detected in December 2019 in Wuhan, Hubei Province, China.

The first trial participant is an American who was repatriated after being quarantined on the Diamond Princess cruise ship that docked in Yokohama, Japan and volunteered to participate in the study. The study can be adapted to evaluate additional investigative treatments and to enroll participants at other sites in the U.S. and worldwide.

There are no specific therapeutics approved by the Food and Drug Administration (FDA) to treat people with COVID-19, the disease caused by the newly emergent SARS-CoV-2 virus (formerly known as 2019-nCoV). Infection can cause mild to severe respiratory illness, and symptoms can include fever, cough and shortness of breath. As of February 24, the World Health Organization (WHO) has reported 77,262 confirmed cases of COVID-19 and 2,595 deaths in China and 2,069 cases of COVID-19 and 23 deaths in 29 other countries. There have been 14 confirmed COVID-19 cases reported in the United States and an additional 39 cases among persons repatriated to the United States, according to the Centers for Disease Control and Prevention (CDC).

Remdesivir, developed by Gilead Sciences Inc., is an investigational broad-spectrum antiviral treatment. It was previously tested in humans with Ebola virus disease and has shown promise in animal models for treating Middle East respiratory syndrome (MERS) and severe acute respiratory syndrome (SARS), which are caused by other coronaviruses.

“We urgently need a safe and effective treatment for COVID-19. Although remdesivir has been administered to some patients with COVID-19, we do not have solid data to indicate it can improve clinical outcomes,” said NIAID Director and U.S. Coronavirus Task Force member Anthony S. Fauci, M.D. “A randomized, placebo-controlled trial is the gold standard for determining if an experimental treatment can benefit patients.”

Clinical trials of remdesivir are also ongoing in China. NIAID developed the current study taking those designs into account, and in accordance with consultations convened by the WHO on the development of a therapeutic trial for patients with COVID-19.

(con't at link)


TOPICS: Culture/Society; Extended News; Government; News/Current Events
KEYWORDS: 2019ncov; antiviral; chloroquine; coronavirus; covid19; medicine; remdesivir

1 posted on 02/26/2020 5:30:28 AM PST by nuconvert
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To: nuconvert

And when did COVID-19 infected patients make their way to Nebraska?


2 posted on 02/26/2020 6:02:46 AM PST by DAC21 ( and Naflet)
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To: nuconvert

May the force be with them.


3 posted on 02/26/2020 6:11:22 AM PST by crusty old prospector
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To: DAC21

>>>And when did COVID-19 infected patients make their way to Nebraska?<<<

As dicussed on several threads, here...back on Feb 17th....arriving via Travis AFB and Lackland AFB (CA and TX), from the Diamond Princess cruise ship.

More info, for you, here...

https://www.ketv.com/article/potential-coronavirus-patients-quarantined-on-cruise-ship-brought-to-omaha-diamond-princess/30963793#


4 posted on 02/26/2020 6:15:50 AM PST by Jane Long (Praise God, from whom ALL blessings flow.cuase)
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To: nuconvert
Smart move. Repatriating folks from the cruise ship gave them a cohort of infected folks to study. Placed them in a center designed for such study and now testing to see if this most promising of pre-existing drugs really works. They may not be typical 'volunteers' but in their circumstances I'd sign on for the chance. We already had decent safety data on it. Saves us from knowing whether to trust Chicom data. If it works I bet Trump can gear up supplies better than Chicoms can speed build hospitals. Even with Rosenstein's sister running the CDC.

Only weird part of this for me is the location—I did my internship there and never dreamed The Andromeda Strain would be approximated in my old stomping grounds. Not that this bug is nearly as scary as the book's.

5 posted on 02/26/2020 6:32:52 AM PST by JohnBovenmyer (waiting fo the tweets to hatch)
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To: DAC21

They also invited Ebola patients here a few years ago.

I read they are testing a promising treatment which they are testing on patients now.

https://www.freerepublic.com/focus/f-news/3819599/posts


6 posted on 02/26/2020 7:04:33 AM PST by Linda Frances (Woe to those who call evil good and good evil, who put darkness for light and light for darkness.)
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