NIH Launches Clinical Trial for Hydroxychloroquine

MedPage Today

Health Editor’s Note: A clinical trial of hydrocychloroquine has been launched to evaluate its potential therapeutic affect on COVID-19. On February 25, a clinical trial for Remdesivir began. Remdesivir is a broad-spectrum antiviral treatment that was previously used in humans with Ebola virus disease and has shown potential for treating MERS and SARS which are two more coronaviruses. While these drugs have been used, more information needs to be collected so they are used to their full potential and in such a way that patients are not harmed. COVID-19 presents a great medical unknown and this virus is claiming lives every day…..Carol

NIH clinical trial of hydroxychloroquine, a potential therapy for COVID-19, begins

by National Institutes of Health

A clinical trial to evaluate the safety and effectiveness of hydroxychloroquine for the treatment of adults hospitalized with coronavirus disease 2019 (COVID-19) has begun, with the first participants now enrolled in Tennessee.

The Outcomes Related to COVID-19 treated with hydroxychloroquine among In-patients with symptomatic Disease study, or ORCHID Study, is being conducted by the Prevention and Early Treatment of Acute Lung Injury (PETAL) Clinical Trials Network of the National Heart, Lung, and Blood Institute (NHLBI), part of the National Institutes of Health.

The first participants have enrolled in the trial at Vanderbilt University Medical Center, Nashville, one of dozens of centers in the PETAL Network. The blinded, placebo-controlled randomized clinical trial aims to enroll more than 500 adults who are currently hospitalized with COVID-19 or in an emergency department with anticipated hospitalization. All participants in the study will continue to receive clinical care as indicated for their condition.  Those randomized to the experimental intervention will also receive hydroxychloroquine.

“Effective therapies for COVID-19 are urgently needed,” said James P. Kiley, director, Division of Lung Diseases, NHLBI.  “Hydroxychloroquine has showed promise in a lab setting against SARS-CoV-2, the virus that causes COVID-19 and preliminary reports suggest potential efficacy in small studies with patients. However, we really need clinical trial data to determine whether hydroxychloroquine is effective and safe in treating COVID-19.”

While COVID-19 usually presents as an acute respiratory infectious illness, it can damage multiple organ systems, including heart, lung, and blood. Most adults with COVID-19 experience fever, cough, and fatigue and then recover within one to three weeks. However, some develop severe illness, typically manifesting as pneumonia and respiratory failure, with continued progression to acute respiratory distress syndrome and death. Currently, no therapies have been demonstrated to prevent the progression of COVID-19 to severe illness, but several medicines available in the United States have been proposed as potential therapies.

Hydroxychloroquine is used to treat malaria and rheumatoid conditions such as arthritis.  In various studies, the drug has demonstrated antiviral activity, an ability to modify the activity of the immune system, and has an established safety profile at appropriate doses, leading to the hypothesis that it may also be useful in the treatment of COVID-19. The drug is not without risks as even short term use can cause cardiac arrythmias, seizures, dermatological reactions, and hypoglycemia.

“Many U.S. hospitals are currently using hydroxychloroquine as first-line therapy for hospitalized patients with COVID-19 despite extremely limited clinical data supporting its effectiveness,” said Wesley Self, M.D., M.P.H., emergency medicine physician at Vanderbilt University Medical Center and PETAL Clinical Trials Network investigator leading the ORCHID trial.  “Thus, data on hydroxychloroquine for the treatment of COVID-19 are urgently needed to inform clinical practice.”

COVID-19 cases were first identified in December 2019 in Wuhan, Hubei Province, China. As of April 8, 2020, the World Health Organization (WHO) has reported more than 1.3 million cases of COVID-19 and more than 79,000 deaths worldwide, and the Centers for Disease Control and Prevention has reported more than 395,000 confirmed COVID-19 cases and 12,700 deaths in the United States.

ORCHID participants will be randomly assigned to receive hydroxychloroquine 400 mg twice daily for two doses (day one), then 200 mg twice daily for the subsequent eight doses (days two to five) or a placebo twice daily for five days.

NIH also recently launched a trial to study Remdesivir as a possible treatment for COVID-19. That clinical trial is sponsored by the National Institute of Allergy and Infectious Diseases (NIAID) [NCT04280705]. These two trials will provide data on the effectiveness and safety of each agent versus placebo in the urgent race to find effective therapies for treating COVID-19.

For more information about the study, visit ClinicalTrials.gov and search identifier NCT04332991.

About the National Heart, Lung, and Blood Institute (NHLBI): NHLBI is the global leader in conducting and supporting research in heart, lung, and blood diseases and sleep disorders that advances scientific knowledge, improves public health, and saves lives. For more information, visit www.nhlbi.nih.gov.

About the National Institutes of Health (NIH): 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 www.nih.gov.

Biography

Carol graduated from Riverside White Cross School of Nursing in Columbus, Ohio and received her diploma as a registered nurse. She attended Bowling Green State University where she received a Bachelor of Arts Degree in History and Literature. She attended the University of Toledo, College of Nursing, and received a Master’s of Nursing Science Degree as an Educator.

She has traveled extensively, is a photographer, and writes on medical issues. Carol has three children RJ, Katherine, and Stephen – two daughters-in-law; Suzy and Katie – two granddaughters; Isabella Marianna and Zoe Olivia – and one grandson, Alexander Paul. She also shares her life with husband Gordon Duff, many cats, and two rescue pups.

Carol’s Archives 2009-2013

Source Article from https://www.veteranstoday.com/2020/04/09/nih-launches-clinical-trial-for-hydroxychloroquine/

Related Posts
THE TRIAL: REGINA V ROY ARTHUR TOPHAM

Editor’s Note: With the exception of the final Charge to the Jury by Read more

Likud ministers at his side, Netanyahu asserts the entire right is on trial

Speaking to the cameras moments before entering the Jerusalem District Court room in which he Read more

As his trial begins, Netanyahu rails against ‘attempted political coup’

Prime Minister Benjamin Netanyahu on Sunday appeared in court for the start of his corruption Read more

Netanyahu says he has been framed as corruption trial starts

Benjamin Netanyahu professed his innocence at the start of his corruption trial Read more

Hits: 19

You can leave a response, or trackback from your own site.

Leave a Reply


The maximum upload file size: 100 MB.
You can upload: image, audio, video, document, spreadsheet, interactive, other.
Links to YouTube, Facebook, Twitter and other services inserted in the comment text will be automatically embedded.

*

Powered by WordPress | Designed by: Premium WordPress Themes | Thanks to Themes Gallery, Bromoney and Wordpress Themes