NIH clinical trial of hydroxychloroquine, a potential therapy for COVID-19, begins
Source: National Institutes of Health
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Thursday, April 9, 2020
NIH clinical trial of hydroxychloroquine, a potential therapy for COVID-19, begins
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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.
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Read more: https://www.nih.gov/news-events/news-releases/nih-clinical-trial-hydroxychloroquine-potential-therapy-covid-19-begins
bucolic_frolic
(43,173 posts)and no longer need oxygen
Response to bucolic_frolic (Reply #1)
redstatebluegirl This message was self-deleted by its author.
bucolic_frolic
(43,173 posts)do not require screening or palpitations
iluvtennis
(19,861 posts)bucolic_frolic
(43,173 posts)thanks!
old guy
(3,283 posts)ananda
(28,864 posts)I guess they picked a state where people were more
ignorant and willing to be tested.
Sheesh
MadLinguist
(790 posts)the enrollment doesn't necessarily even rely on the local population
AC_Mem
(1,979 posts)I have a "gut feeling" that this is not the "cure" that they are hoping it will be. I'm glad they are doing clinical trials on it. Are they using it on people who have the virus with symptoms?
I wish nothing more than the discovery of a cure, but I don't think this is it. I hope I am wrong.
AC
Steelrolled
(2,022 posts)I prefer to let scientific methods determine how effective it is, not politics.
Nitram
(22,803 posts)for COVID-19 is to run a clinical double-blind trial. As for the possible side-effects, millions of people have taken the drug for malaria without suffering ill effects. If a test proved it can help prevent COVID-19 from leading to acute respiratory distress syndrome I wouldn't think twice about taking it if I caught the virus. I took chloroquine for 2 years to prevent and treat malaria when I was in the Peace Corps in West Africa. I didn't suffer any side-effects, but I knew people who said they had. No one died from the drug.
Sapient Donkey
(1,568 posts)I thought they were using it as a last resort sort of thing for patients who would die otherwise.
*somewhat of an answer to my own question https://www.nbcnews.com/health/health-news/no-miraculous-recovery-some-icu-doctors-say-hydroxychloroquine-isn-t-n1177556
Aussie105
(5,401 posts)Trump said it works, what more do you need?
/sarcasm
csziggy
(34,136 posts)By Hannah Osborne On 4/8/20 at 9:43 AM EDT
A hospital in France has had to stop an experimental treatment using hydroxychloroquine on at least one coronavirus patient after it became a "major risk" to their cardiac health.
The University Hospital Center of Nice (CHU de Nice) is one of many hospitals trialing hydroxychloroquine in COVID-19 patients. It announced it had been selected for the trial on March 22. A statement from the hospital said it was testing four experimental treatments, one of which included hydroxychloroquine. It hoped to establish its effectiveness and side effects of this and the other treatments being tested.
In an interview with the French daily newspaper Nice-Matin, Professor Émile Ferrari, the head of the cardiology department at the Pasteur hospital in Nice, said the side effects had already been identified, with some patients having to stop treatment because of the risk posed.
He said electrocardiogram recordings of patients involved with the trial were being constantly monitored. An ECG measures electrical activity in the heart, and represents this on a graph as a QT interval. Ferrari said these recordings are interpreted and, if anomalies are reported, treatment is stopped.
Asked if this had happened yet, he said: "Yes, from the start of the trial. Thanks to this ECG follow-up, we highlighted the major risks of a very serious accident in a patient, and the treatment was immediately stopped."
More: https://www.newsweek.com/hydroxychloroquine-coronavirus-france-heart-cardiac-1496810