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Today, the National Institutes of Health filed and is opening enrollments for Phase 2 clinical trials that will compare at least 4 potential remedies for long COVID, with more clinical trials expected to verify at least seven more remedies in the coming months. Treatments will come with drugs, biologics, medical devices, and other therapies. The trials are designed to compare multiple remedies to more temporally identify which ones are effective. As part of NIH’s Researching COVID to Enhance Recovery (RECOVER) initiative, trials have been reported through the effects of other RECOVER studies over the past two years and focus on some of the symptoms described as the most distressing of other people with COVID over the long term. Through its complementary study efforts, RECOVER has positioned NIH to design and conduct trials that have the potential to provide long-term COVID patients with various symptoms with faster relief than any single test can.
“We know that when patients are suffering, we can never act fast enough,” said NIH Acting Director Lawrence A. Tabak, D. D. S. , Ph. D. “NIH is committed to a highly coordinated and scientifically rigorous technique for locating remedies that will provide relief to the millions of others living with long COVID. “
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RECOVER is a large national study program designed to understand, treat, and save the long COVID, which is characterized by long-term symptoms after infection with SARS-Cov-2, the virus that causes COVID-19. The initial step of the initiative was to launch giant observational studies at multiple sites that examined and tracked other people’s experience with COVID-19 to find out why some people develop long-term symptoms while others recover completely. These studies are ongoing and have enrolled more than 24,000 participants to date. Researchers are also analyzing 60 million electronic physical activity records and conducting more than 40 pathobiological studies on how COVID-19 affects other tissues and organs in the body. The knowledge gathered through those efforts has helped shape the progression of phase 2 clinical trials, which verify the protection and efficacy of remedies usually in teams of one hundred to three hundred participants.
“Hundreds of RECOVER researchers and study participants are striving to discover the biological reasons for prolonged COVID. The condition affects almost every formula in the picture and has more than two hundred symptoms,” said Walter J. Koroshetz, M. D. , director. of the NIH National Institute of Neurological Disorders and Stroke, and co-director of the RECOVER initiative. “Recognizing that more than one solution is likely needed, we have learned from RECOVER participants to design rigorous clinical trial platforms that will identify remedies for others with other symptom groups for their functioning and well-being. “
The trials presented today will focus on viral patience and cognitive disorder “platform protocols,” a term used to describe the adaptive design of those trials.
RECOVER-VITAL will first concentrate on a remedy aimed at the patience of SARS-CoV-2, which can happen if the virus remains in the frame and prevents the immune formula from working well or damages organs. The first intervention will verify a longer dosing regimen of the antiviral PAXLOVID (nirmatrelvir and ritonavir) than that used to treat acute COVID to see if it improves symptoms in patients with prolonged COVID. PAXLOVID is provided through Pfizer, Inc. , New York City, and was recently approved for the remedy of mild to moderate COVID-19 in adults who are at the highest risk of progression to severe COVID-19, adding hospitalization or death. The first control sites have been activated and are recruiting.
RECOVER-NEURO will read about the interventions available for cognitive dysfunctions similar to the long COVID, adding brain fog, reminiscence challenges and difficulties with attention, transparent thinking and challenge solving. Interventions under this protocol will come with a web-based brain education program called BrainHQ, developed through Posit Science Corporation in San Francisco, which has been used for cognitive function; PASC-Cognitive Recovery, an online purpose control educational program, developed through Mount Sinai Health System, New York, that has been used for executive functions; and a device used for direct transcranial stimulation at home developed by Soterix Medical, Inc. , Woodbridge, New Jersey, which has been shown to promote brain activity and blood flow. Test sites are being activated.
Additional trials on the platform’s protocols that are still under review will be presented in the coming months:
RECOVER-SLEEP will evaluate interventions to find changes in sleep patterns or ability to sleep after having COVID-19. A test for hypersomnia, or excessive sleepiness during sunlight hours, will evaluate two drugs that promote wakefulness compared to the placebo control. The moment trial on sleep disorders, such as sleep or sleep disorders, will evaluate other interventions designed for sleep quality to see if those interventions can help regulate sleep patterns in adults with long COVID.
RECOVER-AUTONOMIC will read about interventions to help treat symptoms related to disorders with the autonomic nerve formula, which controls a diversity of physical functions, adding central frequency activity, breathing and digestive formula. The initial trial will focus on postural orthostatic tachycardia syndrome (POTS), a disorder with a number of symptoms, which add abnormal central beats, dizziness and fatigue, and will come with several study groups. The first group will compare a remedy used for immune diseases with a placebo. The group will compare a drug recently used to treat chronic central failure in other people with a higher central rate compared to placebo. Participants in each arm will then be randomly assigned to receive broader coordinated care that does not involve additional medication or the same previous care.
A fifth-platform protocol, focusing on exercise intolerance and fatigue, is being developed with input from the patient network and clinical experts.
All trials are designed to push, separately and together, identity and effective remedies for some of the most debilitating symptoms of long-term COVID. May 2022 RFP.
“Clinical trials to verify effective remedies and interventions are a central component of the whole-of-government response to the long COVID,” Adm said. Rachel L. Levine, MD, Assistant Secretary for Health, Health and Human Services Decomponent. Together with good enough supports and services, medical care, and up-to-date data on what we know about the long COVID, we can work to bring relief to the hardest-hit individuals and families.
RECOVER is committed to recruiting an inclusive exam population that is representative of the communities most affected by the long-term COVID. Study sites will partner with local communities to raise awareness of the long-term COVID and provide opportunities to participate in RECOVER clinical trials. The researchers evolved the trials with extensive feedback from patient representatives, experts in the fields of symptoms and proposed interventions, and after reviewing a host of proposals.
A Data and Safety Monitoring Committee composed of an independent panel of experts will monitor the protection of trial participants and make recommendations.
“Our patient and network representatives have provided critical data to help us make sure the effects of those trials are applicable to others across the country and are available as soon as possible,” said Kanecia Zimmerman, M. D. , Ph. D. , M. P. H. , Principal Investigator of the RECOVER Clinical Trials Data Coordination Center, Duke Clinical Research Institute, Durham, North Carolina.
Trials will continue to be initiated and participants recruited on an ongoing basis. Enrollment will take place at clinical trial sites located in the United States. The recruitment history of participants was a key criterion for site selection. These trials will stick to a classic clinical trial. Recruitment strategy in which sites will touch their patients and citizens in their local communities to enroll in trials.
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