The National Institutes of Health (NIH) will launch clinical trials to investigate potential treatments for long-term symptoms after COVID-19 infection, including sleep disturbances, exercise intolerance and the worsening of symptoms following physical or mental exertion known as post-exertional malaise (PEM).
The mid-stage trials, part of NIH’s Researching COVID to Enhance Recovery (RECOVER) Initiative, will join six other RECOVER studies currently enrolling participants across the United States testing treatments to address viral persistence, neurological symptoms, including cognitive dysfunction (like brain fog) and autonomic nervous system dysfunction. The new trials will enroll approximately 1,660 people across 50 study sites to investigate potential treatments for some of the most frequent and burdensome symptoms reported by people suffering from long COVID.
RECOVER-SLEEP clinical trials will soon begin enrolling participants and include:
- A trial to test two drugs (modafinil and solriamfetol) approved by the Food and Drug Administration to treat people who have problems staying awake during the day, known as hypersomnia. These medications are well-known but have not been studied widely in people with long COVID. Participants will be randomly assigned to receive either the active study drug or a placebo control for eight to 10 weeks, depending on the assigned study drug.
- A trial to test potential treatments for complex sleep disturbances due to long COVID, including melatonin, an over-the-counter supplement commonly used to treat people with sleep disorders and general insomnia; and light therapy, which is used to help people reset their sleep cycles. Participants will be randomly assigned to receive either melatonin or a placebo control, and either high-intensity (active) light therapy or low-intensity (placebo) light therapy for eight weeks.
RECOVER-ENERGIZE clinical trials will soon begin enrolling participants and include:
- A trial to test a program that combines exercise training, strength and flexibility training, education, and social support, collectively known as personalized cardiopulmonary rehabilitation. The program is designed to help people who experience exercise intolerance with symptoms such as shortness of breath and fatigue during exercise after having COVID-19. All participants in RECOVER-ENERGIZE trials will be screened for PEM. Participants who are identified as having PEM, via a validated PEM questionnaire, will not be included in this trial. Participants will be randomly assigned to receive either personalized cardiopulmonary rehabilitation or basic exercise education for three months.
- A trial to test a program known as structured pacing, which is designed to help participants with PEM identify, control, and minimize symptoms that developed after having COVID-19 by regulating or pacing their daily activities. Currently, structured pacing is the only intervention used to treat PEM. The trial will not include any exercise training or physical movement to protect participants from developing worsened symptoms of PEM. Participants will be randomly assigned to receive either structured pacing with a trained coach or basic PEM education for three months.