Find answers to questions about RECOVER Clinical Trials
We will update these FAQs as RECOVER clinical trials begin enrolling participants.
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About RECOVER Research
- Effective treatments by ensuring results benefit people and their loved ones who are most affected by Long COVID
- Improved trust in research through meaningful participant and community connections
- Better research by providing opportunities to people to participate in impactful research now and in the future
The RECOVER phase 2 clinical trials are the next steps for the RECOVER Initiative, and will focus on small groups of participants to test potential treatments for symptoms of Long COVID. (The number of participants in RECOVER trials will vary, but a typical phase 2 trial or trial arm has between 100-300 participants.) Each person who participates in a trial will be randomized to either receive a potential treatment or an appropriate control, such as a placebo. The phase 2 trials, which assess safety and effectiveness, will test at least 11 potential treatments for Long COVID.Learn more about RECOVER clinical trials
In the observational cohort studies, participants share their health information so researchers can identify and learn as much about Long COVID as possible. Participants in studies don’t receive study interventions or medicine, but such studies can help researchers identify possible treatments for Long COVID to test in clinical trials. The observational cohort studies, which will follow participants for several years, may also tell us about the longer-term health outcomes following COVID-19.Learn more about RECOVER studies
The RECOVER research team is committed to sharing what we learn. Once the clinical trials are complete and the data has been analyzed, overall study results will be shared via the RECOVER website and newsletters. The clinical trial researchers will also present findings at scientific conferences and publish results in peer-reviewed scientific journals to share with other researchers and the medical community.Sign up to get emails with the latest information about all RECOVER research, including the clinical trials
Clinical Trials Leadership & Design
The National Institutes of Health (NIH) created the RECOVER Initiative to learn about the long-term effects of COVID. The RECOVER clinical trials are led by the Duke Clinical Research Institute (DCRI) which is the Clinical Trials Data Coordinating Center. Each clinical trial has principal investigators (PIs), or lead researchers, who oversee the research activities.
The RECOVER team includes patients, caregivers, doctors, community leaders, and researchers from across the country. Community partners from various backgrounds help make sure RECOVER research includes and benefits communities that are most affected by Long COVID.Learn more about clinical trials leadership
RECOVER clinical trials are designed as platform protocols that allow researchers to study different study interventions, or possible treatments, at the same time. Each clinical trial will focus on a group of symptoms. Several study interventions may be studied within each focus area. Results from these clinical trials will help us better understand how to treat Long COVID symptoms.Learn more about RECOVER’s platform protocols
- Autonomic Dysfunction: dizziness, fast heart rate, shortness of breath, upset stomach, or other changes in body functions that happen automatically
- Cognitive Dysfunction: brain fog, trouble thinking clearly, memory changes, slowed attention, and other symptoms related to brain function
- Exercise Intolerance and Fatigue: exhaustion or low energy that interferes with daily activities
- Sleep Disturbances: changes in sleep patterns or ability to sleep
- Viral Persistence: when the virus that causes COVID-19 stays in the body and causes damage to organs or the immune system to not function properly
Starting off, we plan to have 5 clinical trials, 1 for each of the focus areas. However, the platform structure of RECOVER clinical trials allows multiple study interventions, or possible treatments, to be studied within each focus area.Learn more about RECOVER’s platform protocols
Depending on the treatment being studied, a RECOVER clinical trial could last for about 3 months to 12 months, including follow-up visits.
Enrollment milestones and updates to interventions will be shared via the RECOVER website and newsletters.
Study Activities & Interventions
Participants will be assigned by chance to an active study intervention group or to a control group.
- Participants in an active study intervention group are given a possible treatment that may help improve Long COVID symptoms.
- Participants in a control group are given an appropriate control, which is what researchers use as a point of comparison to learn how different study interventions affect participants’ health. The appropriate control may include a placebo, which looks like the study intervention but should have no effect.
Participants in a control group are valuable contributors to research studies. Without a control group to compare to the study intervention group, researchers would not be able to learn how well a possible treatment works.
The samples, or biospecimens, will be used for research on COVID and the long-term effects of the virus that causes COVID-19, and may also be used for research on other health problems. Blood, stool (poop), or nasal swab samples collected in RECOVER clinical trials will be securely stored in the RECOVER Research Biorepository. Participants’ data and samples stored in the biorepository will not include any information that can personally identify them, and researchers cannot easily link any identifying information to the data or biospecimens.
Risks & Benefits
We do not know if participants will benefit from taking part in a RECOVER clinical trial. The information learned from this research may help you, your loved ones, and other people with Long COVID in the future. Participants in RECOVER research can help:
- Their loved ones and community members learn why and how COVID and Long COVID affects people in different ways
- Researchers and healthcare providers find ways to treat Long COVID and help people live with fewer symptoms
Safety & Privacy
Like most clinical trials, RECOVER has several groups that work together to protect participants’ safety, rights, and well-being, monitor the research, and track progress. These groups include:
- Protocol Working Groups: develop the protocols, or study plans, for each of the RECOVER clinical trials. Each working group includes doctors, researchers, and patient and community representatives.
- Data and Safety Monitoring Board (DSMB): reviews the clinical trial protocols, or study plans, before the study is implemented. During the clinical trials, the DSMB monitors the data collected in RECOVER research and how the clinical trials are working, and makes recommendations to correct any data quality or safety issues that may come up during the studies.
- Institutional Review Board (IRB): reviews research activities to make sure the rights and well-being of participants are protected throughout the clinical trials.
The protected health information (PHI) collected for RECOVER clinical trials may be given to others only as needed for reasons like monitoring the study, determining the results of the study, and providing required reports. When the clinical trial results are shared publicly, no information that could identify participants will be included.
The Informed Consent Form explains how RECOVER will use participants’ information and samples collected in the clinical trials. The study team will review the Informed Consent Form with potential participants so they know what to expect and they can decide if they want to enroll in the study or not.
Only the RECOVER research team will have access to participants’ protected health information (PHI). To protect participants’ privacy:
- We will follow state and federal laws that protect the privacy and security of participants’ information.
- We will not share participants’ identity and PHI unless it is required to protect their safety, the safety of others, or if they give us permission to share it.
- We will store records in a locked cabinet or on a password-protected computer.
- We will assign participants’ study information a code and keep it separately from their personal record.
- We will limit and monitor access to the data collected.
RECOVER researchers and study teams will make every effort to protect all participants’ safety, well-being, and privacy. Additionally, the RECOVER team partners with patients, caregivers, and community leaders from many different backgrounds throughout all stages of the clinical trials. Our community partners help make sure RECOVER research includes and benefits communities that are most affected by Long COVID.Learn more about how patients and community members are engaged in RECOVER clinical trials