Find answers to questions about RECOVER Clinical Trials
We will update this page as the clinical trials progress. Updates on enrollment and possible treatments being studied will be shared on RECOVER web pages and in newsletters.
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Contact UsAbout 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
- Patient, Caregiver, and Community Representatives for RECOVER clinical trials
- The RECOVER National Community Engagement Group (NCEG)
- The NIH Community Engagement Alliance (CEAL)
In RECOVER clinical trials, participants may take a study drug, use a medical device, or try other approaches to help researchers learn how the possible treatment, also called a study intervention, affects Long COVID symptoms. The RECOVER Initiative’s 8 clinical trials will explore 13 study interventions to learn if they are safe and effective treatments for Long COVID symptoms.
Learn more about RECOVER clinical trialsIn RECOVER observational cohort studies, researchers are studying large groups of people over several years to better understand who gets Long COVID and why, what symptoms people have, and how Long COVID affects their health over time. These longitudinal observational cohort studies do not give a treatment or medicine to participants or change their regular health care — participants keep living their lives as usual and share health information with researchers.
Learn more about RECOVER observational cohort studiesWe are committed to sharing what we learn. After the clinical trials are complete and the data have been analyzed, researchers will share overall study results via the RECOVER website and newsletters. RECOVER researchers will also present results from the clinical trials at professional conferences and publish results in peer-reviewed scientific journals to share with other researchers and the healthcare community. No information that could identify participants will be shared with the public. Sign up for the RECOVER Report to get emails with the latest information about all RECOVER research, including the clinical trials.
Clinical Trials Leadership & Design
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, or lead researchers, who oversee the study plans and activities.
The RECOVER clinical trial teams include patients, caregivers, doctors, community leaders, and researchers from across the country. Community partners from many different backgrounds help make sure RECOVER research includes and benefits communities that are most affected by Long COVID.
Learn more about clinical trials leadershipEight clinical trials will explore 13 possible treatments across 5 areas of Long COVID symptoms.
Learn more about RECOVER clinical trials- 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
Participants
RECOVER clinical trials are phase 2 exploratory trials, which study the safety and effectiveness of possible treatments. A typical phase 2 clinical trial has between 100–300 participants.
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. An appropriate control may include a placebo or comparator that looks like the study intervention but has no treatment value.
Each participant in a RECOVER clinical trial is a valuable contributor to this research. Without control groups to compare to the active study intervention groups, researchers would not be able to learn how the study interventions, or possible treatments, affect Long COVID symptoms.
The samples may be used:
- To check participants’ overall health
- To check the safety of the potential treatments being studied
- For research on COVID and the long-term effects of the virus that causes COVID-19
- For research on other health problems
Risks & Benefits
We do not know if participants will benefit from taking part in a RECOVER clinical trial. What we learn from this research may help participants, their 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
There are several groups that work together throughout the lifecycles of the clinical trials to protect participants’ safety, rights, and well-being, monitor the research, and track progress. These groups include:
- Protocol Working Groups: developed the study plans, or protocols, for each of the RECOVER clinical trials. Each working group included doctors, researchers, and Patient, Caregiver, and Community Representatives.
- Data and Safety Monitoring Board (DSMB): reviews each clinical trial protocol before the study begins. Once the clinical trials begin, the DSMB monitors the data, or information, collected in RECOVER research and the progress of the clinical trials. The DSMB identifies safety issues that may come up during the clinical trials and also makes recommendations to correct any data quality issues.
- Institutional Review Board (IRB): reviews each clinical trial protocol before the study begins and reviews research activities as well as participant materials 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 safety and progress of the studies
- Determining the results of the studies
- Providing required reports to groups that monitor the research and safety of participants
The Informed Consent Form explains how RECOVER will use participants’ information and samples collected in the clinical trials. The study teams 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 has access to participants’ protected health information (PHI). To protect participants’ privacy:
- We follow state and federal laws that protect the privacy and security of participants’ information.
- We do 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 store records in locked cabinets or on password-protected computers.
- We assign participants’ study information a code and keep it separately from their personal record.
- We limit and monitor access to the data collected.
RECOVER researchers and study teams make every effort to protect all participants’ safety, rights, well-being, and privacy. Additionally, the RECOVER team partners with Patient, Caregiver, and Community Representatives 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