RECOVER launches second phase of adult observational study

In May, RECOVER officially launched the second phase of the adult observational study. This next phase will continue to follow about 5,000 adult participants from the almost 15,000 people who took part in the first phase. 

“The next phase of the observational study is primarily about extending what we have been doing in the first phase, with some refinement,” said James Chan, MA, MEd, a senior biostatistician who works with RECOVER’s Data Resource Core. “Surveys should look very familiar to participants with some adjustments to reduce participant burden. We have also rebuilt our data capture system to greatly reduce load times.” 

Currently, it is estimated that 68 study sites at 16 RECOVER hubs will be enrolling participants in the study. People who are eligible to participate in the second phase will be randomly selected from those who participated in the larger first phase. 

Those who choose to participate in this next phase will continue to fill out surveys about their symptoms, visit a clinic to perform study-required tests, and contribute biosamples such as blood and saliva (spit). This phase will require only 2 in-person visits in an effort to make participating in the study easier. 

Visits in the second phase of the adult observational study will continue for 2 years, enabling researchers to better understand how Long COVID impacts people over a longer period. This additional follow-up will give researchers up to 7 years of data on some participants who joined the observational study in 2021. 

“We are not that far into studying a new disease,” Mr. Chan said. “This phase will give us important information as we look for longer-term outcomes. For example, we will be able to see symptoms over time and see where things may be resolving, or we may see new issues or conditions that arise in the longer term.” 

The information collected will help RECOVER build on its published work on Long COVID trajectories, or how the health of people living with Long COVID changes over time. Researchers may see new and distinct symptom patterns or burden, or they may develop a better understanding of how currently identified trajectories progress. 

Researchers will place special emphasis on symptoms that significantly impact people’s daily lives but are still not well understood, such as neurocognitive symptoms (symptoms that affect the brain), cardiopulmonary symptoms (symptoms that affect the heart and lungs), and symptoms that affect the autonomic nervous system (functions in the body that happen automatically, such as breathing and heart rate). They will also conduct studies about other infection-associated chronic conditions and how these conditions may interact with Long COVID. 

People who continue to take part in the adult study will notice changes to the surveys they take. These changes were made in response to recommendations from the adult observational study workgroup and feedback from participants. Updates include the following: 

• Decrease in load times. Survey pages will now load much faster, making it easier for participants to move through the survey. 
• Fewer survey questions. Many follow-up questions have been removed from the survey or streamlined; for example, participants will no longer have to report on some of their other health conditions each time they take a survey because those data have been pulled from the first phase of the study. 
• New survey questions. The surveys now include questions on whether participants have applied for disability benefits or other accommodations. The surveys also now ask all participants questions related to certain health conditions (such as myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS) and postural orthostatistic tachycardia syndrome (POTS)). In the first phase of the adult study, only people who reported relevant symptoms were asked these questions. Collecting this information from all participants will enable easier comparison across the group, Mr. Chan said. 
• Progress markers. The survey will now tell respondents how many parts of the survey are left to answer so that they know how much more of the survey they have to complete. 

The surveys will provide RECOVER with up-to-date information about the symptoms people are experiencing. Mr. Chan said this information could be useful in identifying individuals with specific types of symptoms for future RECOVER clinical trials. He added that the observational study could share this information with RECOVER-Treating Long COVID (RECOVER-TLC) as enrollment for additional clinical trials begins.