RECOVER-ENERGIZE clinical trials achieve early enrollment: How collaboration and communication drove success

Both RECOVER-ENERGIZE clinical trials recently completed enrollment after 16 months—a full 2 months ahead of schedule. This achievement was thanks to a combination of teamwork, transparency, and tireless communication with a network of 42 RECOVER study sites across the country.

“Our sites were enthusiastic and deeply invested in the success of the study,” said Regina Eze, lead clinical research associate at Duke Clinical Research Institute (DCRI), which serves as the RECOVER Clinical Trials Data Coordinating Center. “It wasn’t just the central team—the sites wanted this trial to succeed as much as we did.”

RECOVER-ENERGIZE launched in July 2024 and sought 660 participants across the country whose Long COVID symptoms impacted their physical activity. The first ENERGIZE trial was looking for adults who have exercise intolerance, which can include symptoms of shortness of breath, muscle weakness, and severe fatigue. 

The second ENERGIZE trial recruited participants with post-exertional malaise (PEM), which can leave individuals exhausted after even minor physical or mental activity. Researchers are evaluating personalized cardiopulmonary rehabilitation (for those with exercise intolerance) and structured pacing strategies (for those with PEM) to learn how they might help participants regain physical function, improve quality of life, and safely manage their symptoms.

Keys to success: Resources and proactive solutions

From the outset of the trials, the DCRI study leads recognized that enrollment success hinged on making sure that sites were informed, organized, and engaged. To help give site teams clarity and confidence throughout the recruitment process, the trial team provided a range of resources, including an 80-page Manual of Procedures, eligibility checklists for screening, and scripts for sites to use when talking with potential participants. 

“These resources included details to help sites efficiently navigate so many different scenarios, and we are really proud of how comprehensive they were,” said Helena Pike Welch, PhD, co-project lead for RECOVER-ENERGIZE. 

With a detailed protocol and a multi-step participant screening process that left little room for error, clear and consistent communication became the backbone of the trial. It was also essential to communicate frequently, Pike Welch said. “Monthly check-ins and newsletters weren’t enough; we often connected with site coordinators weekly.”

Clinical research associates stayed closely connected with sites, proactively troubleshooting barriers to enrollment and sharing real-time solutions. “Our goal was to ensure sites never felt alone in addressing challenges,” said Nilda Itchon-Ramos, co-project lead for RECOVER-ENERGIZE. “We wanted them to feel prepared, supported, and able to act quickly when protocol changes occurred.”

Site spotlight: Valencia Medical & Research Center

Among the 42 enrolling sites, several stood out for exceptional performance. One example is Valencia Medical & Research Center, a RECOVER-ENERGIZE site located in Miami, Florida, which quickly became a top enroller with 39 participants in one trial within just 6 months. (For context, the goal for each site was to enroll 2 participants per month, and the actual average was about 1 participant per month per site across both trials.) 

Daniela Casanueva Baeza, Valencia’s site coordinator, attributes much of her site’s success to the clinic’s community partnership with Miami-Dade County. In addition, site principal investigator Inti Fernandez, MD, and sub-investigator Judith Valencia, MD, have built a trusting relationship with the surrounding community over time. “These factors really helped participants feel confident about joining the study,” she said.

The Valencia team also brought valuable experience from their work on the RECOVER-VITAL Viral Persistence (PAXLOVID) study, which focused on the effects of the anti-viral drug PAXLOVID in people with Long COVID. That prior involvement helped the site become familiar with recruiting people who had COVID to participate and understand the complexities of RECOVER protocols. As a result, they were well-positioned to move quickly when they joined RECOVER-ENERGIZE as a site.

To allow for rapid identification of eligible candidates and ensure a steady flow of study participants, the Valencia team leveraged trusted relationships within their clinic network—conducting chart reviews, direct phone calls, and physician referrals. They re-engaged participants from previous COVID-related studies and amplified outreach through social media and word-of-mouth referrals to friends and family members, enabling the site to reach potential participants faster.

“What really made the difference was how we communicated with participants—keeping the conversation personal and simple, and offering bilingual support when needed,” Casanueva Baeza said. “We made sure people understood the study’s purpose and felt supported. We took the time to explain everything clearly, answer questions, and reassure them that their well-being was our top priority.”

Casanueva Baeza also underscored the importance of strong teamwork to carry out a clinical trial like RECOVER-ENERGIZE, saying: “It was critical to involve the entire team in recruitment, prescreening, and follow-up, which kept processes consistent and ensured no participant was overlooked.” She also credited the DCRI study leads for their “quick responses and clear communication, which made everything so much easier and helped keep things moving smoothly.”

With enrollment completed, the last RECOVER-ENERGIZE participants will complete the study activities in Spring 2026. During this period, site study teams will be working with participants to make sure they are following the program correctly, attending their clinic visits, and logging their FitBit data. After that, the trials will move into the next phase: analyzing the data to determine how these interventions might help relieve symptoms for people living with Long COVID.