New Long Covid Trials Open
Photo: Marleen Van Den Neste
Two phase-2 clinical trials have begun to test the safety and effectiveness of three treatments for adults with autonomic nervous system dysfunction from Long Covid.
The autonomic nervous system acts largely unconsciously and regulates bodily functions such as heart rate, digestion and respiratory rate. Symptoms associated with autonomic nervous system dysfunction have been among those that patients with Long Covid say are most burdensome.
The trials are part of NIH’s Researching Covid to Enhance Recovery (RECOVER) Initiative, a nationwide research program to fully understand, diagnose and treat Long Covid. Other RECOVER phase-2 clinical trials testing treatments to address viral persistence and neurological symptoms, including cognitive dysfunction (like brain fog), launched in July 2023.
“As a Long Covid patient, I know firsthand how disruptive and frightening symptoms including rapid heart rate, dizziness and fatigue can be,” said Heather Marti, co-chair of the RECOVER National Community Engagement Group. “Patient representatives across RECOVER have also shared that these symptoms are some of the most debilitating symptoms of Long Covid.”
The two trials, collectively known as RECOVER-AUTONOMIC, are testing three potential treatments in adults who, following Covid-19, now have postural orthostatic tachycardia syndrome (POTS). An autonomic nervous system disorder, POTS is characterized by unexpected fast heart rate, dizziness, fatigue or a combination of these symptoms when a person stands up from sitting or lying down.
“The trials were developed with input from people living with Long Covid, caregivers, community representatives, clinicians and scientists all with unique expertise in the field,” said RECOVER co-chair Dr. Gary Gibbons, director of the National Heart, Lung and Blood Institute.
The trials will initially examine three potential treatments:
- Gamunex-C, a form of intravenous immunoglobulin, contains antibodies to help the body protect itself against infection from various diseases and is given by intravenous infusion
- Ivabradine, an oral medication that reduces heart rate
- Coordinator-guided, non-drug care, such as wearing a compression belt and eating a high-salt diet, which are recommended for patients with POTS to counteract excessive loss of fluids
“Patients who develop POTS after having Covid-19 are often severely limited by their symptoms, and there are no proven effective treatments,” said Dr. Christopher Granger of Duke University Medical Center, who co-leads RECOVER-AUTONOMIC. “These interventions were selected because they have shown potential benefit in treating symptoms for POTS. The theory we’re testing is that they might also help individuals with long Covid.”
RECOVER-AUTONOMIC is an adaptive clinical trial, meaning if additional potential interventions emerge, they can quickly be added and studied in the trial.
Researchers plan to enroll 380 total participants at 50 sites across the country. Teams at the trial sites will recruit participants from their health systems and surrounding communities. The current list of sites for the trials can be found on ClinicalTrials.gov; additional sites will be added as they begin enrolling participants.
With the launch of the RECOVER-AUTONOMIC trials, RECOVER is currently testing seven treatments across four clinical trials and continues to enroll participants. To learn more about RECOVER clinical trials visit trials.recovercovid.org.