The National Institutes of Health (NIH) announced Tuesday the launch of two Phase II clinical trials to evaluate the safety and effectiveness of three treatments for adults suffering from long COVID with autonomic nervous system dysfunction. The trials are a part of the NIH’s Researching COVID to Enhance Recovery (RECOVER) Initiative, a nationwide research program to improve the understanding, diagnosis, and treatment of long COVID.
“As a long COVID patient, I know firsthand how disruptive and frightening symptoms including rapid heart rate, dizziness, and fatigue can be. Patient representatives across RECOVER have also shared that these symptoms are some of the most debilitating symptoms of long COVID,” said Heather Marti, co-chair of the RECOVER National Community Engagement Group. “These trials are giving me and others with long COVID hope that it will restore our health and get us back to the lives we so desire.”
Symptoms associated with autonomic nervous system dysfunction relate to the regulation of bodily functions such as heart rate, respiratory rate, and digestion all of which can be impacted by long COVID. The newly launched trials are testing three potential treatments in adults who contracted COVID-19 but now have a heart condition known as postural orthostatic tachycardia syndrome (POTS). This disorder of the autonomic nervous system disorder results in fast heart rate, dizziness, fatigue, or a combination of these symptoms, when a person stands up from sitting or lying down.
The three drugs that will be evaluated in the trials are:
- Gamunex-C, a form of intravenous immunoglobulin (IVIG), 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, which includes a series of activities managed through weekly phone calls with a care coordinator, 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 Christopher Granger, MD, of Duke University Medical Center, who is co-leading the trial. “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.”
Study participants will first be randomly assigned to receive either IVIG, ivabradine, or a placebo and then will be randomly assigned a second time to receive either coordinator-guided, non-drug care or what is considered the usual non-drug care for POTS following COVID-19, such as diet and lifestyle recommendations. It is an adaptive clinical trial, to allow additional potential emerging interventions to quickly be added and studied in the trial.
The trial aims to enroll a total of 380 participants at 50 sites in the U.S. and will be recruited by teams at the sites from their health systems and the local community. RECOVER places a high priority on studies that have diversity among participants and the sites for this trial were selected based on geographic location and prior success in recruiting a diverse population for clinical studies.
