First Long COVID Clinical Trials Now Open at UH
February 18, 2024
UH Clinical Update | February 2024
The first two clinical trials of treatments for long COVID, part of the federal government’s RECOVER initiative, are now open and enrolling patients at University Hospitals.
RECOVER-VITAL is testing a familiar pandemic medication – the antiviral PAXLOVID. But unlike its use as an acute treatment for COVID-19, RECOVER-VITAL will examine whether a longer dose regimen of PAXLOVID improves symptoms for people with long COVID. PAXLOVID is currently approved by the U.S. Food and Drug Administration for the treatment of mild-to-moderate COVID-19 in adults who are at high risk for progression to severe COVID-19, including hospitalization or death.
“To date, the appropriate duration of therapy for post-acute sequelae of SARS-CoV-2 infection (PASC) remains unknown,” says Grace McComsey, MD, FIDSA, Director of the UH Clinical Research Center and Vice Dean for Clinical and Translational Research and Director of the Clinical and Translational Science Institute (CTSI) at Case Western Reserve University. “This study will test two dosing durations, 15 days and 25 days, which have been chosen to enable evaluation of dose response of prolonged therapy within the range of dosing durations previously used in select clinical practice. No randomized clinical trial has been performed to study PAXLOVID in patients with PASC. Case studies of patients with PASC taking PAXLOVID over five days show equivocal improvements in symptom resolution, so it will be good to get some more clear data through this clinical trial.”
Who is Eligible?
Patients eligible for RECOVER-VITAL must have had a previous case of COVID, but not a current, active case. They must also still have at least ONE of the following symptoms:
- Exhaustion or low energy that interferes with daily activities
- Trouble thinking clearly or brain fog
- Dizziness, fast heart rate, shortness of breath, upset stomach or other changes in body functions that happen automatically
RECOVER-VITAL involves four to five clinic visits to complete surveys, lab tests and physical ability and/or brain function tests, as well as responding to surveys either online or by phone. PAXLOVID is provided to clinical trial participants at no cost, and participants are paid for their time.
Addressing Cognitive Effects
The second new clinical trial as part of the RECOVER initiative is titled RECOVER-NEURO. It will examine accessible interventions for cognitive dysfunction related to long COVID, including brain fog, memory problems and difficulty with attention, thinking clearly and problem solving. Interventions under this protocol will include a web-based brain training program called BrainHQ, which has been used to improve cognitive function; PASC-Cognitive Recovery, a web-based goal management training program that has been used to improve executive function; and a device used for home-based transcranial direct current stimulation, which has been demonstrated to help brain activity and blood flow.
“A prominent PASC symptom is cognitive dysfunction, which can prevent patients’ return to work,” Dr. McComsey says. “Therefore, with the increasing number of people infected with SARS-CoV-2, an urgent and unmet clinical need exists to better understand the pathophysiology of PASC and to develop targeted interventions that restore patients’ cognitive function. This clinical trial aims to investigate interventions with prior evidence of improving cognitive function. If successful, results will enable providers to treat PASC-induced cognitive dysfunction.”