New Data Links Modulation of Key Immune-Related Proteins to Improvement of Specific Symptoms in Long COVID

The study, published in Frontiers in Medicine, suggests a precision medicine approach may enable differentiation and diagnosis of long COVID from ME-CFS and supports further evaluation of two therapeutic agents for treatment

HAYWARD, Calif.--(BUSINESS WIRE)--Data from a new clinical study show modulation of key immune regulating proteins with maraviroc and pravastatin correlates with symptom reduction in patients with post-acute sequelae of COVID (PASC), commonly known as long COVID. The study results, published in Frontiers in Medicine, also support a precision medicine approach to diagnosis of long COVID as well as differentiation of long COVID from ME-CFS (myalgic encephalomyelitis/chronic fatigue syndrome), which presents with similar symptoms.

In the study, 18 COVID-19 survivors experiencing symptoms consistent with long COVID for more than three months after diagnosis and displaying either isolated or combinations of elevated pro-inflammatory markers, received a combination of maraviroc (300 mg per oral twice a day) and pravastatin (10 mg per oral daily).

Participants were evaluated before, throughout and after the study using five validated clinical scales: the New York Heart Association (NYHA) functional classification, the Composite Autonomic Symptom Scale 31 (COMPASS 31), the Medical Research Council (MRC) Dyspnea scale, the Modified Rankin scale for neurologic disability and the Fatigue Severity Scale (FSS) questionnaire.

Symptom improvements were reported within 12 weeks of treatment.

• Subjective neurological, autonomic, respiratory, cardiac and fatigue symptoms scores all decreased by statistically significant margins. In particular, the FSS (fatigue being the most common symptom) decreased and was closely correlated in decreases of IL-2 and TNF-α.

Specific symptom improvements were correlated with reductions in specific inflammatory biomarkers.

• These decreases in reported symptom improvements correlated with statistically significant decreases in objectively measured inflammation-related biomarkers.
• Specifically, the study showed statistically significant positive Pearson’s correlation coefficients between subjective scores and cytokine modulation.

Details and additional findings from this study are available at https://www.frontiersin.org/articles/10.3389/fmed.2023.1122529/full.

Additionally, findings from a related 314 patient extension study are available at [e-mail].

“These data link specific inflammatory markers to specific symptoms of long COVID for the first time” said Bruce Patterson, M.D., CEO of IncellDx, co-lead author of the study with Ram Yogendra, M.D., Medical Director of the Chronic COVID Treatment Center, “providing support for a targeted therapeutic approach aimed at specific inflammatory mediators.”

“The study also shows the utility of precision diagnostics as a means of differentiating patients suffering exclusively from long COVID from those who have conditions with similar symptom profiles, like ME-CFS and Post-Lyme syndromes,” Dr. Patterson said. “In testing potential inclusion and exclusion criteria, the study provides the foundation for development of a protocol for a randomized controlled trial of maraviroc and pravastatin in the treatment of long COVID. We are encouraged by data from this study demonstrating both subjective and biomarker improvement with this regimen.”

The CDC reports that nearly one in five adults who have had COVID-19 continue to suffer with the symptom complex known as long COVID, post-COVID syndrome or PASC (post-acute sequalae of COVID).

Gary Kaplan, D.O. D.A.B.F.M., D.A.B.P.M., F.A.A.M.A., medical director at Kaplan Center for Integrative Medicine, clinical associate professor at Georgetown University School of Medicine Department of Community and Family Medicine and a co-author of the study, said, “There is an urgent need to better understand the pathophysiology of this condition and more importantly find a cure. This paper provides new insights that address both issues.”

“Having identified a correlation between immune dysfunction, specific inflammatory markers and symptoms, this paper also opens up potential for new diagnostic and treatment options for a number of poorly understood chronic disabling medical conditions,” Dr. Kaplan said. “Chronic Fatigue Syndrome (ME/CFS) in particular shares a number of overlapping symptoms with PASC. These data may provide a path forward to improved diagnosis and treatment for the approximately 2 million people in the U.S. and millions more around the world suffering with ME/CFS.”

About IncellDx

IncellDx is a precision medicine company advancing novel diagnostics and prognostics to better understand and treat infectious disease and cancer. The company’s innovative technology platform enables simultaneous cell classification and single cell analysis of proteomic and genomic biomarkers. The company launched the Chronic COVID Treatment Center to apply precision medicine approaches to evaluate, characterize and more effectively address chronic COVID.