Pre-screening Announcement for a Clinical Trial on Long COVID
Are you someone who has been diagnosed with Long COVID or may be suffering from the effects of Long COVID?
HealthBio, Inc. is pleased to announce that the company is initiating a pre-screening process to identify adults living with Long COVID who may be interested in learning more about an upcoming clinical trial evaluating a potential new treatment option.
About the study
HealthBio, Inc is sponsoring an FDA-approved, multi-center, randomized, double-blind, placebo-controlled Phase 3 clinical trial to evaluate a therapeutic for Long COVID. IMPACT-LC is listed as NCT06974084, “A Multi-Center, Individually-Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Superiority Trial to Evaluate the Efficacy of the Combination of Maraviroc and Atorvastatin for the Treatment of Subjects with Long COVID.”
The study is designed to determine whether this oral combination can improve fatigue and other common Long COVID symptoms such as dysautonomia (e.g., rapid heart rate,lightheadedness) and cognitive difficulties (“brain fog”).
Purpose of this pre-screening
NCT06974084 is listed as a multi-center, randomized, double-blind, placebo controlled Phase 3 clinical trial. This announcement is for pre-screening only. It does not mean you are pre-enrolling or enrolling.
The objectives of this pre-screening effort are to:
• Identify individuals who may be interested in hearing more about the study.
• Create a contact list so interested individuals can be informed when formal
screening and enrollment open at participating sites.
No one will be enrolled in the trial based on this announcement alone, and no study
procedures or investigational products will be provided as part of pre-screening. Final eligibility can only be determined through the formal screening process conducted by the study team at a participating site.
Who might be a good fit to respond
Based on the planned study population in the Protocol, individuals who may be
appropriate to respond to pre-screening typically:
• Are adults who developed persistent symptoms following confirmed or probable
COVID-19 infection, with symptoms generally lasting at least several months.
• Experience ongoing issues such as significant fatigue, post-exertional symptom
worsening, dysautonomia symptoms (e.g., rapid heart rate, dizziness on standing),
shortness of breath, or cognitive problems such as “brain fog.”
• Are not currently hospitalized and are interested in learning more about potential
participation in a research study of an oral treatment taken over approximately 12
weeks, with total participation of about 20 weeks including follow-up.
Final eligibility can only be determined through the formal screening process conducted by the study team at a participating site.
What participation in the trial would involve (high-level)
For those who later proceed to full screening and enrollment, the trial is expected to
include:
• Random assignment to receive either the active drug combination or matching
placebos, taken by mouth twice daily for 12 weeks.
• Study visits over approximately 20 weeks, including health assessments, blood
tests, and completion of questionnaires that evaluate fatigue, autonomic
symptoms, cognitive function, and a Long Hauler Index score.
• Ongoing safety monitoring, including physical exams, laboratory evaluations, and
structured collection of any side effects or medical events.
Details on all procedures, risks, and potential benefits will be provided during the informed consent process before any trial-related activities occur.
How to find more information
If you are interested in learning more about the upcoming trial, please view the public information HERE
How to express interest in pre-screening
If you believe you may have Long COVID and would like to be considered for future contact about this trial, you may:
• Submit your contact information through the study designated email provided by
HealthBio, and
• Provide brief information about your Long COVID history (approximate timing of
initial COVID-19 infection, key symptoms, and how long they have persisted).
A member of the study team will review your pre-screening information and may reach out to discuss next steps, including whether a formal screening visit at a participating site is appropriate. Completion of pre-screening does not obligate you to participate and does not guarantee eligibility or enrollment.
For company information, please contact us at: HBtrial@HealthBio.com