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Covid-19 Long Haul Preventative and Health Promotion Care Clinical Trial Acceleration Program.

NCT06441955 · Well- Konnect Healthcare Services and Research Firm
In plain English

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Official title
Covid-19 Long Haul Syndrome: Undiagnosed Disorder Post Covid-19 Alternative Treatment Study.
About this study
Investigators are planning a comprehensive study to understand and address the long-term effects of COVID-19. Investigators aim to recruit 25 to 100 participants who have tested positive or clinically diagnosed with COVID-19, regardless of whether they have received treatment with COVID-19 post-market antivirals, vaccines, or medical care. The study will involve conducting intake eligibility assessments and providing available treatments for COVID-19 to address the core morbidities associated with long-haul COVID-19. Investigators plans also includes collecting data from diverse participants to define seven biomarker categories and create a prognosis indicator for COVID-19 symptoms using precision medicine methods. The focus will be on neurological and respiratory symptoms affecting quality of life, with a special emphasis on women and men who are prone to developing Post COVID-19 long-haul syndrome. Additionally, participants have outlined a diversity plan to ensure representation from a wide range of demographics. It's clear that you are dedicated to addressing the impact of long-haul COVID-19 and are taking a comprehensive approach to understand and treat the persistent symptoms experienced by individuals post-COVID-19 infection.
Eligibility criteria
Inclusion Criteria: * Inclusion of Men, Women, and Minorities * Participants must be at least 18 years old. * Participants must have a positive COVID-19 diagnosis or clinical diagnosis of COVID-19 * Participants must have experienced persistent symptoms after recovering from the acute phase of the illness. * Participants must be willing to provide informed consent to participate in the study. * Participants must be able to communicate effectively in English or have a translator available. * Participants must be able to attend follow-up appointments as required by the study protocol. * Participants must not have any medical conditions or take any medications that could interfere with the study results. Exclusion Criteria: * \>18 years of age * Medical History of Myocarditis * Medical History of Pericarditis * Medical History of Severe renal impairment (eGFR \<30 mL/min).
Study design
Enrollment target: 100 participants
Allocation: randomized
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2024-03-01
Estimated completion: 2030-09-30
Last updated: 2024-11-27
Interventions
Drug: Ritonavir-Boosted Nirmatrelvir (Paxlovid)Diagnostic Test: Physiological EvaluationBiological: Moderna COVID-19 VaccineBehavioral: BiopsychologicalBehavioral: Behavioral (e.g., Psychotherapy, Lifestyle Counseling)Genetic: Genetic (including gene transfer, stem cell and recombinant DNA)Combination Product: Multidisciplinary approach
Primary outcomes
  • Adherence (- Participant Selection and Baseline Data Collection: 36 months - Longitudinal Observation and Intervention Implementation: 24 months - Data Analysis and Findings Dissemination: 36 months)
Sponsor
Well- Konnect Healthcare Services and Research Firm · network
With: All of Us Research Program at the National Institute of Health
Contacts & investigators
ContactKawana J Williams, Ph.D. · contact · Kawana.williams@waldenu.edu · 2406201587
ContactKENNY WILLIAMS · contact · gant2121@gmail.com · 2676067169
InvestigatorKawana J Williams, Ph.D. · principal_investigator, The National Institute of Health All of Us Research Program At Well-Konnect Healthcare Services and Research Center
All locations (1)
NIH Clinical CenterRecruiting
Bethesda, Maryland, United States
Covid-19 Long Haul Preventative and Health Promotion Care Clinical Trial Acceleration Program. · TrialPath