Official Title
Covid-19 Long Haul Syndrome: Undiagnosed Disorder Post Covid-19 Alternative Treatment Study.
Brief Summary

Investigators are conducting a study on alternative treatments for patients who havereceived an current or previous positive COVID-19 diagnosis with mild-serve symptoms orundiagnosable condition after testing positive for severe acute COVID-19 infection andare experiencing long-haul symptoms. The symptoms of long COVID can include extremetiredness (fatigue), shortness of breath, memory and concentration issues (brain fog),heart palpitations, dizziness, joint pain, muscle aches, cough, headaches, anxiety, anddepression.It's important to note that there are various other symptoms that individuals canexperience after a COVID-19 infection, such as loss of smell, chest pain or tightness,difficulty sleeping (insomnia), pins and needles, depression, anxiety, tinnitus,earaches, nausea, diarrhea, stomach aches, loss of appetite, cough, headaches, sorethroat, and changes to the sense of smell or taste.To be included in the study, participants must have had symptoms for more than 4 weeks.The goal of the study is to measure biomarkers, identify new ones through clinicaltrials, and individualize and optimize treatment plans, which may or may not includeCOVID-19 post-market antivirals, vaccines, and medical care.It's essential to conduct thorough clinical trials to understand the long-term effects ofCOVID-19 and to develop personalized treatment plans for individuals experiencinglong-haul symptoms.

Detailed Description

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.

Recruiting
COVID-19, Long Haul

Drug: Ritonavir-Boosted Nirmatrelvir (Paxlovid)

Participant Selection and Baseline Data Collection: 6 months

- Longitudinal Observation and Intervention Implementation: 24 months

- Data Analysis and Findings Dissemination: 6 months Evaluate methodological
advantages and limitations of an international pharmacosurveillance system based on
electronic health records (EHRs). Adverse outcome; Electronic health record; Health
informatics; Medication adherence; Pharmacoepidemiology; Pharmacosurveillance; Risk
assessment.
Other Name: Phramacotherapies

Diagnostic Test: Physiological Evaluation

Common Medical laboratory work-up, Cancer screening test, Biomarkers, tissue biopsy,
blood specimen, diagnostic imagining, Sensitivity and Specificity, HIV PCR, Viral load (
antigen), CD4- T cell count, while implementation of social mediators of prevention,
promotion studies and conceptual models and quality of care.
Other Name: Immunologic Evaluation

Biological: Moderna COVID-19 Vaccine

Single dose, 0.25 mL If previously vaccinated, ≥2 months after receipt of the last
previous dose of COVID-19 vaccine

Behavioral: Biopsychological

Diagnosis of developmental milestones is considered a missing element in care measurement
or a determining factor in disease signs and symptoms in chronic care management.
Cognitive mapping, variations of survey, assessments, cancer counseling, leading to the
realization that adherence requires a whole-person approach to delivering high-quality
and cost-effective care. the project aims to offer opportunities to individuals from
diverse backgrounds, including those underrepresented in biomedical research, in an
inclusive environment in which all trainees can contribute. The proposed training
activities are designed to improve the research skills of the participants and encourage
them to pursue further training and careers in biomedical and/or social/behavioral
research.

Behavioral: Behavioral (e.g., Psychotherapy, Lifestyle Counseling)

Diagnosis of developmental milestones is considered a missing element in care measurement
or a determining factor in disease signs and symptoms in chronic care management.
Cognitive mapping, variations of survey, assessments, cancer counseling, leading to the
realization that adherence requires a whole-person approach to delivering high-quality
and cost-effective care. the project aims to offer opportunities to individuals from
diverse backgrounds, including those underrepresented in biomedical research, in an
inclusive environment in which all trainees can contribute. The proposed training
activities are designed to improve the research skills of the participants and encourage
them to pursue further training and careers in biomedical and/or social/behavioral
research.
Other Name: Biopsychological

Genetic: Genetic (including gene transfer, stem cell and recombinant DNA)

Full genome sequencing, complete genome sequencing, or entire genome sequencing, is the
process of determining the entirety, or nearly the entirety, of the DNA sequence of an
organism's genome at a single time to address the intersection of genomics and health
disparities, recognizing that genetic variations can contribute to health disparities in
several ways. Understanding these genetic contributions to health disparities is crucial
for developing targeted interventions and personalized healthcare strategies that can
help address these disparities. genetics, epidemiology, public health, and social
sciences, the study aims to shed light on the complex interplay between genomics and
health equity. To evaluate cellular errors and the effects of myocardial DNA, you may
need to consider tests such as DNA sequence.
Other Name: Whole Genome Sequence

Combination Product: Multidisciplinary approach

The aim of utilizes psychology-applied science and science in nursing frameworks to
address health disparities and promote health and wellness across the health span to
improve patient population outcomes, evaluate cost-effectiveness, and patient health
literacy competencies. The experimental framework of a compilation of the
bio-psychosocial model, Eric Erickson developmental stages, AI/AML, and cognitive
learning theories address system decision making factors, for sound decision making and
behavioral change cognitive behavioral therapies protocol segmentation demographic and
urban areas affected by social-economic access to healthcare and related ethical stance
of United States healthcare policy developmental outlines. Biology plays a role in the
content of development stages, and the great debate of nurture vs. nature sets the
foundation for addressing the psychosocial approach to healthcare integration as an
applied science model for strengthening primary services and improving

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).

Eligibility Gender
All
Eligibility Age
Minimum: 18 Years ~ Maximum: 65 Years
Countries
United States
Locations

NIH Clinical Center
Bethesda, Maryland, United States

Investigator: Kawana Williams, Ph.D.
Contact: 240-620-1587
Kawana.williams@waldenu.edu

Contacts

Kawana J Williams, Ph.D.
2406201587
Kawana.williams@waldenu.edu

KENNY WILLIAMS
2676067169
gant2121@gmail.com

Kawana 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 of Us Research Program at the National Institute of Health
NCT Number
MeSH Terms
COVID-19
Ritonavir
Nirmatrelvir
Nirmatrelvir and ritonavir drug combination