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

Conditions

• COVID-19, Long Haul

Eligibility Criteria

Sex

ALL

Age

18 Years - 65 Years

Healthy Volunteers

Accepted

Interventions

• Ritonavir-Boosted Nirmatrelvir (Paxlovid) — DRUG
  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.
• Physiological Evaluation — DIAGNOSTIC_TEST
  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.
• Moderna COVID-19 Vaccine — BIOLOGICAL
  Single dose, 0.25 mL If previously vaccinated, ≥2 months after receipt of the last previous dose of COVID-19 vaccine
• Biopsychological — BEHAVIORAL
  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 (e.g., Psychotherapy, Lifestyle Counseling) — BEHAVIORAL
  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.
• Genetic (including gene transfer, stem cell and recombinant DNA) — GENETIC
  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.
• Multidisciplinary approach — COMBINATION_PRODUCT
  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

Study Details

Investigators are conducting a study on alternative treatments for patients who have received an current or previous positive COVID-19 diagnosis with mild-serve symptoms or undiagnosable condition after testing positive for severe acute COVID-19 infection and are experiencing long-haul symptoms. The symptoms of long COVID can include extreme tiredness (fatigue), shortness of breath, memory and concentration issues (brain fog), heart palpitations, dizziness, joint pain, muscle aches, cough, headaches, anxiety, and depression. It's important to note that there are various other symptoms that individuals can experience 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, sore throat, 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 clinical trials, and individualize and optimize treatment plans, which may or may not include COVID-19 post-market antivirals, vaccines, and medical care. It's essential to conduct thorough clinical trials to understand the long-term effects of COVID-19 and to develop personalized treatment plans for individuals experiencing long-haul symptoms.

Key Dates

Start date

Mar 1, 2024

Status verified

Nov 2024

Primary completion

Sep 30, 2030

Completion

Sep 30, 2030

Study Design

Enrollment

100 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

BASIC_SCIENCE

Arms

• Active Comparator: Moderna COVID-19 Vaccine
  Unvaccinated individuals: Two doses of Moderna COVID-19 Vaccine (2023-2024 Formula) are administered. The second dose is administered 1 month after the first. Moderna COVID-19 Vaccine to include the 2023-2024 formula. The Moderna COVID-19 Vaccine (2023-2024 Formula) includes a monovalent (single) component that corresponds to the Omicron variant XBB.1.5 of SARS-CoV-2. The Moderna COVID-19 Vaccine (2023-2024 Formula) is authorized for all doses administered to individuals 6 months through 11 years of age to prevent COVID-19. The Moderna COVID-19 Vaccine, Bivalent is no longer authorized for use in the United States. Moderna COVID-19 Vaccine is a suspension for injection. A single dose is 0.25 mL. (3) History of a severe allergic reaction (e.g., anaphylaxis) to any component of Moderna COVID-19 Vaccine or following a previous dose of a Moderna COVID-19 vaccine.
• Active Comparator: Ritonavir-Boosted Nirmatrelvir (Paxlovid)
  The COVID-19 Treatment Guidelines Panel (the Panel) recommends using nirmatrelvir 300 mg with ritonavir 100 mg (Paxlovid) orally (PO) twice daily for 5 days in nonhospitalized adults with mild to moderate COVID-19 who are at high risk of disease progression (). Treatment should be initiated as soon as possible and within 5 days of symptom onset. Ritonavir-boosted nirmatrelvir is available through an FDA EUA for the treatment of mild to moderate COVID-19 in nonhospitalized adolescents aged 12 to 17 years and weighing ≥40 kg.4 For recommendations on using ritonavir-boosted nirmatrelvir in nonhospitalized children with COVID-19.

Primary Outcome Measure

Adherence [ Time Frame: - Participant Selection and Baseline Data Collection: 36 months - Longitudinal Observation and Intervention Implementation: 24 months - Data Analysis and Findings Dissemination: 36 months ]

Central Contacts

• Kawana J Williams, Ph.D.
  2406201587
  [email protected]
• KENNY WILLIAMS
  2676067169
  [email protected]

Locations (1)

Find similar trials in Bethesda, MD