Covid-19 Long Haul Preventative and Health Promotion Care Clinical Trial Acceleration Program.
Covid-19 Long Haul Syndrome: Undiagnosed Disorder Post Covid-19 Alternative Treatment Study.
1 other identifier
interventional
100
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Mar 2024
Longer than P75 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2024
CompletedFirst Submitted
Initial submission to the registry
June 2, 2024
CompletedFirst Posted
Study publicly available on registry
June 4, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 30, 2030
ExpectedStudy Completion
Last participant's last visit for all outcomes
September 30, 2030
November 27, 2024
November 1, 2024
6.6 years
June 2, 2024
November 24, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
Adherence
Well-Konnect Biopsychosoical Framework and assessment tool (WKBF tool) compared to the APA biopsychological assessment. Health literacy surveillance care program evaluation tool aims to lay the groundwork for a more inclusive and equitable approach to leveraging genomic data and interventions to improve health outcomes for all individuals.
- Participant Selection and Baseline Data Collection: 36 months - Longitudinal Observation and Intervention Implementation: 24 months - Data Analysis and Findings Dissemination: 36 months
Secondary Outcomes (1)
Pharmaco surveillance
- Participant Selection and Baseline Data Collection: 36 months - Longitudinal Observation and Intervention Implementation: 24 months - Data Analysis and Findings Dissemination: 36 months
Other Outcomes (1)
Patient Engagement
- Participant Selection and Baseline Data Collection: 36 months - Longitudinal Observation and Intervention Implementation: 24 months - Data Analysis and Findings Dissemination: 36 months
Study Arms (2)
Moderna COVID-19 Vaccine
ACTIVE COMPARATORUnvaccinated 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.
Ritonavir-Boosted Nirmatrelvir (Paxlovid)
ACTIVE COMPARATORThe 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.
Interventions
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.
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.
Single dose, 0.25 mL If previously vaccinated, ≥2 months after receipt of the last previous dose of COVID-19 vaccine
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.
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.
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.
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
You may qualify if:
- 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.
You may not qualify if:
- \>18 years of age
- Medical History of Myocarditis
- Medical History of Pericarditis
- Medical History of Severe renal impairment (eGFR \<30 mL/min).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
NIH Clinical Center
Bethesda, Maryland, 20892, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Kawana J Williams, Ph.D.
The National Institute of Health All of Us Research Program At Well-Konnect Healthcare Services and Research Center
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Masking Details
- Covid-19 Long Haul Preventative and Health Promotion Care Clinical Trial Acceleration Program.
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- NETWORK
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 2, 2024
First Posted
June 4, 2024
Study Start
March 1, 2024
Primary Completion (Estimated)
September 30, 2030
Study Completion (Estimated)
September 30, 2030
Last Updated
November 27, 2024
Record last verified: 2024-11
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- CSR, ANALYTIC CODE
- Time Frame
- 10 years
- Access Criteria
- Authorization for access to the registered and controlled data tiers will be user based, rather than project-based. Authorized users will receive a "data passport." A data passport is required for access to the registered and controlled data tiers and to set up workspaces to carry out research projects . As one of the first steps in initiating an All of Us registered and controlled tier project and setting up a workspace, users will be required to submit a description of their project. These descriptions will be made public and searchable for auditing purposes to facilitate public engagement.
No participant count of 1 to 20 can be published or distributed directly (a count of 0 is permitted); and No data or statistics can be reported that allow a participant count of 1 to 20 to be derived from other reported cells or information, including in text, tables, or figures.