A Phase 4 interventional study of Ritonavir-Boosted Nirmatrelvir (Paxlovid) and Physiological Evaluation in COVID-19, Long Haul, sponsored by Well- Konnect Healthcare Services and Research Firm. Recruiting at 1 site in United States. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-11-27.
Sponsored by Well- Konnect Healthcare Services and Research Firm · Phase 4, Interventional, and Basic science
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.
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.
7,640 studies on the registry are indexed under COVID-19; 488 are open to participants now.
This study's planned enrollment of 100 is close to the median of 100 across 4,099 interventional studies indexed under COVID-19.
Browse COVID-19 studies →This is the only study on the registry with Well- Konnect Healthcare Services and Research Firm as lead sponsor.
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Inclusion Criteria:
Exclusion Criteria:
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.
Drug: Ritonavir-Boosted Nirmatrelvir (Paxlovid) · Diagnostic Test: Physiological Evaluation · Biological: Moderna COVID-19 Vaccine · Behavioral: Biopsychological · Behavioral: Behavioral (e.g., Psychotherapy, Lifestyle Counseling) · Genetic: Genetic (including gene transfer, stem cell and recombinant DNA) · Combination Product: Multidisciplinary approach
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.
Drug: Ritonavir-Boosted Nirmatrelvir (Paxlovid) · Diagnostic Test: Physiological Evaluation · Biological: Moderna COVID-19 Vaccine · Behavioral: Biopsychological · Behavioral: Behavioral (e.g., Psychotherapy, Lifestyle Counseling) · Genetic: Genetic (including gene transfer, stem cell and recombinant DNA) · Combination Product: Multidisciplinary approach
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.
Also known as: Phramacotherapies
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.
Also known as: Immunologic Evaluation
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.
Also known as: Biopsychological
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.
Also known as: Whole Genome 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
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.
Time frame: - Participant Selection and Baseline Data Collection: 36 months - Longitudinal Observation and Intervention Implementation: 24 months - Data Analysis and Findings Dissemination: 36 months
Pharmaco surveillance
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.
Time frame: - Participant Selection and Baseline Data Collection: 36 months - Longitudinal Observation and Intervention Implementation: 24 months - Data Analysis and Findings Dissemination: 36 months
Patient Engagement
The research will delve into the impact of epigenetic factors on health outcomes, particularly in marginalized communities. By examining genomics and health equity, the study seeks to identify disparities in the prevalence and treatment of epigenetic conditions among different population groups. The goal is to develop targeted interventions and metrics to improve health outcomes and access to genomic interventions for all individuals, irrespective of their background or socioeconomic status.
Time frame: - Participant Selection and Baseline Data Collection: 36 months - Longitudinal Observation and Intervention Implementation: 24 months - Data Analysis and Findings Dissemination: 36 months
Plan to share: Yes — 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.
Supporting information: Csr, Analytic code
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