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.
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
Phase
Phase 4
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
A parallel study is a type of clinical study in which two or more groups of participants
receive different interventions. Participants are assigned to one of the treatment arms
at the beginning of the trial and continue in that arm throughout the length of the
trial. Assignment to a group usually is randomized. Study participants are only exposed
to the treatment that is assigned to the particular study arm they are enrolled in.
For example, a two-arm parallel assignment involves two groups of participants. One group
receives drug A, and the other group receives drug B. So during the trial, participants
in one group receive drug A "in parallel" to participants in the other group, who receive
drug B.
Primary Purpose
Basic Science
Masking
None (Open Label)
Masking Description
Covid-19 Long Haul Preventative and Health Promotion Care Clinical Trial Acceleration
Program.
Arm Groups
Arm
Description
Assigned Intervention
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.
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 names:
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 names:
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 names:
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 names:
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
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.
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 names:
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 names:
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 names:
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 names:
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
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.
Notice
Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health).
The listing of studies provided is not certain to be all studies for which you might be eligible.
Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.