COVID-19 Long Haul Preventative and Health Promotion Care Study

This study is looking into ways to prevent and improve care for people experiencing "long COVID" symptoms after a COVID-19 infection. Researchers are testing interventions like Ritonavir-Boosted Nirmatrelvir (Paxlovid), the Moderna COVID-19 Vaccine, and behavioral therapies (like psychotherapy and lifestyle counseling). They will also conduct physiological evaluations (blood tests, cancer screenings, biopsies, imaging) to understand your health. You can join if you are between 18 and 65 years old, have had a positive COVID-19 diagnosis, and are still experiencing persistent symptoms. The main goal is to see how well participants stick to the study treatments and recommendations over time. The study is currently unclear on its recruitment status.

Study design
This is an interventional study planning to enroll 100 participants. The phase of the study is not specified.
What's involved
The study involves a 6-month period for participant selection and baseline data collection, followed by 24 months of observation and intervention, and then 6 months for data analysis. You would undergo common medical lab work, cancer screening, and potentially receive study interventions.
Compensation
Not stated in the trial record.
Follow-up
Adherence will be measured at 36 months after participant selection and baseline data collection, and at 24 and 36 months during the observation and intervention phase.

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NCT06441955

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

Recruiting
PHASE4Ages 18–65InterventionalBasic science
Well- Konnect Healthcare Services and Research Firm
~100 participants
Updated 2024-11-27 on ClinicalTrials.gov
What's tested:Ritonavir-Boosted Nirmatrelvir (Paxlovid)Physiological EvaluationModerna COVID-19 VaccineBiopsychologicalBehavioral (e.g., Psychotherapy, Lifestyle Counseling)Genetic (including gene transfer, stem cell and recombinant DNA)

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Adherence
Measured over - Participant Selection and Baseline Data Collection: 36 months - Longitudinal Observation and Intervention Implementation: 24 months - Data Analysis and Findings Dissemination: 36 months
COVID-19, Long Haul
1 sites across 1 states
Maryland1
  • 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

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

\>18 years of age
Medical History of Myocarditis
Medical History of Pericarditis
Medical History of Severe renal impairment (eGFR \<30 mL/min).
  • Adherence- Participant Selection and Baseline Data Collection: 36 months - Longitudinal Observation and Intervention Implementation: 24 months - Data Analysis and Findings Dissemination: 36 months

    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.