Actively Recruiting
Covid-19 Long Haul Syndrome: Undiagnosed Disorder Post Covid-19 Alternative Treatment Study
Led by Well- Konnect Healthcare Services and Research Firm · Updated on 2024-11-27
100
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
W
Well- Konnect Healthcare Services and Research Firm
Lead Sponsor
N
National Institutes of Health (NIH)
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating alternative treatments for people who have had a current or past positive COVID-19 diagnosis and are experiencing long-term symptoms often called long-haul COVID. This condition includes symptoms like extreme tiredness, breathing difficulties, memory and concentration problems, heart palpitations, dizziness, joint and muscle pain, cough, headaches, anxiety, and depression. The study aims to understand these persistent effects, identify biomarkers, and develop personalized treatment plans using precision medicine methods. The study involves two main treatment groups: one receiving two doses of the Moderna COVID-19 Vaccine (2023-2024 formula) spaced one month apart, and another treated with the antiviral drug Ritonavir-Boosted Nirmatrelvir (Paxlovid) taken orally twice daily for five days. Additional interventions include physiological evaluations, biopsychological assessments, genetic testing, behavioral therapies, and a multidisciplinary approach combining psychological and nursing sciences to address health disparities and promote wellness. This is a phase 4 randomized trial with no masking, focusing on adults aged 18 to 65. Participants will undergo intake assessments, provide informed consent, and attend follow-up visits as needed. The study collects clinical data, biomarker information, and treatment adherence over several years, including a 36-month selection and baseline period, 24 months of longitudinal observation and intervention, and 36 months for data analysis and sharing findings. Researchers monitor participant health, treatment adherence, and pharmaco surveillance to understand long-term outcomes and optimize care for people living with post-COVID-19 symptoms.
CONDITIONS
Brief Title
Covid-19 Long Haul Preventative and Health Promotion Care Clinical Trial Acceleration Program.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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
You will not qualify if you...
- Older than 65 years of age
- Medical history of myocarditis
- Medical history of pericarditis
- Medical history of severe renal impairment with eGFR less than 30 mL/min
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 6 months
Participants undergo baseline assessments including eligibility confirmation, physiological evaluations, genetic testing, and biopsychological assessments to collect comprehensive health data prior to intervention.
Multiple visits during baseline period
Duration - 24 months
Participants receive assigned interventions which may include Moderna COVID-19 Vaccine doses or Ritonavir-Boosted Nirmatrelvir (Paxlovid), alongside behavioral and multidisciplinary health promotion care.
Multiple visits for vaccine doses and treatment monitoring
Duration - Up to 36 months including baseline and treatment periods
Participants are observed longitudinally to monitor treatment adherence, health outcomes, and progression of long-haul COVID-19 symptoms with ongoing data collection.
Regular follow-up visits during and after treatment
Trial Site Locations
Total: 1 location
1
NIH Clinical Center
Bethesda, Maryland, United States, 20892
Actively Recruiting
Research Team
K
Kawana J Williams, Ph.D.
K
KENNY WILLIAMS
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
BASIC_SCIENCE
Number of Arms
2
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