Covid-19 Long Haul Syndrome: Undiagnosed Disorder Post Covid-19 Alternative Treatment Study.

Status: Recruiting
Location: See location...
Intervention Type: Behavioral, Genetic, Diagnostic test, Drug, Combination product, Biological
Study Type: Interventional
Study Phase: Phase 4
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: t
View:

• 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.

Locations
United States
Maryland
NIH Clinical Center
RECRUITING
Bethesda
Contact Information
Primary
Kawana J Williams, Ph.D.
Kawana.williams@waldenu.edu
2406201587
Backup
KENNY WILLIAMS
gant2121@gmail.com
2676067169
Time Frame
Start Date: 2024-03-01
Estimated Completion Date: 2030-09-30
Participants
Target number of participants: 100
Treatments
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.
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.
Sponsors
Leads: Well- Konnect Healthcare Services and Research Firm
Collaborators: All of Us Research Program at the National Institute of Health

This content was sourced from clinicaltrials.gov