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

Phase

Condition

Covid-19

Treatment

Ritonavir-Boosted Nirmatrelvir (Paxlovid)

Multidisciplinary approach

Moderna COVID-19 Vaccine

Clinical Study ID

NCT06441955

aou-rw-c6288c3f

Ages 18-65
All Genders
Accepts Healthy Volunteers

Study 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 Criteria

Inclusion

Inclusion Criteria:

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 ofCOVID-19
Participants must have experienced persistent symptoms after recovering from theacute phase of the illness.
Participants must be willing to provide informed consent to participate in thestudy.
Participants must be able to communicate effectively in English or have a translatoravailable.
Participants must be able to attend follow-up appointments as required by the studyprotocol.
Participants must not have any medical conditions or take any medications that couldinterfere with the study results.

Exclusion

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

Ritonavir-Boosted Nirmatrelvir (Paxlovid)

March 01, 2024

September 30, 2030

Study Description

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.

Connect with a study center

NIH Clinical Center
Bethesda, Maryland 20892
United States
Active - Recruiting

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