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

Well- Konnect Healthcare Services and Research Firm

Status and phase: Enrolling; Phase 4

Conditions: COVID-19, Long Haul

Treatments: Genetic: Genetic (including gene transfer, stem cell and recombinant DNA); Diagnostic Test: Physiological Evaluation; Combination Product: Multidisciplinary approach; Behavioral: Behavioral (e.g., Psychotherapy, Lifestyle Counseling); Biological: Moderna COVID-19 Vaccine; Drug: Ritonavir-Boosted Nirmatrelvir (Paxlovid); Behavioral: Biopsychological

Study type: Interventional

Funder types: NETWORK; Other

Identifiers

NCT06441955

aou-rw-c6288c3f

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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 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).

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

Moderna COVID-19 Vaccine

Active Comparator group

Description:

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.

Treatment:

Behavioral: Biopsychological

Drug: Ritonavir-Boosted Nirmatrelvir (Paxlovid)

Biological: Moderna COVID-19 Vaccine

Behavioral: Behavioral (e.g., Psychotherapy, Lifestyle Counseling)

Combination Product: Multidisciplinary approach

Genetic: Genetic (including gene transfer, stem cell and recombinant DNA)

Diagnostic Test: Physiological Evaluation

Ritonavir-Boosted Nirmatrelvir (Paxlovid)

Active Comparator group

Description:

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.

Treatment:

Behavioral: Biopsychological

Drug: Ritonavir-Boosted Nirmatrelvir (Paxlovid)

Biological: Moderna COVID-19 Vaccine

Behavioral: Behavioral (e.g., Psychotherapy, Lifestyle Counseling)

Combination Product: Multidisciplinary approach

Genetic: Genetic (including gene transfer, stem cell and recombinant DNA)

Diagnostic Test: Physiological Evaluation