Clinical trial NCT06441955: Covid-19 Long Haul Preventative and Health Promotion Care Clinical Trial Acceleration Program.
Official title: Covid-19 Long Haul Syndrome: Undiagnosed Disorder Post Covid-19 Alternative Treatment Study.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: COVID-19, Long Haul
Lead sponsor: Well- Konnect Healthcare Services and Research Firm
Sponsor class: NETWORK
Collaborators: name: All of Us Research Program at the National Institute of Health
First posted: 2024-06-04
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A parallel study is a type of clinical study in which two or more groups of participants receive different interventions. Participants are assigned to one of the treatment arms at the beginning of the trial and continue in that arm throughout the length of the trial. Assignment to a group usually is randomized. Study participants are only exposed to the treatment that is assigned to the particular study arm they are enrolled in.

For example, a two-arm parallel assignment involves two groups of participants. One group receives drug A, and the other group receives drug B. So during the trial, participants in one group receive drug A "in parallel" to participants in the other group, who receive drug B.
Primary purpose: BASIC_SCIENCE

Brief 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.

Detailed 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.

Eligibility criteria: 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).

Primary outcomes:
measure: Adherence
timeFrame: - Participant Selection and Baseline Data Collection: 36 months - Longitudinal Observation and Intervention Implementation: 24 months - Data Analysis and Findings Dissemination: 36 months
Secondary outcomes:
measure: Pharmaco surveillance
timeFrame: - Participant Selection and Baseline Data Collection: 36 months - Longitudinal Observation and Intervention Implementation: 24 months - Data Analysis and Findings Dissemination: 36 months
Other outcomes:
measure: Patient Engagement
timeFrame: - Participant Selection and Baseline Data Collection: 36 months - Longitudinal Observation and Intervention Implementation: 24 months - Data Analysis and Findings Dissemination: 36 months
Locations:
city: Bethesda
country: United States
facility: NIH Clinical Center
state: Maryland
Study officials:
affiliation: The National Institute of Health All of Us Research Program At Well-Konnect Healthcare Services and Research Center
name: Kawana J Williams, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: