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Comparison of ME/CFS and Long COVID-19 Patients

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ClinicalTrials.gov Identifier: NCT04806620
Recruitment Status : Recruiting
First Posted : March 19, 2021
Last Update Posted : April 6, 2021
Sponsor:
Information provided by (Responsible Party):
Solve ME/CFS Initiative

Study Description
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Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
The purpose of the You + ME Registry and Biobank is to collect clinical and patient-reported data and biological samples (e.g. blood) from people living with Myalgic Encephalomyelitis (also known as chronic fatigue syndrome or ME/CFS), people with long-COVID and control volunteers to improve understanding, diagnosis and treatment of these diseases.

Condition or disease
ME/CFS Covid19

Detailed Description:

The You + ME Registry and Biobank is a collection of clinical and patient-reported data and biological samples (e.g. blood) from people living with Myalgic Encephalomyelitis (also known as chronic fatigue syndrome or ME/CFS), people with long-COVID and control volunteers. The patient registry collates demographic and real-world, longitudinal symptom, patient-reported outcomes, and treatment data from a global cohort into a centralized repository. The Registry will also be linked to a biobank which is a place that stores tissues, blood or other samples from participants. The combination of data and biological samples will be made available to researchers so we can: (1) improve our understanding of the natural history, epidemiology, pathogenesis, resilience/susceptibility factors, disease subsets, and treatment of ME/CFS and long-COVID using a standardized set of demographic and longitudinal data; (2) build an infrastructure and resource to support a range of future research into these diseases; (3) increase opportunities for collaboration between patients, providers, researchers, and industry.

Anyone 18 years of age and older is invited to sign up. After creating a profile and completing an informed consent via an online portal, participants fill out a series of surveys, including medical history, co-occurring conditions, symptoms, quality of life, functional status, and treatments. Participants receive email reminders to complete follow-up surveys to provide researchers with information about their health over time.

The Registry also includes a mobile tracking app co-created with the community that allows participants to monitor at minimum five core symptoms of fatigue, brain fog, unrefreshing sleep, and orthostatic intolerance (on a scale of 0: symptom absent - 4: very severe) as well as any additional symptoms of their choosing, life factors, and activity. Individuals can also capture data in narrative form using a journaling function. Participants are encouraged to capture data every 3 days if possible, but can track as often as daily.

Registry data is stored in a secure, encrypted database. Data is anonymized before being made available on a secure platform for research. Biosamples collected from participants are labeled with a coded number to protect their privacy and confidentiality.

This project is supported by Solve ME/CFS Initiative. You can learn more and sign up at youandmeregistry.com.

Study Design
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Study Type : Observational [Patient Registry]
Estimated Enrollment : 10000 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 2 Years
Official Title: Comparison of ME/CFS and Long COVID-19 Patients
Actual Study Start Date : May 1, 2020
Estimated Primary Completion Date : May 1, 2025
Estimated Study Completion Date : May 1, 2025

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort
People with ME/CFS
No intervention will be administered.
People with Long-COVID
No intervention will be administered.
Healthy Controls
No intervention will be administered.


Outcome Measures
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Primary Outcome Measures :
  1. Phenotypic data collection [ Time Frame: 24 months ]
    We want to collect a large, well-characterized longitudinal dataset to understand causes and identify treatments for ME/CFS and long-COVID.

  2. Subtyping [ Time Frame: 24 months ]
    We aim to use the phenotypic and associated biological samples from the Registry to identify disease subtypes.


Secondary Outcome Measures :
  1. Demographics [ Time Frame: 24 months ]
    We record basic demographic information of our Registry population including: age, race, ethnicity, income, education, employment, marital status. Demographic information is recorded at baseline and updated every 12 months.

  2. Comorbitities [ Time Frame: 24 months ]
    We want to catalogue common comorbidities in our registry population. Participants provide information on diagnosed conditions, age of onset, and whether the condition is still active. Their conditions list can be updated over time.

  3. Treatments [ Time Frame: 24 months ]
    We want to catalogue commonly used treatments in our registry population. Participants provide information on past and current treatments and provide ratings of their effectiveness at relieving symptoms. Their treatments list can be updated over time and information on ongoing use can be recorded via a mobile app.

  4. Quality of Life and Functional Status [ Time Frame: 24 months ]
    Participants fill out the Short Form 36 Quality of Life survey and a version of the Karnofsky Performance Scale modified for self-report over time.

  5. Symptoms [ Time Frame: 24 months ]
    We want to catalogue the common symptoms of ME/CFS and long COVID and analyze the data for symptom-based phenotypes. We administer a survey to assess the frequency and severity of symptoms over time and provide access to a mobile app so participants can log data on their symptoms as often as daily.


Biospecimen Retention:   Samples With DNA
dried blood spot, whole blood, blood components, saliva, urine, fecal, plasma

Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
This is a study of individuals with ME/CFS, individuals with long-COVID and healthy controls.
Criteria

Inclusion Criteria:

  • Patients with ME/CFS,
  • Those without ME/CFS
  • Patients with long-COVID
  • Patients with COVID who recovered.

Exclusion Criteria:

  • Those who never had COVID
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04806620


Contacts
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Contact: Kira Poplowski, PhD 310-463-2953 kpoplowski@solvecfs.org
Contact: Allison Ramiller aramiller@solvecfs.org

Locations
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United States, California
Solve ME/CFS Initiative Recruiting
Los Angeles, California, United States, 91206
Sponsors and Collaborators
Solve ME/CFS Initiative
Investigators
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Study Director: Sadie Whittaker, PhD Solve ME/CFS Initiative
More Information
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Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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Responsible Party: Solve ME/CFS Initiative
ClinicalTrials.gov Identifier: NCT04806620    
Other Study ID Numbers: 1
First Posted: March 19, 2021    Key Record Dates
Last Update Posted: April 6, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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COVID-19
Fatigue Syndrome, Chronic
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
 RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases
Muscular Diseases
Musculoskeletal Diseases
Encephalomyelitis
Central Nervous System Diseases
Nervous System Diseases
Neuromuscular Diseases