Recruiting

Observational Study

Sponsor:

UCLA

Code:

NCT07227441

Conditions

Myalgic Encephalomyelitis/Chronic Fatigue Syndrome

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Study Details

Brief summary:

CHIIME is a study of people who have myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS). People who do not have this condition will also be enrolled. Volunteers will be observed and sampled over time to identify the long-terms biological drivers and impact of their condition. The overall goal is to understand the biological and physiological mechanisms that are driving this condition.

Conditions

Myalgic Encephalomyelitis/Chronic Fatigue Syndrome

Study ID

NCT07227441

Start date

Jan 1, 2026

Status verified date

Mar, 2026

Completion date

Sep, 2030

Anticipated

Primary completion date

Sep, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Inclusion Criteria:

  • Willing and able to provide written informed consent
  • At least 18 years of age
  • Either: (1) a reported diagnosis of ME/CFS or (2) no history of ME/CFS or other infection-associated chronic conditions (healthy control)

Exclusion Criteria:

  • Self reported or documented chronic anemia with hemoglobin <9 g/dL
  • Known HIV, hepatitis B, or hepatitis C infection
  • Diagnosis of an infection-associated chronic condition other than ME/CFS or Long COVID (e.g. chronic Lyme disease, post-Ebola syndrome, etc.)
  • Serious medical or psychiatric illness that, in the opinion of the site investigator, would interfere with the ability to adhere to study requirements or to give informed consent
  • Active drug or alcohol use or dependence that, in the opinion of the PI, would interfere with adherence to study requirements or to give informed consent

Study Design

Enrollment

200 participants

Anticipated

Interventions and Outcome Measures

Arms

Non-COVID ME/CFS

Individuals who received a diagnosis of ME/CFS prior to the beginning of SARS-CoV-2 pandemic and whom SARS-CoV-2 was not expected to be the driver of ME/CFS

Post-COVID ME/CFS

Individuals who received a diagnosis of ME/CFS following the beginning of the SARS-CoV-2 pandemic and in who SARS-CoV-2 was expected to be the driver of ME/CFS

Healthy control

Individuals who have overlapping demographic characteristics (age, sex, race, and other factors determined by PI) with participants who have ME/CFS

Primary outcome measure

  • Participant Sex [ Time Frame: Baseline Visit ]
  • Participant Age [ Time Frame: Baseline Visit ]
  • Participant race/ethnicity [ Time Frame: Baseline Visit ]

Central Contacts and Locations

Central contacts

Beatrice Program Manager

(415) 502-2449chiime@ucsf.edu

Locations

Zuckerberg San Francisco General Hospital

Recruiting

San Francisco, California, United States, 94110

More Information

Sponsor

University of California, San Francisco

Last update posted

Mar 6, 2026

Last verified

Mar, 2026

Keywords

  • ME/CFS
  • myalgic encephalomyelitis
  • chronic fatigue syndrome

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-24. This information was provided to ClinicalTrials.gov by University of California, San Francisco on 2026-03-06. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.