Long COVID Trial, Recruiting

Written by an AI model from the ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

Phase A (Survey phase) — recovering or recovered COVID-19 patients:

• Adults aged 18 or older who have recovered, or are recovering, from a COVID-19 infection in the past 5 years, and can provide documentation of a positive COVID-19 test (such as a PCR test, a home antigen test with a time-stamped photo, or certain antibody tests)
• Adults aged 18 or older who developed ongoing symptoms after a COVID-19 illness but whose test results were negative, and who have a doctor's diagnosis or meet certain symptom criteria for probable COVID-19, along with documentation of a negative antibody test before vaccination
• Adults aged 18 or older who developed persistent symptoms after receiving a COVID-19 vaccine, with documentation of vaccination and a doctor's confirmation of a vaccine-related medical condition
• Adults aged 18 or older who report having had more than one COVID-19 infection, with documentation of at least one positive test
• All Phase A participants must be willing to take part in telephone interviews and able to give informed consent

Phase B (Evaluation phase) — in-depth assessment of recovered individuals:

• Adults aged 18 or older who completed at least 7th grade, are fluent in English, and are willing and able to complete all study procedures
• People who have a regular primary care doctor at the time of joining
• People who are at least six weeks past the start of their COVID-19 symptoms, have had no fever for at least one week, and are within five years of starting to recover
• People who do not currently have an active COVID-19 infection
• People with doctor-documented good health before their COVID-19 illness, a confirmed positive COVID-19 laboratory test, and whose original illness was not severe enough to require intensive care or mechanical ventilation (confirm with trial site)
• Within that group, people may qualify under one of three symptom categories: those with severe ongoing symptoms (Long COVID), those who have fully recovered with no ongoing symptoms, or those with mild to moderate ongoing symptoms — each assessed using a standard health questionnaire (SF-36v2) (confirm with trial site)

Phase C (Deep investigation phase):

• People who completed Phase B and met all relevant criteria for either the Long COVID group or the fully recovered group, with no other explanation found for their ongoing symptoms, and who are fluent in English

Who may not be able to join:

Phase A exclusions:

• People who are not willing to provide personal identifying information to the research team
• People with severe cognitive impairment that affects their ability to give informed consent

Phase B and Phase C exclusions:

• People with a current or past psychotic disorder, including schizophrenia, bipolar disorder with psychotic symptoms, or depression with psychosis
• People with major depression, generalised anxiety disorder, PTSD, panic disorder, or obsessive-compulsive disorder, unless the condition has been stable and well-managed for more than six months
• People with a current or past substance use disorder within the last five years (note: marijuana use alone is not an exclusion)
• People whose urine drug screening shows substances other than marijuana, unless a positive result is clearly linked to a short-term prescribed medication (reviewed case by case by the investigator)
• People who are currently experiencing thoughts of suicide
• People with a history of moderate or severe traumatic brain injury (a history of mild traumatic brain injury does not exclude someone)
• Women who are pregnant, breastfeeding, or within one year of giving birth
• People with a current or previous cancer diagnosis, unless the cancer was fully treated by surgery alone with no chemotherapy, radiation, or immunotherapy
• People with current whole-body (systemic) immune system disorders such as Type 1 diabetes or rheumatoid arthritis (localised immune conditions such as stable autoimmune thyroid disease or skin allergies may be permitted — confirm with trial site)
• People currently using or with a history of long-term immune-suppressing medications (some exceptions apply, such as steroids used to treat COVID-19 or recent allergic reactions — confirm with trial site)
• People with pre-existing medical conditions that cause fatigue or exercise intolerance, such as heart failure, coronary artery disease, chronic obstructive pulmonary disease, severe arthritis, uncontrolled asthma, kidney failure, fibromyalgia, or ME/CFS
• People currently participating in another clinical trial that involves a treatment that could affect this study's results
• People who are not willing to allow their research data and samples to be shared with other researchers
• NIH employees who are directly supervised by the study investigators (family members of NIH employees may participate)
• People whose symptoms are severe enough that travelling to the NIH site would not be possible

Important: Always verify eligibility with the trial site directly before applying.