Phase 2 Long COVID Trial, Recruiting

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

Who might be able to join this trial:

• People who are aged 18 or older but under 70 years old.
• People who are already enrolled, or willing to enroll, in the UCSF Long-term Impact of Infection with Novel Coronavirus (LIINC) study, which is open to any adult who has had a confirmed COVID-19 infection or has received or been found eligible for a COVID-19 vaccination.
• People who have had at least one confirmed COVID-19 infection, proven by a positive PCR test or a positive rapid antigen test. Written proof is preferred but not required if the person can confirm the positive result themselves. People with only a suspected but unconfirmed infection are not eligible.
• People who have been assessed by the study doctor and confirmed to have Long COVID, meeting all of the following conditions:
  • At least 2 symptoms (or 1 severe symptom) that are new or got worse after a COVID-19 infection and are not explained by another condition. These must include at least 2 from the following groups: whole-body symptoms (such as fatigue, chills, or exhaustion after activity), brain and nerve symptoms (such as memory or concentration problems, headaches, dizziness, nerve pain, or sleep problems), heart and lung symptoms (such as chest pain, heart palpitations, breathlessness, cough, or fainting), muscle and joint symptoms (such as muscle aches or joint pain), or digestive symptoms (such as nausea or diarrhoea). The 2 symptoms can be from the same group.
  • Those symptoms must have first appeared at least 60 days before the screening visit, even if they come and go.
  • Those symptoms must be at least somewhat bothersome and must affect quality of life or day-to-day functioning.
  • At least 90 days must have passed since the most recent confirmed or suspected COVID-19 infection at the time of screening.
• People who are not currently in hospital.
• People with a body mass index (a measure of body weight relative to height) between 18 and 50 at the time of screening.
• People who are otherwise in stable health, as assessed by the study doctor within 28 days before screening, based on medical history, physical assessment, blood tests, and vital signs.
• Male participants (or those assigned male sex at birth) who agree to use effective contraception from the start of the study through 7 months after the last dose if their partner could become pregnant; to use condoms during vaginal intercourse from the start of the study through 14 days after the last dose if their partner is pregnant; and to avoid sperm donation from the start of the study through 14 days after the last dose.
• Female participants who are not pregnant or breastfeeding, and who either cannot become pregnant, or who use an effective form of contraception starting 21 days before the study begins and continuing for at least 7 months after the last dose, agree to avoid egg donation during that period, and have a negative pregnancy test within 24 hours before each dose.
• People who are willing and able to follow the study plan, including having reliable transport and enough time to attend all visits.
• People who are able to give written consent to participate.

Who may not be able to join:

• People who have received a COVID-19 antiviral or monoclonal antibody treatment in the 30 days before the planned first dose, or who plan to receive such treatment before leaving the study.
• People who plan to receive any COVID-19 vaccine or booster within 14 days before the planned first dose, or before a specific follow-up visit after the first dose.
• People with a history of an autoimmune disease, including (but not limited to) coeliac disease, rheumatoid arthritis, psoriasis, or inflammatory bowel disease.
• People with active heart or cardiovascular disease, defined as having had a heart attack within 90 days of screening, heart bypass surgery within 90 days of screening, current heart failure with reduced pumping function, or current high blood pressure in the lungs (pulmonary arterial hypertension).
• People who have had a known stroke within 3 months before the planned first dose.
• People with a known active infection (bacterial, fungal, viral, or other, aside from COVID-19) that requires treatment and shows signs of spreading throughout the body within 14 days before the first dose. Minor infections such as simple urinary tract infections, yeast infections, or mild skin infections may be reviewed individually and may not be disqualifying (confirm with trial site).
• People who have had major surgery within 3 months before the planned first dose, or who have major surgery planned within the first 75 days after the first dose.
• People who had an unplanned hospital stay of more than 24 hours within 28 days before screening.
• People with a current or past Hepatitis B infection, based on specific blood test results. A past Hepatitis B infection is also disqualifying, even if there is no ongoing infection.
• People with an active Hepatitis C infection based on blood test results. People who have been cured of Hepatitis C may still be eligible (confirm with trial site).
• People with certain abnormal blood test results at the time of screening, including low white blood cell counts, low platelet counts, elevated liver enzyme levels, low haemoglobin (a sign of anaemia), reduced kidney function, or low lymphocyte counts (confirm specific values with trial site).
• People with a known or suspected HIV infection.
• People with end-stage kidney disease requiring dialysis.
• People with a history of Type 1 or Type 2 diabetes who require medication or insulin to manage it.
• People with severe liver impairment (a specific medical classification called Child-Pugh Class C).
• People with moderate or severe immune system suppression, including those currently receiving treatment for cancer (such as chemotherapy within the past year), those who have had a solid organ transplant and are on immune-suppressing medications, those who have had CAR-T cell therapy or a bone marrow transplant within the past 2 years or are still on immune-suppressing therapy, those with a primary immune deficiency disorder, those with advanced or untreated HIV, or those taking high-dose steroid medication (20mg or more of prednisone or equivalent daily for 2 or more weeks).
• People who were diagnosed with myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS) before their COVID-19 infection and whose condition has not worsened since the infection.
• People who were diagnosed with a condition called dysautonomia (a disorder of the nervous system that controls automatic body functions) before their COVID-19 infection and whose condition has not worsened since the infection.
• People with a known allergy to any ingredient in the study treatment.
• People with a history of a severe allergic reaction (such as anaphylaxis) to any prescription or non-prescription drug or food, or people assessed by the study doctor as having severe allergic conditions that could pose a significant risk.
• People who have taken part in another clinical trial involving an investigational treatment within 28 days before the planned first dose, with the exception of certain PET imaging studies related to Long COVID.
• People whose current alcohol or drug use, in the opinion of the study doctor, would prevent safe participation.
• People with any condition or abnormality that, in the study doctor's opinion, could affect their safety or the reliability of the study data.

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