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 aged 18 to 70 years old.
• People who had COVID-19 confirmed by a PCR or antigen test done in a clinical setting.
• People whose COVID-19 symptoms started on or before August 31, 2023, and who have continued to have Long COVID symptoms for more than 3 months after their COVID-19 diagnosis.
• People whose current symptoms meet the medical case definition for ME/CFS (a condition involving severe, ongoing fatigue and related symptoms).
• People whose symptoms are rated as moderate to severe on a standard health questionnaire called the PROMIS-29 (a score of 60 or higher).
• People who meet the National Academy of Sciences criteria for Long COVID, including those with well-managed common conditions like high blood pressure (below 150/90 mmHg) or diabetes, and those with stable conditions such as fibromyalgia, irritable bowel syndrome, bladder pain, or nervous system regulation problems — provided these have not required a hospital stay in the past two years.
• People who are able to give written consent and agree to attend follow-up visits.

Who may not be able to join:

• People who have had an active COVID-19 infection within 4 weeks before signing consent.
• People with known severe anaemia (very low red blood cell levels, below 8 g/dL).
• People who have had a stroke that caused cognitive (thinking or memory) problems within 3 months of joining.
• People who currently have or report major depression with psychotic or melancholic features, schizophrenia, bipolar disorder, delusional disorders, any form of dementia, nervous system conditions that may affect thinking (such as epilepsy, brain tumours, multiple sclerosis, Parkinson's disease, or Alzheimer's disease), or substance misuse in the past two years (cannabis products excluded).
• People who are allergic to any ingredient in the study drug, sipavibart, or who have had a severe reaction to similar types of medications called humanised monoclonal antibodies.
• People who currently drink more than approximately 15 alcoholic drinks per week, or smoke more than 20 cigarettes (or equivalent) per day.
• People with active chronic infections such as HIV, Hepatitis B, or Hepatitis C, or who have abnormal liver function test results above three times the normal upper limit.
• People with kidney disease or poor kidney function (confirm with trial site for specific blood test thresholds), or who are currently on dialysis.
• People with liver disease or poor liver function based on self-report or blood test results above specific thresholds (confirm with trial site).
• People with uncontrolled diabetes, indicated by a blood sugar level and a diabetes measure called HbA1c above 7.
• People diagnosed with congestive heart failure or certain serious heart rhythm problems, such as rapid ventricular tachycardia, persistent atrial fibrillation, or second- or third-degree heart block.
• People with severe, ongoing high blood pressure above 180/110 mmHg while seated.
• People who, within 4 weeks before signing consent, have experienced a heart attack, unstable chest pain, uncontrolled heart rhythm problems, heart muscle inflammation, acute heart failure, a blood clot in the lungs, a suspected aortic aneurysm, severe low oxygen levels at rest, or any condition that affects exercise ability or is made worse by exercise.
• People with diagnosed bleeding disorders or who are taking blood-thinning medications.
• People who have taken any COVID-19 antiviral medication within 30 days before screening.
• People who have a separate diagnosed condition that could reasonably explain their fatigue and related symptoms, including organ failure, chronic inflammatory diseases, major neurological conditions causing fatigue, conditions requiring treatments such as chemotherapy or transplantation, major hormonal disorders, untreated sleep disorders, a BMI above 40 kg/m², temporary medication effects, ongoing sleep deprivation, or uncontrolled or untreated thyroid problems.
• People with a known diagnosis of chronic Lyme disease with ongoing symptoms or related treatment.
• People who have used marijuana or illicit drugs within 30 days of signing consent.
• People who are unable to stop certain symptom-relief medications for the required periods during the study.
• People who are considered moderately or severely immunocompromised, as defined by national COVID treatment guidelines.
• People scheduled for surgery during the study, or who have had minor surgery within 3 months or major surgery within 6 months before screening.
• People currently taking part in another clinical trial of an investigational treatment, or who have done so within 6 weeks before signing consent, or who plan to join another such trial during this study.
• People who have received a COVID-19 vaccine within 90 days before joining, or who plan to receive one during the study.
• People who are pregnant (a pregnancy test will be offered to women of childbearing age).

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