Anti-SARS-CoV-2 Monoclonal Antibodies for Long COVID (COVID-19)
- Conditions
- Long COVIDPost-Acute Sequela of COVID-19Post-Acute COVID-19
- Interventions
- Other: Placebo
- Registration Number
- NCT05877508
- Lead Sponsor
- Michael Peluso, MD
- Brief Summary
Persistent viral infection with viral reservoirs and detection of circulating spike protein after the initial acute illness is one potential pathogenic mechanism for Long COVID. This mechanism may be able to be targeted by SARS-CoV-2 monoclonal antibodies (mAbs). This trial will study the safety and efficacy of AER002 to treat individuals with Long COVID in an adult population.
- Detailed Description
The study will enroll approximately 30 participants who meet the World Health Organization (WHO) Long COVID criteria, with Long COVID attributed to a SARS-CoV-2 variant susceptible to AER002. Participants will be enrolled at a single center and randomized 2:1 to receive a SARS-CoV-2 monoclonal antibody (AER002) 1200mg or placebo. Evaluations will take place at baseline and at timepoints up to 1-year post-infusion.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 36
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description AER002 AER002 AER002 1200mg administered once by IV Placebo Placebo Placebo administered once by IV
- Primary Outcome Measures
Name Time Method Change in Patient-Reported Outcomes Measurement Information System (PROMIS)-29 Physical Health Summary Score from Baseline. Baseline and Day 90 This measure will evaluate whether there is a difference between treatment with AER002 versus placebo on the PROMIS-29 between baseline and 3 months post-infusion. PROMIS-29 is a validated scale assessing physical function, anxiety, depression, fatigue, sleep disturbance, ability to participate in social activities, and pain. Each domain is scored on a 5-point scale (without any difficulty, with a little difficulty, with some difficulty, with much difficulty, unable to do). The primary outcome evaluated will be change in the Physical Health Summary Score.
- Secondary Outcome Measures
Name Time Method Change in Patient-Reported Outcomes Measurement Information System (PROMIS)-29 Physical Health Summary Score from Baseline. Baseline to Day 30 and Day 180 This measure will evaluate whether there is a difference between treatment with AER002 versus placebo on the PROMIS-29 scale between baseline and 3 months post-infusion. PROMIS-29 is a validated scale assessing physical function, anxiety, depression, fatigue, sleep disturbance, ability to participate in social activities, and pain. Each domain is scored on a 5-point scale (without any difficulty, with a little difficulty, with some difficulty, with much difficulty, unable to do). We will evaluate the change in the Physical Health Summary Score at these timepoints.
Change in Patient-Reported Outcomes Measurement Information System (PROMIS)-29 Mental Health Summary Score from Baseline. Baseline to Day 30 and Day 180 This measure will evaluate whether there is a difference between treatment with AER002 versus placebo on the PROMIS-29 scale between baseline and 3 months post-infusion. PROMIS-29 is a validated scale assessing physical function, anxiety, depression, fatigue, sleep disturbance, ability to participate in social activities, and pain. Each domain is scored on a 5-point scale (without any difficulty, with a little difficulty, with some difficulty, with much difficulty, unable to do). We will evaluate the change in the Mental Health Summary Score at these timepoints.
Change in Quality of Life (Global Health Score) on a 100-point Visual-Analogue Scale from Baseline Baseline and Day 90 This measure will evaluate whether there is a difference between treatment with AER002 versus placebo on self-reported score on a 100-point visual-analogue scale, where 0 represents the worst health a person can imagine and 100 represents the best health a person can imagine.
Change in Quality of Life Score (5-Item EuroQol EQ-5D-5L) Index Value Score from Baseline. Baseline to Day 90 5-Item EuroQol EQ-5D-5L questions assess pain/difficulty in day-to-day activities over the past week.
Change in Duke Activity Status Index (DASI) from Baseline Baseline to Day 90 The Duke Activity Status Index is a patient-reported estimate of functional capacity, maximal oxygen consumption (VO2 max) and maximum metabolic equivalent of tasks (METs). The DASI questionnaire produces a score between 0 and 58.2 points, which is linearly correlated with a patient's VO2 max and METs, as measured from cardiopulmonary exercise testing (CPET). It inquires about a person's ability to perform self-care, walk, climb stairs, run, do house and yard work, engage in sexual intercourse, and perform moderate recreational activities.
Change in Composite Autonomic Symptom Score (COMPASS-31) Score from Baseline. Baseline and Day 90 This measure will evaluate whether there is a difference between treatment with AER002 versus placebo on the COMPASS-31 scale between baseline and 3 months post-infusion. COMPASS-31 asks 31 questions related to autonomic dysfunction. The answer to each question generates a numeric score for the question, which is then summed at the end of the questionnaire. A total score out of 100 is generated summarizing orthostatic intolerance, vasomotor, secretomotor, gastrointestinal, urinary, pupillomotor, temperature intolerance, and sexual impairment.
Change in World Health Organization Disability Assessment Schedule 2.0 (WHO-DAS 2.0) questionnaire from Baseline Baseline and Day 90 The World Health Organization Disability Assessment Schedule 2.0 questionnaire asks about difficulties due to health conditions. Health conditions include diseases or illnesses, other health problems that may be short or long lasting, injuries, mental or emotional problems, and problems with alcohol or drugs.
Patient Global Impression of Change (PGIC) at D90 Day 90 The self-report measure Patient Global Impression of Change (PGIC) reflects a patient's belief about the efficacy of treatment. We will use a modified PGIC scale which has been used to study pain syndromes and has been employed in other Long COVID clinical trials. It is a common data element developed by the National Institutes of Mental Health.
Change in Everyday Cognition Form (ECog-39) instrument from Baseline Baseline and Day 90 The ECog is an instrument that measures the decline in everyday cognitive and functional abilities that map to six cognitive domains, adapted specifically to describe change in abilities since having COVID
Change in 6 Minute Walking Test (6MWT) from Baseline Baseline and Day 90 This measure will evaluate whether there is a difference between treatment with AER002 versus placebo on 6MWT performance between baseline and at 3 months post-infusion. The 6MWT requires an individual to walk at their normal pace for 6 minutes on a marked track (for example, a hallway). Vital signs are assessed, and the total distance covered is the primary outcome of interest.
Change in Active Stand Test from Baseline Baseline and Day 90 Measurements of heart rate and blood pressure measured after resting lying down, and at standardized increments for up to 10 minutes (as tolerated).
Change in Neurocognition Index (NCI) standard score from the CNS-VS from Baseline Baseline and Day 90 A neurocognitive assessment to assess motor, emotional, sensory, and cognitive function. It is available in English and Spanish and is administered using an iPad or computer.
Change in CRP from Baseline Baseline and Day 90 Change in laboratory measurement measured as the difference in mean change from Baseline.
Change in ESR from Baseline Baseline and Day 90 Change in laboratory measurement measured as the difference in mean change from Baseline.
Change in D-Dimer from Baseline Baseline and Day 90 Change in laboratory measurement measured as the difference in mean change from Baseline.
Change in Fibrinogen from Baseline Baseline and Day 90 Change in laboratory measurement measured as the difference in mean change from Baseline.
Trial Locations
- Locations (1)
UCSF/Zuckerberg San Francisco General Hospital
🇺🇸San Francisco, California, United States