Persistent viral infection with viral reservoirs and detection of circulating spikeprotein after the initial acute illness is one potential pathogenic mechanism for LongCOVID. 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 withLong COVID in an adult population.
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.
Drug: AER002
Intravenous infusion of AER002
Other: Placebo
Placebo infusion
Key Inclusion Criteria (note, additional eligibility criteria not listed here will be
assessed at Screening):
- Male, female, or transgender ≥18 years of age at Screening.
- History of confirmed acute SARS-CoV-2 infection.
- Long COVID attributed to a SARS-CoV-2 infection with a variant against which AER002
is known to have neutralizing activity (prior to August 15, 2022). Note: While
individuals re-infected with SARS-CoV-2 after August 15, 2022 will not be excluded,
the SARS-CoV-2 infection after which Long COVID symptoms began must pre-date August
15, 2022.
- At least two symptoms that are new or worsened since the time of SARS-CoV-2
infection, not known to be attributable to another cause upon assessment by the PI.
Symptoms must have been present for at least 60 days prior to screening and must be
reported to be at least somewhat bothersome.
- Body mass index (BMI) 18 to 50 kilograms/meter squared (kg/m2), inclusive, at the
time of screening.
- Participants who are of childbearing potential (CBP) and male participants with
sexual partner(s) who are females of CBP must agree to use adequate contraception
from study consent through 360 days after dosing.
Key Exclusion Criteria (note, additional eligibility criteria not listed here will be
assessed at Screening):
- Long COVID attributed to a SARS-CoV-2 infection after August 15, 2022.
- Previously received treatment or prophylaxis with a SARS-CoV-2-specific mAb, or plan
to receive such treatment before exiting the study.
- Previously received COVID-19 convalescent plasma treatment within 60 days prior to
Day 0 or plan to receive such treatment before exiting the study.
- Plans to receive any investigational or approved vaccine or booster for SARS-CoV-2
within 60 days prior to Day 0 or before Day 30 following Day 0.
- Active cardiovascular disease or recent (within 3 months) stroke.
- Recent (within 6 months) or planned major surgery.
- Currently hospitalized or recent (within 1 month) unplanned hospitalization.
- Active Hepatitis Bor C infection .
- Untreated or unstable HIV infection (two or more consecutive plasma HIV RNA values
>48 copies/mL in the 6 months prior to screen).
- Severe coagulopathy (international normalized ratio ((INR) >2.0, history of
hemophilia).
- Severe anemia (hemoglobin <9 grams/deciliter (g/dL)).
- Moderate or severe immunocompromise, according to the current NIH COVID-19 Treatment
Guidelines as of March 6, 2023.
- History of anaphylaxis or hypersensitivity upon receiving IV antibody infusions, any
componenets of the intervention, prescription or non-prescription drugs, or food
products in the past.
- Pregnant, breastfeeding, or unwilling to practice birth control abide by the
contraception requirements outlined in the inclusion criteria.
- Participation in a clinical trial with receipt of an investigational product within
28 days or 5 half-lives (whichever is longer) prior to Day 0.
- Presence of a condition or abnormality that in the opinion of the Investigator would
compromise the safety of the patient or the quality of the data.
UCSF/Zuckerberg San Francisco General Hospital
San Francisco, California, United States
Michael J Peluso, MD, Principal Investigator
University of California, San Francisco