Anti-SARS-CoV-2 Monoclonal Antibodies for Long COVID (COVID-19)

Launched by MICHAEL PELUSO, MD · May 24, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a treatment called AER002, which is a type of medicine known as a monoclonal antibody. It aims to determine if this treatment can help people suffering from Long COVID, a condition where symptoms persist long after the initial COVID-19 infection. The researchers believe that some people may still have lingering virus in their bodies, and AER002 might help to clear that out and improve their symptoms.

To qualify for the trial, participants need to be at least 18 years old and have a confirmed case of COVID-19 before August 15, 2022, along with ongoing symptoms that have been bothering them for at least two months. These symptoms should not be caused by anything else. Participants will be monitored closely throughout the study, but it’s important to note that those with certain health issues or recent treatments for COVID-19 may not be eligible. Overall, this trial hopes to provide new insights and potential relief for those struggling with Long COVID.

Gender

ALL

Eligibility criteria

• 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.