Monoclonal Antibodies for Long COVID

(outSMART-LC Trial)

Overseen By Study Email

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Michael Peluso, MD

Must not be taking: Monoclonal antibodies, Convalescent plasma

Disqualifiers: Cardiovascular disease, Stroke, Surgery, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 2

Duration: 1 day

36 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial will test a special medicine called AER002, which is designed to help people with Long COVID. The medicine works by targeting and helping to remove leftover virus or viral proteins in the body. The study will include about 30 adults who still have symptoms long after their initial COVID-19 infection.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss your specific situation with the trial team.

What data supports the effectiveness of the drug AER002 for treating long COVID?

Research shows that monoclonal antibodies have helped some people recover from severe long COVID symptoms quickly. Additionally, similar treatments have been effective in reducing the risk of long COVID and improving outcomes in COVID-19 cases. ^{1 2 3 4 5}

Is the monoclonal antibody treatment AER002 safe for humans?

In a study of 142 pediatric patients treated with monoclonal antibodies for COVID-19, 9% experienced mild side effects, but none required ventilators or died, suggesting a generally safe profile. ^{2 4 6 7 8}

How does the drug AER002 differ from other treatments for Long COVID?

AER002 is a monoclonal antibody treatment that targets specific parts of the virus's spike protein, potentially offering a more targeted approach compared to other treatments. This specificity may help in neutralizing various SARS-CoV-2 variants, which could be beneficial for managing Long COVID symptoms. ^{6 8 9 10 11}

Research Team

Michael J Peluso, MD

Principal Investigator

University of California, San Francisco

Eligibility Criteria

Adults over 18 with Long COVID, having symptoms for at least 60 days post SARS-CoV-2 infection. Must have a BMI of 18-50 and agree to use contraception if of childbearing potential. Excludes those who've had certain treatments for COVID-19, recent hospitalizations or surgeries, active hepatitis B/C or cardiovascular disease, severe coagulopathy or anemia, untreated HIV, immunocompromise conditions as per NIH guidelines.

Inclusion Criteria

Your body mass index (BMI) is between 18 and 50.

I have long COVID from a variant before August 15, 2022, that AER002 can target.

I have had new or worse symptoms for over 60 days since getting COVID-19.

Exclusion Criteria

I have a severe bleeding disorder.

Pregnant, breastfeeding, or unwilling to practice birth control abide by the contraception requirements outlined in the inclusion criteria

You have a weakened immune system based on the current guidelines for treating COVID-19.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a single IV infusion of AER002 or placebo

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

1 year

Multiple visits up to 1 year post-infusion

Treatment Details

Interventions

• AER002

Trial Overview The trial is testing AER002's safety and effectiveness against Long COVID by targeting viral reservoirs and circulating spike proteins. Participants will either receive AER002 or a placebo to determine if the monoclonal antibody can alleviate long-term symptoms.

Participant Groups

Group I: AER002 Experimental Treatment 1 Intervention

AER002 1200mg administered once by IV

Group II: Placebo Placebo Group 1 Intervention

Placebo administered once by IV

Who Is Running the Clinical Trial?

Michael Peluso, MD

Lead Sponsor

Trials

1

Recruited

40+

PolyBio Research Foundation

Collaborator

Trials

3

Recruited

250+

Patient-Led Research Collaborative

Collaborator

Trials

1

Recruited

40+

Aerium Therapeutics

Collaborator

Trials

1

Recruited

40+

References

1. United States pubmed.ncbi.nlm.nih.gov

Remission of severe forms of long COVID following monoclonal antibody (MCA) infusions: A report of signal index cases and call for targeted research. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

Efficacy and Safety of LY3127804, an Anti-Angiopoietin-2 Antibody, in a Randomized, Double-Blind, Placebo-Controlled Clinical Trial in Patients Hospitalized with Pneumonia and Presumed or Confirmed COVID-19. [2022]

3. Switzerland pubmed.ncbi.nlm.nih.gov

Monoclonal Antibodies and Antivirals against SARS-CoV-2 Reduce the Risk of Long COVID: A Retrospective Propensity Score-Matched Case-Control Study. [2023]

4. United States pubmed.ncbi.nlm.nih.gov

Antibody-mediated protection against symptomatic COVID-19 can be achieved at low serum neutralizing titers. [2023]

5. United States pubmed.ncbi.nlm.nih.gov

Early treatment with a combination of two potent neutralizing antibodies improves clinical outcomes and reduces virus replication and lung inflammation in SARS-CoV-2 infected macaques. [2023]

6. England pubmed.ncbi.nlm.nih.gov

Broadly neutralizing antibodies derived from the earliest COVID-19 convalescents protect mice from SARS-CoV-2 variants challenge. [2023]

7. England pubmed.ncbi.nlm.nih.gov

Monoclonal Antibody Use for Coronavirus Disease 2019 in Pediatric Patients: A Multicenter Retrospective Study. [2023]

8. United States pubmed.ncbi.nlm.nih.gov

Distinct in vitro and in vivo neutralization profiles of monoclonal antibodies elicited by the receptor binding domain of the ancestral SARS-CoV-2. [2023]

9. China pubmed.ncbi.nlm.nih.gov

[Preparation of monoclonal antibodies against SARS coronavirus and staining usage in lung autopsy specimens]. [2022]

10. Switzerland pubmed.ncbi.nlm.nih.gov

Rabbit Monoclonal Antibody Specifically Recognizing a Linear Epitope in the RBD of SARS-CoV-2 Spike Protein. [2021]

11. Switzerland pubmed.ncbi.nlm.nih.gov

Selection and Characterization of Monoclonal Antibodies Targeting Middle East Respiratory Syndrome Coronavirus through a Human Synthetic Fab Phage Display Library Panning. [2023]