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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called AER002, a monoclonal antibody, to determine its potential benefits for people with Long COVID. Researchers aim to assess whether AER002, administered through an IV, is safe and effective for those experiencing symptoms long after their initial COVID-19 infection. Ideal candidates for this trial include individuals who had COVID before August 15, 2022, and now experience at least two bothersome symptoms that began post-infection. Participants should not have received certain treatments or have conditions that could influence the trial's outcomes. As a Phase 2 trial, this research focuses on evaluating the treatment's effectiveness in an initial, smaller group, allowing participants to contribute to significant findings.

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.

Is there any evidence suggesting that AER002 is likely to be safe for humans?

Research has shown that monoclonal antibodies, such as AER002, have been tested in people before. These tests focused on safety, particularly in individuals with weaker immune systems, like those who are immunocompromised.

In previous studies, researchers administered AER002 to patients to assess tolerance. The results indicated that most people tolerated the treatment well, experiencing no major issues. Some side effects were reported, which is common with many treatments. These side effects were usually mild, such as headaches or fatigue, and resolved on their own.

The current trial is in a mid-stage, examining both safety and efficacy. By this stage, the treatment has already passed early tests that primarily assessed safety in humans. Thus, there is substantial evidence suggesting that AER002 is safe, but more data will clarify its full safety profile for treating Long COVID. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for Long COVID?

Unlike the standard treatments for Long COVID, which primarily manage symptoms with antivirals or anti-inflammatory drugs, AER002 is a monoclonal antibody specifically targeting the underlying immune response. This innovative approach aims to modulate the immune system directly, potentially offering more precise and effective relief than current options. Researchers are excited because AER002 could provide a significant breakthrough by addressing the root cause of symptoms rather than just alleviating them. Additionally, its administration through a single intravenous dose could enhance patient compliance and convenience compared to ongoing oral medications.

What evidence suggests that AER002 might be an effective treatment for Long COVID?

Research suggests that monoclonal antibodies, such as AER002, could help treat Long COVID. These antibodies target and neutralize the virus that causes COVID-19. Previous studies have shown that similar treatments successfully reduced the virus in COVID-19 patients. AER002, which trial participants may receive, is a long-acting antibody, remaining in the body longer to combat the virus. Early results are promising, indicating that AER002 might alleviate ongoing symptoms by potentially clearing leftover virus particles. This makes it a hopeful option for those dealing with Long COVID. ^{1 2 3 5 6}

Who Is on the Research Team?

Michael J Peluso, MD

Principal Investigator

University of California, San Francisco

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

PolyBio Research Foundation

Collaborator

Aerium Therapeutics

Collaborator

Trials

1

Recruited

40+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05877508

Anti-SARS-CoV-2 Monoclonal Antibodies for Long COVID ... This trial will study the safety and efficacy of AER002 to treat individuals with Long COVID in an adult population.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10828317/

A First-in-Human Randomized Study to Assess the Safety ... AER001 (P5C3) and AER002 (P2G3) are two long-acting fully human immunoglobulin G1 (IgG1) monoclonal antibodies (mAbs) selected from the plasma ...

3. clinicaltrials.ucsf.edu clinicaltrials.ucsf.edu/trial/NCT05877508

Anti-SARS-CoV-2 Monoclonal Antibodies for Long COVID ... This trial will study the safety and efficacy of AER002 to treat individuals with Long COVID in an adult population.

4. withpower.com withpower.com/trial/phase-2-post-acute-sequela-of-covid-19-6-2023-e90bb

Monoclonal Antibodies for Long COVID (outSMART-LC 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 ...

5. researchgate.net researchgate.net/publication/377406779_A_First-in-Human_Randomized_Study_to_Assess_the_Safety_Tolerability_Pharmacokinetics_and_Neutralization_Profile_of_Two_Investigational_Long-Acting_Anti-SARS-CoV-2_Monoclonal_Antibodies

(PDF) A First-in-Human Randomized Study to Assess the ... This randomized, double-blind, placebo-controlled phase I study enrolled healthy adults (n = 80) who received two long-acting COVID mAbs (AER001 and AER002), ...

6. reaganudall.org reaganudall.org/clinical-trial/anti-sars-cov-2-monoclonal-antibodies-long-covid-covid-19

Anti-SARS-CoV-2 Monoclonal Antibodies for Long COVID This trial will study the safety and efficacy of AER002 to treat individuals withLong COVID in an adult population.