What side effects are associated with this type of intervention?

Common treatments for COVID-19, such as monoclonal antibodies targeting the spike protein, remdesivir, dexamethasone, and convalescent plasma, have various side effects. Monoclonal antibodies can cause infusion-related reactions, including fever, chills, and rash. Remdesivir may lead to liver enzyme elevations and gastrointestinal symptoms like nausea. Dexamethasone, a corticosteroid, can cause hyperglycemia, increased risk of infection, and mood changes. Convalescent plasma therapy may result in allergic reactions and transfusion-related complications.

What prior FDA approvals exist?

The FDA has granted Emergency Use Authorization (EUA) for several monoclonal antibody treatments targeting the spike protein of SARS-CoV-2. These include therapies such as bamlanivimab, etesevimab, casirivimab, and imdevimab. These monoclonal antibodies are designed to neutralize the virus by binding to its spike protein, preventing it from entering human cells. These treatments have been used for mild to moderate COVID-19 in high-risk patients to reduce the risk of severe disease progression.

What other types of research exist?

Promising alternatives to AER002 for COVID-19 treatment include: 1) Sotrovimab (VIR-7831), which has shown efficacy against various SARS-CoV-2 variants including Omicron. 2) AZD8895 and AZD1061 from AstraZeneca, which are also designed to target the spike protein. 3) New monoclonal antibodies identified through antibody engineering and phage display libraries, such as the R3P1-E4 clone, which have shown improved neutralization activity against spike protein mutants. These alternatives are being actively studied and may offer effective treatment options in 2024.

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Monoclonal Antibodies

Monoclonal Antibodies for Long COVID (outSMART-LC Trial)

Phase 2

Waitlist Available

Led By Michael J Peluso, MD

Research Sponsored by Michael Peluso, MD

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

History of confirmed acute SARS-CoV-2 infection

Be older than 18 years old

Must not have

Severe coagulopathy (international normalized ratio ((INR) >2.0, history of hemophilia)

Untreated or unstable HIV infection (two or more consecutive plasma HIV RNA values >48 copies/mL in the 6 months prior to screen)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline and 3 months post-infusion.

Awards & highlights

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

While specific side effects are not listed here, monoclonal antibodies like AER002 may cause allergic reactions including anaphylaxis, infusion-related reactions such as fever or chills, fatigue, headache and possible impacts on organ function.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have had a confirmed case of COVID-19.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a severe bleeding disorder.

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My HIV is not under control or untreated.

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I have heart disease or had a stroke in the last 3 months.

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I have received or plan to receive a COVID-19 antibody treatment.

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I do not have an active Hepatitis B or C infection.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline and 3 months post-infusion.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline and 3 months post-infusion.

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline and 3 months post-infusion. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in Patient-Reported Outcomes Measurement Information System (PROMIS)-29 Score from Baseline.

Other study objectives

CNS-Vital Signs Global Neurocognitive Index

Change in Composite Autonomic Symptom Score (COMPASS-31) Score from Baseline.

Distance walked on 6 minute walk test (6MWT).

+1 more

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: AER002Experimental Treatment1 Intervention

AER002 1200mg administered once by IV

Group II: PlaceboPlacebo Group1 Intervention

Placebo administered once by IV

0 / 6Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for COVID-19 include monoclonal antibodies, antivirals, and anti-inflammatory drugs. Monoclonal antibodies, such as those being studied in the AER002 trial, target the SARS-CoV-2 spike protein, neutralizing the virus and preventing it from entering human cells. This is particularly important for COVID-19 patients as it can reduce viral load and prevent severe disease progression. Antivirals inhibit viral replication, while anti-inflammatory drugs help manage the immune system's response to prevent complications. Understanding these mechanisms allows for more effective treatment strategies, improving patient outcomes.

Determining available strategies for prevention and therapy: Exploring COVID‑19 from the perspective of ACE2 (Review).The Pipeline of Therapeutics Testing During the Emergency Phase of the COVID-19 Outbreak.Evidence and the Main Adverse Effects Regarding Drug Therapies in the War Against COVID-19.