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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 belowSelect...
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:Select...
I have a severe bleeding disorder.
Select...
My HIV is not under control or untreated.
Select...
I have heart disease or had a stroke in the last 3 months.
Select...
I have received or plan to receive a COVID-19 antibody treatment.
Select...
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.
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 moreTrial 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
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.
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.
Find a Location
Who is running the clinical trial?
PolyBio Research FoundationUNKNOWN
2 Previous Clinical Trials
210 Total Patients Enrolled
Patient-Led Research CollaborativeUNKNOWN
Michael Peluso, MDLead Sponsor
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am 18 years old or older.Your body mass index (BMI) is between 18 and 50.I have a severe bleeding disorder.You have a weakened immune system based on the current guidelines for treating COVID-19.My HIV is not under control or untreated.I have long COVID from a variant before August 15, 2022, that AER002 can target.I have heart disease or had a stroke in the last 3 months.Your hemoglobin level is very low, less than 9 grams per deciliter.I have had new or worse symptoms for over 60 days since getting COVID-19.I have received or plan to receive a COVID-19 antibody treatment.I have long COVID symptoms from an infection after August 15, 2022.I have had major surgery in the last 6 months or plan to soon.I do not have an active Hepatitis B or C infection.I have not had COVID-19 plasma treatment in the last 60 days nor plan to before the study ends.I plan to get a COVID-19 vaccine or booster close to my trial start date.I have had a confirmed case of COVID-19.I am currently in the hospital or was unexpectedly hospitalized within the last month.You have had a severe allergic reaction to IV antibody infusions, any parts of the treatment, prescribed or over-the-counter drugs, or certain foods in the past.
Research Study Groups:
This trial has the following groups:- Group 1: AER002
- Group 2: Placebo
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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