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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline and 3 months post-infusion.
Awards & highlights
outSMART-LC Trial Summary
This trial will study if a drug called AER002 can treat Long COVID, which may be caused by a persistent viral infection and circulating spike protein.
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.Check my eligibility
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.See study design
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.
outSMART-LC Trial 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.
outSMART-LC Trial 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
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in Patient-Reported Outcomes Measurement Information System (PROMIS)-29 Score from Baseline.
Other outcome measures
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 moreoutSMART-LC 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
Find a Location
Who is running the clinical trial?
PolyBio Research FoundationUNKNOWN
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any known risks associated with AER002 usage?
"AER002's safety has been partially proven in clinical settings, thus it rated a 2 on the scale. Unfortunately, no efficacy data exists yet for this medication."
Answered by AI
Is the research team actively seeking participants for this trial?
"According to clinicaltrials.gov, this research project is no longer active and has not been accepting new candidates since May 24th of 2023. Despite the conclusion of this investigation, there are currently 844 other medical studies in search of participants at this very moment."
Answered by AI
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