Clinical Trial

Anti-SARS-CoV-2 Monoclonal Antibodies for Long COVID (COVID-19)

Study acronym: outSMART-LC
Active, Not Recruiting Phase 2
View on ClinicalTrials.gov →
Summary
Persistent viral infection with viral reservoirs and detection of circulating spike protein after the initial acute illness is one potential pathogenic mechanism for Long COVID. This mechanism may be able to be targeted by SARS-CoV-2 monoclonal antibodies (mAbs). This trial will study the safety and efficacy of AER002 to treat individuals with Long COVID in an adult population.
Protocol Amendment History 11 amendments
This ClinicalTrials.gov record has been amended 11 times since 2023-05-24; most recent amendment 2025-10-14.
Status change: Recruiting → Active, Not Recruiting 2024-01-03
Status change: Enrolling by Invitation → Recruiting 2023-08-01
Status change: Not Yet Recruiting → Enrolling by Invitation 2023-08-01
Trial Details
NCT Number NCT05877508
Lead Sponsor Michael Peluso, MD
Collaborators: Aerium Therapeutics, Patient-Led Research Collaborative, PolyBio Research Foundation
Conditions Long COVID, Post-Acute Sequela of COVID-19, Post-Acute COVID-19
Enrollment 36 participants
Start Date 2023-08-01
Primary Completion 2024-07-29 (estimated)
Study Completion 2026-07-31 (estimated)
Updated on ClinicalTrials.gov 2025-10-28