CI

At a glance

ClinicalIndex Comparison Record
Phase 2Active· 36 enrolled
Drug / intervention
AER002 +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05877508
NCT05877508Phase 2Active
CompareCT.gov

An Exploratory, Randomized, Double-Blind Placebo-Controlled Study to Assess the Safety of an Anti-SARS-CoV-2 Monoclonal Antibody and Response to Treatment in Individuals With Long COVID (outSMART-LC)

Michael Peluso, MD·interventional·Posted May 26, 2023·Updated Oct 28, 2025

In Brief

A Phase 2 clinical trial evaluating AER002 and Placebo for Long COVID and 2 related conditions. Active but no longer recruiting, targeting 36 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsLong COVID, Post-Acute Sequela of COVID-19, Post-Acute COVID-19
CountriesUnited States
CollaboratorsAerium Therapeutics, Patient-Led Research Collaborative, PolyBio Research Foundation

Timeline

Phase 2Active
202420252026
First PostedMay 26, 2023
Enrollment StartAug 1, 2023
Primary CompletionJul 29, 2024
Study CompletionJul 31, 2026
TodayJul 2, 2026
Enrollment to primary: 12 monthsPosted 3.1 years ago

Interventions

AER002drug

Intravenous infusion of AER002

Placeboother

Placebo infusion