NCT05877508

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

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)

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 36 (actual)
• Sponsor: Michael Peluso, MD · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The study will enroll approximately 30 participants who meet the World Health Organization (WHO) Long COVID criteria, with Long COVID attributed to a SARS-CoV-2 variant susceptible to AER002. Participants will be enrolled at a single center and randomized 2:1 to receive a SARS-CoV-2 monoclonal antibody (AER002) 1200mg or placebo. Evaluations will take place at baseline and at timepoints up to 1-year post-infusion.

Conditions

• Long COVID
• Post-Acute Sequela of COVID-19
• Post-Acute COVID-19

Interventions

Type	Name	Description
DRUG	AER002	Intravenous infusion of AER002
OTHER	Placebo	Placebo infusion

Timeline

• Start date: 2023-08-01
• Primary completion: 2024-07-29
• Completion: 2026-07-31
• First posted: 2023-05-26
• Last updated: 2025-10-28
• Results posted: 2025-10-28

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study