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

Long COVID Clinical Trial

Official title:
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)

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05877508
Study type Interventional
Source University of California, San Francisco
Contact
Status Active, not recruiting
Phase Phase 2
Start date August 1, 2023
Completion date July 31, 2025
View Details
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