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)

Peluso et al., NCT05877508, outSMART-LC, NCT05877508, Oct 2025

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https://c19early.org/peluso2.html

RCT 36 patients showing no improvement in long COVID with AER002.

Standard of Care (SOC) for COVID-19 in the study country, the USA, is very poor with very low average efficacy for approved treatments1. Only expensive, high-profit treatments were approved for early treatment. Low-cost treatments were excluded, reducing the probability of early treatment due to access and cost barriers, and eliminating complementary and synergistic benefits seen with many low-cost treatments.

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risk of PASC, 6.5% higher, RR 1.06, p = 0.25, treatment mean 41.7 (±6.5) n=24, control mean 44.4 (±6.45) n=12, relative PROMIS-29 score.

Effect extraction follows pre-specified rules prioritizing more serious outcomes. Submit updates

1. c19early.org, c19early.org/soc/usa.html.

Peluso et al., 28 Oct 2025, Double Blind Randomized Controlled Trial, placebo-controlled, USA, preprint, 1 author, trial NCT05877508 (history) (outSMART-LC). Contact: michael.peluso@ucsf.edu.

This Paper AER002 All

Late treatment
is less effective

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