A phase 2a double-blind, placebo-controlled randomized trial of the SARS-CoV-2-specific monoclonal antibody AER002 in people with Long COVID
et al., medRxiv, doi:10.64898/2026.03.07.26347857 (results released 10/28/25), outSMART-LC, NCT05877508, Oct 2025
RCT 36 long COVID outpatients showing no significant clinical benefit with the AER002 monoclonal antibody compared to placebo.
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.
|
risk of long COVID, 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 |
Peluso et al., 28 Oct 2025, Double Blind Randomized Controlled Trial, placebo-controlled, USA, preprint, median age 42.0, 40 authors, study period July 2023 - April 2024, trial NCT05877508 (history) (outSMART-LC).
Contact: michael.peluso@ucsf.edu.
Abstract: medRxiv preprint doi: https://doi.org/10.64898/2026.03.07.26347857; this version posted March 9, 2026. The copyright holder for this preprint
(which was not certified by peer review) is the author/funder, who has granted medRxiv a license to display the preprint in perpetuity.
It is made available under a CC-BY 4.0 International license .
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A phase 2a double-blind, placebo-controlled randomized trial of the SARS-CoV-2-specific
monoclonal antibody AER002 in people with Long COVID
Michael J. Peluso1*^, Dylan Ryder1*, Thomas Dalhuisen1, Danny Hoi Tsun Chu2, Meghann C. Williams1,
Antonio E. Rodriguez1, Brian LaFranchi3, Joanna Vinden3, Emily A. Fehrman1, Beatrice Huang1, Rebecca
Hoh1, Kofi A. Asare1, Kathleen Bellon Pizarro1, Mohammad Rahman2, Emilio de Narvaez3, Mark M. Painter5,
E. John Wherry5, Zoe N. Swank6, Louise L. Hansen6, David R. Walt6, Yoshinori Fukazawa3, Anisha Sekar7,
Steven E. Bellan7, Holly Tieu8, Josephat Asiago8, Prakash Bhuyan8, Rajeev Venkayya8, Robert R. Flavell9,
Henry VanBrocklin9, J. Daniel Kelly10, Priscilla Y. Hsue11, Matthew S. Durstenfeld4, Peter W. Hunt3, Leonard
Calabrese12, Ma Somsouk13, Jeffrey N. Martin10, David V. Glidden10, Amelia N. Deitchman2, Timothy J.
Henrich3, Steven G. Deeks1
*Co-first authors
1
Division of HIV, Infectious Diseases, and Global Medicine, University of California, San Francisco, San
Francisco, CA, USA
2
Department of Clinical Pharmacy, University of California, San Francisco, San Francisco, CA, USA
3
Division of Experimental Medicine, University of California, San Francisco, San Francisco, CA, USA
4
Division of Cardiology, University of California, San Francisco, San Francisco, CA, USA
5
University of Pennsylvania, Philadelphia, PA, USA
6
Department of Pathology, Brigham & Women’s Hospital, Harvard Medical School, Boston, MA, USA
7
Patient-Led Research Collaborative
8
Aerium Therapeutics, Boston, MA, USA
9
Department of Radiology and Biomedical Imaging, University of California, San Francisco, San Francisco,
CA, USA
10
Department of Epidemiology and Biostatistics, University of California, San Francisco, San Francisco, CA,
USA
11
Division of Cardiology, University of California, Los Angeles, CA, USA
12
Cleveland Clinic, Cleveland, OH, USA
13
Division of Gastroenterology, University of California, San Francisco, San Francisco, CA, USA
^Corresponding Author:
Michael J. Peluso, MD
2540 23rd Street, #4807
San Francisco CA 94110
michael.peluso@ucsf.edu
NOTE: This preprint reports new research that has not been certified by peer review and should not be used to guide clinical practice.
medRxiv preprint doi: https://doi.org/10.64898/2026.03.07.26347857; this version posted March 9, 2026. The copyright holder for this preprint
(which was not certified by peer review) is the author/funder, who has granted medRxiv a license to display the preprint in perpetuity.
It is made available under a CC-BY 4.0 International license .
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ABSTRACT
Long COVID is a disabling chronic illness with no proven treatments. Persistence of SARS-CoV-2 has been
proposed as a biological driver of the disease. We conducted a placebo-controlled, double-blind, 2:1
randomized mechanistic trial of the SARS-CoV-2-specific monoclonal antibody AER002 in 36 participants
who met the World Health..
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Late treatment
is less effective
is less effective
