Temelimab as a Disease Modifying Therapy in Patients With Neuropsychiatric Symptoms in Post-COVID 19 or PASC Syndrome

Summary

This study is a Phase 2, 24-week, randomized, prospective, double-blind, multicenter study in patients experiencing neuropsychiatric symptoms and functional impairment in the course of PASC. The purpose of the study is to evaluate the efficacy and safety of Temelimab as a treatment for PASC neuropsychiatric symptoms in patients who had severe acute respiratory syndrome coronavirus - type 2 (SARS-CoV-2) infection but did not undergo intensive care treatment during the acute period. Patients meeting eligibility criteria will be randomized to Temelimab or placebo in a 1:1 ratio via interactive voice/web response system to obtain 182 protocol completers. The randomization will be stratified by age (≤65 years versus \>65 years).

Timeline

Start

2022-08-29

Primary completion

2024-05-10

Completion

2024-05-10

Outcome

Missed primary endpoint

paper In adults with persistent symptoms due to post-COVID condition, the use of Temelimab did not show improvement in fatigue compared to placebo PMID 42409185 ↗

Publications

• Nehme M, Hund-Georgiadis M, Corral Beamonte ED, Bridevaux PO, Hoepner R, Penner IK, Strobel J, Fretz G, Rovira MB, Puchades F, Landi F, Vasco PG, Guaraldi G, Cordero FM, Sebastianelli L, Sarmati L, Berthuy N, Wojcik J, Keddad K, Post A, Leppert D, Guessous I. Temelimab versus placebo in patients with post-COVID condition. Brain Behav Immun. 2026 Jul 6:106892. doi: 10.1016/j.bbi.2026.106892. Online ahead of print.

Drugs

Indications