Sponsor study identifier
Secondary identifiers
EUDRACT_NUMBER
interventional
203
3 countries
14
Study Start
August 29, 2022
Actual (reported)Primary Completion
May 10, 2024
Actual (reported)Study Completion
May 10, 2024
Actual (reported)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).
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
May 10, 2024
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
August 3, 2022
Actual (reported)August 11, 2022
Actual (reported)August 29, 2022
Actual (reported)May 10, 2024
Actual (reported)May 10, 2024
Actual (reported)Improvement in fatigue in PASC patients
Occurrence of an improvement in fatigue, measured by a decrease of ≥3 points in the Patient-Reported Outcomes Measurement Information System Fatigue Short Form 7a (PROMIS Fatigue SF 7a) score, at Week 24 as compared to baseline.
24 weeks
Fatigue
24 weeks
Cognitive function
24 weeks
Cognitive function
24 weeks
Cognitive function
24 weeks
Cognitive function
24 weeks
Monthly IV repeated dose in addition to standard of care
Monthly IV repeated dose in addition to standard of care
Temelimab 54mg/kg will be given as monthly (every 4 weeks) intravenous (IV) infusion over 24 weeks (6 infusions in total)
Placebo will be given as monthly (every 4 weeks) intravenous (IV) infusion over 24 weeks (6 infusions in total)
Clinica Metabolica dell'Università di Modena e Reggio Emilia
Modena, 41124, Italy
U.O.C. Malattie Infettive Tor Vergata, Policlincio Tor Vergata
Roma, 00133, Italy
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Roma, 00168, Italy
Hospital of Vipiteno
Sterzing, 39049, Italy
Ace Alzheimer Center
Barcelona, 08028, Spain
Private clinic Blue Healthcare
Madrid, 28036, Spain
Hospital Universitario Quirónsalud Madrid
Madrid, 28223, Spain
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;138:106892. doi: 10.1016/j.bbi.2026.106892. Online ahead of print.
David LEPPERT, MD
GeNeuro SA
203 participants (actual enrollment reported by the registry).
First Submitted
August 3, 2022
First Posted
August 11, 2022
Study Start
August 29, 2022
Actual (reported)Mental Intervention and Nicotinamide Riboside Supplementation in Long Covid
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Hospital General Universitario- Servicio de Medicina Interna
Valencia, 46014, Spain
Hospital Royo Villanova
Zaragoza, 50015, Spain
REHAB Clinic for Neurorehabilitation and Paraplegiology
Basel, 4055, Switzerland
Inselspital Bern University Hospital Bern
Bern, 301, Switzerland
Kantonsspital Graubünden
Chur, 7000, Switzerland
Geneva University Hospital
Geneva, 1211, Switzerland
Centre hospitalier du Valais Romand (CHVR) - Hôpital du Valais
Sion, 1951, Switzerland
Primary Completion
May 10, 2024
Actual (reported)Study Completion
May 10, 2024
Actual (reported)Last Updated
May 17, 2024
Record last verified: 2024-05
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Source: ClinicalTrials.gov.
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