Clinical trial of Postacute Sequelae of COVID-19 (PASC) Syndrome
Research type
Research Study
Full title
Temelimab as a Disease Modifying Therapy in Patients with Neurological, Neuropsychological, and Psychiatric (=Neuropsychiatric) Symptoms in Post-COVID-19 or Postacute Sequelae of COVID-19 (PASC) Syndrome
IRAS ID
1008186
Contact name
David Leppert
Contact email
Sponsor organisation
GeNeuro S.A.
Eudract number
2022-000618-32
Research summary
The primary goal of the study is to evaluate the efficacy of treatment with Temelimab plus local standard of care (SoC) treatments versus local SoC alone over 6 months, on improvement in cognitive impairment or fatigue in PASC patients.
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.Test product & Reference Therapy, dose, and mode of administration:
Temelimab: 54 mg/kg dose strength, to be diluted in glucose 5% solution and administered by IV infusion
Placebo: matching placebo IV infusion for Temelimab to be diluted in glucose 5% solution.
Temelimab is an antibody that neutralizes the Human Endogenous Retrovirus-W Envelope (HERV-W Env). This protein has been found to be involved in different pathologies, including Multiple Sclerosis, but also to be associated with PASC. The aim of the study is to investigate if the neutralization of HERV-W Env contributes to the improvement of patients suffering from PASC.
The study includes a screening period of up to 4 weeks before Day 1 that includes a collection of demographics, medical history, vital signs, physical examination, blood parameters and electrocardiogram. Patients will undergo the neuropsychological
assessment at screening and Baseline to assess the level of functional impairment, using amongst other scales, the Brief Assessment of Cognition (BAC) and/or the WHO PostCOVID Functional Scale (PCFS).
Patients will be asked to complete questionnaires and undergo tests assessing other neuropsychiatric symptoms.
Patients who meet the eligibility requirements will be randomized at Day 1 to Temelimab or placebo in a 1:1 ratio. Up to 200 patients will receive 6 intravenous (IV) infusions of Temelimab at a dose of 54 mg/kg, every 4 weeks over 20 weeks or matching placebo. All patients can continue to receive current standard of care throughout the treatment period.REC name
East Midlands - Leicester South Research Ethics Committee
REC reference
23/EM/0140
Date of REC Opinion
15 Aug 2023
REC opinion
Further Information Favourable Opinion