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

• Status: Not yet recruiting
• Trial end date: 2023-03-31
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: GeNeuro SA

Criteria

Main Inclusion Criteria:

• PASC Syndrome in accordance with NICE criteria with symptoms still occurring >12 to 48 weeks post diagnostic RT-PCR date

• PROMIS Fatigue SF 7a total raw score ≥21 with onset of fatigue post coronavirus disease 2019 (COVID-19) infection

• Patients affected with at least one of the following measures of objective impairment of cognitive function or of quality of life as defined by: i. Token Motor Test ≥1 z-score below the age/sex-adjusted mean ii. EQ5D-5L: Presence of at least 1 score ≥3 in any of the 5 variables of EQ5D-5L questionnaire (mobility; self-care; usual activities; pain/discomfort; anxiety/depression) iii. PQD-20 ≥27

• HERV-W ENV positive as defined by automated capillary western system, specific signal level over background noise (S/N) >1.

Main Exclusion Criteria:

• Intubation and mechanical ventilation in the course of COVID19 or reception of convalescent COVID19 plasma treatment at any time prior to study entry

• Major psychiatric conditions including but not restricted to (attention deficit/hyperactivity disorder, substance use disorder, schizophrenia documented in patient history or diagnosed using M.I.N.I) these do not refer to patients with typical mild to moderate symptoms of depression and anxiety associated with PASC

• Neurological signs and symptoms including change in level of consciousness, seizures, movement disorders or focal neurological deficits, disorders of the central nervous system with tissue damage or a pre-COVID-19 diagnosis of Chronic Fatigue Syndrome documented in the patient history or diagnosed during the neurological examination

• Current immunosuppressive medication (e.g., azathioprine, tacrolimus, cyclosporine, methotrexate, hydroxychloroquine, cytotoxic chemotherapy, or neutralizing antibodies against SARS-CoV-2 epitopes) or therapy with HIV protease inhibitors