Clinical trial NCT05497089: Temelimab as a Disease Modifying Therapy in Patients With Neuropsychiatric Symptoms in Post-COVID 19 or PASC Syndrome
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Post-COVID-19 Syndrome
Keywords: GNbAC1
Human Endogenous Retrovirus Type W
HERV-W
Temelimab
Post-COVID-19
PASC syndrome
Neuropsychiatric sequelae
Lead sponsor: GeNeuro SA
Sponsor class: INDUSTRY
First posted: 2022-08-11
Enrollment: 203
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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).


Eligibility criteria: Main Inclusion Criteria:

* PASC Syndrome in accordance with NICE criteria with neuropsychiatric symptoms still occurring \>12 weeks after their first appearance.
* Has had a SARS-CoV-2-positive diagnostic test (using a validated SARS-CoV-2 antigen, reverse transcription polymerase chain reaction \[RT-PCR\], or other molecular diagnostic assay, and an appropriate sample such as nasopharyngeal \[NP\], nasal, oropharyngeal \[OP\], or saliva). In case that the local standard of care did not foresee the previously mentioned tests, a confirmed SARS-CoV-2 nucleocapsid or membrane antibody test associated to a medical report documenting the date of COVID-19 clinical diagnostic, will be accepted.
* 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 (e.g. attention deficit/hyperactivity disorder, substance use disorder, schizophrenia documented in patient history or diagnosed using M.I.N.I), at the discretion of the site investigator, 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//immunomodulating medication (e.g., azathioprine, tacrolimus, cyclosporine, methotrexate, hydroxychloroquine, cytotoxic chemotherapy, or neutralizing antibodies against SARS-CoV-2 epitopes) or therapy with HIV protease inhibitors

Primary outcomes:
measure: Improvement in fatigue in PASC patients
timeFrame: 24 weeks
Secondary outcomes:
measure: Fatigue
timeFrame: 24 weeks
measure: Cognitive function
timeFrame: 24 weeks
measure: Cognitive function
timeFrame: 24 weeks
measure: Cognitive function
timeFrame: 24 weeks
measure: Cognitive function
timeFrame: 24 weeks
measure: Anxiety
timeFrame: 24 weeks
measure: Depression
timeFrame: 24 weeks
measure: Overall quality of Life
timeFrame: 24 weeks
measure: Functional impairment
timeFrame: 24 weeks
measure: Post-COVID-19 Functional Status
timeFrame: 24 weeks
measure: Safety and tolerability of Temelimab in PASC patients
timeFrame: 24 weeks
Other outcomes:
Locations:
city: Modena
country: Italy
facility: Clinica Metabolica dell'Università di Modena e Reggio Emilia
city: Roma
country: Italy
facility: U.O.C. Malattie Infettive Tor Vergata, Policlincio Tor Vergata
city: Roma
country: Italy
facility: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
city: Vipiteno
country: Italy
facility: Hospital of Vipiteno
city: Barcelona
country: Spain
facility: Ace Alzheimer Center
city: Madrid
country: Spain
facility: Private clinic Blue Healthcare
city: Madrid
country: Spain
facility: Hospital Universitario Quirónsalud Madrid
city: Valencia
country: Spain
facility: Hospital General Universitario- Servicio de Medicina Interna
city: Zaragoza
country: Spain
facility: Hospital Royo Villanova
city: Basel
country: Switzerland
facility: REHAB Clinic for Neurorehabilitation and Paraplegiology
city: Bern
country: Switzerland
facility: Inselspital Bern University Hospital Bern
city: Chur
country: Switzerland
facility: Kantonsspital Graubünden
city: Geneva
country: Switzerland
facility: Geneva University Hospital
city: Sion
country: Switzerland
facility: Centre hospitalier du Valais Romand (CHVR) - Hôpital du Valais
Study officials:
affiliation: GeNeuro SA
name: David LEPPERT, MD
role: STUDY_DIRECTOR
References: