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

NCT ID: NCT05497089

Last Updated: 2024-05-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 203 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-08-29
• Study Completion Date: 2024-05-10

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).

Conditions

Post-COVID-19 Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Temelimab 54mg/kg

Monthly IV repeated dose in addition to standard of care

Group Type: EXPERIMENTAL

Temelimab 54mg/kg

Intervention Type: DRUG

Temelimab 54mg/kg will be given as monthly (every 4 weeks) intravenous (IV) infusion over 24 weeks (6 infusions in total)

Placebo

Monthly IV repeated dose in addition to standard of care

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo will be given as monthly (every 4 weeks) intravenous (IV) infusion over 24 weeks (6 infusions in total)

Interventions

Temelimab 54mg/kg

Temelimab 54mg/kg will be given as monthly (every 4 weeks) intravenous (IV) infusion over 24 weeks (6 infusions in total)

Intervention Type: DRUG

Placebo

Placebo will be given as monthly (every 4 weeks) intravenous (IV) infusion over 24 weeks (6 infusions in total)

Intervention Type: DRUG

Eligibility Criteria

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.

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

GeNeuro SA

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

David LEPPERT, MD

Role: STUDY_DIRECTOR

GeNeuro SA

Locations

Clinica Metabolica dell'Università di Modena e Reggio Emilia

Modena, , Italy

U.O.C. Malattie Infettive Tor Vergata, Policlincio Tor Vergata

Roma, , Italy

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Roma, , Italy

Hospital of Vipiteno

Sterzing, , Italy

Ace Alzheimer Center

Barcelona, , Spain

Private clinic Blue Healthcare

Madrid, , Spain

Hospital Universitario Quirónsalud Madrid

Madrid, , Spain

Hospital General Universitario- Servicio de Medicina Interna

Valencia, , Spain

Hospital Royo Villanova

Zaragoza, , Spain

REHAB Clinic for Neurorehabilitation and Paraplegiology

Basel, , Switzerland

Inselspital Bern University Hospital Bern

Bern, , Switzerland

Kantonsspital Graubünden

Chur, , Switzerland

Geneva University Hospital

Geneva, , Switzerland

Centre hospitalier du Valais Romand (CHVR) - Hôpital du Valais

Sion, , Switzerland

Countries

Italy; Spain; Switzerland

Other Identifiers

2022-000618-32

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

GNC-501

Identifier Type: -

Identifier Source: org_study_id