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

NCT05497089 | Completed Phase 2 DMC

• 2 other identifiers: GNC-5012022-000618-32
• Study Type: interventional
• Target: 203
• Locations: 3 countries
• Sites: 14

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

Keywords

GNbAC1; Human Endogenous Retrovirus Type W; HERV-W; Temelimab; Post-COVID-19; PASC syndrome; Neuropsychiatric sequelae

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (11)

• Fatigue

  24 weeks

• Cognitive function

  24 weeks

• Cognitive function

  24 weeks

• Cognitive function

  24 weeks

• Cognitive function

  24 weeks

Study Arms (2)

Temelimab 54mg/kg

EXPERIMENTAL

Monthly IV repeated dose in addition to standard of care

Drug: Temelimab 54mg/kg

Placebo

PLACEBO COMPARATOR

Monthly IV repeated dose in addition to standard of care

Drug: Placebo

Interventions

Temelimab 54mg/kg DRUG

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

Temelimab 54mg/kg

Placebo DRUG

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

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• GeNeuro SA: lead

Study Sites (14)

Clinica Metabolica dell'Università di Modena e Reggio Emilia

Modena, 41124, Italy

Location

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

Roma, 00133, Italy

Location

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Roma, 00168, Italy

Location

Hospital of Vipiteno

Sterzing, 39049, Italy

Location

Ace Alzheimer Center

Barcelona, 08028, Spain

Location

Private clinic Blue Healthcare

Madrid, 28036, Spain

Location

Hospital Universitario Quirónsalud Madrid

Madrid, 28223, Spain

Location

Hospital General Universitario- Servicio de Medicina Interna

Valencia, 46014, Spain

Location

Hospital Royo Villanova

Zaragoza, 50015, Spain

Location

REHAB Clinic for Neurorehabilitation and Paraplegiology

Basel, 4055, Switzerland

Location

Inselspital Bern University Hospital Bern

Bern, 301, Switzerland

Location

Kantonsspital Graubünden

Chur, 7000, Switzerland

Location

Geneva University Hospital

Geneva, 1211, Switzerland

Location

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

Sion, 1951, Switzerland

Location

MeSH Terms

Conditions

Post-Acute COVID-19 Syndrome

Interventions

temelimab

Condition Hierarchy (Ancestors)

COVID-19; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Post-Infectious Disorders; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• David LEPPERT, MD

  GeNeuro SA

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 3, 2022
• First Posted: August 11, 2022
• Study Start: August 29, 2022
• Primary Completion: May 10, 2024
• Study Completion: May 10, 2024
• Last Updated: May 17, 2024

Record last verified: 2024-05

Locations

ES (5); CH (5); IT (4)