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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05497089
Recruitment Status : Recruiting
First Posted : August 11, 2022
Last Update Posted : May 10, 2023
Sponsor:
Information provided by (Responsible Party):
GeNeuro SA

Study Description
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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).

Condition or disease Intervention/treatment Phase
Post-COVID-19 Syndrome Drug: Temelimab 54mg/kg Drug: Placebo Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : August 29, 2022
Estimated Primary Completion Date : June 30, 2024
Estimated Study Completion Date : June 30, 2024

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Temelimab 54mg/kg
Monthly IV repeated dose in addition to standard of care
 Drug: Temelimab 54mg/kg
Temelimab 54mg/kg will be given as monthly (every 4 weeks) intravenous (IV) infusion over 24 weeks (6 infusions in total)
Placebo Comparator: Placebo
Monthly IV repeated dose in addition to standard of care
 Drug: Placebo
Placebo will be given as monthly (every 4 weeks) intravenous (IV) infusion over 24 weeks (6 infusions in total)


Outcome Measures
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Primary Outcome Measures :
  1. Composite endpoint: improvement in cognitive impairment or fatigue in PASC patients [ Time Frame: 24 weeks ]
    Occurrence of an improvement in cognitive impairment, measured by an increase of ≥0.5 z-scores in the Token Motor Test, or 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.


Secondary Outcome Measures :
  1. Fatigue [ Time Frame: 24 weeks ]
    Change from baseline to Week 24 in the Severity of fatigue as measured by the PROMIS Fatigue SF 7a score

  2. Cognitive function [ Time Frame: 24 weeks ]
    Change from baseline to Week 24 in 5 domain scores (verbal memory test, digit sequencing test, Token Motor Test, verbal semantic and letter fluency, and Tower of London) as measured by BAC tests

  3. Cognitive function [ Time Frame: 24 weeks ]
    Change from baseline to Week 24 in Symbol Digit Modalities Test (SDMT) score

  4. Cognitive function [ Time Frame: 24 weeks ]
    Change from baseline to Week 24 in Cognitive function as measured by the composite score of the BAC excluding symbol coding test

  5. Cognitive function [ Time Frame: 24 weeks ]
    Change from baseline to Week 24 in Cognitive function as measured by the Perceived Deficits Questionnaire, 20 items (PDQ-20)

  6. Anxiety [ Time Frame: 24 weeks ]
    Change from baseline to Week 24 in Severity of anxiety as measured by the Generalized Anxiety Disorder, 7 Items (GAD 7)

  7. Depression [ Time Frame: 24 weeks ]
    Change from baseline to Week 24 in Severity of depression as measured by the Patient Health Questionnaire, 9 Items (PHQ-9)

  8. Quality of Life [ Time Frame: 24 weeks ]
    Change from baseline to Week 24 in Overall quality of life as measured by the European Quality of Life 5 Dimensions, 5 Levels (EQ5D-5L)

  9. Functional impairment [ Time Frame: 24 weeks ]
    Change from baseline to Week 24 in Level of functional impairment as measured by the Sheehan Disability Scale (SDS)

  10. Post-COVID-19 Functional Status [ Time Frame: 24 weeks ]
    Change from baseline to Week 24 in Post-COVID-19 Functional Status Scale (PCFS)

  11. Safety and tolerability of Temelimab in PASC patients [ Time Frame: 24 weeks ]
    Incidence of serious AEs [SAEs], AEs and analysis of physical examination findings, clinical laboratory values results


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Main Inclusion Criteria:

  • PASC Syndrome in accordance with NICE criteria with symptoms still occurring >12 to 96 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), 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 medication (e.g., azathioprine, tacrolimus, cyclosporine, methotrexate, hydroxychloroquine, cytotoxic chemotherapy, or neutralizing antibodies against SARS-CoV-2 epitopes) or therapy with HIV protease inhibitors
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05497089


Contacts
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Contact: Karim KEDDAD, MD, PhD +41 22 552 48 00 kk@geneuro.com
Contact: Nathalie BERTHUY +41 22 552 48 00 nab@geneuro.com

Locations
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Italy
Clinica Metabolica dell'Università di Modena e Reggio Emilia Recruiting
Modena, Italy, 41124
Contact: Giovanni Guaraldi, Prof         
U.O.C. Malattie Infettive Tor Vergata, Policlincio Tor Vergata Recruiting
Roma, Italy, 00133
Contact: Loredana Sarmati, MD, Prf         
Hospital of Vipiteno Recruiting
Vipiteno, Italy, 39049
Contact: Luca Sebastianelli, MD         
Spain
Ace Alzheimer Center Recruiting
Barcelona, Spain, 08028
Contact: Mercé Boada Rovira, MD         
Hospital General Universitario- Servicio de Medicina Interna Recruiting
Valencia, Spain, 46014
Contact: Francesc Puchades, MD         
Hospital Royo Villanova Recruiting
Zaragoza, Spain, 50015
Contact: Beamonte Del Corral, MD         
Switzerland
REHAB Clinic for Neurorehabilitation and Paraplegiology Recruiting
Basel, Switzerland, 4055
Contact: Georgiadis Hund, MD         
Inselspital Bern University Hospital Bern Recruiting
Bern, Switzerland, 301
Contact: Robert Hoepner, MD         
Kantonsspital Graubünden Recruiting
Chur, Switzerland, 7000
Contact: Gregory Fretz, MD         
Geneva University Hospital Recruiting
Geneva, Switzerland, 1211
Contact: Idris Guessous, MD         
Centre hospitalier du Valais Romand (CHVR) - Hôpital du Valais Recruiting
Sion, Switzerland, 1951
Contact: Pierre Olivier Bridevaux, MD         
Sponsors and Collaborators
GeNeuro SA
Investigators
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Study Director: David LEPPERT, MD GeNeuro SA
More Information
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Responsible Party: GeNeuro SA
ClinicalTrials.gov Identifier: NCT05497089    
Other Study ID Numbers: GNC-501
2022-000618-32 ( EudraCT Number )
First Posted: August 11, 2022    Key Record Dates
Last Update Posted: May 10, 2023
Last Verified: May 2023

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by GeNeuro SA:
GNbAC1
Human Endogenous Retrovirus Type W
HERV-W
Temelimab
 Post-COVID-19
PASC syndrome
Neuropsychiatric sequelae
Additional relevant MeSH terms:
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COVID-19
Syndrome
Disease
Pathologic Processes
Pneumonia, Viral
Pneumonia
Respiratory Tract Infections
Infections
 Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases