- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05497089
Temelimab as a Disease Modifying Therapy in Patients With Neuropsychiatric Symptoms in Post-COVID 19 or PASC Syndrome
March 5, 2024 updated by: GeNeuro SA
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
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).
Study Overview
Status
Active, not recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
200
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Karim KEDDAD, MD, PhD
- Phone Number: +41 22 552 48 00
- Email: kk@geneuro.com
Study Contact Backup
- Name: Nathalie BERTHUY
- Phone Number: +41 22 552 48 00
- Email: nab@geneuro.com
Study Locations
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Modena, Italy, 41124
- Clinica Metabolica dell'Università di Modena e Reggio Emilia
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Roma, Italy, 00168
- Fondazione Policlinico Universitario Agostino Gemelli Irccs
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Roma, Italy, 00133
- U.O.C. Malattie Infettive Tor Vergata, Policlincio Tor Vergata
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Vipiteno, Italy, 39049
- Hospital of Vipiteno
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Barcelona, Spain, 08028
- Ace Alzheimer Center
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Madrid, Spain, 28223
- Hospital Universitario Quironsalud Madrid
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Madrid, Spain, 28036
- Private clinic Blue Healthcare
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Valencia, Spain, 46014
- Hospital General Universitario- Servicio de Medicina Interna
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Zaragoza, Spain, 50015
- Hospital Royo Villanova
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Basel, Switzerland, 4055
- REHAB Clinic for Neurorehabilitation and Paraplegiology
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Bern, Switzerland, 301
- Inselspital Bern University Hospital Bern
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Chur, Switzerland, 7000
- Kantonsspital Graubünden
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Geneva, Switzerland, 1211
- Geneva University Hospital
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Sion, Switzerland, 1951
- Centre hospitalier du Valais Romand (CHVR) - Hôpital du Valais
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Temelimab 54mg/kg
Monthly IV repeated dose in addition to standard of care
|
Temelimab 54mg/kg will be given as monthly (every 4 weeks) intravenous (IV) infusion over 24 weeks (6 infusions in total)
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Placebo Comparator: Placebo
Monthly IV repeated dose in addition to standard of care
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Placebo will be given as monthly (every 4 weeks) intravenous (IV) infusion over 24 weeks (6 infusions in total)
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Improvement in fatigue in PASC patients
Time Frame: 24 weeks
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
24 weeks
|
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
|
24 weeks
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Cognitive function
Time Frame: 24 weeks
|
Change from baseline to Week 24 in Symbol Digit Modalities Test (SDMT) score
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24 weeks
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Cognitive function
Time Frame: 24 weeks
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Change from baseline to Week 24 in Cognitive function as measured by the composite score of the BAC excluding symbol coding test
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24 weeks
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Cognitive function
Time Frame: 24 weeks
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Change from baseline to Week 24 in Cognitive function as measured by the Perceived Deficits Questionnaire, 20 items (PDQ-20)
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24 weeks
|
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)
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24 weeks
|
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)
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24 weeks
|
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)
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24 weeks
|
Post-COVID-19 Functional Status
Time Frame: 24 weeks
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Change from baseline to Week 24 in Post-COVID-19 Functional Status Scale (PCFS)
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24 weeks
|
Safety and tolerability of Temelimab in PASC patients
Time Frame: 24 weeks
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Incidence of serious AEs [SAEs], AEs and analysis of physical examination findings, clinical laboratory values results
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24 weeks
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Overall quality of Life
Time Frame: 24 weeks
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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)
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24 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: David LEPPERT, MD, GeNeuro SA
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 29, 2022
Primary Completion (Estimated)
June 30, 2024
Study Completion (Estimated)
June 30, 2024
Study Registration Dates
First Submitted
August 3, 2022
First Submitted That Met QC Criteria
August 9, 2022
First Posted (Actual)
August 11, 2022
Study Record Updates
Last Update Posted (Estimated)
March 6, 2024
Last Update Submitted That Met QC Criteria
March 5, 2024
Last Verified
December 1, 2023
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- GNC-501
- 2022-000618-32 (EudraCT Number)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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