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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
203
Temelimab 54mg/kg will be given as monthly (every 4 weeks) intravenous (IV) infusion over 24 weeks (6 infusions in total)
Placebo will be given as monthly (every 4 weeks) intravenous (IV) infusion over 24 weeks (6 infusions in total)
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
...and 4 more locations
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.
Time frame: 24 weeks
Fatigue
Change from baseline to Week 24 in the Severity of fatigue as measured by the PROMIS Fatigue SF 7a score
Time frame: 24 weeks
Cognitive function
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
Time frame: 24 weeks
Cognitive function
Change from baseline to Week 24 in Symbol Digit Modalities Test (SDMT) score
Time frame: 24 weeks
Cognitive function
Change from baseline to Week 24 in Cognitive function as measured by the composite score of the BAC excluding symbol coding test
Time frame: 24 weeks
Cognitive function
Change from baseline to Week 24 in Cognitive function as measured by the Perceived Deficits Questionnaire, 20 items (PDQ-20)
Time frame: 24 weeks
Anxiety
Change from baseline to Week 24 in Severity of anxiety as measured by the Generalized Anxiety Disorder, 7 Items (GAD 7)
Time frame: 24 weeks
Depression
Change from baseline to Week 24 in Severity of depression as measured by the Patient Health Questionnaire, 9 Items (PHQ-9)
Time frame: 24 weeks
Overall quality of Life
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)
Time frame: 24 weeks
Functional impairment
Change from baseline to Week 24 in Level of functional impairment as measured by the Sheehan Disability Scale (SDS)
Time frame: 24 weeks
Post-COVID-19 Functional Status
Change from baseline to Week 24 in Post-COVID-19 Functional Status Scale (PCFS)
Time frame: 24 weeks
Safety and tolerability of Temelimab in PASC patients
Incidence of serious AEs \[SAEs\], AEs and analysis of physical examination findings, clinical laboratory values results
Time frame: 24 weeks
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.