Postacute Sequelae of COVID-19 (PASC) Syndrome MedDRA version: 20.0 Level: PT Classification code 10071323 Term: Neuropsychiatric syndrome System Organ Class: 10037175 - Psychiatric disorders MedDRA version: 20.0 Level: PT Classification code 10078497 Term: Neuropsychiatric symptoms System Organ Class: 10037175 - Psychiatric disorders
Conditions
Interventions
Product Name: Temelimab
Product Code: [GNbAC1]
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: Temelimab
CAS Number: 1393641-34-3
Current Sponsor code: GNbAC1
Concentration unit: mg/ml
Sponsors
GENEURO SA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Adult patients =18 years of age on date informed consent is obtained 2. Written informed consent to participate in the study 3. 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), or confirmed SARS-CoV-2 nucleocapsid or membrane antibodies 4. Postacute Sequelae of COVID-19 Syndrome in accordance with NICE criteria (see Appendix 6 of protocol) with symptoms still occurring >12 to 48 weeks postdiagnostic RT-PCR date 5. Has a SARS-CoV-2-negative diagnostic test 72 hours before investigational medicinal product (IMP) administration (using a validated SARS-CoV-2 antigen, RT-PCR, or other molecular diagnostic assay, and an appropriate sample such as NP, nasal, OP, or saliva) 6. PROMIS Fatigue SF 7a total raw score =21 with onset of fatigue post coronavirus disease 2019 (COVID-19) infection 7. 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 median 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 8. HERV-W ENV positive as defined by automated capillary western system, specific signal level over background noise (S/N) >1. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 150 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 32
Exclusion criteria
Exclusion criteria: 1. Pregnant or breastfeeding women; or female patients of childbearing potential or fertile male patients, or their respective partners, unable, or unwilling to practice effective contraception (Appendix 5) 2. Body mass index below 18.5 or above 35 kg/m2 3. History of, or positive serology for viral hepatitis B not explained by vaccination or for viral hepatitis C or human immunodeficiency virus (HIV) at any time (Appendix 7). 4. Any of the following cardiac conditions or ECG abnormalities: • History or presence of serious or acute heart disease such as uncontrolled cardiac dysrhythmia or arrhythmia, uncontrolled angina pectoris, cardiomyopathy, or un-controlled congestive heart failure (New York Heart Association [NYHA] class 3 or 4) • A prolonged QT interval corrected with Bazett's formula (QTcB) or QT interval corrected with Fridericia's formula (QTcF) (greater than 450 ms). If QTcB or QTcF is greater than 450 ms on the first ECG, a second ECG recording will be performed after at least 30 min. If QTcB or QTcF is greater than 450 ms on the second ECG, the patient is not eligible • A history of additional risk factors for torsade de pointes (e.g., heart failure, hypokalemia, family history of long QT syndrome) • ECG with clinically significant atrioventricular (AV) conduction disturbance (e.g., second- or third-degree AV block), sick sinus syndrome, bradycardia (resting pulse 8 times upper limit of normal (ULN), or conjugated bilirubin >2 times ULN, or alkaline phosphatase or gamma-glutamyl transferase >3 times ULN or if repeat AST/ALT >5 × ULN 6. Severe renal impairment: known or defined as estimated creatinine clearance 48 hours 12. Intubation and mechanical ventilation in the course of COVID-19, or reception of convalescent COVID-19 plasma treatment at any time prior to study entry 13. Receipt of systemic steroids or inhaled steroids within 30 days prior to study entry unless used for a chronic condition For the complete list, please refer to protocol.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the efficacy of treatment with temelimab plus local standard of care (SoC) treatments versus local SoC alone over 6 months on improvement in cognitive impairment or fatigue in PASC patients.;Secondary Objective: • To evaluate the efficacy of treatment with temelimab plus local SoC treatment versus local SoC alone over 6 months on measures of cognition, fatigue, anxiety, depression, functional impairment/disability, and quality of life in PASC patients • To evaluate safety and tolerability of temelimab in PASC patients.;Primary end point(s): The primary endpoint is the 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.;Timepoint(s) of evaluation of this end point: Week 24 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Change from baseline to Week 24 in: o Severity of fatigue as measured by the PROMIS Fatigue SF 7a score o 5 domain scores (verbal memory and learning [verbal memory test], working memory [digit sequencing test], psychomotor coordination [Token Motor Test], verbal fluency [semantic and letter fluency], and executive function [Tower of London]) as measured by BAC tests o Symbol Digit Modalities Test (SDMT) score o Cognitive functions as measured by the composite score of the BAC excluding the symbol coding test o Subjective cognitive function as measured by the Perceived Deficits Questionnaire, 20 Items (PDQ-20) o Severity of anxiety as measured by the Generalized Anxiety Disorder, 7 Items (GAD 7) o Severity of depression as measured by the Patient Health Questionnaire, 9 Items (PHQ-9). o Overall quality of life as measured by the European Quality of Life 5 Dimensions, 5 Levels (EQ5D-5L) o Level of functional impairment as measured by the Sheehan Disability Scale (SDS) o Post-COVID-19 Functional Status Scale (PCFS) • Safety (serious AEs [SAEs], AEs, physical signs, clinical laboratory values).;Timepoint(s) of evaluation of this end point: Week 24 | — |
Countries
Italy, Spain, Switzerland
Contacts
Public ContactNathalie Berthuy
GeNeuro S.A.
Outcome results
None listed