COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT05497089

Karim KEDDAD, MD, PhD

kk@geneuro.com

2022-08-11

Recruiting

RCT

Randomized

Parallel

Blind label

multi-center

Long covid

main inclusion criteria: pasc syndrome in accordance with nice criteria with with neuropsychiatric symptoms still occurring >12 to 96 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

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//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

2

GeNeuro SA

18

100

Italy;Spain;Switzerland

Patients recovered from covid

N/A

200

Composite endpoint: improvement in cognitive impairment or fatigue in PASC patients

None

Phase 2

[{"arm_notes": "nan", "treatment_id": 2659, "treatment_name": "Temelimab", "treatment_type": "Monoclonal antibodies", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "nan", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]