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Post-COVID-19 SyndromePhase 2NCT05497089

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

A Phase 2 study testing Temelimab 54mg/kg in people with Post-COVID-19 Syndrome, run by GeNeuro SA at 14 sites in 3 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Post-COVID-19 Syndrome
What is being tested?
Temelimab 54mg/kg
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
203 participants
Where
14 sitesin 3 countries
Study dates
29 Aug 2022to 10 May 2024
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Trial locations and contacts

14 sites in 3 countries.

14 sites in 3 countries

Spain5 sites

  • Ace Alzheimer Center

    Barcelona, 08028

  • Private clinic Blue Healthcare

    Madrid, 28036

  • Hospital Universitario Quirónsalud Madrid

    Madrid, 28223

  • Hospital General Universitario- Servicio de Medicina Interna

    Valencia, 46014

  • Hospital Royo Villanova

    Zaragoza, 50015

Other trials in Spain

Switzerland5 sites

  • REHAB Clinic for Neurorehabilitation and Paraplegiology

    Basel, 4055

  • Inselspital Bern University Hospital Bern

    Bern, 301

  • Kantonsspital Graubünden

    Chur, 7000

  • Geneva University Hospital

    Geneva, 1211

  • Centre hospitalier du Valais Romand (CHVR) - Hôpital du Valais

    Sion, 1951

Other trials in Switzerland

Italy4 sites

  • Clinica Metabolica dell'Università di Modena e Reggio Emilia

    Modena, 41124

  • U.O.C. Malattie Infettive Tor Vergata, Policlincio Tor Vergata

    Roma, 00133

  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS

    Roma, 00168

  • Hospital of Vipiteno

    Sterzing, 39049

Other trials in Italy

About this study

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

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).

Being tested
Temelimab 54mg/kg, Placebo
Keywords
GNbAC1, Human Endogenous Retrovirus Type W, HERV-W, Temelimab, Post-COVID-19, PASC syndrome, Neuropsychiatric sequelae
Medical subject headings
Post-Acute COVID-19 Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Temelimab 54mg/kgDrug

    Temelimab 54mg/kg will be given as monthly (every 4 weeks) intravenous (IV) infusion over 24 weeks (6 infusions in total)

  • PlaceboDrug

    Placebo will be given as monthly (every 4 weeks) intravenous (IV) infusion over 24 weeks (6 infusions in total)

Study groups in NCT05497089
Study groupRoleWhat they receive
Temelimab 54mg/kgExperimentalMonthly IV repeated dose in addition to standard of care
Receives: Drug: Temelimab 54mg/kg
PlaceboPlacebo comparatorMonthly IV repeated dose in addition to standard of care
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 24 weeks

Secondary outcomes (11)

  1. Fatigue

    Change from baseline to Week 24 in the Severity of fatigue as measured by the PROMIS Fatigue SF 7a score

    Measured: 24 weeks

  2. 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

    Measured: 24 weeks

  3. Cognitive function

    Change from baseline to Week 24 in Symbol Digit Modalities Test (SDMT) score

    Measured: 24 weeks

  4. Cognitive function

    Change from baseline to Week 24 in Cognitive function as measured by the composite score of the BAC excluding symbol coding test

    Measured: 24 weeks

  5. Cognitive function

    Change from baseline to Week 24 in Cognitive function as measured by the Perceived Deficits Questionnaire, 20 items (PDQ-20)

    Measured: 24 weeks

  6. Anxiety

    Change from baseline to Week 24 in Severity of anxiety as measured by the Generalized Anxiety Disorder, 7 Items (GAD 7)

    Measured: 24 weeks

  7. Depression

    Change from baseline to Week 24 in Severity of depression as measured by the Patient Health Questionnaire, 9 Items (PHQ-9)

    Measured: 24 weeks

  8. 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)

    Measured: 24 weeks

  9. Functional impairment

    Change from baseline to Week 24 in Level of functional impairment as measured by the Sheehan Disability Scale (SDS)

    Measured: 24 weeks

  10. Post-COVID-19 Functional Status

    Change from baseline to Week 24 in Post-COVID-19 Functional Status Scale (PCFS)

    Measured: 24 weeks

  11. Safety and tolerability of Temelimab in PASC patients

    Incidence of serious AEs [SAEs], AEs and analysis of physical examination findings, clinical laboratory values results

    Measured: 24 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Aug 2022
  2. Study start29 Aug 2022
  3. Primary completion10 May 2024
  4. Study completion10 May 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
203 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05497089
Sponsor's protocol ID
GNC-501
Other IDs
2022-000618-32
Status last verified
May 2024
First submitted
3 Aug 2022
Last updated
17 May 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Nehme M, Hund-Georgiadis M, Corral Beamonte ED, Bridevaux PO, Hoepner R, Penner IK, Strobel J, Fretz G, Rovira MB, Puchades F, Landi F, Vasco PG, Guaraldi G, Cordero FM, Sebastianelli L, Sarmati L, Berthuy N, Wojcik J, Keddad K, Post A, Leppert D, Guessous I. Temelimab versus placebo in patients with post-COVID condition. Brain Behav Immun. 2026 Jul 6;138:106892. doi: 10.1016/j.bbi.2026.106892. Online ahead of print.

    PubMed 42409185

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Temelimab 54mg/kg in people with Post-COVID-19 Syndrome, run by GeNeuro SA at 14 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 May 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 14 sites in Spain, Switzerland, Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Improvement in fatigue in PASC patients (time frame: 24 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05497089, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 May 2024.

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