Evidence map›Paper›PMID 34475873›Full record

ArticleFrontiers in immunology

Nasal Administration of Anti-CD3 Monoclonal Antibody (Foralumab) Reduces Lung Inflammation and Blood Inflammatory Biomarkers in Mild to Moderate COVID-19 Patients: A Pilot Study.

Thais G Moreira, Kimble T F Matos, Giovana S De Paula, Thais M M Santana, Raquel G Da Mata, Fernando C Pansera, Andre S Cortina, Marcelle G Spinola, Clare M Baecher-Allan, Gerson D Keppeke and 9 more

Erratum issued 2 registry-linked trialsOpen access · goldAbstract read
In one paragraph

Article in Frontiers in immunology. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. It is linked to 2 registered trials, which are not on this map. Cited by 12 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
12citing papers in PubMed, 3 pooled it
0.9field-weighted citation impact, top 22% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT06489548 phase2recruitingnot on this map

Assessment of Foralumab Safety and Modulation of Microglial Activation Evaluated by PET Imaging in Patients With Early Symptomatic Alzheimer's Disease

TypeinterventionalSponsorBrigham and Women's HospitalRan2025 to 2026Enrolled16ConditionsDementia, Alzheimers Disease, Mild Cognitive Impairment Due to Alzheimer's DiseaseArmsForalumab TZLS-401 50 µg, Foralumab TZLS-401 100 µg
NCT06868628 phase2recruitingnot on this map

A Phase 2a Study to Evaluate Microglial Activation, Safety, and Clinical Effects of Foralumab Nasal in Patients With Multiple System Atrophy (MSA)

TypeinterventionalSponsorTiziana Life Sciences LTDRan2025 to 2027Enrolled5ConditionsMultiple System AtrophyArmsForalumab Nasal
3 · Its place in the literature

Who cites it

12 citing papers in PubMed, 3 syntheses or guidelines pooled it, 19 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Pooled it
  4. Nasal administration of anti-CD3 mAb (Foralumab) downregulatesProceedings of the National Academy of Sciences of the United States of America · 2023
    Trial
  5. Article
  6. Article
  7. Article
  8. Nasal administration of anti-CD3 monoclonal antibody ameliorates disease in a mouse model of Alzheimer's disease.Proceedings of the National Academy of Sciences of the United States of America · 2023
    Article
  9. Article
  10. Nasal sprays for treating COVID-19: a scientific note.Pharmacological reports : PR · 2023
    Review
  11. Article
  12. Article
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

19 authors at 5 institutions in 2 countries.

Thais G MoreiraAnn Romney Center for Neurologic Diseases, Department of Neurology, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, United States.
Kimble T F MatosEscola Paulista de Medicina, Universidade Federal de São Paulo, São Paulo, Brazil.
Giovana S De PaulaSanta Casa de Misericordia de Santos, Santos, Brazil.
Thais M M SantanaSanta Casa de Misericordia de Santos, Santos, Brazil.
Raquel G Da MataSanta Casa de Misericordia de Santos, Santos, Brazil.
Fernando C PanseraSanta Casa de Misericordia de Santos, Santos, Brazil.
Andre S CortinaSanta Casa de Misericordia de Santos, Santos, Brazil.
Marcelle G SpinolaEscola Paulista de Medicina, Universidade Federal de São Paulo, São Paulo, Brazil.
Clare M Baecher-AllanAnn Romney Center for Neurologic Diseases, Department of Neurology, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, United States.
Gerson D KeppekeEscola Paulista de Medicina, Universidade Federal de São Paulo, São Paulo, Brazil.
Jules JacobTiziana LifeScience, Doylestown, PA, United States.
Vaseem PalejwalaTiziana LifeScience, Doylestown, PA, United States.
Karen ChenDepartment of Radiology, Boston Children's Hospital, Harvard Medical School, Boston, MA, United States.
Saef IzzyAnn Romney Center for Neurologic Diseases, Department of Neurology, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, United States.
Brian C HealeyAnn Romney Center for Neurologic Diseases, Department of Neurology, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, United States.
Rafael M RezendeAnn Romney Center for Neurologic Diseases, Department of Neurology, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, United States.
Rogerio A DedivitisSanta Casa de Misericordia de Santos, Santos, Brazil.
Kunwar ShailubhaiTiziana LifeScience, Doylestown, PA, United States.
Howard L WeinerAnn Romney Center for Neurologic Diseases, Department of Neurology, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, United States.
Santa Casa de Misericórdia de Marília · BRBrigham and Women's Hospital · USUniversidade Federal de São Paulo · BRHarvard University · USBoston Children's Hospital · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundImmune hyperactivity is an important contributing factor to the morbidity and mortality of COVID-19 infection. Nasal administration of anti-CD3 monoclonal antibody downregulates hyperactive immune responses in animal models of autoimmunity through its immunomodulatory properties. We performed a randomized pilot study of fully-human nasal anti-CD3 (Foralumab) in patients with mild to moderate COVID-19 to determine if its immunomodulatory properties had ameliorating effects on disease.

methodsThirty-nine outpatients with mild to moderate COVID-19 were recruited at Santa Casa de Misericordia de Santos in Sao Paulo State, Brazil. Patients were randomized to three cohorts: 1) Control, no Foralumab (n=16); 2) Nasal Foralumab (100ug/day) given for 10 consecutive days with 6 mg dexamethasone given on days 1-3 (n=11); and 3) Nasal Foralumab alone (100ug/day) given for 10 consecutive days (n=12). Patients continued standard of care medication.

resultsWe observed reduction of serum IL-6 and C-reactive protein in Foralumab alone

conclusionsThis pilot study suggests that nasal Foralumab is well tolerated and may be of benefit in treatment of immune hyperactivity and lung involvement in COVID-19 disease and that further studies are warranted.

Indexed as

Administration, IntranasalAdolescentAdultAntibodies, MonoclonalBiomarkersCohort StudiesCOVID-19C-Reactive ProteinFemaleHumansImmunityInterleukin-6LungMaleMiddle AgedOutpatientsAntibodies, MonoclonalBiomarkersC-Reactive ProteinforalumabInterleukin-6anti-CD3COVID-19foralumabimmune responsesSARS-CoV-2

Identifiers

PMID34475873
PMCPMC8406802
OpenAlexW3196056203

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.