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NCT04573855

TREATMENT WITH ANTI-SARS-COV-2 IMMUNOGLOBULIN IN PATIENTS WITH COVID-19

Status unknown Phase 1, PHASE2 Last updated 5 October 2020
What this trial tests

Phase 1, PHASE2 trial testing Anti-SARS-CoV-2 immunoglobulin in Covid19 in 41 participants. Status unknown.

Timeline
1 December 2020
Primary endpoint
28 February 2021
31 March 2021

Quick facts

Lead sponsorD'Or Institute for Research and Education
PhasePhase 1, PHASE2
StatusStatus unknown
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingnone
Primary purposetreatment
Enrollment41
Start date1 December 2020
Primary completion28 February 2021
Estimated completion31 March 2021

Drugs / interventions tested

Conditions studied

Sponsor

D'Or Institute for Research and Education

Who can join

Adults 18 to 75, any sex, with Covid19. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

A Phase I/II clinical trial for safety and efficacy evaluation of treatment with anti-SARS-CoV-2 equine immunoglobulin (F(ab')2) in hospitalized patients with COVID-19 not requiring of invasive ventilation support.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Convalescent plasma or hyperimmune immunoglobulin for people with COVID-19: a living systematic review.
    Piechotta V, Iannizzi C, Chai KL, Valk SJ, et al · · 2021 · cited 106× · PMID 34013969 · DOI 10.1002/14651858.cd013600.pub4
  2. Convalescent plasma for people with COVID-19: a living systematic review.
    Iannizzi C, Chai KL, Piechotta V, Valk SJ, et al · · 2023 · cited 24× · PMID 36734509 · DOI 10.1002/14651858.cd013600.pub5
  3. Polyclonal F(ab')<sub>2</sub> fragments of equine antibodies raised against the spike protein neutralize SARS-CoV-2 variants with high potency.
    Cunha LER, Stolet AA, Strauch MA, Pereira VAR, et al · · 2021 · cited 24× · PMID 34723156 · DOI 10.1016/j.isci.2021.103315
  4. Polyclonal hyper immunoglobulin: A proven treatment and prophylaxis platform for passive immunization to address existing and emerging diseases.
    Tharmalingam T, Han X, Wozniak A, Saward L. · · 2022 · cited 22× · PMID 34010089 · DOI 10.1080/21645515.2021.1886560
  5. Convalescent plasma for people with COVID-19: a living systematic review.
    Iannizzi C, Chai KL, Piechotta V, Valk SJ, et al · · 2023 · cited 21× · PMID 37162745 · DOI 10.1002/14651858.cd013600.pub6
  6. The Road towards Polyclonal Anti-SARS-CoV-2 Immunoglobulins (Hyperimmune Serum) for Passive Immunization in COVID-19.
    Focosi D, Tuccori M, Franchini M. · · 2021 · cited 21× · PMID 33671893 · DOI 10.3390/life11020144
  7. Hyperimmune immunoglobulin for people with COVID-19.
    Kimber C, Valk SJ, Chai KL, Piechotta V, et al · · 2023 · cited 10× · PMID 36700518 · DOI 10.1002/14651858.cd015167.pub2
  8. Heterologous Hyperimmune Polyclonal Antibodies Against SARS-CoV-2: A Broad Coverage, Affordable, and Scalable Potential Immunotherapy for COVID-19.
    Alape-Girón A, Moreira-Soto A, Arguedas M, Brenes H, et al · · 2021 · cited 9× · PMID 34552950 · DOI 10.3389/fmed.2021.743325

Verify or expand the search:

Other recruiting trials for Covid19

Currently open trials in the same condition.

Other D'Or Institute for Research and Education trials

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Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04573855.

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