Evidence map›Paper›PMID 34785274›Full record

ArticleToxicology and applied pharmacology2022

Non-clinical safety assessment and in vivo biodistribution of CoviFab, an RBD-specific F(ab')2 fragment derived from equine polyclonal antibodies.

Facundo Salinas, Belkis E Marelli, Santiago Sanguineti, Fernando Goldbaum, Luciana Muñoz, Lucas Etchevers, Paula Silvestrini, Ulises S Notaro, Natalia R Salvetti, Vanesa Zylberman and 1 more

Open access · greenAbstract read
In one paragraph

Article in Toxicology and applied pharmacology, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
0.2field-weighted citation impact, top 45% 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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

2 citing papers in PubMed, 4 citations in OpenAlex.

  1. Article
  2. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

11 authors at 4 institutions in 1 country.

Facundo SalinasCentro de Medicina Comparada, Instituto de Ciencias Veterinarias del Litoral (ICiVet-Litoral), Universidad Nacional del Litoral (UNL) / Consejo Nacional de Investigaciones Científicas y Técnicas (CONICET), Esperanza, Santa Fe, Argentina.
Belkis E MarelliCentro de Medicina Comparada, Instituto de Ciencias Veterinarias del Litoral (ICiVet-Litoral), Universidad Nacional del Litoral (UNL) / Consejo Nacional de Investigaciones Científicas y Técnicas (CONICET), Esperanza, Santa Fe, Argentina; Facultad de Ciencias Veterinarias del Litoral, Universidad Nacional del Litoral (UNL), Esperanza, Santa Fe, Argentina.
Santiago SanguinetiINMUNOVA S.A., Av. Patricias Argentinas 435, Ciudad de Buenos Aires C1405BWE, Argentina.
Fernando GoldbaumINMUNOVA S.A., Av. Patricias Argentinas 435, Ciudad de Buenos Aires C1405BWE, Argentina; CRIP-Centro de Rediseño e Ingeniería de Proteínas UNSAM, Campus Miguelete, San Martín, Provincia de Buenos Aires, Argentina; Laboratorio de Inmunología y Microbiología Molecular, Fundación Instituto Leloir, IIBBA-CONICET, Buenos Aires, Argentina.
Luciana MuñozINMUNOVA S.A., Av. Patricias Argentinas 435, Ciudad de Buenos Aires C1405BWE, Argentina.
Lucas EtcheversCentro de Medicina Comparada, Instituto de Ciencias Veterinarias del Litoral (ICiVet-Litoral), Universidad Nacional del Litoral (UNL) / Consejo Nacional de Investigaciones Científicas y Técnicas (CONICET), Esperanza, Santa Fe, Argentina.
Paula SilvestriniCentro de Medicina Comparada, Instituto de Ciencias Veterinarias del Litoral (ICiVet-Litoral), Universidad Nacional del Litoral (UNL) / Consejo Nacional de Investigaciones Científicas y Técnicas (CONICET), Esperanza, Santa Fe, Argentina.
Ulises S NotaroCentro de Medicina Comparada, Instituto de Ciencias Veterinarias del Litoral (ICiVet-Litoral), Universidad Nacional del Litoral (UNL) / Consejo Nacional de Investigaciones Científicas y Técnicas (CONICET), Esperanza, Santa Fe, Argentina.
Natalia R SalvettiCentro de Medicina Comparada, Instituto de Ciencias Veterinarias del Litoral (ICiVet-Litoral), Universidad Nacional del Litoral (UNL) / Consejo Nacional de Investigaciones Científicas y Técnicas (CONICET), Esperanza, Santa Fe, Argentina; Facultad de Ciencias Veterinarias del Litoral, Universidad Nacional del Litoral (UNL), Esperanza, Santa Fe, Argentina.
Vanesa ZylbermanINMUNOVA S.A., Av. Patricias Argentinas 435, Ciudad de Buenos Aires C1405BWE, Argentina; Consejo Nacional de Investigaciones Científicas y Técnicas, (CONICET), Argentina.
Hugo H OrtegaCentro de Medicina Comparada, Instituto de Ciencias Veterinarias del Litoral (ICiVet-Litoral), Universidad Nacional del Litoral (UNL) / Consejo Nacional de Investigaciones Científicas y Técnicas (CONICET), Esperanza, Santa Fe, Argentina; Facultad de Ciencias Veterinarias del Litoral, Universidad Nacional del Litoral (UNL), Esperanza, Santa Fe, Argentina. Electronic address: hhortega@fcv.unl.edu.ar.
National University of the Littoral · ARConsejo Nacional de Investigaciones Científicas y Técnicas · ARCentro Científico Tecnológico - San Juan · ARNational University of General San Martín · AR

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

The severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) has required the urgent development of new therapies, among which passive immunotherapy is contemplated. CoviFab (INM005) is a RBD-specific F(ab')2 fragment derived from equine polyclonal antibodies. We investigate their preclinical security and biodistribution by in vivo and ex vivo NIR imaging after intravenous administration of a dose of 4 mg/kg at time 0 and 48 h. Images were taken at 1, 12, 24, 36, 48, 49, 60, 72, 84, 96, 108, 120, 132 and 144 h after the first intravenous injection. At 96 and 144 h, mice were sacrificed for haematology, serum chemistry, clinical pathology, histopathology and ex vivo imaging. The biodistribution profile was similar in all organs studied, with the highest fluorescence at 1 h after each injection, gradually decreasing after that each one and until the end of the study (144 h). The toxicology study revealed no significant changes in the haematology and serum chemistry parameters. Further, there were no changes in the gross and histological examination of organs. Nonclinical data of the current study confirm that CoviFab is safe, without observable adverse effects in mice. Furthermore, we confirm that bioimaging studies are a useful approach in preclinical trials to determine biodistribution.

Indexed as

COVID-19 Drug TreatmentAdministration, IntravenousAnimalsAntibodies, ViralCOVID-19HEK293 CellsHorsesHumansMaleMiceMice, Inbred BALB CMice, TransgenicReceptors, ImmunologicRecombinant ProteinsSARS-CoV-2Spectroscopy, Near-InfraredAntibodies, ViralF(ab')2 receptorReceptors, ImmunologicRecombinant ProteinsBiodistributionCOVID-19CoviFabGood laboratory practicesPreclinical studies

Identifiers

PMID34785274
PMCPMC8590615
OpenAlexW3211579577

What OpenQuestion holds

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Registered trials

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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.