Evidence map›Paper›PMID 36668842›Full record

ArticleToxins2022

The BRAVO Clinical Study Protocol: Oral Varespladib for Inhibition of Secretory Phospholipase A2 in the Treatment of Snakebite Envenoming.

Rebecca W Carter, Charles J Gerardo, Stephen P Samuel, Surendra Kumar, Suneetha D Kotehal, Partha P Mukherjee, Farshad M Shirazi, Peter D Akpunonu, Chanaveerappa Bammigatti, Ashish Bhalla and 4 more

Open access · goldAbstract readClinical Trial Protocol
In one paragraph

Article in Toxins, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 24 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
24citing papers in PubMed, 1 pooled it
6.7field-weighted citation impact, top 3% 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

24 citing papers in PubMed, 1 synthesis or guideline pooled it, 37 citations in OpenAlex.

  1. Pooled it
  2. Trial
  3. Review
  4. Review
  5. Novel antivenoms bite back.Nature biotechnology · 2026
    Article
  6. Article
  7. Comment on: Nucleotidase as a Clinical Prognostic Marker in Snakebites: A Prospective Study.Indian journal of critical care medicine : peer-reviewed, official publication of Indian Society of Critical Care Medicine · 2025
    Article
  8. Article
  9. Article
  10. Article
  11. Review
  12. Article
  13. Article
  14. Antivenom slithers back to life.Nature biotechnology · 2024
    Article
  15. Review
  16. The Chinese guideline for management of snakebites.World journal of emergency medicine · 2024
    Article
  17. Article
  18. [A global core outcome measurement set for snakebite clinical trials].Medecine tropicale et sante internationale · 2023
    Article
  19. Article
  20. 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

14 authors at 9 institutions in 2 countries.

Rebecca W CarterOphirex, Inc., Corte Madera, CA 94295, USA.ORCID 0000-0002-5977-7338
Charles J GerardoDepartment of Emergency Medicine, Duke University, Durham, NC 27708, USA.
Stephen P SamuelOphirex, Inc., Corte Madera, CA 94295, USA.
Surendra KumarDepartment of Medicine, Sardar Patel Medical College, PBM Hospital, Bikaner 334001, India.
Suneetha D KotehalDepartment of Medicine, Mysore Medical College and Research Institute, Mysore 570001, India.
Partha P MukherjeeDepartment of General Medicine, Calcutta National Medical College, Kolkata 700014, India.
Farshad M ShiraziArizona Poison & Drug Information Center, College of Pharmacy and University of Arizona College of Medicine, University of Arizona, Tucson, AZ 85721, USA.
Peter D AkpunonuDepartment of Emergency Medicine and Medical Toxicology, University of Kentucky College of Medicine, Lexington, KY 40506, USA.ORCID 0000-0002-6968-686X
Chanaveerappa BammigattiDepartment of Medicine, Jawaharlal Institute of Postgraduate Medical Education and Research, Puducherry 605006, India.
Ashish BhallaDepartment of Internal Medicine, Postgraduate Institute of Medical Education and Research, Chandigarh 160012, India.
Neeraj ManikathDepartment of Emergency Medicine, Government Medical College, Kozhikode 673008, India.
Timothy F Platts-MillsOphirex, Inc., Corte Madera, CA 94295, USA.
Matthew R LewinOphirex, Inc., Corte Madera, CA 94295, USA.ORCID 0000-0003-4480-9891
BRAVO Study Group
Calcutta National Medical College and Hospital · INDuke University · USGovernment Medical College · INJawaharlal Institute of Post Graduate Medical Education and Research · INMysore Medical College · INPost Graduate Institute of Medical Education and Research · INSardar Patel Medical College · INUniversity of Arizona · USUniversity of Kentucky · US

Funding

Wellcome Trust
6 · The paper itself

Abstract

introductionSnakebite is an urgent, unmet global medical need causing significant morbidity and mortality worldwide. Varespladib is a potent inhibitor of venom secretory phospholipase A METHODS AND ANALYSIS: BRAVO (Broad-spectrum Rapid Antidote: Varespladib Oral for snakebite) is a multicenter, randomized, double-blind, placebo-controlled, phase 2 study to evaluate the safety, tolerability, and efficacy of oral varespladib-methyl plus standard of care (SoC) vs. SoC plus placebo in patients presenting with acute SBE by any venomous snake species. Male and female patients 5 years of age and older who meet eligibility criteria will be randomly assigned 1:1 to varespladib-methyl or placebo. The primary outcome is the Snakebite Severity Score (SSS) that has been modified for international use. This composite outcome is based on the sum of the pulmonary, cardiovascular, nervous, hematologic, and renal systems components of the updated SSS. ETHICS AND DISSEMINATION: This protocol was submitted to regulatory authorities in India and the US. A Clinical Trial No Objection Certificate from the India Central Drugs Standard Control Organisation, Drug Controller General-India, and a Notice to Proceed from the US Food and Drug Administration have been obtained. The study protocol was approved by properly constituted, valid institutional review boards or ethics committees at each study site. This study is being conducted in compliance with the April 1996 ICH Guidance for Industry GCP E6, the Integrated Addendum to ICH E6 (R2) of November 2016, and the applicable regulations of the country in which the study is conducted. The trial is registered on Clinical trials.gov, NCT#04996264 and Clinical Trials Registry-India, 2021/07/045079 000062.

Indexed as

Phospholipases A2, SecretorySnake BitesAcetatesClinical Trials, Phase II as TopicFemaleHumansIndolesKeto AcidsMaleMulticenter Studies as TopicNitrilesRandomized Controlled Trials as TopicAcetatesIndolesKeto AcidsNitrilesPhospholipases A2, Secretorytetrachloroisophthalonitrilevarespladibvarespladib methylBRAVOclinical trialdirect toxin inhibitorprotocolsnakebitesnakebite severity scorevarespladib

Identifiers

PMID36668842
PMCPMC9862656
OpenAlexW4313327570

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

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.