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The SnaFab versus the Razi antivenom for treatment of snakebite envenomation

A randomized, double-blind (investigator and victims), active controlled, non-inferiority clinical trial

Bibliographic Data

ID19593275
AuthorsSeyed Reza Mousavi (0000-0001-8188-3818, Mashhad University of Medical Sciences), Alihasan Rahmani, Ali Hassan Rahmani (0000-0001-7337-4642, Ahvaz Jundishapur University of Medical Sciences), Maryam Amini Pouya (0000-0002-8415-8678, Tehran University of Medical Sciences), Elnaz Zabihi Eidgahi (Shahid Beheshti University of Medical Sciences), Mohamad Delirrad (Urmia University), Hamed Hosseini (0000-0003-2368-6749, Tehran University of Medical Sciences), Alireza Ghassemi Toussi (0000-0002-2029-8399, Mashhad University of Medical Sciences), Behnaz Hedayatjoo (Islamic Azad University, Science and Research Branch), Seyyedeh Maryam Afshani (0009-0005-1547-2072, Tehran University of Medical Sciences), Mohammad Amin Ghobadi (National Iranian Oil Company (Iran)), Mohammad Reza Shahidi (Tehran University of Medical Sciences), Seyed Amirhossein Mousavi, Maryam Barghbani (Universidade de Ribeirão Preto), Mahdi Jannati Yazdan Abad (0000-0002-3659-2963, Mashhad University of Medical Sciences)
EditorsMuhammed O Afolabi (0000-0002-9967-6419)
Year2025
Volume5
Issue11
Pagese0004281
Publication date2025-11-24
Open AccessYes
TypeARTICLE
VenuePLOS Global Public Health (JOURNAL)
Journal identifiersISSN: 2767-3375 • E-ISSN: 2767-3375
PublisherPublic Library of Science (PLoS) (PUBLISHER)
DOI10.1371/journal.pgph.0004281
PMID41284702
OpenAlexW4416582188
LanguageEN
References cited51

Snakebite envenomation is a significant public health issue in Iran, and it is crucial to have effective and easily accessible antivenom treatments. This study aimed to evaluate the non-inferiority of the SnaFab and the Razi antivenoms for treating snakebite envenomation. The study was a randomized, double-blind, multicenter, active-controlled, non-inferiority trial involving 98 snakebite victims. The patients received either the SnaFab or the Razi antivenoms, with the primary endpoint being the recovery rate within 48 hours after antivenom infusion. The secondary endpoints included adverse events over a 14-day monitoring period and total antivenom consumption. The non-inferiority margin (NIM) was set at 20 percent. The study was commenced on April 17th, 2020, and concluded on May 15th, 2021. The recovery rate was 100 percent in the SnaFab group, which was non-inferior to the Razi antivenom group (98%). The mean number of antivenom units administered was 8.95 ± 4.40 units in the SnaFab group, compared to 9.04 ± 4.49 units in the Razi group (P value: 0.92). Adverse events were reported by 10.2% of individuals in the SnaFab group and 20.4% in the Razi group (p value = 0.27). Muscle weakness was the most commonly reported adverse event in the Razi group (8%), while vertigo was most frequent in the SnaFab group (4%). Moreover, there were no reports of anaphylactic shock or serum sickness. In summary, this study found that SnaFab antivenom is non-inferior to Razi antivenom for treating snakebite envenomation in Iran. Overall, the incidence of adverse events was comparable between groups, with no statistically significant differences observed

Adverse effect · Antivenom · Clinical trial · Envenomation · Randomized controlled trial · Healthcare and Venom Research · Marine Invertebrate Physiology and Ecology · Venomous Animal Envenomation and Studies

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