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IRCT20180515039672N2 IRCT 2020-02-19 Padra Serum Alborz Company Phase 3, multi-center clinical trial for evaluation of two types of snake anti-venom Phase 3, multi-center, randomized, two-arm, parallel, double blinded, active controlled for non-inferiority evaluation of efficacy and safety of snake anti-venom produced by Padra Serum Alborz in comparison with snake anti-venom produced by Razi Vaccine and Serum Research Institute in snakebite victims. 2020-02-20 anticipated 98 Complete https://irct.ir/trial/41983 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization sequences have been made online using the quadruple blocks for the total sample size of 98 victims (ratio of 1:1). The produced randomization sequences would be located in the study site. Each randomization code have been already labeled on each related anti-venom (2 groups of intervention) and be presented in the study site drug stock. After assurance of victim eligibility and receiving the informed consent, according to the randomization sequence, the specific anti-venom would be injected to victims, Blinding description: All victims after meeting the eligibility criteria are examined by physician. After allocating of randomization code to each victim, the nurse with using the drug stock in the study site (with the research tag on them) prepare the infusion bag for Intravenous infusion. Due to identical appearance of infusion bags and administration process, none of the victims would be aware of the group of intervention. It is tried to minimize the awareness of physician from the type of intervention but it's unavoidable. Importance of blindness is emphasized while education the nurses and physicians. In addition since the data are documented in eCRF as untitled codes, the data management team would receive the information without the identification of victims. Therefore, the blindness in victims and outcome assessor team would be obtained completely and for physician would be partial. 3 Snake-Bite. Intervention 1: Intervention group: Vial containing 10 mL of sterile solution of snake antivenom produced by Padra Serum Alborz which each mL is able to neutralize more than 50 LD50. Initial dose: Moderate or severe signs and symptoms, 5 and 10 vials, respectively; Repeat dose: 1 to 6 hours after initial dose, 5 vials until symptom treatment or administration of totally 20 vials; Maintenance dose: 2 vials Infusion every 6 hours up to 3 doses. Intervention 2: Control group: Ampules containing 10 mL of sterile solution of snake antivenom produced by Razi Vaccine and Serum Research Institute which each mL is able to neutralize more than 50 LD50. Initial dose: Moderate or severe signs and symptoms, 5 and 10 ampules, respectively; Repeat dose: 1 to 6 hours after initial dose, 5 ampules until symptom treatment or administration of totally 20 vials; Maintenance dose: 2 ampules Infusion every 6 hours up to 3 doses. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is There is no more information.
public Maryam Amini Pouya
Third floor, Atam building, South Jannat Abad.
Tehran Iran (Islamic Republic of) 1473883378 +98 942 600 1123 maryam.aminipooya@gmail.com Arta Zist Pharmed scientific Seyed Reza Mousavi
Imam Reza square; Mashhad
Mashhad Iran (Islamic Republic of) 1473883378 44418514 mousaviR@mums.ac.ir Mashhad University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) History of snakebite Informed consent for participating in the study Men or Women victims with age of 2 to 60 years Victims who arrive at mentioned hospitals within 12 hours after snakebite Victims who need anti-venom according to the bite severity scale Victims who have Iranian nationality (having national ID) 2 years 60 years Both Victims with history of allergy to horse serum Victims who have experience of prior treatment with snake or scorpion antivenom due to snakebite or scorpion sting in the past. Victims with two or more number of bites on arrival at hospital. Victims who already have received antivenom prior to reach to hospital. Victims who do wound manipulation (incision, suction, burning and so on) before hospital entrance. Victims with life threatening bleeding (such as bleeding in mouth and upper respiratory tract) Victims who receive heparin and warfarin Victims with history of coagulopathy, cardiac disease, neuromuscular disease, kidney and liver failure. Pregnant or breastfeeding women. Victims who have sea snakebite. Victims who need for mechanical ventilation at the time of registration. T63.0 Toxic effect of snake venom Treatment - Drugs Treatment - Drugs Intervention group: Vial containing 10 mL of sterile solution of snake antivenom produced by Padra Serum Alborz which each mL is able to neutralize more than 50 LD50. Initial dose: Moderate or severe signs and symptoms, 5 and 10 vials, respectively; Repeat dose: 1 to 6 hours after initial dose, 5 vials until symptom treatment or administration of totally 20 vials; Maintenance dose: 2 vials Infusion every 6 hours up to 3 doses. Control group: Ampules containing 10 mL of sterile solution of snake antivenom produced by Razi Vaccine and Serum Research Institute which each mL is able to neutralize more than 50 LD50. Initial dose: Moderate or severe signs and symptoms, 5 and 10 ampules, respectively; Repeat dose: 1 to 6 hours after initial dose, 5 ampules until symptom treatment or administration of totally 20 vials; Maintenance dose: 2 ampules Infusion every 6 hours up to 3 doses. Percentage of victims with improving in snakebite symptoms. Timepoint: At baseline and 48 hours after antivenom administration. Method of measurement: A) Stopping progression of swelling B) Normalized coagulation abnormalities C) Stopping the progression of neurotoxicity. Percentage of adverse events. Timepoint: 0.5, 1, 6, 12, 24, 48, 72 hours, 7 and 14 days after Intervention. Method of measurement: Reporting the incidence proportion. Dose of antivenom administrated. Timepoint: 0.5, 1, 6, 12, 24, 48, 72 hours after Intervention. Method of measurement: Number of injected vials. Padra Serum Alborz Approved 2020-01-18 Mashhad University of Medical Sciences Shahid Fakouri Blvd. Mashhad Razavi Khorasan Iran (Islamic Republic of) Approved 2020-01-02 Ahvaz Jundishapur University of Medical Sciences Golestan High Way Ahvaz Khouzestan Iran (Islamic Republic of) Approved 2020-05-13 Urmia University of Medical Sciences Resalat BLVD., Urgans Aven., Urmia West Azarbaijan Iran (Islamic Republic of) Approved 2020-09-07 Kerman University of Medical Sciences Beginning of Haft Bagh Alavi Kerman Kerman Iran (Islamic Republic of)