Protocol summary
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Study aim
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Evaluation of efficacy and safety of anti-venom produced by Padra Serum Alborz
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Design
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An active controlled, parallel group, double blinded, randomized clinical trial
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Settings and conduct
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The study is double blinded, multi-center in Mashhad, Ahvaz, Shiraz and Uromia. victims will be receiving the intervention treatments randomly after inclusion /exclusion evaluation and signing of inform consent form. Quantity of required antivenoms based on physical examination, para-clinic tests and physicians diagnosis will be prepared for injection by nurse and will be infused. thirty minutes, 1, 6, 12, 48 and 72 hours after injection victims will be visited by physician and everything will be recorded in eCRF. After discharge of victim from hospital, serum sickness questioner through phone call one and two weeks after antivenom administration will be asked.
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Participants/Inclusion and exclusion criteria
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Inclusion criteria:
Iranian Victims of 2- 60 years of age with snake bite, signed Informed consent,
hospital entrance within 12 hours of snake bite and indication of antivenom administration.
Exclusion criteria:
Victims with history of allergy to horse serum, history of snake bite or scorpion sting, presence of two or more numbers of bites, sea snakebite, received antivenom prior to reach to study center, Having chronic disease.
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Intervention groups
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Intervention group 1: Anti-venom of Padra Serum Alborz (Vial).
Intervention group 2: Anti-venom of Razi (Ampule)
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Main outcome variables
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Stopping progression of swelling and neurotoxicity symptoms, Normalized coagulation abnormalities till 48 hours.
General information
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Reason for update
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Information Updating
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20180515039672N2
Registration date:
2020-02-19, 1398/11/30
Registration timing:
prospective
Last update:
2020-11-03, 1399/08/13
Update count:
1
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Registration date
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2020-02-19, 1398/11/30
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2020-02-20, 1398/12/01
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Expected recruitment end date
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2020-06-20, 1399/03/31
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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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.
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Public title
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Phase 3, multi-center clinical trial for evaluation of two types of snake anti-venom
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
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)
Exclusion criteria:
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.
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Age
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From 2 years old to 60 years old
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Gender
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Both
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Phase
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3
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Groups that have been masked
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- Participant
- Outcome assessor
- Data analyser
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Sample size
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Target sample size:
98
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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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.
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Blinding (investigator's opinion)
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Double blinded
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Blinding description
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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.
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Placebo
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Not used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2020-01-18, 1398/10/28
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Ethics committee reference number
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IR.MUMS.REC.1398.295
2
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Ethics committee
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Approval date
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2020-01-02, 1398/10/12
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Ethics committee reference number
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IR.AJUMS.REC.1398.955
3
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Ethics committee
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Approval date
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2020-05-13, 1399/02/24
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Ethics committee reference number
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IR.UMSU.REC.1399.058
4
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Ethics committee
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Approval date
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2020-09-07, 1399/06/17
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Ethics committee reference number
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IR.KMU.REC.1399.336
Health conditions studied
1
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Description of health condition studied
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Snake-Bite
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ICD-10 code
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T63.0
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ICD-10 code description
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Toxic effect of snake venom
Primary outcomes
1
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Description
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Percentage of victims with improving in snakebite symptoms
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Timepoint
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At baseline and 48 hours after antivenom administration
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Method of measurement
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A) Stopping progression of swelling B) Normalized coagulation abnormalities C) Stopping the progression of neurotoxicity
Secondary outcomes
1
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Description
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Percentage of adverse events
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Timepoint
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0.5, 1, 6, 12, 24, 48, 72 hours, 7 and 14 days after Intervention
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Method of measurement
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Reporting the incidence proportion
2
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Description
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dose of antivenom administrated
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Timepoint
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0.5, 1, 6, 12, 24, 48, 72 hours after Intervention
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Method of measurement
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Number of injected vials
Intervention groups
1
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Description
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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.
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Category
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Treatment - Drugs
2
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Description
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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.
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Category
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Treatment - Drugs
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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No
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Title of funding source
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Padra Serum Alborz
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Proportion provided by this source
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100
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Public or private sector
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Private
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Persons
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Undecided - It is not yet known if there will be a plan to make this available
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Study Protocol
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Undecided - It is not yet known if there will be a plan to make this available
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Statistical Analysis Plan
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Undecided - It is not yet known if there will be a plan to make this available
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Informed Consent Form
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Undecided - It is not yet known if there will be a plan to make this available
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Clinical Study Report
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Undecided - It is not yet known if there will be a plan to make this available
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Analytic Code
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Undecided - It is not yet known if there will be a plan to make this available
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Data Dictionary
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Undecided - It is not yet known if there will be a plan to make this available