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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به روز رسانی اطلاعات
به روز رسانی اطلاعات
Ethics committees
#1
empty
2020-01-02, 1398/10/12
2020-01-02 00:00:00
empty
IR.AJUMS.REC.1398.955
IR.AJUMS.REC.1398.955
#2
empty
2020-05-13, 1399/02/24
2020-05-13 00:00:00
empty
IR.UMSU.REC.1399.058
IR.UMSU.REC.1399.058
#3
empty
2020-09-07, 1399/06/17
2020-09-07 00:00:00
empty
IR.KMU.REC.1399.336
IR.KMU.REC.1399.336
Recruitment centers
#1
Name of recruitment center - English: Imam Reza hospital
Name of recruitment center - Persian: بیمارستان امام رضا
Full name of responsible person - English: Seyed reza mousavi
Full name of responsible person - Persian: سید رضا موسوی
Street address - English: Next to Imam Reza Square
Street address - Persian: نبش میدان امام رضا
City - English: Mashhad
City - Persian: مشهد
Province: Razavi Khorasan
Country: Iran (Islamic Republic of)
Postal code: 9137913316
Phone: +98 51 3859 8973
Fax:
Email: mousaviR@mums.ac.ir
Web page address:
Name of recruitment center - English: Imam Reza hospital
Name of recruitment center - Persian: بیمارستان امام رضا
Full name of responsible person - English: Seyed Reza Mousavi
Full name of responsible person - Persian: سید رضا موسوی
Street address - English: Next to Imam Reza square
Street address - Persian: نبش میدان امام رضا
City - English: Mashhad
City - Persian: مشهد
Province: Razavi Khorasan
Country: Iran (Islamic Republic of)
Postal code: 9137913316
Phone: +98 51 3859 8973
Fax:
Email: mousaviR@mums.ac.ir
Web page address:
Name of recruitment center - English: Imam Reza hospital Name of recruitment center - Persian: بیمارستان امام رضا Full name of responsible person - English: Seyed reza mousaviReza Mousavi Full name of responsible person - Persian: سید رضا موسوی Street address - English: Next to Imam Reza Squaresquare Street address - Persian: نبش میدان امام رضا City - English: Mashhad City - Persian: مشهد Province: Razavi Khorasan Country: Iran (Islamic Republic of) Postal code: 9137913316 Phone: +98 51 3859 8973 Fax: Email: mousaviR@mums.ac.ir Web page address:
#2
Name of recruitment center - English: Razi Hospital
Name of recruitment center - Persian: بیمارستان رازی
Full name of responsible person - English: Ahmad Ghorbani
Full name of responsible person - Persian: احمد قربانی
Street address - English: Felestin St., Amanieh
Street address - Persian: امانیه، خیابان فلسطین
City - English: Ahvaz
City - Persian: اهواز
Province: Khouzestan
Country: Iran (Islamic Republic of)
Postal code: 3318461357
Phone: +98 61 3333 5935
Fax:
Email: ahmadghorbanidr@gmail.com
Web page address:
Name of recruitment center - English: Abouzar Hospital
Name of recruitment center - Persian: بیمارستان ابوذر
Full name of responsible person - English: Ahmad Ghorbani
Full name of responsible person - Persian: احمد قربانی
Street address - English: Pasdaran BLVD., Parastar Street
Street address - Persian: بلوار پاسداران، خیابان پرستار
City - English: Ahvaz
City - Persian: اهواز
Province: Khouzestan
Country: Iran (Islamic Republic of)
Postal code: 1417561636
Phone: +98 61 3444 9003
Fax:
Email: ahmadghorbanidr@gmail.com
Web page address:
Name of recruitment center - English: RaziAbouzar Hospital Name of recruitment center - Persian: بیمارستان رازیابوذر Full name of responsible person - English: Ahmad Ghorbani Full name of responsible person - Persian: احمد قربانی Street address - English: Felestin StPasdaran BLVD., AmaniehParastar Street Street address - Persian: امانیهبلوار پاسداران، خیابان فلسطینپرستار City - English: Ahvaz City - Persian: اهواز Province: Khouzestan Country: Iran (Islamic Republic of) Postal code: 33184613571417561636 Phone: +98 61 3333 59353444 9003 Fax: Email: ahmadghorbanidr@gmail.com Web page address:
#3
Name of recruitment center - English: Ayat Allah Taleghani Hospital
Name of recruitment center - Persian: بیمارستان آیت الله طالقانی
Full name of responsible person - English: Mahmoud Dalirrad
Full name of responsible person - Persian: محمود دلیری راد
Street address - English: Kashani St., Urmia Town.
Street address - Persian: شهرستان ارومیه، خیابان کاشانی
City - English: Urmia
City - Persian: ارومیه
Province: West Azarbaijan
Country: Iran (Islamic Republic of)
Postal code: 5715974677
Phone: +98 44 3348 7990
Fax:
Email: dalirrad@yahoo.com
Web page address:
Name of recruitment center - English: Emam Khomeinii Hospital
Name of recruitment center - Persian: بیمارستان امام خمینی
Full name of responsible person - English: Mohammad Dalirrad
Full name of responsible person - Persian: محمد دلیرراد
Street address - English: Modarres BLVD., Ershad Street.
Street address - Persian: بلوار مدرس، خیابان ارشاد
City - English: Urmia
City - Persian: ارومیه
Province: West Azarbaijan
Country: Iran (Islamic Republic of)
Postal code: 8135157157
Phone: +98 44 3346 9931
Fax:
Email: dalirrad@yahoo.com
Web page address:
Name of recruitment center - English: Ayat Allah TaleghaniEmam Khomeinii Hospital Name of recruitment center - Persian: بیمارستان آیت الله طالقانیامام خمینی Full name of responsible person - English: MahmoudMohammad Dalirrad Full name of responsible person - Persian: محمود دلیری رادمحمد دلیرراد Street address - English: Kashani StModarres BLVD., Urmia TownErshad Street. Street address - Persian: شهرستان ارومیهبلوار مدرس، خیابان کاشانیارشاد City - English: Urmia City - Persian: ارومیه Province: West Azarbaijan Country: Iran (Islamic Republic of) Postal code: 57159746778135157157 Phone: +98 44 3348 79903346 9931 Fax: Email: dalirrad@yahoo.com Web page address:
#4
Name of recruitment center - English: Hazrate Aliasghar Hospital
Name of recruitment center - Persian: بیمارستان حضرت علی اصغر (ع)
Full name of responsible person - English: Hosein sanaeizadeh
Full name of responsible person - Persian: حسین صناعی زاده
Street address - English: In Front of Homa Hotel, Meshkin Fam St.,
Street address - Persian: خیابان مشکین فام ، روبروی هتل هما
City - English: Shiraz
City - Persian: شیراز
Province: Fars
Country: Iran (Islamic Republic of)
Postal code: 7143918796
Phone: +98 71 3228 8602
Fax:
Email: sanaeizadeh@gmail.com
Web page address:
Name of recruitment center - English: Afzalipour hospital
Name of recruitment center - Persian: بیمارستان افضلی پور
Full name of responsible person - English: Zohreh Oghabian
Full name of responsible person - Persian: زهره عقابیان
Street address - English: Beginning of Haft Bagh Alavi
Street address - Persian: ابتدای محور هفت باغ علوی
City - English: Kerman
City - Persian: کرمان
Province: Kerman
Country: Iran (Islamic Republic of)
Postal code: 7616913555
Phone: +98 34 3132 5700
Fax:
Email: zoghabian@yahoo.com
Web page address:
Name of recruitment center - English: Hazrate Aliasghar HospitalAfzalipour hospital Name of recruitment center - Persian: بیمارستان حضرت علی اصغر (ع)افضلی پور Full name of responsible person - English: Hosein sanaeizadehZohreh Oghabian Full name of responsible person - Persian: حسین صناعی زادهزهره عقابیان Street address - English: In FrontBeginning of Homa Hotel, Meshkin Fam St.,Haft Bagh Alavi Street address - Persian: خیابان مشکین فام ، روبروی هتل هماابتدای محور هفت باغ علوی City - English: ShirazKerman City - Persian: شیرازکرمان Province: FarsKerman Country: Iran (Islamic Republic of) Postal code: 71439187967616913555 Phone: +98 71 3228 860234 3132 5700 Fax: Email: sanaeizadehzoghabian@gmail.comyahoo.com Web page address:
#5
Name of recruitment center - English: Emam Khomeini Hospital
Name of recruitment center - Persian: بیمارستان امام خمینی
Full name of responsible person - English: Ali Hasan Rahmani
Full name of responsible person - Persian: علی حسن رحمانی
Street address - English: Azadegan Street
Street address - Persian: خیابان آزادگان
City - English: Ahvaz
City - Persian: اهواز
Province: Khouzestan
Country: Iran (Islamic Republic of)
Postal code: ۶۱۹۳۶۷۳۱۱۱
Phone: +98 61 3292 3985
Fax:
Email: alir884@yahoo.com
Web page address:
Name of recruitment center - English: Emam Khomeini Hospital Name of recruitment center - Persian: بیمارستان امام خمینی Full name of responsible person - English: Ali Hasan Rahmani Full name of responsible person - Persian: علی حسن رحمانی Street address - English: Azadegan Street Street address - Persian: خیابان آزادگان City - English: Ahvaz City - Persian: اهواز Province: Khouzestan Country: Iran (Islamic Republic of) Postal code: ۶۱۹۳۶۷۳۱۱۱ Phone: +98 61 3292 3985 Fax: Email: alir884@yahoo.com Web page address:
Sponsors / Funding sources
#1
contact.organization_id:
Name of organization / entity - English: Padra Serum Alborz Company
Name of organization / entity - Persian: شرکت پادرا سرم البرز
Full name of responsible person - English: Mohamad Amin Ghobadi
Full name of responsible person - Persian: محمد امین قبادی
Street address - English: No. 110, Khaje Nasir Tousi St., Bahman St., Sepehr Industrial Town.
Street address - Persian: شماره 110، خیابان خواجه نصیر طوسی، خیابان بهمن، شهرک صنعتی سپهر
City - English: Nazar Abad
City - Persian: نظر آباد
Province: Alborz
Country: Iran (Islamic Republic of)
Postal code: 3331495894
Phone: +98 26 4533 4189
Fax:
Email: a.ghobadi@padraserum.com
Web page address:
contact.organization_id:
Name of organization / entity - English: Padra Serum Alborz Company
Name of organization / entity - Persian: شرکت پادرا سرم البرز
Full name of responsible person - English: Mohamad Amin Ghobadi
Full name of responsible person - Persian: محمد امین قبادی
Street address - English: No.110, Khaje Nasir Tousi street, Bahman street, Sepehr Industrial Town.
Street address - Persian: شهرک صنعتی سپهر، خیابان بهمن، خیابان خواجه نصیر طوسی، شماره 110
City - English: Nazar Abad
City - Persian: نظر آباد
Province: Alborz
Country: Iran (Islamic Republic of)
Postal code: 3331495894
Phone: +98 26 4533 4189
Fax:
Email: a.ghobadi@padraserum.com
Web page address:
contact.organization_id: Name of organization / entity - English: Padra Serum Alborz Company Name of organization / entity - Persian: شرکت پادرا سرم البرز Full name of responsible person - English: Mohamad Amin Ghobadi Full name of responsible person - Persian: محمد امین قبادی Street address - English: No. 110No.110, Khaje Nasir Tousi St.street, Bahman St.street, Sepehr Industrial Town. Street address - Persian: شماره 110شهرک صنعتی سپهر، خیابان بهمن، خیابان خواجه نصیر طوسی، خیابان بهمن، شهرک صنعتی سپهرشماره 110 City - English: Nazar Abad City - Persian: نظر آباد Province: Alborz Country: Iran (Islamic Republic of) Postal code: 3331495894 Phone: +98 26 4533 4189 Fax: Email: a.ghobadi@padraserum.com Web page address:
Person responsible for general inquiries
contact.organization_id:
Name of organization / entity - English: Arta Zist Pharmed
Name of organization / entity - Persian: آرتا زیست فارمد
Full name of responsible person - English: Maryam Amini Pouya
Full name of responsible person - Persian: مریم امینی پویا
Position - English: Medical department manager
Position - Persian: مدیر دپارتمان مدیکال
Latest degree: med_doctor
Area of specialty/work: 41
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: Third floor, Atam building, South Jannat Abad.
Street address - Persian: جنت آباد جنوبی، ساختمان آتام، طبقه 3
City - English: Tehran
City - Persian: تهران
Province: Tehran
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 1473883378
Phone: +98 942 600 1123
Mobile: +98 912 057 5680
Fax:
Email: m.amini@artapharmed
Web page address:
contact.organization_id:
Name of organization / entity - English: Arta Zist Pharmed
Name of organization / entity - Persian: آرتا زیست فارمد
Full name of responsible person - English: Maryam Amini Pouya
Full name of responsible person - Persian: مریم امینی پویا
Position - English: Medical department manager
Position - Persian: مدیر دپارتمان مدیکال
Latest degree: med_doctor
Area of specialty/work: 41
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: Third floor, Atam building, South Jannat Abad.
Street address - Persian: جنت آباد جنوبی، ساختمان آتام، طبقه 3
City - English: Tehran
City - Persian: تهران
Province: Tehran
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 1473883378
Phone: +98 942 600 1123
Mobile: +98 912 057 5680
Fax:
Email: maryam.aminipooya@gmail.com
Web page address:
contact.organization_id: Name of organization / entity - English: Arta Zist Pharmed Name of organization / entity - Persian: آرتا زیست فارمد Full name of responsible person - English: Maryam Amini Pouya Full name of responsible person - Persian: مریم امینی پویا Position - English: Medical department manager Position - Persian: مدیر دپارتمان مدیکال Latest degree: med_doctor Area of specialty/work: 41 Area of specialty/work title - English: Area of specialty/work title - Persian: Street address - English: Third floor, Atam building, South Jannat Abad. Street address - Persian: جنت آباد جنوبی، ساختمان آتام، طبقه 3 City - English: Tehran City - Persian: تهران Province: Tehran Province - English: Province - Persian: contact.provinces_available: 1 Country: Iran (Islamic Republic of) Postal code: 1473883378 Phone: +98 942 600 1123 Mobile: +98 912 057 5680 Fax: Email: m.aminimaryam.aminipooya@artapharmedgmail.com Web page address:
Person responsible for scientific inquiries
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Seyed Reza Mousavi
Full name of responsible person - Persian: سید رضا موسوی
Position - English: Associate Professor of Forensic Medicine and Clinical Toxicology
Position - Persian: دانشیار پزشکی قانونی و مسمومیت ها
Latest degree: specialist
Area of specialty/work: 31
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: Imam Reza square; Mashhad
Street address - Persian: مشهد؛ میدان امام رضا
City - English: Mashhad
City - Persian: مشهد
Province: Razavi Khorasan
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 1473883378
Phone: 44418514
Mobile: +98 912 214 2165
Fax:
Email: e.zabihi@artapharmed.com
Web page address:
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Seyed Reza Mousavi
Full name of responsible person - Persian: سید رضا موسوی
Position - English: Associate Professor of Forensic Medicine and Clinical Toxicology
Position - Persian: دانشیار پزشکی قانونی و مسمومیت ها
Latest degree: specialist
Area of specialty/work: 31
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: Imam Reza square; Mashhad
Street address - Persian: مشهد؛ میدان امام رضا
City - English: Mashhad
City - Persian: مشهد
Province: Razavi Khorasan
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 1473883378
Phone: 44418514
Mobile: +98 912 214 2165
Fax:
Email: mousaviR@mums.ac.ir
Web page address:
Name of organization / entity - English: Name of organization / entity - Persian: Full name of responsible person - English: Seyed Reza Mousavi Full name of responsible person - Persian: سید رضا موسوی Position - English: Associate Professor of Forensic Medicine and Clinical Toxicology Position - Persian: دانشیار پزشکی قانونی و مسمومیت ها Latest degree: specialist Area of specialty/work: 31 Area of specialty/work title - English: Area of specialty/work title - Persian: Street address - English: Imam Reza square; Mashhad Street address - Persian: مشهد؛ میدان امام رضا City - English: Mashhad City - Persian: مشهد Province: Razavi Khorasan Province - English: Province - Persian: contact.provinces_available: 1 Country: Iran (Islamic Republic of) Postal code: 1473883378 Phone: 44418514 Mobile: +98 912 214 2165 Fax: Email: e.zabihimousaviR@artapharmed.commums.ac.ir Web page address:
Protocol summary
Study aim
Evaluation of efficacy and safety of anti-venom produced by Padra Serum Alborz
Design
An active controlled, parallel group, double blinded, randomized clinical trial
Settings and conduct
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.
Participants/Inclusion and exclusion criteria
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.
Intervention groups
Intervention group 1: Anti-venom of Padra Serum Alborz (Vial).
Intervention group 2: Anti-venom of Razi (Ampule)
Main outcome variables
Stopping progression of swelling and neurotoxicity symptoms, Normalized coagulation abnormalities till 48 hours.
General information
Reason for update
Information Updating
Acronym
IRCT registration information
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
Registration date
2020-02-19, 1398/11/30
Registrant information
Name
Maryam Amini Pouya
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8889 6696
Email address
maryam.aminipooya@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-02-20, 1398/12/01
Expected recruitment end date
2020-06-20, 1399/03/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
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.
Public title
Phase 3, multi-center clinical trial for evaluation of two types of snake anti-venom
Purpose
Treatment
Inclusion/Exclusion criteria
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.
Age
From 2 years old to 60 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Outcome assessor
Data analyser
Sample size
Target sample size:
98
Randomization (investigator's opinion)
Randomized
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 (investigator's opinion)
Double blinded
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.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Mashhad University of Medical Sciences
Street address
Shahid Fakouri Blvd.
City
Mashhad
Province
Razavi Khorasan
Postal code
9138813944
Approval date
2020-01-18, 1398/10/28
Ethics committee reference number
IR.MUMS.REC.1398.295
2
Ethics committee
Name of ethics committee
Ahvaz Jundishapur University of Medical Sciences
Street address
Golestan High Way
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Approval date
2020-01-02, 1398/10/12
Ethics committee reference number
IR.AJUMS.REC.1398.955
3
Ethics committee
Name of ethics committee
Urmia University of Medical Sciences
Street address
Resalat BLVD., Urgans Aven.,
City
Urmia
Province
West Azarbaijan
Postal code
5714783734
Approval date
2020-05-13, 1399/02/24
Ethics committee reference number
IR.UMSU.REC.1399.058
4
Ethics committee
Name of ethics committee
Kerman University of Medical Sciences
Street address
Beginning of Haft Bagh Alavi
City
Kerman
Province
Kerman
Postal code
7616913555
Approval date
2020-09-07, 1399/06/17
Ethics committee reference number
IR.KMU.REC.1399.336
Health conditions studied
1
Description of health condition studied
Snake-Bite
ICD-10 code
T63.0
ICD-10 code description
Toxic effect of snake venom
Primary outcomes
1
Description
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
Secondary outcomes
1
Description
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
2
Description
dose of antivenom administrated
Timepoint
0.5, 1, 6, 12, 24, 48, 72 hours after Intervention
Method of measurement
Number of injected vials
Intervention groups
1
Description
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.
Category
Treatment - Drugs
2
Description
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.