Phase 3 clinical trial for non-inferiority evaluation of efficacy and safety of scorpion antivenom "Padra Serum Alborz " production vs "Razi Vaccine and Serum Research Institute" in the treatment of scorpion sting victims age of 2 to 60
Red color represents old content. It may be empty showing addition in the new version.
Green color represents new content. It may be empty showing deletion in the new version.
Inline
Side by side
Added new contents,
deleted old contents,contents that are not changed.
New table contents
New table contents
Old table contents
Old table contents
Unchanged contents
Unchanged contents
Added new contents, contents that are not changed.
Deleted old contents, contents that are not changed.
Old table contents
Old table contents
Unchanged contents
Unchanged contents
New table contents
New table contents
Unchanged contents
Unchanged contents
Protocol summary
Efficacy and safety non-inferiority evaluation of "Padra Serum Alborz" vs "Razi Vaccine Serum Research Institute" scorpion antivenom productions
Non-inferiority evaluation of efficacy and safety of "Padra Serum Alborz" vs "Razi Vaccine Serum Research Institute" scorpion antivenom productions
EfficacyNon-inferiority evaluation of efficacy and safety non-inferiority evaluation of "Padra Serum Alborz" vs "Razi Vaccine Serum Research Institute" scorpion antivenom productions
Active control, double blind, two-armed, randomized clinical trial designed for 98 scorpion sting victims age of 2 to 60
Active control, double blind, two-armed, randomized(1:1), phase 3 clinical trial designed for 98 scorpion sting victims age of 2 to 60
Active control, double blind, two-armed, randomizedrandomized(1:1), phase 3 clinical trial designed for 98 scorpion sting victims age of 2 to 60
کارآزمایی بالینی تصادفی سازی شده، دو بازویی، موازی، دوسو کور، کنترل فعال در 98 مصدوم عقرب گزیده بین 2 تا 60 سال
کارآزمایی بالینی فاز 3، تصادفی سازی شده (1:1)، دو بازویی، موازی، دوسو کور، کنترل فعال در 98 مصدوم عقرب گزیده بین 2 تا 60 سال
کارآزمایی بالینی فاز 3، تصادفی سازی شده (1:1)، دو بازویی، موازی، دوسو کور، کنترل فعال در 98 مصدوم عقرب گزیده بین 2 تا 60 سال
Scorpion sting victims who arrived the Razi Hospital in Ahvaz, will be assessed about inclusion and exclusion criteria. The victims will be treated with antivenom and concomitant therapy based on the initial sings & symptoms of systemic envenomation. The victims will be reassessed 2, 6, 12 & 24 hours after first antivenom infusion in hospital. The serum sickness incidence will be evaluated after 7 & 14 days. The victim, physician and the outcome assessor are blinded about type of antivenom.
Scorpion sting victims who will refer to Razi hospital in Ahvaz, will be assessed for inclusion and exclusion criteria. Then they will be treated with antivenom and concomitant therapy based on the initial sings & symptoms of systemic envenomation. The victims will be reassessed 2, 6, 12 & 24 hours after first antivenom infusion in hospital. The serum sickness incidence will be evaluated after 7 & 14 days. The victim, physician and the outcome assessor are blinded about type of antivenom.
Scorpion sting victims who arrived thewill refer to Razi Hospitalhospital in Ahvaz, will be assessed aboutfor inclusion and exclusion criteria. The victimsThen they will be treated with antivenom and concomitant therapy based on the initial sings & symptoms of systemic envenomation. The victims will be reassessed 2, 6, 12 & 24 hours after first antivenom infusion in hospital. The serum sickness incidence will be evaluated after 7 & 14 days. The victim, physician and the outcome assessor are blinded about type of antivenom.
Inclusion: Scorpion sting victims age of 2 to 60; Hospital entrance at maximum 6 hours after scorpion sting; Signs of systemic scorpion envenomation or having the Indication for Antivenom Infusion
Exclusion: History of allergic reactions to plasma derived productions; History of severe allergic diseases such as atopic asthma; Present of systemic diseases such as cardiovascular and kidney diseases; Pregnant and nursing women
Inclusion: Scorpion sting victims age of 2 to 60; Arriving to hospital maximum 6 hours after scorpion sting; Signs of systemic scorpion envenomation or having the Indication for Antivenom Infusion
Exclusion: History of allergic reactions to plasma derived productions; History of severe allergic diseases such as atopic asthma; Present of systemic diseases such as cardiovascular and kidney diseases; Pregnant and breast feeding women
Inclusion: Scorpion sting victims age of 2 to 60; Hospital entrance atArriving to hospital maximum 6 hours after scorpion sting; Signs of systemic scorpion envenomation or having the Indication for Antivenom Infusion Exclusion: History of allergic reactions to plasma derived productions; History of severe allergic diseases such as atopic asthma; Present of systemic diseases such as cardiovascular and kidney diseases; Pregnant and nursingbreast feeding women
Proportion of victims with alleviation of systemic scorpion envenomation (12 hours after antivenom injection)
Alleviation of systemic scorpion envenomation (12 hours after antivenom injection)
Proportion of victims with alleviationAlleviation of systemic scorpion envenomation (12 hours after antivenom injection)
General information
empty
98
98
empty
2019-02-06, 1397/11/17
2019-02-06 00:00:00
empty
2019-04-16, 1398/01/27
2019-04-16 00:00:00
empty
2019-04-30, 1398/02/10
2019-04-30 00:00:00
Phase 3 clinical trial for non-inferiority efficacy and safety evaluation of scorpion "Padra Serum Alborz antivenom" production vs "Razi Vaccine and Serum Research Institute" in the treatment of scorpion sting victims age of 2 to 60
Phase 3 clinical trial for non-inferiority evaluation of efficacy and safety of scorpion antivenom "Padra Serum Alborz " production vs "Razi Vaccine and Serum Research Institute" in the treatment of scorpion sting victims age of 2 to 60
Phase 3 clinical trial for non-inferiority evaluation of efficacy and safety evaluation of scorpion antivenom "Padra Serum Alborz antivenom" production vs "Razi Vaccine and Serum Research Institute" in the treatment of scorpion sting victims age of 2 to 60
Randomization sequences will be made by online software using the quadruple blocks before the start of study to achieve the sample size of 98 victims. Each of these sequences will be converted to untitled code (e.g. c45, a37, ...).
Antivenoms presented in the study cite drug stock, have been labeled with the research label & the unique untitled code before initiation of the study.
After entrance of each victim, according to the randomization sequence, the specific antivenom will prepared by the nurse. So through the randomization process, concealment & blindness of victims, physicians & outcome assessor also be maintained.
Randomization sequences will be made by online software using the quadruple blocks before the start of study to achieve the sample size of 98 victims. Each of these sequences will be converted to untitled code (e.g. c45, a37, ...).
Antivenoms that will be presented in the study cite drug stock, have been labeled with the research label & the unique untitled code before initiation of the study.
After arrival of each victim, according to the randomization sequence, the specific antivenom will be prepared by the nurse. So through the randomization process, concealment & blindness of victims, physicians & outcome assessor also would be kept.
Randomization sequences will be made by online software using the quadruple blocks before the start of study to achieve the sample size of 98 victims. Each of these sequences will be converted to untitled code (e.g. c45, a37, ...). Antivenoms that will be presented in the study cite drug stock, have been labeled with the research label & the unique untitled code before initiation of the study. After entrancearrival of each victim, according to the randomization sequence, the specific antivenom will be prepared by the nurse. So through the randomization process, concealment & blindness of victims, physicians & outcome assessor also would be maintainedkept.
After the victim consent and according to the antivenom infusion by the nurse, the victim and physician won't be aware of the injected antivenom brand. Also the final results will be given to outcome assessor with untitled codes.
So we expected the blindness in victims, physicians and outcome assessor would be obtained properly.
After the victim consent and according to the antivenom infusion by the nurse, the victim and physician will not be aware of the injected antivenom brand. Also the final results will be given to outcome assessor with untitled codes.
So we would expect that the blindness in victims, physicians and outcome assessor will be obtained properly.
After the victim consent and according to the antivenom infusion by the nurse, the victim and physician won'twill not be aware of the injected antivenom brand. Also the final results will be given to outcome assessor with untitled codes. So we expectedwould expect that the blindness in victims, physicians and outcome assessor wouldwill be obtained properly.
Secondary outcomes
#1
Proportion of victims with alleviation of scorpion envenomation symptoms
The mean time of scorpion envenomation symptoms duration alleviation
Proportion of victims with alleviationThe mean time of scorpion envenomation symptoms duration alleviation
درصد مصدومین با تخفیف علائم عقرب گزیدگی
میانگین مدت زمان تخفیف علائم عقرب گزیدگی
درصد مصدومین بامیانگین مدت زمان تخفیف علائم عقرب گزیدگی
2, 6 & 24 hours after antivenom injection
24 hours after antivenom infusion
2, 6 & 24 hours after antivenom injectioninfusion
2، 6 و 24 ساعت پس از تجویز پادزهر
24 ساعت پس از تزریق پادزهر
2، 6 و 24 ساعت پس از تجویزتزریق پادزهر
Symptom alleviation: Alleviate the initial symptoms from "severe" to "moderate to mild" by the physician diagnosis
The time recording
Symptom alleviation: Alleviate the initial symptoms from "severe" to "moderate to mild" by the physician diagnosisThe time recording
تخفیف علائم: کاهش شدت علائم از «شدید» به «متوسط تا خفیف» طبق نظر پزشک معالج
ثبت مدت زمان
تخفیف علائم: کاهش شدت علائم از «شدید» به «متوسط تا خفیف» طبق نظر پزشک معالجثبت مدت زمان
#2
The mean duration of scorpion envenomation symptoms alleviation
The incidence of anaphylactic reactions
The mean durationincidence of scorpion envenomation symptoms alleviationanaphylactic reactions
میانگین مدت زمان تخفیف علائم عقرب گزیدگی
درصد وقوع شوک آنافیلاکسی
میانگین مدت زمان تخفیف علائم عقرب گزیدگیدرصد وقوع شوک آنافیلاکسی
24 hours after antivenom infusion
During the study time
24 hours after antivenom infusionDuring the study time
24 ساعت پس از تزریق پادزهر
طی مدت زمان مطالعه
24 ساعت پس از تزریق پادزهرطی مدت زمان مطالعه
The time recording
Reporting the incidence proportion
The time recordingReporting the incidence proportion
ثبت مدت زمان
گزارش درصد وقوع
ثبت مدت زمانگزارش درصد وقوع
#3
The incidence of anaphylactic reactions
The Serum Sickness incidence
The Serum Sickness incidence of anaphylactic reactions
درصد وقوع شوک آنافیلاکسی
درصد وقوع Serum Sickness
درصد وقوع شوک آنافیلاکسیSerum Sickness
#4
The Serum Sickness incidence
The incidence of any other adverse events
The Serum Sickness incidence of any other adverse events
درصد وقوع Serum Sickness
درصد سایر عوارض ناخواسته
درصد وقوع Serum Sicknessسایر عوارض ناخواسته
#5
The incidence of any other adverse events
Duration of the victims' hospitalization
The incidenceDuration of any other adverse eventsthe victims' hospitalization
درصد سایر عوارض ناخواسته
مدت زمان بستری بودن مصدومین
درصد سایر عوارض ناخواستهمدت زمان بستری بودن مصدومین
Reporting the incidence proportion
The time recording
Reporting the incidence proportionThe time recording
Intervention group: 1 to 3, 5ml vials (by physician diagnosis based on initial signs) of Scorpion Antivenom (Padra Serum Alborz Production) with dose of 10 LD50/ml for 20 to 30 minutes IV infusion
Intervention group: 1 to 3, 5ml vials (by physician diagnosis based on initial signs) of Scorpion Antivenom Vial (Padra Serum Alborz Production) with dose of 10 LD50/ml for 20 to 30 minutes IV infusion
گروه مداخله: ویال پادزهر عقرب(ساخت شرکت پادرا سرم البرز)
گروه مداخله: 1 تا 3 ویال 5 میلی لیتری (طبق نظر پزشک و بر اساس شدت علائم اولیه) از پادزهر شش ظرفیتی ضد عقرب گزیدگی(ساخت شرکت پادرا سرم البرز) با دوز 10LD50/ml جهت انفوزیون وریدی بین 20 تا 30 دقیقه
گروه مداخله: 1 تا 3 ویال 5 میلی لیتری (طبق نظر پزشک و بر اساس شدت علائم اولیه) از پادزهر عقرب(ساختشش ظرفیتی ضد عقرب گزیدگی(ساخت شرکت پادرا سرم البرز) با دوز 10LD50/ml جهت انفوزیون وریدی بین 20 تا 30 دقیقه
#2
Control group: Scorpion Antivenom Ampule (Razi Vaccine and Serum Research Institute)
Control group: 1 to 3, 5ml ampules (by physician diagnosis based on initial signs) of Scorpion Antivenom (Razi Vaccine and Serum Research Institute) with dose of 10 LD50/ml for 20 to 30 minutes IV infusion Scorpion
Control group: 1 to 3, 5ml ampules (by physician diagnosis based on initial signs) of Scorpion Antivenom Ampule (Razi Vaccine and Serum Research Institute) with dose of 10 LD50/ml for 20 to 30 minutes IV infusion Scorpion
گروه کنترل: آمپول پادزهر عقرب(ساخت موسسه تحقیقات واکسن و سرم سازی رازی)
گروه کنترل: 1 تا 3 آمپول 5 میلی لیتری(طبق نظر پزشک و بر اساس شدت علائم اولیه) از پادزهر شش ظرفیتی ضد عقرب گزیدگی(ساخت موسسه تحقیقات واکسن و سرم سازی رازی)، با دوز 10LD50/ml جهت انفوزیون وریدی بین 20 تا 30 دقیقه
گروه کنترل: 1 تا 3 آمپول 5 میلی لیتری(طبق نظر پزشک و بر اساس شدت علائم اولیه) از پادزهر عقرب(ساختشش ظرفیتی ضد عقرب گزیدگی(ساخت موسسه تحقیقات واکسن و سرم سازی رازی)، با دوز 10LD50/ml جهت انفوزیون وریدی بین 20 تا 30 دقیقه
Protocol summary
Study aim
Non-inferiority evaluation of efficacy and safety of "Padra Serum Alborz" vs "Razi Vaccine Serum Research Institute" scorpion antivenom productions
Design
Active control, double blind, two-armed, randomized(1:1), phase 3 clinical trial designed for 98 scorpion sting victims age of 2 to 60
Settings and conduct
Scorpion sting victims who will refer to Razi hospital in Ahvaz, will be assessed for inclusion and exclusion criteria. Then they will be treated with antivenom and concomitant therapy based on the initial sings & symptoms of systemic envenomation. The victims will be reassessed 2, 6, 12 & 24 hours after first antivenom infusion in hospital. The serum sickness incidence will be evaluated after 7 & 14 days. The victim, physician and the outcome assessor are blinded about type of antivenom.
Participants/Inclusion and exclusion criteria
Inclusion: Scorpion sting victims age of 2 to 60; Arriving to hospital maximum 6 hours after scorpion sting; Signs of systemic scorpion envenomation or having the Indication for Antivenom Infusion
Exclusion: History of allergic reactions to plasma derived productions; History of severe allergic diseases such as atopic asthma; Present of systemic diseases such as cardiovascular and kidney diseases; Pregnant and breast feeding women
Intervention groups
Intervention group: Scorpion Antivenom Vial (Padra Serum Alborz Production)
Control group: Scorpion Antivenom Ampule (Razi Vaccine Serum Research Institute)
Main outcome variables
Alleviation of systemic scorpion envenomation (12 hours after antivenom injection)
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180515039672N1
Registration date:2019-01-28, 1397/11/08
Registration timing:prospective
Last update:2019-05-12, 1398/02/22
Update count:1
Registration date
2019-01-28, 1397/11/08
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
2019-01-10, 1397/10/20
Expected recruitment end date
2019-04-21, 1398/02/01
Actual recruitment start date
2019-02-06, 1397/11/17
Actual recruitment end date
2019-04-16, 1398/01/27
Trial completion date
2019-04-30, 1398/02/10
Scientific title
Phase 3 clinical trial for non-inferiority evaluation of efficacy and safety of scorpion antivenom "Padra Serum Alborz " production vs "Razi Vaccine and Serum Research Institute" in the treatment of scorpion sting victims age of 2 to 60
Public title
Efficacy and safety evaluation of "Padra Serum Alborz" vs "Razi Vaccine and Serum Research Institute" scorpion antivenom productions
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Scorpion sting victims age of 2 to 60
Hospital entrance at maximum 6 hours after scorpion sting
Signs of systemic scorpion envenomation or having the Indication for Antivenom Infusion
Exclusion criteria:
History of allergic reactions to plasma derived productions
History of severe allergic diseases such as atopic asthma
Present of systemic diseases such as cardiovascular and kidney diseases
Pregnant and nursing women
Age
From 2 years old to 60 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Investigator
Outcome assessor
Sample size
Target sample size:
98
Actual sample size reached:
98
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization sequences will be made by online software using the quadruple blocks before the start of study to achieve the sample size of 98 victims. Each of these sequences will be converted to untitled code (e.g. c45, a37, ...).
Antivenoms that will be presented in the study cite drug stock, have been labeled with the research label & the unique untitled code before initiation of the study.
After arrival of each victim, according to the randomization sequence, the specific antivenom will be prepared by the nurse. So through the randomization process, concealment & blindness of victims, physicians & outcome assessor also would be kept.
Blinding (investigator's opinion)
Double blinded
Blinding description
After the victim consent and according to the antivenom infusion by the nurse, the victim and physician will not be aware of the injected antivenom brand. Also the final results will be given to outcome assessor with untitled codes.
So we would expect that the blindness in victims, physicians and outcome assessor will be obtained properly.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
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
2019-01-26, 1397/11/06
Ethics committee reference number
IR.AJUMS.REC.1397.790
Health conditions studied
1
Description of health condition studied
Scorpion sting
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Proportion of victims with alleviation of scorpion envenomation symptoms
Timepoint
12 hours after antivenom infusion
Method of measurement
Symptom alleviation: Alleviate the initial symptoms from "severe" to "moderate to mild" by the physician diagnosis
Secondary outcomes
1
Description
The mean time of scorpion envenomation symptoms duration alleviation
Timepoint
24 hours after antivenom infusion
Method of measurement
The time recording
2
Description
The incidence of anaphylactic reactions
Timepoint
During the study time
Method of measurement
Reporting the incidence proportion
3
Description
The Serum Sickness incidence
Timepoint
During the study time
Method of measurement
Reporting the incidence proportion
4
Description
The incidence of any other adverse events
Timepoint
During the study time
Method of measurement
Reporting the incidence proportion
5
Description
Duration of the victims' hospitalization
Timepoint
During the study time
Method of measurement
The time recording
Intervention groups
1
Description
Intervention group: 1 to 3, 5ml vials (by physician diagnosis based on initial signs) of Scorpion Antivenom (Padra Serum Alborz Production) with dose of 10 LD50/ml for 20 to 30 minutes IV infusion
Category
Treatment - Drugs
2
Description
Control group: 1 to 3, 5ml ampules (by physician diagnosis based on initial signs) of Scorpion Antivenom (Razi Vaccine and Serum Research Institute) with dose of 10 LD50/ml for 20 to 30 minutes IV infusion Scorpion