History
# Registration date Revision Id
3 2022-05-29, 1401/03/08 228220
2 2022-05-07, 1401/02/17 226118
1 2022-01-12, 1400/10/22 212818
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  • Protocol summary

    A single-arm, phase 2 clinical study to assess the efficacy of the COVID-19 vaccine following allogeneic HSCT on 100 consecutive patients enrolled between 01/2022 and 09/2022 and followed for one year
    A single-arm, phase 2 clinical study to assess the efficacy of the COVID-19 vaccine following allogeneic HSCT on 40 consecutive patients enrolled between 01/2022 and 09/2022 and followed for one year
    کارآزمایی بالینی تک گروهی فاز 2 بر روی 100 بیمار پیوند شده که در فواصل 01/2022 تا 09/2022 وارد مطالعه شده و بمدت یکسال پیگیری میشوند.
    کارآزمایی بالینی تک گروهی فاز 2 بر روی 40 بیمار پیوند شده که در فواصل 01/2022 تا 09/2022 وارد مطالعه شده و بمدت یکسال پیگیری میشوند.
    َAll consecutive adult patients who are a candidate for transplant at the Stem Cell Transplantation Research Center will be enrolled. Patients will receive two doses of COVID-19 vaccines at 3 and 4 months post-transplant according to the EBMT recommendation (version 7.0). SARS-CoV-2 specific IgG (anti-S1) and immune subsets reconstitution will be measured to assess the immune response.
    َAll patients who underwent allo-HSCT at the Stem Cell Transplantation Research Center of Tehran University are enrolled from 3 to 12 months after Allo-HSCT and are vaccinated with the three doses of Pastucovac. SARS-CoV-2 specific IgG (anti-S1) and immune subsets reconstitution are measured to assess the immune response.
    همه بیماران بزرگسال که کاندیدای پیوند آلوژن در مرکز تحقیقات هماتولوژی، انکولوژی و پیوند سلول‌های بنیادی هستند وارد مطالعه خواهند شد. بیماران 2 دوز واکسن کووید-19 را 3 و 4 ماه پس از پیوند (طبق توصیه EBMT نسخه 7.0) دریافت خواهند کرد. پاسخ سیستم ایمنی به واکسیناسیون با اندازه گیری IgG اختصاصی SARS-CoV-2 (anti-S1) و ریکاوری سلولهای ایمنی ارزیابی می شود.
    تمام بیمارانی که تحت پیوند آلوژن در مرکز تحقیقات هماتولوژی، انکولوژی و پیوند سلول‌های بنیادی دانشگاه تهران قرار گرفته اند از 3 تا 12 ماه پس از پیوند آلوژن وارد مطالعه می‌شوند و با سه دوز واکسن Pastucovac واکسینه می شوند. پاسخ سیستم ایمنی به واکسیناسیون با اندازه گیری IgG اختصاصی SARS-CoV-2 (anti-S1) و ریکاوری سلولهای ایمنی ارزیابی می شود.
    All patients >=18 years recipient of allogeneic stem cells transplant (ASCT) A transplant from a related or unrelated donor A transplant from HLA-matched or mismatched
    All recipients of Allo-HSCT who meet the criteria, including; "age ≥ 18 years, successfully engraftment with full donor chimerism, absence of grade 3,4 acute GvHD or severe extensive chronic GvHD, no receive more than 0.5 mg/kg prednisolone, and no positive RT-PCR test for COVID-19 during the last three months" are enrolled to study from 3 to 12 months after Allo-HSCT.
    بیماران بیشتر مساوی 18 سال دریافت کننده پیوندآلوژن مغز استخوان پیوند از دهنده خویشاوند یا غیر خویشاوند پیوند از دهنده با HLA سازگار یا ناسازگار
    تمام دریافت کنندگان پیوند سلول های بنیادی آلوژنیک که معیارهای زیر را برآورده می کنند، از جمله "سن ≥ 18 سال، پیوند موفق با کایمریسم کامل دهنده، عدم وجود GvHD حاد درجه 3،4 و یا GvHD مزمن گسترده، عدم دریافت بیش از 0.5 میلی گرم در کیلوگرم پردانیزولون، و عدم تست مثبت RT-PCR برای COVID-19 در طول سه ماه گذشته" از 3 تا 12 ماه پس از پیوند وارد مطالعه می‌شوند.
    All consecutive patients who are a candidate for ASCT and agree to receive post-transplant COVID-19 vaccines will be enrolled. From 3 months post-transplant in the absence of grade 3,4 acute GVHD, patients will receive an approved COVID-19 vaccine according to the EBMT guideline (version 7.0) and a second dose will receive after four weeks (±7 days) interval. The serologic response will be assessed by measurement of SARS-CoV-2 specific IgG (anti-S1) before the first vaccine, one week before the second vaccine, four weeks after the second vaccine, and six months after the first vaccine.
    All patients who underwent allo-HSCT and have inclusion criteria are enrolled from 3 to 12 months after Allo-HSCT and will be vaccinated with the first two doses of Pastucovac at a 4-week (±7 days) interval and a third additional dose with an 8-week (±7 days) interval from the second dose. The blood samples are collected before the first vaccine and three weeks (± one week) after each dose of vaccine to assess serologic response.
    تمام بیماران کاندیدای پیوند سلول های بنیادی آلوژنیک که با دریافت واکسن کووید-19 پس از پیوند موافقت می کنند، در مطالعه بالینی ثبت نام خواهند شد. همه بیماران 3 ماه پس از پیوند و در غیاب بیماری حاد گرافت در مقابل میزبان درجه 3،4، یک واکسن های تایید شده COVID-19 (طبق دستورالعمل EBMT، نسخه 7.0) را دریافت خواهند کرد. دوز دوم واکسن COVID-19 با فاصله چهار هفته (7± روز) تجویز خواهد شد. پاسخ سرولوژیک با اندازه‌گیری IgG اختصاصی SARS-CoV-2 (ضد S1) قبل از واکسن اول، یک هفته قبل از واکسن دوم، چهار هفته پس از واکسن دوم و شش ماه پس از واکسن اول ارزیابی می‌شود.
    تمام بیمارانی که تحت پیوند آلوژن قرار گرفته اند و معیارهای ورود را دارند از 3 تا 12 ماه پس از پیوند آلوژن وارد مطالعه می‌شوند و با دو دوز اول Pastucovac در فاصله 4 هفته ای (±7 روز) و یک دوز اضافی سوم با فاصله 8 هفته ای (±7 روز) از دوز دوم واکسینه می شوند. نمونه های خون قبل از اولین دوز واکسن و سه هفته (± یک هفته) پس از هر سه دوز واکسن برای ارزیابی پاسخ سرولوژیک جمع آوری می شوند.
    SARS-CoV-2 vaccine effectiveness by measuring of SARS-CoV-2 IgG (anti-S1) titer at 4 weeks post second COVID-19 vaccine; Measuring how early Immune cells reconstitution at 3 months post-HSCT (T cells, NK cells, B cells) could predict the response to the covid-19 vaccine.
    To assess the serologic response, by measurement of SARS-CoV-2 binding antibody titer 3-week (±7 days) after the second dose of vaccine; To describe vaccine-related adverse reactions until 14 days after administration of each vaccine dose.
    ارزیابی اثر بخشی ایمونولوژیک واکسیناسیون کوید.۱۹ بعد از پیوندآلوژن مغز استخوان توسط اندازه گیری تیتر آنتی بادی اختصاصی کوید (anti-S1) چهار هفته پس از دومین دوز واکسن ارزیابی اثر پیشگویی کننده ریکاوری انواع ساب تایپهای ایمنی (T cells, NK cells, B cell, DCs) 3 ماه بعد از پیوند در اثر بخشی واکسن کوید
    ارزیابی اثر بخشی ایمونولوژیک واکسیناسیون کوید.۱۹ بعد از پیوندآلوژن مغز استخوان توسط اندازه گیری تیتر آنتی بادی اختصاصی کوید (anti-S1) سه هفته پس از دومین دوز واکسن ؛ برای توصیف واکنش های نامطلوب مرتبط با واکسن تا 14 روز پس از استفاده از هر دوز واکسن.
  • General information

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    modification of the study method by adding a third dose of vaccine to improve efficacy in transplant patients and reduce the sample size according to the initial data.
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    اصلاح روش اجرا با افزودن دوز سوم واکسن جهت بهبود اثربخشی در بیماران پیوند شده و کاهش حجم نمونه با توجه به بررسی دیتا های اولیه
    ارزیابی اثر بخشی واکسیناسیون کوید.۱۹ بعد از پیوند مغز استخوان
    ارزیابی اثر بخشی واکسیناسیون کوید.۱۹ توسط پاستوکووک بعد از پیوند مغز استخوان
    Evaluation of SARS-CoV-2 Vaccine Effectiveness and serologic response in Patients Receiving Hematopoietic Stem Cell Transplantation; A phase 2 clinical trial
    Evaluation of safety and immunogenicity of the SARS-CoV-2 recombinant spike RBD protein vaccine in Patients Receiving Allogeneic Hematopoietic Stem Cell Transplantation; A phase 2 clinical trial
    ارزیابی بی خطری، اثربخشی و پاسخ سرولوژیک واکسیناسیون رایج کوید.۱۹ در بیماران دریافت کننده پیوندآلوژن مغز استخوان: یک کارازمایی بالینی فاز 2
    ارزیابی بی خطری و اثربخشی ایمنی واکسن کوید.۱۹ پاستوکووک [SARS-CoV-2 recombinant spike RBD protein] در بیماران دریافت کننده پیوندآلوژن مغز استخوان: یک کارازمایی بالینی فاز 2
    Allogeneic stem cell transplantation
    Related or unrelated donor
    Age >=18
    Matched or mismatched HLA typing between patients and donors
    malignant and non-malignant underline disease
    Allogeneic stem cell transplantation
    successfully engraftment with full donor chimerism
    Age >=18
    between 3 to 12 months after Allo-HSCT
    پیوندآلوژن مغز استخوان
    پیوند از دهنده خویشاوند یا غیر خویشاوند
    سن بیشتر مساوی 18 سال
    HLA typing سازگار یا ناسازگار بین بیمار و دهنده
    بیماریهای زمینه ای بدخیم و خوش خیم
    پیوندآلوژن مغز استخوان
    engraftment موفق با chimerism کامل دهنده
    سن بیشتر مساوی 18 سال
    فاصله زمانی بین 3 تا 12 ماه پس از Allo-HSCT
    Patients who are not candidates for the COVID-19 vaccine after transplantation due to severe complications.
    Patients who do not consent to vaccination after transplantation
    grade 3,4 acute GvHD or severe extensive chronic GvHD
    Patients who do not consent to vaccination after transplantation
    receive more than 0.5 mg/kg/day prednisolone
    positive RT-PCR test for COVID-19 during the last three months
    بیمارانی که به دلیل عوارض پیوند مثل GvHD شدید کاندید دریافت واکسن کوید بعد از پیوند نباشند
    بیمارانی که رضایت به واکسیناسیون کوید بعد از پیوند ندهند
    وجود GvHD حاد درجه 3،4 و یا GvHD مزمن گسترده
    بیمارانی که رضایت به واکسیناسیون کوید بعد از پیوند ندهند
    دریافت روزانه بیش از 0.5 میلی گرم در کیلوگرم پردانیزولون
    تست مثبت RT-PCR برای COVID-19 در طول سه ماه گذشته
    Sampling for SARS-CoV-2 specific IgG (anti-S1) titers will be performed prior to the first vaccine, one week before the second vaccine, four weeks after the second vaccine, and six months after the first vaccine.
    Sampling for SARS-CoV-2 specific IgG (anti-S1) titers will be performed for recipients of allo-HSCT before the conditioning regimen, prior to the first vaccine, and three weeks (± one week) after each dose of vaccine.
    نمونه گیری جهت اندازه گیری تیتر آنتی بادی اختصاصی کوید (anti-S1) در بیماران دریافت کننده پیوندآلوژن مغز استخوان در مقاطع زیر انجام میشود: قبل از اولین دوز واکسن، یک هفته قبل از دومین دوز واکسن، چهار هفته بعد از دومین دوز واکسن و 6 ماه بعد از اولین دوز واکسن کوید
    نمونه گیری جهت اندازه گیری تیتر آنتی بادی اختصاصی کوید (anti-S1) در بیماران دریافت کننده پیوندآلوژن مغز استخوان قبل از رژیم conditioning، قبل از اولین واکسن، و سه هفته (± یک هفته) پس از هر دوز واکسن انجام میشود.
  • Intervention groups

    #1
    All consecutive patients who are a candidate for ASCT and agree to receive post-transplant COVID-19 vaccines will be enrolled. From three months post-transplant in the absence of grade 3,4 acute GVHD, patients will receive an approved COVID-19 vaccine according to the EBMT guideline (version 7.0) and a second dose will receive after four weeks (±7 days) interval. The serologic response will be assessed by measurement of SARS-CoV-2 specific IgG (anti-S1) before the first vaccine, one week before the second vaccine, four weeks after the second vaccine, and six months after the first vaccine.
    All consecutive adult patients who are candidates for Allo-HSCT at HORCSCT are recruited. They sign an informed consent to administer the Pastocovac vaccine and take blood samples. All patients who meet the inclusion criteria are enrolled to study from 3 to 12 months after Allo-HSCT and will be vaccinated with the first two doses of Pastucovac at a 4-week (±7 days) interval and a third additional dose with an 8-week (±7 days) interval from the second dose. Peripheral blood samples are collected before conditioning and before the first dose of vaccine to test particular lymphocyte subpopulations and SARS-CoV-2 IgG titers. The blood samples are also collected three weeks (± one week) after each dose of vaccine to assess serologic response by SARS-CoV-2 IgG titer.
    تمام بیماران کاندیدای پیوند سلول های بنیادی آلوژنیک که با دریافت واکسن کووید-19 پس از پیوند موافقت می کنند، در مطالعه بالینی ثبت نام خواهند شد. همه بیماران 3 ماه پس از پیوند و در غیاب بیماری حاد گرافت در مقابل میزبان درجه 3،4، یک واکسن های تایید شده COVID-19 (طبق دستورالعمل EBMT، نسخه 7.0) را دریافت خواهند کرد. دوز دوم واکسن COVID-19 با فاصله چهار هفته (7± روز) تجویز خواهد شد. پاسخ سرولوژیک با اندازه‌گیری IgG اختصاصی SARS-CoV-2 (ضد S1) قبل از واکسن اول، یک هفته قبل از واکسن دوم، چهار هفته پس از واکسن دوم و شش ماه پس از واکسن اول ارزیابی می‌شود. .
    تمام بیماران بزرگسال که کاندید پیوند آلوژن در HORCSCT هستند در مطالعه بالینی ثبت نام خواهند شد. آن ها رضایت آگاهانه ای را برای تجویز واکسن پاستاکوواک و گرفتن نمونه خون امضا می کنند. تمام بیمارانی که معیارهای ورود را دارند از 3 تا 12 ماه پس از پیوند آلوژن وارد مطالعه می‌شوند و با دو دوز اول Pastucovac با فاصله 4 هفته ای (±7 روز) و یک دوز اضافی سوم با فاصله 8 هفته ای (±7 روز) از دوز دوم واکسینه خواهند شد. نمونه های خون محیطی قبل از پیوند و قبل از اولین دوز واکسن برای آزمایش زیرمجموعه های لنفوسیت و تیترهای SARS-CoV-2 IgG جمع آوری می شوند. نمونه های خون نیز سه هفته (± یک هفته) پس از هر دوز واکسن برای ارزیابی پاسخ سرولوژیک توسط تیتر SARS-CoV-2 IgG جمع آوری می شود. .

Protocol summary

Study aim
Evaluation of the immunologic effects of COVID-19 vaccination following allogeneic stem cell transplantation
Design
A single-arm, phase 2 clinical study to assess the efficacy of the COVID-19 vaccine following allogeneic HSCT on 40 consecutive patients enrolled between 01/2022 and 09/2022 and followed for one year
Settings and conduct
َAll patients who underwent allo-HSCT at the Stem Cell Transplantation Research Center of Tehran University are enrolled from 3 to 12 months after Allo-HSCT and are vaccinated with the three doses of Pastucovac. SARS-CoV-2 specific IgG (anti-S1) and immune subsets reconstitution are measured to assess the immune response.
Participants/Inclusion and exclusion criteria
All recipients of Allo-HSCT who meet the criteria, including; "age ≥ 18 years, successfully engraftment with full donor chimerism, absence of grade 3,4 acute GvHD or severe extensive chronic GvHD, no receive more than 0.5 mg/kg prednisolone, and no positive RT-PCR test for COVID-19 during the last three months" are enrolled to study from 3 to 12 months after Allo-HSCT.
Intervention groups
All patients who underwent allo-HSCT and have inclusion criteria are enrolled from 3 to 12 months after Allo-HSCT and will be vaccinated with the first two doses of Pastucovac at a 4-week (±7 days) interval and a third additional dose with an 8-week (±7 days) interval from the second dose. The blood samples are collected before the first vaccine and three weeks (± one week) after each dose of vaccine to assess serologic response.
Main outcome variables
To assess the serologic response, by measurement of SARS-CoV-2 binding antibody titer 3-week (±7 days) after the second dose of vaccine; To describe vaccine-related adverse reactions until 14 days after administration of each vaccine dose.

General information

Reason for update
modification of the study method by adding a third dose of vaccine to improve efficacy in transplant patients and reduce the sample size according to the initial data.
Acronym
ESVIRHSCT
IRCT registration information
IRCT registration number: IRCT20140818018842N22
Registration date: 2022-01-12, 1400/10/22
Registration timing: prospective

Last update: 2022-05-15, 1401/02/25
Update count: 2
Registration date
2022-01-12, 1400/10/22
Registrant information
Name
Leyla Sharifi Aliabadi
Name of organization / entity
Research Institute for Hematology, Oncology and Stem Cell Transplantation,Tehran University of Medic
Country
Iran (Islamic Republic of)
Phone
+98 21 8490 2635
Email address
ctu@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-01-15, 1400/10/25
Expected recruitment end date
2022-10-23, 1401/08/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of safety and immunogenicity of the SARS-CoV-2 recombinant spike RBD protein vaccine in Patients Receiving Allogeneic Hematopoietic Stem Cell Transplantation; A phase 2 clinical trial
Public title
Evaluation of the COVID-19 vaccine efficacy following allogeneic stem cell transplantation
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Allogeneic stem cell transplantation successfully engraftment with full donor chimerism Age >=18 between 3 to 12 months after Allo-HSCT
Exclusion criteria:
grade 3,4 acute GvHD or severe extensive chronic GvHD Patients who do not consent to vaccination after transplantation receive more than 0.5 mg/kg/day prednisolone positive RT-PCR test for COVID-19 during the last three months
Age
From 18 years old to 70 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size: 40
More than 1 sample in each individual
Number of samples in each individual: 4
Sampling for SARS-CoV-2 specific IgG (anti-S1) titers will be performed for recipients of allo-HSCT before the conditioning regimen, prior to the first vaccine, and three weeks (± one week) after each dose of vaccine.
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethic committee of Hematology- Oncology and Stem Cell Transplantation Research Center, Tehran Univer
Street address
Kargar shomali Ave., Shariati hospital
City
Tehran
Province
Tehran
Postal code
14114
Approval date
2021-10-29, 1400/08/07
Ethics committee reference number
IR.TUMS.HORCSCT.REC.1400.021

Health conditions studied

1

Description of health condition studied
Allogeneic stem cells transplantation
ICD-10 code
Z94.84
ICD-10 code description
Stem cells transplant status

Primary outcomes

1

Description
SARS-CoV-2 specific IgG (anti-S1) titer
Timepoint
four weeks after the second vaccine
Method of measurement
ٍٍEnzyme-linked immunosorbent assay

2

Description
B lymphocyte count
Timepoint
Three months after allogeneic transplantation
Method of measurement
multicolor flow cytometry

3

Description
NK cell count
Timepoint
Three months after allogeneic transplantation
Method of measurement
multicolor flow cytometry

4

Description
T cell count
Timepoint
Three months after allogeneic transplantation
Method of measurement
multicolor flow cytometry

5

Description
Cumulative incidence of COVID-19
Timepoint
12 months following bone marrow transplantation
Method of measurement
RT-PCR test

6

Description
Acute graft versus host disease
Timepoint
100 days following bone marrow transplantation
Method of measurement
Physical exam, biopsy, lab test

7

Description
Overall survival
Timepoint
12 months following bone marrow transplantation
Method of measurement
electronic data bank

Secondary outcomes

1

Description
Overall survival
Timepoint
One-year post transplantation
Method of measurement
Time

2

Description
Acute Graft versus Host Disease
Timepoint
100 days post-transplantation
Method of measurement
physical exam, lab test, and biopsy

3

Description
Relapse
Timepoint
One-year post-transplantation
Method of measurement
bone marrow aspiration and biopsy

Intervention groups

1

Description
All consecutive adult patients who are candidates for Allo-HSCT at HORCSCT are recruited. They sign an informed consent to administer the Pastocovac vaccine and take blood samples. All patients who meet the inclusion criteria are enrolled to study from 3 to 12 months after Allo-HSCT and will be vaccinated with the first two doses of Pastucovac at a 4-week (±7 days) interval and a third additional dose with an 8-week (±7 days) interval from the second dose. Peripheral blood samples are collected before conditioning and before the first dose of vaccine to test particular lymphocyte subpopulations and SARS-CoV-2 IgG titers. The blood samples are also collected three weeks (± one week) after each dose of vaccine to assess serologic response by SARS-CoV-2 IgG titer.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Hematology- Oncology and Stem Cell Transplantation Research Center, Tehran University of Medical Sci
Full name of responsible person
Maryam Barkhordar
Street address
Shariati hospital, North Kargar Ave.
City
Tehran
Province
Tehran
Postal code
1417713135
Phone
+98 21 8800 4140
Email
barkhordarm.n@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Maryam Barkhordar
Street address
Shariati hospital, North Kargar Ave.
City
Tehran
Province
Tehran
Postal code
1417713135
Phone
+98 21 8800 4140
Email
mbarkhordar@sina.tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Leyla Sharifi Aliabadi
Position
Research Assistant
Latest degree
Master
Other areas of specialty/work
Epidemiology
Street address
Shariati Hospital, North Kargar Ave.
City
Tehran
Province
Tehran
Postal code
1417713135
Phone
00982288004140
Email
ctu@sina.tums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Maryam Barkhordar
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Hematology
Street address
Shariati Hospital, North Kargar Ave.
City
Tehran
Province
Tehran
Postal code
1411713135
Phone
+98 21 8490 2635
Email
mbarkhordar@sina.tums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Leyla Sharifi Aliabadi
Position
Research Assistant
Latest degree
Master
Other areas of specialty/work
Epidemiology
Street address
Shariati Hospital, North Kargar Ave.
City
Tehran
Province
Tehran
Postal code
1411713135
Phone
+98 21 8800 4140
Email
ctu@sina.tums.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
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