1. Home
  2. Approved trials
  3. » فارسی

Effects of High-dose Vitamin C on Treatment, Clinical Symptoms and Laboratory Signs of Iranian COVID-19 Patients: A Double Blind Randomized Clinical Trial

View the latest revision

History
# Registration date Revision Id
2 2021-07-04, 1400/04/13 189691
1 2020-03-31, 1399/01/12 127546
Changes made to previous revision

  • Help:

    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

    in hospital mortality; length of hospital stay; need to ICU admission; need to intubation; need to respiratory support; inflammatory indices; organs function specially pulmonary function; Quality of life
    Time to clinical improvement (TTIC), change in Sequential Organ Failure Assessment (SOFA) score, National Early Warning Score (NEWS) 2, Ordinal scale for clinical improvement, Length of hospital stays, inflammatory indices, and mortality
    مرگ و میر در بیمارستان؛ طول مدت بستری؛ نیاز به بستری در بخش مراقبتهای ویژه؛ نیاز به انتوباسیون؛ میزان نیاز به حمایت تنفسی؛ شاخص های التهابی؛ عملکرد ارگانها بخصوص عملکرد ریوی؛ تغییرات کیفیت زندگی؛
    مدت زمان لازم تا بهبودی، تغییر در میزان SOFA و NEWS2، مقیاس ترتیبی بهبود بالینی، طول مدت بستری، شاخص های التهابی و میزان مرگ و میر

  • General information

    empty
    Revision of inclusion and exclusion criteria and outcomes
    empty
    اصلاح شرایط عمده ورود و عدم ورود به مطالعه و پیامدهای مورد ارزیابی
    Older than 18 years old
    admission with moderate to severe COVID-19 based on WHO definition
    Illness of any duration, and at least one of the following: Radiographic infiltrates by imaging (chest x-ray, CT scan, etc.), or Clinical assessment AND SpO2 ≤ 94% on room air,
    Willing and be able to provide written informed consent prior to performing study procedures
    Older than 18 years old
    admission with moderate to severe COVID-19 based on WHO definition
    Illness of any duration, and at least one of the following: Radiographic infiltrates by imaging (chest x-ray, CT scan, etc.), or Clinical assessment AND respiratory rate > 30 breaths/min; or severe respiratory distress; or SpO2 < 90% on room air.
    Willing and be able to provide written informed consent prior to performing study procedures
    سن بالای 18 سال
    بستری با بیماری متوسط تا شدید COVID-19 بر اساس تعریف WHO
    هر مدتی از تظاهرات بیماری و حداقل یکی از علائم انفیلتراسیون در تصاویر رادیولوژیک (chest X-ray, CT scan) یا ارزیابی های بالینی و اشباع اکسیژن مساوی یا کمتر از 94% در هوای اتاق
    تمایل و توانایی موافقت کتبی پیش از ورود به مطالعه
    سن بالای 18 سال
    بستری با بیماری متوسط تا شدید COVID-19 بر اساس تعریف WHO
    هر مدتی از تظاهرات بیماری و حداقل یکی از علائم زیر: انفیلتراسیون در تصاویر رادیولوژیک (chest X-ray, CT scan) یا ارزیابی های بالینی و ریت تنفس بیشتر از ۳۰ بار در دقیقه، یا سندروم زجر تنفسی ویا اکسیژن اشباع کمتر از ۹۰ درصد در دمای اتاق
    تمایل و توانایی موافقت کتبی پیش از ورود به مطالعه
    Participation in any other clinical trial of an experimental treatment for COVID-19
    Critical ill patients that need invasive mechanical ventilation
    Stage 4 severe chronic kidney disease or requiring dialysis (i.e. eGFR < 30)
    Patents with past medical history of kidney stone
    Pregnancy or breastfeeding
    Participation in any other clinical trial of an experimental treatment for COVID-19
    Critical ill patients that need invasive mechanical ventilation
    Stage 4 severe chronic kidney disease or requiring dialysis (i.e. eGFR < 30)
    Patients with past medical history of kidney stone
    Pregnancy or breastfeeding
    Documented diagnosis of cancer‎
    History of G6PD deficiency ‎and interstitial lung disease ‎
    More than 1 gram/day intake of vitamin C ‎supplement in last 7 days
    عضویت در هر یک از کارآزمایی های بالینی دیگر در درمان COVID-19
    وخامت بیماری که نیازمند تهویه مکانیکی باشد
    مرحله 4 بیماری های مزمن کلیوی و یا نیاز به دیالیز
    سابقه ابتلا به سنگ کلیه
    بارداری و شیردهی
    عضویت در هر یک از کارآزمایی های بالینی دیگر در درمان COVID-19
    وخامت بیماری که نیازمند تهویه مکانیکی باشد
    مرحله 4 بیماری های مزمن کلیوی و یا نیاز به دیالیز (i.e. eGFR < 30)
    سابقه ابتلا به سنگ کلیه
    بارداری و شیردهی
    تشخیص قطعی سرطان
    سابقه کمبود G6PD و بیماری های ریوی
    دریافت بیش از یگ گرم ویتامین C در روز طی هفت روز گذشته
    The method of randomization is based on block randomization using random 4, 6 and 8 blocks.Table of patients number and block Randomization codes will be created by Online randomization web page and will be presented to pharmacist in-charged for serum content preparation. investigator informs patient inclusion number and serum ingredient will be determined by pharmacist based on randomization table.
    The method of randomization is based on block randomization using random 4 blocks. Table of patients number and block Randomization codes will be created by Online randomization web page and will be presented to pharmacist in-charged for serum content preparation. investigator informs patient inclusion number and serum ingredient will be determined by pharmacist based on randomization table.
    روش تصادفی سازی بر اساس تصادفی سازی بلوک با بلوک های تصادفی 4، 6 و 8 تایی است. جدولی از شماره بیمار وارد شده به مطالعه و کدهای تصادفی سازی شده بصورت بلوکی بوسیله وبسایت تصادفی سازی تهیه شده و در اختیار داروساز سازنده قرار میگیرد. شماره بیمار واجد شرایط به داروساز اعلام گشته و بر اساس آن محتوای سرم توسط داروساز بر اساس جدول تعیین میگردد.
    روش تصادفی سازی بر اساس تصادفی سازی بلوک با بلوک های تصادفی 4 تایی است. جدولی از شماره بیمار وارد شده به مطالعه و کدهای تصادفی سازی شده بصورت بلوکی بوسیله وبسایت تصادفی سازی تهیه شده و در اختیار داروساز سازنده قرار میگیرد. شماره بیمار واجد شرایط به داروساز اعلام گشته و بر اساس آن محتوای سرم توسط داروساز بر اساس جدول تعیین میگردد.

  • Primary outcomes

    #1
    Time to clinical improvement (TTIC) of NEWS2 (National Early Warning Score 2) of 0 maintained for 24 hours
    Change in Sequential Organ Failure Assessment (SOFA) score
    زمان مورد نیاز برای بهبودی با سیستم امتیاز دهی NEWS2 (National Early Warning Score 2) و حفظ امتیاز 0 به مدت 24 ساعت
    تغییر در امتیاز Sequential Organ Failure Assessment (SOFA)
    day 0, 5, at discharge
    day 0, 3, and 5
    روز 0 و 5 و حین ترخیص
    روز ۰، ۳ و ۵
    NEWS2 (National Early Warning Score 2) questionaire
    SOFA scoring system
    با استفاده از سیستم امتیازدهی (NEWS2 (National Early Warning Score 2
    با استفاده از سیستم امتیازدهی SOFA

  • Secondary outcomes

    #1
    Intensive Care Unit Admissions
    National Early Warning Score (NEWS) 2
    بستری در بخش مراقبتهای ویژه
    امتیاز National Early Warning Score (NEWS) 2
    during 30 days after serum infusion
    On day 0, 3, and 5
    در طی 30 روز پس از دریافت دارو
    در روزهای ۰، ۳ و ۵
    number of subjects
    NEWS 2 scoring system
    تعداد افراد
    سیستم امتیاز دهی NEWS 2
    #2
    Hospital Mortality
    Ordinal scale for clinical improvement
    مرگ و میر در بیمارستان
    مقیاس ترتیبی بهبود بالینی
    during 30 days of receiving infusion
    On day 0, 3, and 5
    طی 30 روز از دریافت انفوزیون
    در روزهای ۰، ۳ و ۵
    number of subjects
    WHO scoring system
    تعداد نفرات
    سیستم امتیازدهی WHO
    #3
    Type of respiratory support
    The change of inflammatory markers
    نوع حمایت تنفسی دریافتی
    تغییر در شاخص های التهابی
    from time of receiving infusion till discharge / expiration
    On day 0, 3, and 5
    از زمان دریافت انفوزیون تا زمان ترخیص/ مرگ
    در روزهای ۰، ۳ و ۵
    type of support e.g. nasal cannula, high flow nasal cannula, non invasive ventilations , intubation
    C-reactive protein, Neutrophil-lymphocyte ratio, Ferritin
    نوع حمایت تنفسی دریافتی مانند نازال کانولا ، نازال کانولا با جریان بالا ، تهویه غیرتهاجمی و انتوباسیون
    پروتئین واکنشگر C، نسبت نوتروفیل به لنفوسیت ، فریتین
    #4
    Duration of respiratory support
    Mortality
    طول مدت دریافت حمایت تنفسی
    مرگ و میر
    from day 0 of study to discharge or death
    During 30 days of receiving infusion
    از روز ورود به مطالعه تا زمان ترخیص یا مرگ
    در طی 30 روز پس از دریافت دارو
    day
    Number of subjects
    روز
    تعداد افراد
    #5
    The change of inflammatory markers
    empty
    تغییر در شاخص های التهابی
    empty
    day 0 , day 5 and at discharge
    empty
    روزهای 0 و 5 و زمان ترخیص
    empty
    C-reactive protein, Erythrocyte sedimentation rate, neutrophil-lymphocyte ratio, ferritin
    empty
    پروتئین واکنشگر C ، سرعت سدیمان اریتروسیت ، نسبت نوتروفیل به لنفوسیت ، فریتین
    empty

  • Sponsors / Funding sources

    #1

    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: kurosh sadeghi
    Full name of responsible person - Persian: کوروش صادقی
    Street address - English: 16th azar street
    Street address - Persian: خیابان 16 آذر
    City - English: Tehran
    City - Persian: تهران
    Province: Tehran
    Country: Iran (Islamic Republic of)
    Postal code: 1417614411
    Phone: +98 21 8490 1000
    Fax:
    Email: sadeghi_k@tums.ac.ir
    Web page address:

    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Mohammad Ali Sahraian
    Full name of responsible person - Persian: محمد علی صحرائیان
    Street address - English: Vice Chancellor for Research and Technology, Sixth Floor, Qods Ave., Keshavarz Blvd.
    Street address - Persian: بلوار کشاورز، نبش خیابان قدس، سازمان مرکزی دانشگاه، طبقه ششم معاونت تحقیقات و فناوری
    City - English: Tehran
    City - Persian: تهران
    Province: Tehran
    Country: Iran (Islamic Republic of)
    Postal code: 1417614411
    Phone: +98 21 6670 6142
    Fax:
    Email: msahrai@tums.ac.ir
    Web page address:

Protocol summary

Study aim
We aimed to assess the effect of high dose vitamin C on clinical improvement and inflammatory indices in moderate to severe COVID-19 patients.
Design
Randomized double blind clinical trial on two arms containing control and treatment group
Settings and conduct
After selecting eligible patients in Dr. Shariati teaching hospital, pharmacist will allocate each patient to one study group by table of randomization and prepare the serum content. investigator, physician and healthcare provider are blinded. biochemical tests, inflammatory indices and respiratory support will be assessed based on defined schedule. At the end of the study results will be presented to analyzer in two blinded groups.
Participants/Inclusion and exclusion criteria
Confirmed moderate to severe COVID-19, age more than 18 years and consent for participation in the study, negative history for nephrolithiasis, chronic kidney disease (stage 4) and hemodialysis, pregnancy and breastfeeding will included in this study.
Intervention groups
Treatment group will receive 12g Vitamin C in dextrose5% to total volume of 200 ml for 4 days and placebo group will receive distilled water in dextrose5% to total volume of 200 ml for 4 days.
Main outcome variables
Time to clinical improvement (TTIC), change in Sequential Organ Failure Assessment (SOFA) score, National Early Warning Score (NEWS) 2, Ordinal scale for clinical improvement, Length of hospital stays, inflammatory indices, and mortality

General information

Reason for update
Revision of inclusion and exclusion criteria and outcomes
Acronym
IRCT registration information
IRCT registration number: IRCT20190917044805N2
Registration date: 2020-03-31, 1399/01/12
Registration timing: prospective

Last update: 2021-07-10, 1400/04/19
Update count: 1
Registration date
2020-03-31, 1399/01/12
Registrant information
Name
Kourosh Sadeghi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 6695 4709
Email address
sadeghi_k@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-04-03, 1399/01/15
Expected recruitment end date
2020-10-06, 1399/07/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of High-dose Vitamin C on Treatment, Clinical Symptoms and Laboratory Signs of Iranian COVID-19 Patients: A Double Blind Randomized Clinical Trial
Public title
Effects of High-dose Vitamin C on COVID-19
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Older than 18 years old admission with moderate to severe COVID-19 based on WHO definition Illness of any duration, and at least one of the following: Radiographic infiltrates by imaging (chest x-ray, CT scan, etc.), or Clinical assessment AND respiratory rate > 30 breaths/min; or severe respiratory distress; or SpO2 < 90% on room air. Willing and be able to provide written informed consent prior to performing study procedures
Exclusion criteria:
Participation in any other clinical trial of an experimental treatment for COVID-19 Critical ill patients that need invasive mechanical ventilation Stage 4 severe chronic kidney disease or requiring dialysis (i.e. eGFR < 30) Patients with past medical history of kidney stone Pregnancy or breastfeeding Documented diagnosis of cancer‎ History of G6PD deficiency ‎and interstitial lung disease ‎ More than 1 gram/day intake of vitamin C ‎supplement in last 7 days
Age
From 18 years old
Gender
Both
Phase
2-3
Groups that have been masked
  • Participant
  • Care provider
  • Investigator
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Randomized
Randomization description
The method of randomization is based on block randomization using random 4 blocks. Table of patients number and block Randomization codes will be created by Online randomization web page and will be presented to pharmacist in-charged for serum content preparation. investigator informs patient inclusion number and serum ingredient will be determined by pharmacist based on randomization table.
Blinding (investigator's opinion)
Double blinded
Blinding description
this study will be conducted as a double blind process. patients, investigator, health care workers including nurses and physicians, statistical analyzer will be blinded, by preparing serum content by pharmacist and allocating a code to each serum. pharmacist is the only one who knows the content and has no role in data gathering and result interpretation.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Vice-Chancellor In Research Affairs- Tehran University of Medical Science
Street address
Vice Chancellor for Research and Technology, Sixth Floor, Qods Ave., Keshavarz Blvd.
City
Tehran
Province
Tehran
Postal code
۱۴۱۷۴۱۴۴۱۸
Approval date
2020-03-27, 1399/01/08
Ethics committee reference number
IR.TUMS.VCR.REC.1399.056

Health conditions studied

1

Description of health condition studied
COVID-19
ICD-10 code
U07.1
ICD-10 code description
COVID-19 confirmed by laboratory testing

Primary outcomes

1

Description
Time to clinical improvement (TTIC)
Timepoint
day 0, 5, at discharge
Method of measurement
assessing respiratory rate, blood oxygen saturation, fever

2

Description
Change in Sequential Organ Failure Assessment (SOFA) score
Timepoint
day 0, 3, and 5
Method of measurement
SOFA scoring system

Secondary outcomes

1

Description
National Early Warning Score (NEWS) 2
Timepoint
On day 0, 3, and 5
Method of measurement
NEWS 2 scoring system

2

Description
Ordinal scale for clinical improvement
Timepoint
On day 0, 3, and 5
Method of measurement
WHO scoring system

3

Description
Hospital Length of Stay
Timepoint
Days after receiving infusion
Method of measurement
days

4

Description
The change of inflammatory markers
Timepoint
On day 0, 3, and 5
Method of measurement
C-reactive protein, Neutrophil-lymphocyte ratio, Ferritin

5

Description
Mortality
Timepoint
During 30 days of receiving infusion
Method of measurement
Number of subjects

Intervention groups

1

Description
Intervention group: this group adjunct to standard treatment will receive intravenous infusion of 12 grams of vitamin C in Dextrose 5% serum to the total volume of 200 ml over 24 hours for 4 days
Category
Treatment - Drugs

2

Description
Control group: infusion of serum containing 120 ml distilled water in Dextrose 5% serum to the total volume of 200 ml over 24 hours for 4 days beside receiving standard treatment.
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Dr. Shariati hospital
Full name of responsible person
Kourosh Sadeghi
Street address
Dr Shariati Educational and Research Center, Jalal Al Ahmad Road, North Kargar Ave., Tehran
City
Tehran
Province
Tehran
Postal code
1411713135
Phone
+98 21 8490 1000
Fax
+98 21 8863 3039
Email
kourosh.sadeghi@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mohammad Ali Sahraian
Street address
Vice Chancellor for Research and Technology, Sixth Floor, Qods Ave., Keshavarz Blvd.
City
Tehran
Province
Tehran
Postal code
1417614411
Phone
+98 21 6670 6142
Email
msahrai@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
Kourosh Sadeghi
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Medical Pharmacy
Street address
No. 226, Qods St., Keshavarz Blvd., Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1416753955
Phone
+98 21 8889 6696
Email
kourosh.sadeghi@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Kourosh Sadeghi
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Medical Pharmacy
Street address
Pharmacy school, Tehran university of medical sciences, 16 Azar street
City
Tehran
Province
Tehran
Postal code
1416753955
Phone
+98 21 6695 4709
Fax
Email
Sadeghi_k@tums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Kourosh Sadeghi
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Medical Pharmacy
Street address
16th Azar street
City
Tehran
Province
Tehran
Postal code
14176114411
Phone
+98 21 8490 1000
Email
sadeghi_k@tums.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is 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
Not applicable
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Not applicable
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
data for primary outcomes can be available after requesting scientific responsible person.
When the data will become available and for how long
starting 6 months after publication
To whom data/document is available
this only available for people working in academic institutions
Under which criteria data/document could be used
there is no limitation
From where data/document is obtainable
documents are available by scientific responsible person by email kourosh.sadeghi@gmail.com
What processes are involved for a request to access data/document
documents are available after assessing the aim and identity of requesting person
Comments
Loading...