Protocol summary

Study aim
Overall objective: comparison of three therapies in patients with Super Acute Respiratory Syndrome with and without corona testing for a positive virus
Design
Clinical trial with control group, with parallel, two-way blind groups, randomized to 30 patients, random number table was used for randomization.
Settings and conduct
After the approval of the plan in the University Research Council and obtaining the code of ethics, sampling will begin among patients who have the conditions to participate in the study. First, randomization will be performed and then individuals will be randomly divided into 3 groups. The study will be blinded in two ways. Vitamin D and C levels are measured in all three groups before the intervention, and patients who are deficient will be included in the study. Then, we will select patients with vitamin D and C deficiency and treat them with vitamin D and vitamin C supplements, and we will study the patient as a control group among other patients who did not have vitamin deficiency. We will examine the rate of recovery in untreated patients with vitamin D and C according to the checklist.
Participants/Inclusion and exclusion criteria
Inclusion criteria: the patient was admitted to the acute respiratory center; consent to participate in the study; age 15 years and older. Exclusion criteria: the patient has lung cancer; patients undergoing chemotherapy and radiotherapy.
Intervention groups
Group one: taking vitamin D supplements and routine treatment under the supervision of an infectious disease specialist, group two: taking vitamin C supplements and routine treatment under the supervision of an infectious disease specialist and the third group:receiving routine treatment under the supervision of a specialist. Infections are classified as control groups.
Main outcome variables
Vitamin D; Vitamin C; RT-PCR results; CT-Scan findings; CX-Ray Findings; CBC; Vital signs; Respiratory Symptoms

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20140305016852N4
Registration date: 2020-05-04, 1399/02/15
Registration timing: registered_while_recruiting

Last update: 2020-05-04, 1399/02/15
Update count: 0
Registration date
2020-05-04, 1399/02/15
Registrant information
Name
somayyeh nayyeri
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 5222 9202
Email address
s.nayyeri86@yahoo.com
Recruitment status
recruiting
Funding source
Expected recruitment start date
2020-04-20, 1399/02/01
Expected recruitment end date
2020-09-21, 1399/06/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of three methods of treatment in patients with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) with and without coronavirus positive test (Kovid-19)
Public title
Comparison of three methods of treatment in patients with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) with and without coronavirus positive test
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
The patient was admitted to the acute respiratory center Consent to participate in the study Age 15 to above Do not take vitamin C and D supplements No gout Lack of kidney and liver disease No pregnancy or lactation No treatment with anti convulsants
Exclusion criteria:
The patient has lung cancer Patients undergoing chemotherapy and radiotherapy If the patient dies If the patient has a decreased level of consciousness If the patient does not want to continue working on the plan
Age
From 15 years old
Gender
Both
Phase
2-3
Groups that have been masked
  • Participant
  • Investigator
Sample size
Target sample size: 30
Randomization (investigator's opinion)
Randomized
Randomization description
A random number table is used to randomize. To use the table of random numbers, first to read the numbers of the table will be determined, then the numbers will be considered for different groups. We touch on one of the numbers and move in one of the predefined directions and assign the numbers to different groups.
Blinding (investigator's opinion)
Double blinded
Blinding description
The study will be blinded in two ways. Patients will be blinded by the type of intervention, and the researcher who has to enter the data in the relevant checklist will be blinded by the type of intervention.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of sabzevar University of Medical Sciences
Street address
Deputy of Research and Technology-Campus of the University of Medical Sciences-above the memory of the shohadaye gomnam-shohadaye hasteii Boulevard-Sabzevar
City
Sabzevar
Province
Razavi Khorasan
Postal code
9617913112
Approval date
2020-04-19, 1399/01/31
Ethics committee reference number
IR.MEDSAB.REC.1399.015

Health conditions studied

1

Description of health condition studied
Coronavirus disease (covid-19)
ICD-10 code
B97.29
ICD-10 code description
Other coronavirus as the cause of diseases classified elsewhere

Primary outcomes

1

Description
Complete recovery of clinical symptoms of 2019 disease
Timepoint
About a week after starting treatment
Method of measurement
Clinical and laboratory questionnaire

2

Description
Normalization of chest symptoms in CT scan.
Timepoint
About 7 to 14 days after starting treatment
Method of measurement
CT scan result

Secondary outcomes

1

Description
Improving and normalizing the level of laboratory symptoms
Timepoint
At least 1 to 2 weeks after starting treatment
Method of measurement
Laboratory techniques

Intervention groups

1

Description
Intervention group: In this group, untreated COVID-19 patients are treated with routine treatments and 50,000 units of vitamin D daily for one week.
Category
Treatment - Drugs

2

Description
Intervention group: In this group, untreated COVID-19 patients are treated with routine and vitamin C-containing treatments containing 500 mg daily for one week.
Category
Treatment - Drugs

3

Description
Control group: The control group includes patients who are under routine care only.
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Vasei Educational and Medical Center
Full name of responsible person
Ebrahim Shirzade
Street address
Vasei hospital , Shohadaye Hasteii Blvd , Sabzevar
City
sabzevar
Province
Razavi Khorasan
Postal code
9617913114
Phone
+98 51 4401 4000
Email
vasei.h@medsab.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Sabzevar University of Medical Sciences
Full name of responsible person
Fereshteh Ghorat
Street address
Deputy of Research and Technology-Campus of the University of Medical Sciences-above the memory of the shohadaye gomnam-shohadaye hasteii Boulevard-Sabzevar
City
Sabzevar
Province
Razavi Khorasan
Postal code
9613873136
Phone
+98 51 4401 8319
Email
GhoratF@medsab.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Sabzevar 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
Sabzevar University of Medical Sciences
Full name of responsible person
Ebrahim Shirzade
Position
Faculty member
Latest degree
Subspecialist
Other areas of specialty/work
Ophthalmology
Street address
School of medicine-Campus of the University of Medical Sciences-above the memory of the shohadaye gomnam-shohadaye hasteii Boulevard-Sabzevar
City
Sabzevar
Province
Razavi Khorasan
Postal code
33787-95196
Phone
+98 51 4401 1300
Email
dreshirzad@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Torbate-Heidaria University of Medical Sciences
Full name of responsible person
Somayyeh Nayyeri
Position
Faculty membe
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Torbat Heydariyeh University of Medical Sciences, Razi St., North Ferdowsi St.
City
Torbat-Heydariyeh
Province
Razavi Khorasan
Postal code
33787-95196
Phone
+98 51 5222 6013
Email
s.nayyeri86@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Sabzevar University of Medical Sciences
Full name of responsible person
Ebrahim Shirzade
Position
Faculty member
Latest degree
Subspecialist
Other areas of specialty/work
Ophthalmology
Street address
School of Medicine-Campus of the University of Medical Sciences-above the memory of the shohadaye gomnam-shohadaye hasteii Boulevard-Sabzevar
City
Sabzevar
Province
Razavi Khorasan
Postal code
9613873136
Phone
+98 51 4401 1300
Email
dreshirzad@yahoo.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Clinical information (including therapeutic outcomes), laboratory and demographic of Coronavirus patients 2019 under treatment with routine and vitamin D and C
When the data will become available and for how long
About 5 to 10 months after the start of the study
To whom data/document is available
Public
Under which criteria data/document could be used
Careful study information can be provided to qualified researchers interested in treating patients.
From where data/document is obtainable
Corresponding author
What processes are involved for a request to access data/document
Competent and enthusiastic researchers can receive data documentation from the responsible author after presenting the work by presenting their academic information and identification.
Comments
The clinical trial, titled "Comparison of three therapies in patients with super-acute respiratory syndrome (SARS-COV-2) with and without positive coronavirus testing (Covid-19)", has not been previously reported elsewhere. Not sent elsewhere. We are very happy to have registered our clinical trial on the IRCT website (www.irct.ir). thank you. Wishing you good health and happy moments
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