Protocol summary

Study aim
Determining and comparing the effectiveness of standard treatment with standard treatment plus vitamin A in the treatment of patients with covid 19
Design
In a controlled double-blind trial, a parallel plan of 140 patients will be randomly assigned to the experimental (70 subjects) and control (70 subjects) groups and will be followed for 10 days.
Settings and conduct
70 experimental group patients in Saveh will receive vitamin A, in addition to the standard treatment recommended for COVID 19 in the national protocol. Patients with COVID-19 in the control group will receive standard national treatment and placebo. Before and after treatment, the rate of recovery in both experimental and control groups is measured. The patients will be randomly allocated to the experimental group or the control group. In this study, they will be blind: laboratory technicians and radiologists, the therapist who was responsible for prescribing the drug, receiving the sample and completing the questionnaire, and the researcher responsible for evaluating the results and analyzing Statistics on group therapy of patients.
Participants/Inclusion and exclusion criteria
Inclusion criteria: aged 1–75 years Exclusion criteria: Autoimmune diseases (lupus, MS, etc.), Hepatit B, C, vitamin A supplement users, pregnant and lactating women
Intervention groups
The experimental group will receive a standard medical protocol, in addition to which vitamin A will be taken orally by 25,000 IU/day for ten days. The control group will receive the standard medical protocol and plasebo.
Main outcome variables
Clinical: body temperature, number of breaths، oxygen saturation ) and cough. Paraclinical: changes in CRP levels, and lymphocytes before and after treatment, ESR, CBC diff, CPK, LDH, blood pH,o2 sat, creatinine and LFT

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20180520039738N2
Registration date: 2020-04-10, 1399/01/22
Registration timing: retrospective

Last update: 2020-04-10, 1399/01/22
Update count: 0
Registration date
2020-04-10, 1399/01/22
Registrant information
Name
Mohamadreza Rohani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 4460 4118
Email address
mohamadreza.rohani@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-04-07, 1399/01/19
Expected recruitment end date
2020-04-07, 1399/01/19
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effectiveness of standard treatment with stand treatment plus Vitamin A in treatment in covid19 patients
Public title
Evaluation and comparison of the effectiveness of standard treatment with stand treatment plus Vitamin A in treatment in covid19 patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Covid 19 patients Age over one year Age less than 75 years Tendency to participate in research Completion of informed written consent
Exclusion criteria:
pregnant women lactating women hepatitis B, C Autoimmune diseases Chronic renal failure (CRF) Liver failure Congestive heart failure (CHF) Chronic obstructive pulmonary disease (COPD)
Age
From 1 year old to 75 years old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
  • Care provider
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 140
Randomization (investigator's opinion)
Randomized
Randomization description
At the beginning of the study, an evaluator examines the criteria for entering the study of patients, and if there are conditions for entering the study, using the table of random numbers, patients will be assigned to the experimental and control group. And this process will continue until the formation of two equal groups of 70 people.
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study, patients, laboratory technicians, radiologists, and therapists who will be responsible for prescribing the drug, receiving the sample and completing the questionnaire, as well as the researcher responsible for evaluating the results and statistically analyzing the treatment group will blind patients. Were, and will not know the intervention group. The physicians responsible for prescribing medication will not be blind. vitamin A and placebo were purchased from the same factory and coded by the third person who is not involved in the study. the patients have received the random code by the secretariat who is not involved in the study. the patients with even numbers will receive the capsules from box A and the patients with odd numbers will receive the capsules from box B. To make a placebo, Since Zahrawi Vitamin A will be used for the experimental group, the control group will also use Zahrawi's placebo drug to make the placebo look and feel similar to the original vitamin A, but the active ingredient will be an ineffective substance.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Saveh University of Medical Sciences
Street address
Yas street, Kaveh industrial city, Saveh
City
Saveh
Province
Markazi
Postal code
3941617698
Approval date
2020-04-03, 1399/01/15
Ethics committee reference number
IR.SAVEHUMS.REC.1399.003

Health conditions studied

1

Description of health condition studied
Corona virus disease 2019 (COVID-19)
ICD-10 code
U07.1
ICD-10 code description
COVID-19, virus identified

Primary outcomes

1

Description
body temperature
Timepoint
before the start of the intervention and 10 days after the supplement Vitamin A
Method of measurement
Measureing body temperature with a thermometer through the mouth

2

Description
Blood oxygen saturation percentage
Timepoint
Before and ten days after starting treatment
Method of measurement
Pulse oximeter

3

Description
Cough rate
Timepoint
Before and ten days after starting treatment
Method of measurement
Physical examination

4

Description
C-Reactive Protein (CRP) Test rate
Timepoint
Before and ten days after starting treatment
Method of measurement
Laboratory

5

Description
Complete blood count (CBC) Rate
Timepoint
Before and ten days after starting treatment
Method of measurement
Laboratory

6

Description
Creat. Rate
Timepoint
Before and ten days after starting treatment
Method of measurement
Laboratory

7

Description
lymphocytes Rate
Timepoint
Before and ten days after starting treatment
Method of measurement
Laboratory

8

Description
Erythrocyte Sedimentation Rate (ESR) rate
Timepoint
Before and ten days after starting treatment
Method of measurement
Laboratory

9

Description
Number of breaths
Timepoint
Before and ten days after starting treatment
Method of measurement
Physical examination

10

Description
The pH of the blood
Timepoint
Before and ten days after starting treatment
Method of measurement
Laboratory

11

Description
Creatine phosphokinase (CPK) rate
Timepoint
Before and ten days after starting treatment
Method of measurement
Laboratory

12

Description
Lactate Dehydrogenase (LDH) rate
Timepoint
Before and ten days after starting treatment
Method of measurement
Laboratory

13

Description
Liver function tests rate
Timepoint
Before and ten days after starting treatment
Method of measurement
Laboratory

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group:25000 IU vitamin A per day for ten days, the plus, the standard national treatment for COVID 19
Category
Treatment - Other

2

Description
Control group: the standard national treatment for COVID19 ,and placebo
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Dr Mozaffar's office
Full name of responsible person
Hasan Mozaffar
Street address
No.2, Morvarid Doctors Building., Enghelab street., Saveh
City
Saveh
Province
Markazi
Postal code
3941946637
Phone
+98 86 4221 4138
Email
hassan.mozaffar@gmail.com

2

Recruitment center
Name of recruitment center
Mostafakhomeini medical center
Full name of responsible person
Dr, Mohammad Ghorbanli
Street address
No.12, Mostafakhomeini medical center., Shariati Street, Saveh
City
Saveh
Province
Markazi
Postal code
3941945539
Phone
+98 86 4223 8874
Email
karimymahmood6686@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Saveh University of Medical Sciences
Full name of responsible person
Dr., Hamidreza Koohestani
Street address
No.10, Yas st, 15th Ave, Kaveh Industrial City, Saveh, Saveh University of medical science
City
Saveh
Province
Markazi
Postal code
3914334911
Phone
+98 86 4234 3396
Email
koohestani709@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Saveh 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
Saveh University of Medical Sciences
Full name of responsible person
Mohammadreza Rouhani
Position
َAssistant professor
Latest degree
Subspecialist
Other areas of specialty/work
Internal Medicine
Street address
No.4, Shahid Shiroodi St. - Alam Al-Huda St., Arak University of Medical Sciences, School of Medicine, Department of Internal Medicine
City
Arak
Province
Markazi
Postal code
٣٨١٩٦٩٣٣٤٥
Phone
+98 86 3368 4615
Email
mohamadreza.rohani@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Mohamadreza Rohani
Position
Assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
Internal Medicine
Street address
Shahid Shiroodi St. - Alam Al-Huda St., Arak University of Medical Sciences, School of Medicine, Department of Internal Medicine
City
Arak
Province
Markazi
Postal code
٣٨١٩٦٩٣٣٤٥
Phone
+98 86 3368 4615
Email
mohamadreza.rohani@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Saveh University of Medical Sciences
Full name of responsible person
Mahmood Karimy
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Health Promotion
Street address
Yas st, 15th Ave, Kaveh Industrial City, Saveh, Markazi Province, Iran
City
Saveh
Province
Markazi
Postal code
3914334911
Phone
+98 86 4234 3395
Email
karimymahmood@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
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
Yes - There is 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
Title and more details about the data/document
By publishing an article
When the data will become available and for how long
Access started on September 2020
To whom data/document is available
Researchers working in academic and scientific institutions
Under which criteria data/document could be used
Scientific and therapeutic
From where data/document is obtainable
Mohamad Reza Rohani, 00989122859099, mohamadreza.rohani@yahoo.com
What processes are involved for a request to access data/document
72 hours after a phone call or email
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