View older revisions Content changed at 2020-11-29, 1399/09/09

Protocol summary

Study aim
1-Evaluation of the efficacy and safety of inhaled magnesium sulfate in combination with standard treatment in COVID-19 patients.
Design
Randomized controlled clinical trial, with intervention and control groups, without blinding, randomized, phase 3 per 100 patients, randomized by Permuted block randomization
Settings and conduct
This study is a prospective, not-blinded, randomized controlled clinical trial and will be performed on on 100 patients aged 18 to 80 years, in Masih Daneshvari Hospital in Tehran, Shahid Labbafinejad hospital in Tehran and Shahid Sadoughi Hospital in Yazd. Patients are randomly divided into two intervention groups in and control group . At the beginning of the study, patients will be randomly assigned to one of two divided groups (50 people in each group) by permutation block method. Patients in the intervention group receive magnesium sulfate by inhalation (5 cc of a 20% injectable vial or 2 cc of a 50% injectable vial will be diluted by 50 cc distilled water and nebulized via a nebulizer with oxygen mask) in addition to standard treatment. Patients in the control group also receive standard treatment. groups of 50 control or intervention.
Participants/Inclusion and exclusion criteria
Minimum age 18 and maximum age 80 years, Candidate for hospitalization, Signing up the informed consent form The first 24 to 48 hours of hospitalization ؛Patients with heart block, Patients with myocardial injury.
Intervention groups
Intervention group: includes 50 patients who receive magnesium sulfate inhaled (5 cc of 20% injectable vial or 2 cc of 50% injectable vial) every 8 hours for 5 days along with standard treatment. Control group: includes 50 patients who receive standard treatment.
Main outcome variables
Improve respiratory symptoms including shortness of breath, cough; oxygen saturation

General information

Reason for update
1-Correction two numbers in the description of how to randomize - English 2-Correction expected recruitment start date and Correction expected recruitment end date
Acronym
IRCT registration information
IRCT registration number: IRCT20191211045691N1
Registration date: 2020-07-28, 1399/05/07
Registration timing: prospective

Last update: 2020-11-29, 1399/09/09
Update count: 3
Registration date
2020-07-28, 1399/05/07
Registrant information
Name
Seyed Ruhollah Mousavinasab
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 3647 4332
Email address
mousavinasab@sums.ac.ir
Recruitment status
recruiting
Funding source
Expected recruitment start date
2020-07-30, 1399/05/09
Expected recruitment end date
2020-12-30, 1399/10/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the efficacy and safety of inhaled magnesium sulfate in combination with standard treatment in Covid-19 patients: a clinical trial
Public title
Evaluation of the efficacy and safety of inhaled magnesium sulfate in combination with standard treatment in Covid-19 patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Minimum age 18 and maximum age 80 years Candidate for hospitalization ( o2sat<93% یا RR>24 یا Pao2/Fio2<300) The first 24 hours or 48 hours of hospitalization Signing up the informed consent form
Exclusion criteria:
Patients with heart block Patients with myocardial injury
Age
From 18 years old to 80 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size: 100
Randomization (investigator's opinion)
Randomized
Randomization description
Block randomization (quadruple blocks) All possible blocks are arranged as follows: block 1: ABAB block 2: AABB block 3: ABBA block 4: BBAA block 5: BABA block 6: BAAB We need 25 blocks to select 100 people. We randomly select these blocks from the numbers 1 to 6.Using R software, we choose a random number between the numbers 1 to 6. For example, number 6 is chosen as the first block and number 2 as the forth block. The people who enter the study are given B-A-A-B-A-A-B-B, respectively. Finally, group A receives control intervention and group B receives treatment intervention
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
National Research Institute of Tuberculosis and Lung Diseases(NRITLD), Masih Daneshvari Hospital
Street address
Tehran, Shahid Bahonar St. (Niavaran), Darabad, National Research Institute of Tuberculosis and Lung Diseases Masih Daneshvari Hospital
City
Tehran
Province
Tehran
Postal code
1956944413
Approval date
2020-07-26, 1399/05/05
Ethics committee reference number
IR.SBMU.NRITLD.REC.1399.148

Health conditions studied

1

Description of health condition studied
Covid-19
ICD-10 code
U07.1
ICD-10 code description
COVID-19, virus identified

Primary outcomes

1

Description
Improve respiratory symptoms including shortness of breath and cough
Timepoint
Days 1 to 5 and at the end of the first week
Method of measurement
Questionnaire

2

Description
Blood o2 saturation
Timepoint
Just before and 1 hour after prescribe medication
Method of measurement
Pulse oximetry device

Secondary outcomes

1

Description
C-reactive protein
Timepoint
C-reactive protein is measured daily for days 1 to 5.
Method of measurement
Measurement of C-reactive protein is performed by a laboratory sample of blood taken from the patient.

2

Description
Total number of lymphocytes.
Timepoint
The total number of lymphocytes is measured daily for days 1 to 5.
Method of measurement
Measurement of The total number of lymphocytes is performed by a laboratory sample of blood taken from the patient.

3

Description
D-dimer test
Timepoint
The D-dimer test is measured daily for days one to five
Method of measurement
The D-dimer test is performed with a blood sample taken from the patient by a laboratory

4

Description
Ferritin
Timepoint
Ferritin is measured daily for days 1 to 5.
Method of measurement
Measurement of ferritin is performed by a laboratory sample of blood taken from the patient

Intervention groups

1

Description
Intervention group: includes 50 patients who receive magnesium sulfate inhaled (5 cc of a 20% injectable vial or 2 cc of a 50% injectable vial will be diluted by 50 cc distilled water and nebulized via a nebulizer with oxygen mask) along with standard treatment.
Category
Treatment - Drugs

2

Description
Control group: includes 50 patients who receive standard treatment.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
National Research Institute of Tuberculosis and Lung Diseases(NRITLD), Masih Daneshvari Hospital
Full name of responsible person
Guitti Pourdowlat
Street address
Tehran, Shahid Bahonar St. (Niavaran), Darabad, National Research Institute of Tuberculosis and Lung Diseases Masih Daneshvari Hospital
City
Tehran
Province
Tehran
Postal code
1956944413
Phone
+98 21 2712 2000
Fax
+98 21 2610 5050
Email
pourdowlat_g@yahoo.com
Web page address
http://nritld.sbmu.ac.ir/

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
National Research Institute of Tuberculosis and Lung Diseases(NRITLD), Masih Daneshvari Hospital
Full name of responsible person
‪Parissa Farnia
Street address
Tehran, Shahid Bahonar St. (Niavaran), Darabad, National Research Institute of Tuberculosis and Lung Diseases Masih Daneshvari Hospital
City
Tehran
Province
Tehran
Postal code
4 1957515
Phone
+98 21 2712 2000
Fax
+98 21 2610 9680
Email
pfarnia@hotmail.com
Web page address
http://nritld.sbmu.ac.ir/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
National Research Institute of Tuberculosis and Lung Diseases(NRITLD), Masih Daneshvari Hospital
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
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Guitti Pourdowlat
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Internal Medicine
Street address
Tehran, Shahid Bahonar St. (Niavaran), Darabad, National Research Institute of Tuberculosis and Lung Diseases Masih Daneshvari Hospital
City
Tehran
Province
Tehran
Postal code
1956944413
Phone
+98 21 2712 2000
Fax
+98 21 2610 9680
Email
pourdowlat_g@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
National Research Institute of Tuberculosis and Lung Diseases(NRITLD), Masih Daneshvari Hospital
Full name of responsible person
Guitti Pourdowlat
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Internal Medicine
Street address
Tehran, Shahid Bahonar St. (Niavaran), Darabad, National Research Institute of Tuberculosis and Lung Diseases Masih Daneshvari Hospital
City
Tehran
Province
Tehran
Postal code
1956944413
Phone
+98 21 2712 2000
Fax
+98 21 2610 9680
Email
pourdowlat_g@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Seyed Ruhollah Mousavinasab
Position
Resident
Latest degree
Specialist
Other areas of specialty/work
Medical Pharmacy
Street address
Zand Avenue,Namazi Square, Namazi hospital,Shiraz
City
Shiraz
Province
Fars
Postal code
71937-11351
Phone
+98 71 3647 4332
Fax
+98 71 3647 4326
Email
srmn48@gmail.com

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
No - There is not 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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