Protocol summary
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Study aim
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1-Evaluation of the efficacy and safety of inhaled magnesium sulfate in combination with standard treatment in COVID-19 patients.
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Design
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Randomized controlled clinical trial, with intervention and control groups, without blinding, randomized, phase 3 per 100 patients, randomized by Permuted block randomization
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Settings and conduct
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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.
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Participants/Inclusion and exclusion criteria
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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.
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Intervention groups
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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.
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Main outcome variables
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Improve respiratory symptoms including shortness of breath, cough; oxygen saturation
General information
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Reason for update
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1-Correction two numbers in the description of how to randomize - English
2-Correction expected recruitment start date and Correction expected recruitment end date
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Acronym
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IRCT registration information
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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
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Registration date
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2020-07-28, 1399/05/07
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Registrant information
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Recruitment status
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recruiting
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Funding source
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Expected recruitment start date
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2020-07-30, 1399/05/09
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Expected recruitment end date
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2020-12-30, 1399/10/10
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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Evaluation of the efficacy and safety of inhaled magnesium sulfate in combination with standard treatment in Covid-19 patients: a clinical trial
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Public title
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Evaluation of the efficacy and safety of inhaled magnesium sulfate in combination with standard treatment in Covid-19 patients
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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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
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Age
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From 18 years old to 80 years old
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Gender
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Both
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Phase
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3
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Groups that have been masked
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No information
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Sample size
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Target sample size:
100
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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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
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Blinding (investigator's opinion)
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Not blinded
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Blinding description
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Placebo
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Not used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2020-07-26, 1399/05/05
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Ethics committee reference number
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IR.SBMU.NRITLD.REC.1399.148
Health conditions studied
1
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Description of health condition studied
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Covid-19
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ICD-10 code
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U07.1
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ICD-10 code description
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COVID-19, virus identified
Primary outcomes
1
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Description
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Improve respiratory symptoms including shortness of breath and cough
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Timepoint
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Days 1 to 5 and at the end of the first week
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Method of measurement
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Questionnaire
2
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Description
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Blood o2 saturation
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Timepoint
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Just before and 1 hour after prescribe medication
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Method of measurement
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Pulse oximetry device
Secondary outcomes
1
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Description
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C-reactive protein
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Timepoint
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C-reactive protein is measured daily for days 1 to 5.
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Method of measurement
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Measurement of C-reactive protein is performed by a laboratory sample of blood taken from the patient.
2
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Description
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Total number of lymphocytes.
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Timepoint
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The total number of lymphocytes is measured daily for days 1 to 5.
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Method of measurement
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Measurement of The total number of lymphocytes is performed by a laboratory sample of blood taken from the patient.
3
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Description
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D-dimer test
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Timepoint
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The D-dimer test is measured daily for days one to five
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Method of measurement
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The D-dimer test is performed with a blood sample taken from the patient by a laboratory
4
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Description
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Ferritin
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Timepoint
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Ferritin is measured daily for days 1 to 5.
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Method of measurement
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Measurement of ferritin is performed by a laboratory sample of blood taken from the patient
Intervention groups
1
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Description
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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.
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Category
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Treatment - Drugs
2
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Description
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Control group: includes 50 patients who receive standard treatment.
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Category
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Treatment - Drugs
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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No
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Title of funding source
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National Research Institute of Tuberculosis and Lung Diseases(NRITLD), Masih Daneshvari Hospital
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Undecided - It is not yet known if there will be a plan to make this available
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Study Protocol
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No - There is not a plan to make this available
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Statistical Analysis Plan
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Undecided - It is not yet known if there will be a plan to make this available
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Informed Consent Form
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Undecided - It is not yet known if there will be a plan to make this available
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Clinical Study Report
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Undecided - It is not yet known if there will be a plan to make this available
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Analytic Code
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Undecided - It is not yet known if there will be a plan to make this available
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Data Dictionary
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Undecided - It is not yet known if there will be a plan to make this available