Protocol summary
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Study aim
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Determining the effect of plasma administration of COVID-19 survivors on one-month mortality of patients with acute respiratory distress syndrome during COVID-19 disease
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Design
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All hospitalized patients with acute COVID-19 respiratory distress syndrome who are eligible are placed in the intervention arm. In the intervention arm, in addition to first-line therapies such as corticosteroids, antibiotics, and hydroxychloroquine, patients will receive the survivor's plasma. Patients in the control arm are selected based on information recorded in the university registry system and will be similar to the control group in terms of age, sex, underlying disease and severity of respiratory disease. In the control arm, the necessary care and first-line therapies such as corticosteroids, antibiotics, and hydroxychloroquine will be prescribed according to the current symptoms. Due to the study conditions, blinding is not performed.
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Settings and conduct
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Imam Reza Hospital, Mashhad
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Participants/Inclusion and exclusion criteria
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Entry requirements:
1- Po2 / FIO2 ratio less than 300
2- The patient should be 18 to 75 years old
Conditions of non-entry:
1-Intubated patient
2- Uncontrolled HTN
3. Advanced hepatic, heart or renal failure
4- COPD
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Intervention groups
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In the control group, patients receive all available supportive and specific therapies based on existing standards.
In the intervention group, in addition to similar treatments in the control group, patients were given 600 cc of freshly survivors plasma.
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Main outcome variables
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1- The length of hospital stay in the ICU from the time of entering the study
2- The length of hospital stay from the time of entering the study
3- The need for mechanical ventilation from the time of entering the study
4 - Severity of the disease based on SOFA score
5- Severity of the disease based on Pao2 / Fio2 ratio
General information
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Reason for update
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According to the clinical condition of Covid 19 patients, the clinical trials execution committee in Mashhad University of Medical Sciences decided to perform this trial non-randomly so the control group with similar clinical conditions to the intervention group was selected from patients registered in the university registry system.
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20200409047007N1
Registration date:
2020-04-12, 1399/01/24
Registration timing:
prospective
Last update:
2020-08-10, 1399/05/20
Update count:
1
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Registration date
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2020-04-12, 1399/01/24
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2020-04-13, 1399/01/25
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Expected recruitment end date
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2020-08-15, 1399/05/25
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Actual recruitment start date
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2020-04-21, 1399/02/02
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Actual recruitment end date
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2020-05-31, 1399/03/11
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Trial completion date
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2020-06-27, 1399/04/07
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Scientific title
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The effect of plasma administration of COVID-19 survivors in patients with acute respiratory distress syndrome due to COVID-19
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Public title
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Effect of COVID 19 survivors plasma in COVID 19 patients with ARDS
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
Po2 / FIO2 ratio less than 300 despite receiving standard treatment
The patient should be between 18 and 75 years old
Normal IgA level
Less than a week has passed since the patient entered the ICU
Exclusion criteria:
Uncontrolled HTN
Advanced heart failure
Systolic blood pressure less than 90 mm Hg
COPD
The patient is intubated
Chronic renal failure with GFR less than 30
Advanced hepatic failure
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Age
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From 18 years old to 75 years old
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Gender
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Both
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Phase
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N/A
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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:
64
Actual sample size reached:
64
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Randomization (investigator's opinion)
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Not randomized
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Randomization description
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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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2020-04-06, 1399/01/18
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Ethics committee reference number
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IR.MUMS.REC.1399.055
Health conditions studied
1
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Description of health condition studied
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COVID-19 Disease
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ICD-10 code
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U07.02
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ICD-10 code description
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COVID-19 Disease
Primary outcomes
1
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Description
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mortality rate in 4 weeks from the time of entry into the study
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Timepoint
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The first month of entering the study
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Method of measurement
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Continuous clinical evaluation
Secondary outcomes
1
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Description
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The length of hospital stay in the ICU from the time of entering the study
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Timepoint
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Daily evaluation
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Method of measurement
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Clinical evaluation
Intervention groups
1
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Description
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Intervention group: In the intervention group, patients, in addition to the current standard treatments, also receive 600 cc survivor's plasma. For the preparation of fresh plasma products, survivors with 18 to 60 years old were contacted and tested for CRP, CBC, HBS Ag, HCV Ab, HIV Ab, HTLV1 Ab, COVID 19 PCR and COVID 19 IgM & IgG antibody if they were without symptoms for at least 14 days. If all tests are normal, 600 cc plasma will be taken from them and are prescribed to patients in less than 12 hours. Survivors should have a positive initial PCR test for coronavirus, be male, or have no history of pregnancy if they are female. The donor and the patient must be the same in blood group.
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Category
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Treatment - Other
2
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Description
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Control group: Patients in the control arm are selected based on information recorded in the university registry system and will be similar to the control group in terms of age, sex, underlying disease and severity of respiratory disease. In the control arm, the necessary care and first-line therapies such as corticosteroids, antibiotics, and hydroxychloroquine will be prescribed according to the current symptoms.
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Category
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Treatment - Other
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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Yes
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Title of funding source
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Mashhad University of Medical Sciences
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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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Yes - There is a plan to make this available
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Study Protocol
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Yes - There is a plan to make this available
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Statistical Analysis Plan
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Yes - There is 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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Yes - There is a plan to make this available
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Analytic Code
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Not applicable
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Data Dictionary
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Not applicable
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Title and more details about the data/document
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After collecting and analyzing the data, the results will be made available to the public in the form of articles.
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When the data will become available and for how long
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After the publication of the article
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To whom data/document is available
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physicians
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Under which criteria data/document could be used
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There are no restrictions
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From where data/document is obtainable
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1- Dr Abolghasem Allahyari, Mashhad University of Medical Science
2- Dr Mohsen Seddigh Shamsi, Mashhad University of Medical Science
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What processes are involved for a request to access data/document
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Refer to the project supervisor
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Comments
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