Protocol summary
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Study aim
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The purpose of this study is immediate uses of convalescent covid-19 plasma in the treatment of new infected patients at the first day of hospitalization in a clinical trail and evaluate the effectiveness of this type of treatment.
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Design
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Clinical trials have a control group, with parallel groups and phase 3 on 100 patients.
The case group are 50 patients. The control group are 50 patients who are either not in randomization or not satisfied with receiving plasma.
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Settings and conduct
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The study is being conducted in Khuzestan province: Ahvaz, Razi Hospital and in Sistan and Baluchestan province: Zahedan, Bouali Hospital.
After being hospitalized by the treating physician in hospital, treatment begins with the diagnosis and judgment of Covid-19. In the case group, plasma injection will be one of the first hospital treatment orders.
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Participants/Inclusion and exclusion criteria
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Symptomatic COVID-19 patients who are hospitalized and have Score>4 in terms of WHO Progression Scale will enter the study.
COVID-19 patients who have Score<4 in terms of WHO Progression Scale and more than 24 hours passed from the hospitalization, wont enter the study.
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Intervention groups
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Convalescent plasma injection, a 500 cc unit will be injected to the case group within 4 hours in addition to antiviral and treatments available at the hospital.
The control group treatment will only be antiviral and inpatient care.
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Main outcome variables
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The rate of reduction in the duration of hospital stay of patients; mortality reduction; requirement of artificial ventilation and entry into the ICU; The rate of achieve to minimum 2 point decrease in WHO clinical scale since plasma usage OR WHO score less than 3 (each achieved first)
General information
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Reason for update
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20200525047562N1
Registration date:
2020-06-14, 1399/03/25
Registration timing:
registered_while_recruiting
Last update:
2020-06-24, 1399/04/04
Update count:
1
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Registration date
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2020-06-14, 1399/03/25
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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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2020-05-25, 1399/03/05
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Expected recruitment end date
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2020-07-26, 1399/05/05
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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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Immediate uses of convalescent covid-19 plasma in the treatment of new infected patients at the first day of hospitalization in a clinical trail
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Public title
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Treatment of Covid-19 patients with convalescent plasma
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
Symptomatic COVID-19 patients who are hospitalized and have Score>4 in terms of WHO Progression Scale.
The least reasons of hospitalization are dyspnea and/or SPO2<93% or RR>30
The intervention should be performed within the first 24 hours of hospitalization.
Exclusion criteria:
COVID-19 patients having Score<4 in terms of WHO Progression Scale.
More than 24 hours passed from hospitalization.
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Age
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No age limit
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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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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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2020-05-20, 1399/02/31
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Ethics committee reference number
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IR.TMI.REC.1399.003
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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ICD-10 code description
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Primary outcomes
1
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Description
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Reduce at least 2 points on clinical signs or score less than 3, each earlier.
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Timepoint
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At the beginning of the study (before the start of the intervention) and day 4 of hospitalization, day 7 of hospitalization and discharge time.
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Method of measurement
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WHO Progression Scale
2
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Description
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length of hospital stay
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Timepoint
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Hospitalization time to discharge
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Method of measurement
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Counting days
Secondary outcomes
1
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Description
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The rate of need for artificial ventilation and entry into the ICU
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Timepoint
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From hospitalization to discharge
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Method of measurement
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Percentage calculation
Intervention groups
1
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Description
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Intervention group: Symptomatic COVID-19 patients who are hospitalized and have Score>4 in terms of WHO Progression Scale. Before 24 hours passed from the hospitalization. A 500 cc unit with blood group compatibility between receiver and donor is injected within 4 hours. In patients with grade 7 and above, a plasma unit can be re-injected after 24 hours. Plasma is obtained by apheresis from patients who have recovered from the covid-19 virus in blood transfusion centers.
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Category
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Treatment - Drugs
2
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Description
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Control group: The control group is a patient who is hospitalized with suspicion of Covid-19 but either not in randomization or not satisfied with receiving plasma.
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Category
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N/A
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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High Educational and Research Institute of Transfusion Medicine
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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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Yes - There is 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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Yes - There is 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
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Title and more details about the data/document
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Information about the main and secondary consequences can be shared.
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When the data will become available and for how long
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The access period will start 6 months after the results are printed.
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To whom data/document is available
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Researchers working at academic and scientific institutes, as well as craftsmen, can apply to receive them.
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Under which criteria data/document could be used
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The data/document can be used if the reasons of the request are determined .
The type of analysis that will be performed on the delivered data are specified.
Any type of data exploitation must be approved by the project supervisor.
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From where data/document is obtainable
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He or she can refere to the High Educational and Research Institute of Blood Transfusion Medicine.
Shahid Hemmat HWY at Sheikh Fazlollah Nouri HWY, next to Milad Tower
Phone:0098 21 88601564
Website: ibto.ir
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What processes are involved for a request to access data/document
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The High Educational and Research Institute of Blood Transfusion Medicine will receive and review the request, coordinate with the project manager, provide data files and inform to the applicant.
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Comments
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