Investigating Effect of Convalescent Plasma on COVID-19 Patients Outcome: A Clinical Trial

March 30, 2020 updated by: Amir Shamshirian, Mazandaran University of Medical Sciences
Coronavirus disease 2019 (COVID-19) was recognized as a pandemic on March 11, 2020 by the World Health Organization. The virus that causes COVID-19 (SARS-CoV-2) is easily transmitted through person to person and there is still no specific approach against the disease and mortality rate in severe cases is also significant. Therefore, finding effective treatment for the mortality of these patients is very important. In this study the investigators aim to determine the effect of Convalescent Plasma on COVID-19 patients Outcome through a Clinical Trial

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
30

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Iran, Islamic Republic of
    • Mazandaran
      • Sari, Mazandaran, Iran, Islamic Republic of, 4816633131
        • Imam Khomeini Hospital, Mazandaran University of Medical Sciences

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

30 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

Recipient:

  1. COVID-19 Patients
  2. Consent to attend the study
  3. Age 30 to 70 years
  4. Don't be intubated
  5. PaO2 / FiO2 is above 200 or Spo2 is greater than 85%.

Donator:

  1. Complete recovery from severe COVID-19 disease and hospital discharge
  2. Consent to donate blood to the infected person
  3. Age 30 to 60 years
  4. Has normal CBC test results
  5. Negative COVID-19 RT-PCR test

Exclusion Criteria:

Recipient:

  1. A history of hypersensitivity to blood transfusions or its products
  2. History of IgA deficiency
  3. Heart failure or any other factor that prevents the transmission of of 500 ml plasma
  4. Entering the intubation stage

Donator:

  1. Patients infected with blood-borne viral / infectious diseases
  2. Underlying heart disease, low or high blood pressure, diabetes, epilepsy, and anything that may prohibit blood donation.
  3. Use of banned drugs for blood donation (eg, ethertinate, acitretin, aliotretinoin, isotretinoin, antiandrogens, NSAIDs, etc.)
  4. Use of different drugs
  5. Other prohibited donations based on blood transfusion standards

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Other: COVID-19 Patients
Biological: Convalescent Plasma
Intervention to evaluate convalescent plasma transfer to COVID-19 patients admitted to ICU

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Mortality changes in day 10
Time Frame: 10 days after plasma transmission
Measure of the number of deaths in a particular population, scaled to the size of that population, per unit of time.
10 days after plasma transmission
Mortality changes in day 30
Time Frame: 30 days after plasma transmission
Measure of the number of deaths in a particular population, scaled to the size of that population, per unit of time.
30 days after plasma transmission
Changes of C-reactive protein
Time Frame: Day 1
Measurement of CRP
Day 1
Changes of C-reactive protein
Time Frame: Day 3
Measurement of CRP
Day 3
Changes of C-reactive protein
Time Frame: Day 7
Measurement of CRP
Day 7
Changes of Interleukin 6
Time Frame: Day 1
Measurement of IL-6
Day 1
Changes of Interleukin 6
Time Frame: Day 3
Measurement of IL-6
Day 3
Changes of Interleukin 6
Time Frame: Day 7
Measurement of IL-6
Day 7
Changes of tumor necrosis factor-α
Time Frame: Day 1
Measurement of TNF-α
Day 1
Changes of tumor necrosis factor-α
Time Frame: Day 3
Measurement of TNF-α
Day 3
Changes of tumor necrosis factor-α
Time Frame: Day 7
Measurement of TNF-α
Day 7
Changes of PaO2/FiO2 Ratio
Time Frame: Day 1
Partial pressure of arterial oxygen/Percentage of inspired oxygen
Day 1
Changes of PaO2/FiO2 Ratio
Time Frame: Day 3
Partial pressure of arterial oxygen/Percentage of inspired oxygen
Day 3
Changes of PaO2/FiO2 Ratio
Time Frame: Day 7
Partial pressure of arterial oxygen/Percentage of inspired oxygen
Day 7

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Changes of CD3
Time Frame: Day 1
Day 1
Changes of CD3
Time Frame: Day 3
Day 3
Changes of CD3
Time Frame: Day 7
Day 7
Changes of CD4
Time Frame: Day 1
Day 1
Changes of CD4
Time Frame: Day 3
Day 3
Changes of CD4
Time Frame: Day 7
Day 7
Changes of CD8
Time Frame: Day 1
Day 1
Changes of CD8
Time Frame: Day 3
Day 3
Changes of CD8
Time Frame: Day 7
Day 7
Changes of CD4/CD8 ratio
Time Frame: Day 1
Day 1
Changes of CD4/CD8 ratio
Time Frame: Day 3
Day 3
Changes of CD4/CD8 ratio
Time Frame: Day 7
Day 7
Changes of lymphocyte count
Time Frame: Day 1
Day 1
Changes of lymphocyte count
Time Frame: Day 3
Day 3
Changes of lymphocyte count
Time Frame: Day 7
Day 7
Changes of leukocyte count
Time Frame: Day 1
Day 1
Changes of leukocyte count
Time Frame: Day 3
Day 3
Changes of leukocyte count
Time Frame: Day 7
Day 7
Changes of alanine transaminase (ALT)
Time Frame: Day 1
Day 1
Changes of alanine transaminase (ALT)
Time Frame: Day 3
Day 3
Changes of alanine transaminase (ALT)
Time Frame: Day 7
Day 7
Changes of aspartate transaminase (AST)
Time Frame: Day 1
Day 1
Changes of aspartate transaminase (AST)
Time Frame: Day 3
Day 3
Changes of aspartate transaminase (AST)
Time Frame: Day 7
Day 7
Changes of alkaline phosphatase (ALP)
Time Frame: Day 1
Day 1
Changes of alkaline phosphatase (ALP)
Time Frame: Day 3
Day 3
Changes of alkaline phosphatase (ALP)
Time Frame: Day 7
Day 7
Changes of lactate dehydrogenase (LDH)
Time Frame: Day 1
Day 1
Changes of lactate dehydrogenase (LDH)
Time Frame: Day 3
Day 3
Changes of lactate dehydrogenase (LDH)
Time Frame: Day 7
Day 7
Changes of creatine phosphokinase (CPK)
Time Frame: Day 1
Day 1
Changes of creatine phosphokinase (CPK)
Time Frame: Day 3
Day 3
Changes of creatine phosphokinase (CPK)
Time Frame: Day 7
Day 7
Changes of Creatine kinase-MB (CK-MB)
Time Frame: Day 1
Day 1
Changes of Creatine kinase-MB (CK-MB)
Time Frame: Day 3
Day 3
Changes of Creatine kinase-MB (CK-MB)
Time Frame: Day 7
Day 7
Changes of Specific IgG
Time Frame: Day 1
Day 1
Changes of Specific IgG
Time Frame: Day 3
Day 3
Changes of Specific IgG
Time Frame: Day 7
Day 7
Radiological findings
Time Frame: Within 2 hours after admission
Computed tomography Scan and Chest X-Ray
Within 2 hours after admission
Radiological findings
Time Frame: Day 14
Computed tomography Scan and Chest X-Ray
Day 14
Number of days ventilated
Time Frame: Through study completion, an average of 2 weeks
Through study completion, an average of 2 weeks
Length of hospitalization
Time Frame: Through study completion, an average of 2 weeks
Through study completion, an average of 2 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Mazandaran University of Medical Sciences

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Majid Saeedi, Ph.D., Vice-Chancellor for Research, Mazandaran University of Medical Sciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 28, 2020

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 20, 2020

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 30, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 24, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 30, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 31, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 31, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 30, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • IR.MAZUMS.REC.1399.7330
  • IRCT20181104041551N1 (Registry Identifier: Iranian Registry of Clinical Trials (IRCT))

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

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