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

NCT ID: NCT04327349

Last Updated: 2020-03-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-03-28

Study Completion Date

2020-09-30

Brief Summary

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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

Detailed Description

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Conditions

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Coronavirus Infections

Keywords

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Coronavirus COVID-19 SARS-CoV-2 Severe acute respiratory syndrome coronavirus 2

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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COVID-19 Patients

Group Type OTHER

Convalescent Plasma

Intervention Type BIOLOGICAL

Intervention to evaluate convalescent plasma transfer to COVID-19 patients admitted to ICU

Interventions

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Convalescent Plasma

Intervention to evaluate convalescent plasma transfer to COVID-19 patients admitted to ICU

Intervention Type BIOLOGICAL

Eligibility Criteria

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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
Minimum Eligible Age

30 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Mazandaran University of Medical Sciences

OTHER

Sponsor Role lead

Responsible Party

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Amir Shamshirian

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Majid Saeedi, Ph.D.

Role: STUDY_CHAIR

Vice-Chancellor for Research, Mazandaran University of Medical Sciences

Locations

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Imam Khomeini Hospital, Mazandaran University of Medical Sciences

Sari, Mazandaran, Iran

Site Status

Countries

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Iran

Other Identifiers

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IRCT20181104041551N1

Identifier Type: REGISTRY

Identifier Source: secondary_id

IR.MAZUMS.REC.1399.7330

Identifier Type: -

Identifier Source: org_study_id