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Effectiveness of Convalescent Immune Plasma Therapy

Primary Purpose

Acute Respiratory Distress Syndrome

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Convalescent Immune Plasma
Sponsored by
Bagcilar Training and Research Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Respiratory Distress Syndrome

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria Clinical diagnosis of Covid-19

Exclusion Criteria Age lower than 18 Lower plasma IgA levels PaO2/FiO2 higher than 300 mmHg SpO2 higher than 90

Sites / Locations

  • Istanbul Bagcılar Training and Research Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Convalescent Plasma Therapy Group

Non-Plasma Therapy Group

Arm Description

One dose of 200 mL of convalescent ımmune plasma derived from recently recovered donors with the neutralizing antibody titers above 1:640 was transfused to the patients as an addition to standart critical care treatment.

Standart critical care treatment group

Outcomes

Primary Outcome Measures

Plasma ferritin level
Acute phase reactant
Lymphocyte count
Infection markers
D-Dimer level
Hypercoagulability
C-Reactive protein level
Infection markers
Plasma procalcitonin level
Infection markers
Plasma fibrinogen level
Coagulopathy

Secondary Outcome Measures

Fractional Inspired Oxygen Level
Arterial oxygenation
Partial Oxygen Saturation level
Arterial oxygenation
Arterial Oxygen level
Arterial oxygenation

Full Information

First Posted
June 17, 2020
Last Updated
June 30, 2020
Sponsor
Bagcilar Training and Research Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04442958
Brief Title
Effectiveness of Convalescent Immune Plasma Therapy
Official Title
Effectiveness of Convalescent Immune Plasma Therapy in Severe COVID-19 Patients With Acute Respiratory Distress Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
June 2020
Overall Recruitment Status
Completed
Study Start Date
May 15, 2020 (Actual)
Primary Completion Date
June 15, 2020 (Actual)
Study Completion Date
June 17, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bagcilar Training and Research Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The aim of the study is to evaluate the safety, improvement of clinical symptoms and laboratory parameters of convalescent immune plasma treatment in severe Covid-19 patients with ARDS.
Detailed Description
The aim of the study is to evaluate the safety, improvement of clinical symptoms with hypoxemia, metabolic and laboratory parameters of patients with convalescent immune plasma treatment in severe Covid-19 patients followed up in critical care unit.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Respiratory Distress Syndrome

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Convalescent Plasma Therapy Group
Arm Type
Experimental
Arm Description
One dose of 200 mL of convalescent ımmune plasma derived from recently recovered donors with the neutralizing antibody titers above 1:640 was transfused to the patients as an addition to standart critical care treatment.
Arm Title
Non-Plasma Therapy Group
Arm Type
No Intervention
Arm Description
Standart critical care treatment group
Intervention Type
Other
Intervention Name(s)
Convalescent Immune Plasma
Intervention Description
One dose of 200 mL of convalescent ımmune plasma derived from recently recovered donors with the neutralizing antibody titers above 1:640 was transfused to the patients as an addition to standart critical care treatment.
Primary Outcome Measure Information:
Title
Plasma ferritin level
Description
Acute phase reactant
Time Frame
7. day
Title
Lymphocyte count
Description
Infection markers
Time Frame
7. day
Title
D-Dimer level
Description
Hypercoagulability
Time Frame
7. day
Title
C-Reactive protein level
Description
Infection markers
Time Frame
7. day
Title
Plasma procalcitonin level
Description
Infection markers
Time Frame
7. day
Title
Plasma fibrinogen level
Description
Coagulopathy
Time Frame
7. day
Secondary Outcome Measure Information:
Title
Fractional Inspired Oxygen Level
Description
Arterial oxygenation
Time Frame
7. day
Title
Partial Oxygen Saturation level
Description
Arterial oxygenation
Time Frame
7. day
Title
Arterial Oxygen level
Description
Arterial oxygenation
Time Frame
7. day

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria Clinical diagnosis of Covid-19 Exclusion Criteria Age lower than 18 Lower plasma IgA levels PaO2/FiO2 higher than 300 mmHg SpO2 higher than 90
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Salih SS Sevdi, Md
Organizational Affiliation
Istanbul Bagcılar Training and Research Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Istanbul Bagcılar Training and Research Hospital
City
Istanbul
ZIP/Postal Code
34375
Country
Turkey

12. IPD Sharing Statement

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Effectiveness of Convalescent Immune Plasma Therapy

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