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Effectiveness of Convalescent Immune Plasma Therapy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04442958
Recruitment Status : Completed
First Posted : June 23, 2020
Last Update Posted : July 1, 2020
Sponsor:
Information provided by (Responsible Party):
Bagcilar Training and Research Hospital

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.

Condition or disease Intervention/treatment Phase
Acute Respiratory Distress Syndrome Other: Convalescent Immune Plasma Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Effectiveness of Convalescent Immune Plasma Therapy in Severe COVID-19 Patients With Acute Respiratory Distress Syndrome
Actual Study Start Date : May 15, 2020
Actual Primary Completion Date : June 15, 2020
Actual Study Completion Date : June 17, 2020


Arm Intervention/treatment
Experimental: Convalescent Plasma Therapy Group
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.
Other: Convalescent Immune Plasma
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.

No Intervention: Non-Plasma Therapy Group
Standart critical care treatment group



Primary Outcome Measures :
  1. Plasma ferritin level [ Time Frame: 7. day ]
    Acute phase reactant

  2. Lymphocyte count [ Time Frame: 7. day ]
    Infection markers

  3. D-Dimer level [ Time Frame: 7. day ]
    Hypercoagulability

  4. C-Reactive protein level [ Time Frame: 7. day ]
    Infection markers

  5. Plasma procalcitonin level [ Time Frame: 7. day ]
    Infection markers

  6. Plasma fibrinogen level [ Time Frame: 7. day ]
    Coagulopathy


Secondary Outcome Measures :
  1. Fractional Inspired Oxygen Level [ Time Frame: 7. day ]
    Arterial oxygenation

  2. Partial Oxygen Saturation level [ Time Frame: 7. day ]
    Arterial oxygenation

  3. Arterial Oxygen level [ Time Frame: 7. day ]
    Arterial oxygenation



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04442958


Locations
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Turkey
Istanbul Bagcılar Training and Research Hospital
Istanbul, Turkey, 34375
Sponsors and Collaborators
Bagcilar Training and Research Hospital
Investigators
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Principal Investigator: Salih SS Sevdi, Md Istanbul Bagcılar Training and Research Hospital
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Responsible Party: Bagcilar Training and Research Hospital
ClinicalTrials.gov Identifier: NCT04442958    
Other Study ID Numbers: 2020.05.2.14.070
First Posted: June 23, 2020    Key Record Dates
Last Update Posted: July 1, 2020
Last Verified: June 2020

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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
Additional relevant MeSH terms:
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Respiratory Distress Syndrome, Newborn
Respiratory Distress Syndrome, Adult
Acute Lung Injury
Syndrome
Disease
Pathologic Processes
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Infant, Premature, Diseases
Infant, Newborn, Diseases
Lung Injury