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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

Tracking Information
First Submitted Date  ICMJE June 17, 2020
First Posted Date  ICMJE June 23, 2020
Last Update Posted Date July 1, 2020
Actual Study Start Date  ICMJE May 15, 2020
Actual Primary Completion Date June 15, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 30, 2020)
  • Plasma ferritin level [ Time Frame: 7. day ]
    Acute phase reactant
  • Lymphocyte count [ Time Frame: 7. day ]
    Infection markers
  • D-Dimer level [ Time Frame: 7. day ]
    Hypercoagulability
  • C-Reactive protein level [ Time Frame: 7. day ]
    Infection markers
  • Plasma procalcitonin level [ Time Frame: 7. day ]
    Infection markers
  • Plasma fibrinogen level [ Time Frame: 7. day ]
    Coagulopathy
Original Primary Outcome Measures  ICMJE
 (submitted: June 19, 2020)
  • Blood [ Time Frame: Change from baseline level at 7. day ]
    White Blood Cell Count
  • Metabolic [ Time Frame: Change from baseline level at 7. day ]
    Ferritin
  • Blood [ Time Frame: Change from baseline level at 7. day ]
    Lymphocyte Count
  • Blood [ Time Frame: Change from baseline level at 7. day ]
    Platelet Count
  • Metabolic [ Time Frame: Change from baseline level at 7. day ]
    D-Dimer
  • Infection [ Time Frame: Change from baseline level at 7. day ]
    C Reactive Protein
  • Infection [ Time Frame: Change from baseline level at 7. day ]
    Procalcitonin
  • Coagulation [ Time Frame: Change from baseline level at 7. day ]
    Fibrinogen
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 30, 2020)
  • Fractional Inspired Oxygen Level [ Time Frame: 7. day ]
    Arterial oxygenation
  • Partial Oxygen Saturation level [ Time Frame: 7. day ]
    Arterial oxygenation
  • Arterial Oxygen level [ Time Frame: 7. day ]
    Arterial oxygenation
Original Secondary Outcome Measures  ICMJE
 (submitted: June 19, 2020)
  • Oxygenization [ Time Frame: Change from baseline level at 7. day ]
    Fractional Inspired Oxygen Level
  • Oxygenization [ Time Frame: Change from baseline level at 7. day ]
    Partial Oxygen Saturation level
  • Oxygenization [ Time Frame: Change from baseline level at 7. day ]
    Arterial Oxygen level
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effectiveness of Convalescent Immune Plasma Therapy
Official Title  ICMJE Effectiveness of Convalescent Immune Plasma Therapy in Severe COVID-19 Patients With Acute Respiratory Distress Syndrome
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Acute Respiratory Distress Syndrome
Intervention  ICMJE 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.
Study Arms  ICMJE
  • 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.
    Intervention: Other: Convalescent Immune Plasma
  • No Intervention: Non-Plasma Therapy Group
    Standart critical care treatment group
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 19, 2020)
60
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE June 17, 2020
Actual Primary Completion Date June 15, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 90 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Turkey
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04442958
Other Study ID Numbers  ICMJE 2020.05.2.14.070
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Bagcilar Training and Research Hospital
Study Sponsor  ICMJE Bagcilar Training and Research Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Salih SS Sevdi, Md Istanbul Bagcılar Training and Research Hospital
PRS Account Bagcilar Training and Research Hospital
Verification Date June 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP