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NCT04442958 Clinical Trial

Effectiveness of Convalescent Immune Plasma Therapy

Acute Respiratory Distress Syndrome Clinical Trial

Official title:
Effectiveness of Convalescent Immune Plasma Therapy in Severe COVID-19 Patients With Acute Respiratory Distress Syndrome

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04442958
Other study ID # 2020.05.2.14.070
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date May 15, 2020
Est. completion date June 17, 2020

Study information
Verified date June 2020
Source Bagcilar Training and Research Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 60
Est. completion date June 17, 2020
Est. primary completion date June 15, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years to 90 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

  • Acute Lung Injury
  • Acute Respiratory Distress Syndrome
  • Respiratory Distress Syndrome, Adult
  • Respiratory Distress Syndrome, Newborn
  • Syndrome

Intervention

Other:
• Convalescent Immune Plasma
One dose of 200 mL of convalescent immune 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.

Locations
Country Name City State
Turkey Istanbul Bagcilar Training and Research Hospital Istanbul

Sponsors (1)
Lead Sponsor Collaborator
Bagcilar Training and Research Hospital

Country where clinical trial is conducted

Turkey, 

Outcome
Type Measure Description Time frame Safety issue
Primary Plasma ferritin level Acute phase reactant 7. day
Primary Lymphocyte count Infection markers 7. day
Primary D-Dimer level Hypercoagulability 7. day
Primary C-Reactive protein level Infection markers 7. day
Primary Plasma procalcitonin level Infection markers 7. day
Primary Plasma fibrinogen level Coagulopathy 7. day
Secondary Fractional Inspired Oxygen Level Arterial oxygenation 7. day
Secondary Partial Oxygen Saturation level Arterial oxygenation 7. day
Secondary Arterial Oxygen level Arterial oxygenation 7. day
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