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Completed

NCT Number: NCT04442958

Effectiveness of Convalescent Immune Plasma Therapy

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.

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Key information

Conditions

Acute Respiratory Distress Syndrome Lung Diseases Respiration Disorders Respiratory Distress Syndrome Respiratory Tract Diseases

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Istanbul Bagcılar Training and Research Hospital

Istanbul, 34375, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Convalescent Immune Plasma

Other

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 outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Bagcilar Training and Research Hospital

Other Gov

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Jun 23, 2020
Registry last updated
Jul 1, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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