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NCT Number: NCT04973488

Therapeutic Plasma Exchange Followed by Convalescent Plasma Transfusion in Severe and Critically Ill COVID-19 Patients

Therapeutic plasma exchange (TPE) has been proposed as a rescue therapy in critically ill COVID-19 patients. The aim of this study is to determine whether combining TPE with convalescent plasma (CVP) transfusion early during the intensive care unit (ICU) stay, improves survival among this heterogeneous population.

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Key information

Conditions

COVID-19 Pneumonia Acute Respiratory Distress Syndrome Acute Respiratory Failure COVID-19 Respiratory Infection 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

Municipal Hospital "Dr. Teodor Andrei" Lugoj

Lugoj, Timiș County, 305500, Romania

About this study

This single centre prospective, non-randomised controlled trial will be conducted in an 8 bed COVID-19 ICU and will include patients with severe COVID-19 pneumonia requiring ICU monitoring and therapy. 19 patients will be treated performing TPE followed by CVP transfusion while for 19 patients will receive standard treatment according to hospital protocols. TPE will be initiated during the first 24 hours after ICU admission, followed immediately by transfusion of CVP. The primary endpoint is survival at 30 days. Secondary endpoints include assessing the evolution of biomarkers, such as the partial pressure of arterial oxygen (PaO2) to fractional inspired oxygen (FiO2) ratio (P/F ratio), C reactive protein (CRP), lactate dehydrogenase (LDH) and ferritin at the 7-day follow-up.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • positive reverse transcriptase PCR test for COVID 19
  • COVID-19 pneumonia
  • All patients included were adults (>18 years)
  • Acute respiratory failure

Exclusion criteria

  • pregnant women
  • patients with suspected or confirmed pulmonary embolism
  • patients with terminal disease

Treatment and study plan

Therapeutic plasma exchange

Other

The intervention is a combination between the procedure of Therapeutic plasma exchange and biological transfusion of convalescent plasma from donors that have have COVID-19

Other names: Transfusion of convalescent plasma

Primary outcomes

  1. Survival

    Time frame: 30 day period

    Number of Participants who Survived

Secondary outcomes

  1. P/F Ratio

    Time frame: 7 day period

    Average Partial pressure of arterial oxygen (PaO2) to fractional inspired oxygen (FiO2) ratio - P/F ratio calculated between the values from day 1 and day 7

  2. C Reactive Protein (CRP)

    Time frame: 7 day period

    Average value of CRP calculated using the values from day 1 and day 7

  3. Lactate Dehydrogenase (LDH)

    Time frame: 7 day period

    Average value of LDH calculated using the values from day 1 and day 7

  4. Ferritin

    Time frame: 7 day period

    Average value of ferritin calculated using the values from day 1 and day 7

Sponsors and collaborators

Lead sponsor

Novacescu Alexandru

Other

Collaborators

  • University of Medicine and Pharmacy "Victor Babes" Timisoara

Registry information

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Jul 22, 2021
Registry last updated
Aug 26, 2024

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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