CovidResearchTrials by Shray Alag

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COVID Convalescent PlasmaWiki

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There is one clinical trial.

Clinical Trials

1 An Open Label Trial of Transfusion of COVID-19 Convalescent Plasma (CCP) to Patients With Moderate to Severe COVID-19

This research study evaluates the safety and effectiveness for the use of convalescent plasma transfusion as a treatment option for novel coronavirus SARS-CoV-2 infection (COVID-19). Donors who have recovered from COVID-19 with high antibody levels to the CoV-2 virus will donate plasma at a Mississippi Blood Services facility. Recipients with COIVD-19 who have severe or life threatening conditions will receive plasma from those persons who have recovered from COVID-19.

NCT04412486 COVID-19 Biological: COVID Convalescent Plasma

Primary Outcomes

Description: Change in pre-transfusion respiratory status compared to Day 3 respiratory status measured by PaO2/FiO2.

Measure: Change in PaO2/FiO2 after CCP transfusion.

Time: 3 Days

Description: Change in pre-transfusion respiratory status compared to Day 3 respiratory status measured by pulse oximetry.

Measure: Change in pulse oximetry status after CCP transfusion.

Time: 3 Days

Description: Change in pre-transfusion respiratory status compared to Day 3 respiratory status measured by aO2.

Measure: Change in aO2 after CCP transfusion.

Time: 3 Days

Description: Change in pre-transfusion respiratory status compared to Day 3 respiratory status measured by respiratory rate.

Measure: Change in respiratory rate after CCP transfusion.

Time: 3 Days

Description: Change in pre-transfusion respiratory status compared to Day 3 respiratory status measured by intubation status.

Measure: Change in intubation status after CCP transfusion.

Time: 3 Days

Secondary Outcomes

Description: Change in SOFA score pre-transfusion to Days 1, 3, 7, and 28 post-transfusion.

Measure: Change in Sequential Organ Failure Assessment (SOFA).

Time: Days 1, 3, 7, and 28

Description: Change in 8-point ordinal clinical deterioration scale pre-transfusion to Days 1, 3, 7, and 28 post-transfusion. The 8-point ordinal scale measured by: 8-death, 7-ventilation in addition to ECMO, CRRT and/or vasopressor; 6-intubation and mechanical ventilation; 5-non-invasive mechanical ventilation or high flow oxygen 4- supplemental oxygen by mask or nasal cannula; 3- hospitalization without supplemental oxygen; 2- limitation of activities and 1- no limitation of activities, discharge from hospital.

Measure: Change in 8-point ordinal clinical deterioration scale.

Time: Days 1, 3, 7, and 28

Description: Total length of stay in ICU/hospital.

Measure: Length of ICU/hospital stay.

Time: Days 1, 3, 7, and 28

Description: Presence of any signs or symptoms of plasma transfusion reactions at Days 1, 3, 7, and 28 post-transfusion.

Measure: Development of plasma transfusion reactions.

Time: Days 1, 3, 7, and 28

Description: Presence of any signs or symptoms of immune complex disorders (fever spike, urticarial lesion, arthralgias, myalgias, hematuria, non IgE-mediated anaphylaxis) at Days 1, 3, 7, and 28 post-transfusion.

Measure: Development of immune complex disorders.

Time: Days 1, 3, 7, and 28

Description: Change in anti CoV-2 IgM and IgG levels pre-transfusion compared to levels on Days 1, 3, 7, and 28 post-transfusion.

Measure: Change in anti CoV-2 IgM and IgG levels.

Time: Days 1, 3, 7, and 28

No related HPO nodes (Using clinical trials)