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Multiple Doses of Anti-SARS-CoV-2 convalescent plasmaWiki

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There is one clinical trial.

Clinical Trials


1 A Feasibility Study Assessing the Safety of Multiple Doses of Anti-SARS-CoV-2 Plasma in Mechanically Ventilated Intubated Patients With Respiratory Failure Due to COVID-19

This study will assess the feasibility of administering multiple doses of convalescent plasma (from people who have recovered form SARS-CoV-2) to Covid-19 positive patients in the Intensive Care Unit receiving mechanical ventilation. Donor plasma will not be obtained under this protocol, but all plasma used will follow FDA guidelines for Investigational COVID-19 Convalescent Plasma use. Patients may receive single or double plasma units infused on days 0, 3, and 6. This decision may be based on availability of blood plasma. The primary objective of this study is feasibility. Feasibility will be assessed based on the proportion of subjects who consent and receive at least one dose of convalescent plasma. The study will be declared 'feasible' if at least 80% of subjects who consent receive at least one dose. The secondary study endpoint is overall survival at day 60 after first dose of convalescent plasma. Respiratory status and overall clinical status will be reviewed during follow up on days 14, 28, and 60.

NCT04353206 Covid-19 Sars-CoV2 Biological: Multiple Doses of Anti-SARS-CoV-2 convalescent plasma
MeSH:Respiratory Insufficiency

Primary Outcomes

Description: Feasibility of administering convalescent plasma to patients in the ICU who are intubated and mechanically ventilated due to COVID-19-induced respiratory failure will be assessed based on the proportion of subjects who consent and receive at least one dose of CP. The study will be declared 'feasible' if at least 80% of subjects who consent receive at least one dose.

Measure: Proportion of subjects who consent to the study and receive at least one dose of convalescent plasma.

Time: 60 days

Secondary Outcomes

Description: Overall survival (days, until Day 60). This will be quantified as number of trial patients alive at Day 60 after first dose of CP / total number of patients who received at least one dose of CP.

Measure: Overall survival of patients in the ICU receiving at least once dose of convalescent plasma for Covid-19-induced respiratory failure.

Time: 60 days


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