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.

Brief Title

Convalescent Plasma in ICU Patients With COVID-19-induced Respiratory Failure

Official Title

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

Brief Summary

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

Detailed Description

Convalescent plasma is an antibody-rich product made from blood donated by people who have
recovered from the disease caused by the virus. Prior experience with respiratory viruses and
limited data that have emerged from China suggest that convalescent plasma has the potential
to lessen the severity or shorten the length of illness caused by COVID-19. It is important
that we evaluate this potential therapy in the context of clinical trials.

As such, 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.

This study will be opened across three separate site: Cedars-Sinai Medical Center, Johns
Hopkins University, and University of Pittsburgh Medical Center. 30 patients will be
recruited at each site. Each site has received its own FDA IND and IRB approval. As such, the
following people are serving as sponsor-investigators at their respective institutions.

David Hager, MD PhD, Johns Hopkins University

Noah Merin, MD PhD, Cedars-Sinai Medical Center

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.

Outcome Measures

Outcome measures are the tests that investigators perform to prove whether or not a treatment being tested in a clinical trial is having any effect.