Protocol for severe/critical illness

Consent Forms

The suggested addendum addendum to standard institutional blood transfusion consent.

Protocols

Study Testing Convalescent Plasma vs Best Supportive Care (Baylor, Approved) 

Plasma Therapy of COVID-19 in Critically Ill Patients (O'Donnell and Eisenberger, Approved)

Rhu-pGSN for Severe Covid-19 Pnemonia (DiNubile and Levinson, Approved) 

 

Single Arm Studies for Severe/Critical Illness 

Convalescent Plasma to Treat Coronavirus - Associated Severe Pulmonary Complications: 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 (Merin, Approved) 

This is a single-site, open-label study designed to determine the feasibility of administering convalescent plasma (CP) to patients in the ICU who are intubated and mechanically ventilated due to COVID-19-induced respiratory failure. Screened plasma will be obtained from SARS-CoV-2+ clinically-resolved individuals. The secondary objective is to determine overall survival of patients in the ICU receiving at least once dose of CP for Covid-19-induced respiratory failure. As these patients may be unable to consent given their current state, informed consent will be obtained from the Legally Authorized Representative. Subjects who are more than 72 hours since first meeting inclusion criteria will be excluded from study.

 Dosing of single or double plasma units will be administered on Day 0, Day 3, Day 6, unless PaO2/FiO2 > 300 (or SpO2/FiO2 >315), extubation has occurred, or futility as determined by the ICU or site investigator. All plasma utilized will meet the FDA guidelines for Investigational COVID-19 Convalescent Plasma. Plasma will be collected using apheresis technology or whole blood collection in accordance with standard FDA and blood bank protocols. The approved sample size for the study is 30. The study duration per subject will be up to 60 days after receipt of first dose of study drug.

 No off-label therapies are prohibited (patients may receive concomitant tocilizumab, hydroxychloriquine, azithromycin, remdesivir, Kaletra, statins, interferons, etc.) but patients are not permitted to enroll in more than one clinical trial at the same time. Labs will not be done solely for the purposes of the study. CP administration may be delayed or dose-modified at the clinician’s discretion for any reason, including risk of circulatory overload. Infusion of CP may be halted per treating physician discretion if any of the following manifestations of anaphylaxis develop: Skin or mucous membrane manifestations, respiratory compromise, defined decrease in systolic blood pressure, defined tachycardia or bradycardia.