Expanded Access

 

Study & PI
Summary
Expanded Access to Convalescent Plasma for the Treatment of Patients with COVID-19

PI: Christian Merlo
This umbrella expanded access protocol provides access to investigational convalescent plasma for patients with a laboratory confirmed diagnosis of SARS-CoV-2 infection who have or are at high risk for progression to severe or life-threatening disease. Safety information will be collected, as will patient demographics and data associated with the utilization of acute care facility resources.
Compassionate Use of Remdesivir for the Treatment of SARS-CoV-2 COVID-19

PI: David Berman
When approved by the FDA in individual single patient compassionate use applications, this umbrella protocol can provide pediatric patients with access to remdesivir for the treatment of COVID-19.
Compassionate Use of Remdesivir for the Treatment of SARS-CoV-2 COVID-19 in Pregnancy

PI: Jeanne Sheffield
This umbrella protocol will be used when submitting an expanded access single patient IND to the FDA to treat hospitalized pregnant women with a 10-day course of the anti-viral drug remdesivir (200mg IV loading dose, followed by 100mg IV for days 2-10). Baseline clinical and laboratory information is collected and then assessed daily while the patient is hospitalized. Subjects will also be assessed for obstetric and neonatal complications.