This expanded access protocol will provide access to the investigational product Zofin for patients in outpatient facilities infected with SARS-CoV-2 who have mild to moderate COVID-19, or who are judged by a healthcare provider to be at high risk of progression to moderate disease.
Provide written informed consent
Subjects age > 18 years at the time of signing the Informed Consent Form.
Male or Female
Must have a clinical diagnosis of COVID-19 by the qualitative reverse-transcription polymerase chain reaction (RT-PCR), with at least one of mild or moderate COVID-19 clinical symptoms which are defined below in #5
Patients who have moderate to severe respiratory distress syndrome due to COVID-19
Be a female who is pregnant, nursing, or of childbearing potential while not practicing effective contraceptive methods. Female subjects must undergo a blood pregnancy test at screening which will be within 72 hours of the IP infusion.
Inability to perform any of the assessments required.
Active listing (or expected future listing) for transplant of any organ.