A Clinical Safety Study on AT-100 in Treating Adults With Severe COVID-19 Infection or Severed Co… (NCT04659122) | Clinical Trial Compass
TerminatedPhase 1
A Clinical Safety Study on AT-100 in Treating Adults With Severe COVID-19 Infection or Severed Community Acquired Pneumonia
Stopped: Termination / study goals reached
United States5 participantsStarted 2021-08-17
Plain-language summary
The purpose of this study is to determine if an investigational drug, AT-100, is safe and tolerated by adults who have severe corona virus disease 2019 (COVID-19) or respiratory failure secondary to severe community acquired pneumonia.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. The subject is an adult ≥18 years of age.
✓. The subject has documented, laboratory-confirmed SARS-CoV-2 infection within 2 weeks prior to enrollment, or meets criteria for severe community acquired pneumonia (CAP) specified in inclusion 3 below.
✓. The subject has severe SARS-CoV-2 infection requiring intubation and mechanical ventilation. Or, the subject is admitted for severe CAP with respiratory failure as demonstrated by the following:
Exclusion criteria
✕. The subject refuses to participate, or the subject's legally authorized representative acting on the subject's behalf refuses the subject's participation.
✕. The subject is pregnant or breastfeeding.
✕. The subject is anticipated to be transferred to another hospital that is not a study site within 36 hours of enrollment.
✕. The subject has received or is receiving extracorporeal membrane oxygenation (ECMO) treatment for COVID-19 or CAP treatment.
✕. The subject has Human Immunodeficiency virus (HIV) under highly active antiretroviral therapy (HAART).
✕. The subject has cancer and is receiving chemotherapy treatment at any time during trial duration, or has received chemotherapy treatment within 30 days of trial enrollment.
✕. The subject has a prior history of lung transplant, lobectomy, or other significant lung surgeries that would indicate an already compromised lung.
What they're measuring
1
Determining the highest-tolerated & safety-tested AT-100 dose
Timeframe: From time of initial AT-100 dosing until the end of the dosing period, up to 7 days