We changed our trial to allow Elmo and vent patien
Post# of 155038
(Total Views: 500)
Posted On: 11/24/2020 6:04:20 PM
We changed our trial to allow Elmo and vent patients mid stream . Will it hurt us ??
The SAC-COVID Phase III clinical trial is randomized, placebo-controlled and blinded to participants, the clinical teams, the investigators, and the Sponsor. Hospitalized COVID-19 patients who required oxygen support, including those requiring supplemental oxygen, high flow oxygen, and non-invasive ventilation were randomly assigned into two arms receiving either SOC plus a single dose of SACCOVIDTM or SOC plus placebo. The trial had a planned enrollment of 270 patients. The pre-specified interim efficacy and safety analyses were performed when 146 patients achieved clinical recovery from COVID-19, a milestone achieved with 203 enrollments. The trial was opened in April this year and was activated in 15 medical centers in the US.
The SAC-COVID Phase III clinical trial is randomized, placebo-controlled and blinded to participants, the clinical teams, the investigators, and the Sponsor. Hospitalized COVID-19 patients who required oxygen support, including those requiring supplemental oxygen, high flow oxygen, and non-invasive ventilation were randomly assigned into two arms receiving either SOC plus a single dose of SACCOVIDTM or SOC plus placebo. The trial had a planned enrollment of 270 patients. The pre-specified interim efficacy and safety analyses were performed when 146 patients achieved clinical recovery from COVID-19, a milestone achieved with 203 enrollments. The trial was opened in April this year and was activated in 15 medical centers in the US.
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