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Wednesday, September 30, 2020 1:58:23 PM
https://www.revivethera.com/2020/09/revive-therapeutics-announces-irb-approval-of-us-expanded-access-treatment-program-compassionate-use-for-bucillamine-in-covid-19/
Expanded Access Protocol (“EAP”) for compassionate use of Bucillamine.
"“The EAP serves as an option for patients that are not eligible for inclusion criteria in our Phase 3 clinical study in COVID-19 and the resulting data from the EAP will be valuable in supporting our clinical development of Bucillamine.”
"About the Expanded Access Study
The expanded access study is titled, “Multi-Center, Open-Label, Expanded Access Study of Bucillamine in Hospitalized Patients with Severe COVID-19 (EA-ARISE)”. Patients will receive Bucillamine 200 mg orally, 3 times a day (TID), for up to 14 days. The objective is to monitor the safety and efficacy of Bucillamine (600 mg/day) and any clinical symptoms when administered up to 14 days in hospitalized patients with severe COVID-19. Following completion of the treatment course, follow up safety assessments will be performed by a study nurse 14 and 42 days following the end of treatment."
Even so, I am not sure that has much bearing on our clinical trial. As severe cases will be discontinued.
If the patient requires hospitalization during the study period, treatment will be discontinued.
https://clinicaltrials.gov/ct2/show/NCT04504734
I am hoping the trial goes well and Bucillamine will be administered for severe cases as well. But first things first...
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