we have been thru hell today- after getting approved for the antibody therapy spouse and I were told Thursday. The infusion center then called and said if we wanted to get today to go to emergency. So we go to emergency and they say they will do it. We go back and they do a bunch of tests and because as soo as we got there they automatically put us on oxygen (my oxygen levels ranging between 92 to 94) spouse was 90. The doctor then comes in and says no according to FDA they cannot give it because we have hypoxia and would have had to be 95. THIS IS WHAT I’M DEALING WITH.
— terart, 2021/07/14
both my mom and dad were put into icu. they could not get the therapy. they both have covid pneumonia. my dad was put on a ventilator. and my mom they are trying to get her oxygen levels fixed and under control. she is scared.
— terart's daughter, 2021/07/18
I seriously feel uncomfortable responding to this specific example but here’s the guidance on monoclonals that medical staff have to follow. monoclonals have a tight window. If the parameters aren’t met, i.e., progresssed to severe, then in-hospital treatments are probably best:
“Given the sustained increase in variants resistant to bamlanivimab alone and bamlanivimab/etesevimab, the Assistant Secretary for Preparedness and Response (ASPR) within the U.S. Department of Health and Human Services (HHS) stopped the distribution of both products to California.
The FDA recommends that health care providers in California instead use casirivimab plus imdevimab (i.e., REGEN-COV) therapy until further notice.”
“Monoclonal antibody treatments are not authorized for use in patients who are hospitalized due to COVID-19 OR who require oxygen therapy due to COVID-19 OR who require an increase in baseline oxygen flow rate due to COVID-19 in those on chronic oxygen therapy due to underlying non-COVID-19 related morbidity.”
Can a patient who is asymptomatic receive this treatment?
No
Can a patient without positive results from direct SARS-CoV-2 viral testing receive this treatment?
No
Can a patient who is hospitalized due to COVID-19 receive this treatment?
No
Can a patient requiring oxygen therapy due to COVID-19 receive this treatment?
No