Tuesday, December 1, 2020

Breaking News! Monoclonal Antibody alone and in combination available for covid positive patients

 A patient called me today covid positive and coughing.

“When did you start to feel sick?” I asked innocently
“On November 9th” was the response.
I am proud to say I was calm “ Really? that's Interesting” .
Oh dear, here comes another email I thought to myself.
And so when I decided to write this email today I had not yet read today’s communiqué from the Maryland State department of health. But it is truly a coincidence because it emphasizes why it is important to immediately notify me if you test positive for covid.
We have had a few tools in our toolkit for treating covid-19 as an outpatient but as of today we have an even bigger one.
Get excited! You may be eligible to receive the same Regeneron monoclonal antibody that President Trump received before going to Walter Reed hospital when he discovered he had covid-19.
The bottom line is: I want you to talk with me if you have a positive covid test ASAP.

The sooner, the better chances of success and of keeping you out of the hospital. Why? The hospitals are full, there is not enough room for everyone and you don’t want to be there anyway.
This is the real motivation behind the news that came out from the health department today. The FDA approved an EUA (read my last email if you don’t know what that is) for this antibody treatment. We can now treat high risk individuals with mild to moderate covid-19 cases and keep them out of the hospital and prevent mild cases from worsening.

There are five initial regional infusion locations across the state that have been designated to allow geographic equity distribution for this scarce therapeutic. Future plans for additional subsidiary sites will be based on available supply from the USG. As of today's letter, the five sites include the following:
● Region 1: University of Pittsburgh Medical Center (UPMC) Western Maryland
● Region 2: Meritus Health
● Region 3: Baltimore Convention Center Field Hospital
● Region 4: Tidal Health Peninsula Regional
● Region 5: Adventist HealthCare Takoma Park Alternate Care Site
If I have a patient who may benefit from this COVID-19 therapeutic antibody I can refer the patient to one of these currently available infusion sites.

The FDA authorizes use of the aforementioned investigational mAbs for treatment of high-risk COVID-19 outpatients (ages Version 01 December 1, 2020 ≥12 y/o, weight ≥40 kg) with mild-to-moderate symptoms at risk for progressing to severe disease or hospitalization based on the following criteria:
● Direct SARS-CoV-2 test (e.g., PCR, rapid antigen test) must be positive
● Administered as soon as possible after positive test result and within 10 days of symptom onset
● Provider to review EUA fact sheet, including risks and benefits, with the patient
● Patient/caregiver to be provided with EUA fact sheets
● Administered in a setting where healthcare providers have direct access to medications to manage severe reactions

Please note that these monoclonal antibody infusions: bamlanivimab and Regeneron mAbs 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 comorbidity

High-risk summary definitions are as follows
All Patients (who meet at least 1 of the following criteria):
● BMI ≥35
● Chronic kidney disease
● Diabetes ● Immunosuppressive disease
● Receiving immunosuppressive treatment
● Age ≥ 65 years
● Age ≥ 55 years AND have any of the following: cardiovascular disease, hypertension, COPD/other chronic respiratory disease; are eligible.

Adolescents (age 12-17 years) who meet at least 1 of the following criteria:
● BMI ≥85th percentile for age/gender
● Sickle cell disease
● Congenital or acquired heart disease
● Neurodevelopmental disorders (e.g. cerebral palsy)
● Medical-related technological gastronomy, or positive pressure ventilation (not related to COVID-19)
● Asthma, reactive airway, or other chronic respiratory disease that requires daily medication for control; are also eligible.

The infusion is given into the vien in one of the centers as an outpatient and takes about 60 minutes to infuse. You must be referred by your doctor.
I have summarized the information to try and make it easier to read but for those who would like to know more please read the communiqué from the Maryland state department of health.
Here is the link to the letter:
One of the appendices to the link above is frequently asked questions.

Go Maryland strong, cutting edge!
There may be a light at the end of this long tunnel.

Of course it’s better not to catch covid in the first place (one patient told me on Monday that 9 members of her family got covid, one died on Friday). Do everything you can to avoid catching it, even though it is inconvenient.
But at least now we have something to offer to those who could get a lot sicker.

Information is crucial and that’s why I write these emails. Now you can be treated like a president if you want to (smile).

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