COVID Treatment Advances

[Chocaholic]

Somehow I don’t think any schmuck with a brand new positive nasal swab is getting a Regen infusion. Yet any schmuck can get all the jabs he wants even if he already has antibodies. Heck, no reason to even check first. Free jabs for all!

But test positive and catch it early...go home, lock yourself in a room, take aspirin and Vitamin D until you’re too sick to breathe.

Does anyone else detect a slight difference between vaccine and treatment protocols?

[sc_rufctr]

It looks like the last posts aren't showing up in the forum list...

[Sooner or later]

https://www.wthr.com/article/news/health/coronavirus/regulators-approve-extended-emergency-use-of-eli-lillys-covid-19-treatment-coronavirus-indianapolis-indiana-remdesivir/531-888b0298-b94b-4bd3-bf90-0bb6afa76853

INDIANAPOLIS — The U.S. Food and Drug Administration (FDA) has broadened the Emergency Use Authorization for Eli Lilly's anti-inflammatory drug baricitinib used to treat COVID-19.

The treatment can now be used on its own, when previously it had to be used in conjunction with remdesivir. Previously, the FDA said the drug combination appeared to reduce recovery time in hospitalized patients, compared to patients who received only remdesivir.

The expanded Emergency Use Authorization allows baricitinib to be used for treatment of COVID-19 in hospitalized adults and pediatric patients 2 years of age or older requiring supplemental oxygen, non-invasive or invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO).

“Baricitinib in combination with remdesivir has already provided many people with a treatment option that could help prevent progression to ventilation or death and increase recovery speed for certain hospitalized patients with COVID-19 under its currently authorized use,” said Ilya Yuffa, senior vice president and president of Lilly Bio-Medicines. “Today’s FDA action provides physicians additional treatment regimen options for baricitinib to continue to meet the urgent medical needs posed by this pandemic. Based on the increasing body of evidence, we are confident in the potential of baricitinib as an important treatment for the hospitalized COVID-19 patient populati…

[Chocaholic]

“Hospitalized adults requiring supplemental oxygen…”

May be used for treatment of COVID-19 in hospitalized adults and pediatric patients 2 years of age or older requiring supplemental oxygen, non-invasive or invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO).

That would be the guy I described above. Was told to stay home until he can’t breathe.

Amazing progress.

[Rawknees'Turbo]

All of the Pelican subforums are totally jacked for me, Aussie Orange, on both PC and phone.

[Racerbvd]

[SCadaddle]

Neighbor down the street works in the lab at the major catholic hospital in Jackson MS. I call him "Blood" i.e. "Hey Blood, whats up?" He says they've been using something called "Bam" and are seeing really good results. Must be Bamlanivimab.

[nota]

byron

the smell is from very small light molecules CH4 ATOMIC WEIGHT 16
vs a virus atomic weight a few MILLION OR MORE

so yes they are very different in size

https://www.drugtargetreview.com/news/56325/researchers-map-vital-atomic-scale-protein-on-covid-19/

https://www.forbes.com/sites/jamesconca/2020/04/14/scientist-takes-magnetic-aim-at-the-coronavirus-at-the-pacific-northwest-national-laboratory/?sh=6ca6c2745bc3

[island911]

You think that CH4 is the only thing in farts passing thru? oh nota...

How many times bigger is visible smoke? - compared to the invisible China Virus? ...you know, that China Virus so small that visible spectrum is too big to light it up? ...need an electron microscope...

[cstreit]

BTW did we run out of medication names?

Anakinra
Baricitinib
Ruxolitinib
Tofacitinib
Acalabrutinib

Its like they just shook up the boggle jar and took whatever came out.

[Chocaholic]

Don’t forget Wastamoneynib.

[pmax]

Originally Posted by Chocaholic

Somehow I don’t think any schmuck with a brand new positive nasal swab is getting a Regen infusion. Yet any schmuck can get all the jabs he wants even if he already has antibodies. Heck, no reason to even check first. Free jabs for all!

But test positive and catch it early...go home, lock yourself in a room, take aspirin and Vitamin D until you’re too sick to breathe.

Does anyone else detect a slight difference between vaccine and treatment protocols?

https://www.fda.gov/drugs/drug-safety-and-availability/fda-authorizes-regen-cov-monoclonal-antibody-therapy-post-exposure-prophylaxis-prevention-covid-19

FDA authorizes REGEN-COV monoclonal antibody therapy for post-exposure prophylaxis (prevention) for COVID-19

REGEN-COV should only be used as post-exposure prophylaxis for individuals who are:

not fully vaccinated or who are not expected to mount an adequate immune response to complete SARS-CoV-2 vaccination (for example, people with immunocompromising conditions, including those taking immunosuppressive medications), and
have been exposed to an individual infected with SARS-CoV-2 consistent with close contact criteria per Centers for Disease Control and Prevention (CDC), or
who are at high risk of exposure to an individual infected with SARS-CoV-2 because of occurrence of SARS-CoV-2 infection in other individuals in the same institutional setting (for example, nursing homes or prisons)

The primary data supporting the EUA reissuance for post-exposure prophylaxis of COVID-19 are from a Phase 3 trial. The trial was a randomized, double-blind, placebo-controlled clinical trial studying a single dose of REGEN-COV for prevention of COVID-19 in household contacts of individuals infected with SARS-CoV-2. Cases were confirmed using real-time reverse transcription–polymerase chain reaction (RT-PCR), one of the most accurate laboratory methods for detecting, tracking, and studying COVID-19. An 81% reduction in confirmed symptomatic COVID-19 cases was observed with REGEN-COV compared to placebo at day 29 in cases who were RT-PCR negative and seronegative at baseline (the primary analysis population). In the overall trial population, there was a 62% reduction in RT-PCR confirmed symptomatic COVID-19 cases in the REGEN-COV group compared to placebo at day 29.

... the Phase 3 trial results from Apr.

So yes.

[Sooner or later]

Originally Posted by pmax

https://www.fda.gov/drugs/drug-safety-and-availability/fda-authorizes-regen-cov-monoclonal-antibody-therapy-post-exposure-prophylaxis-prevention-covid-19

FDA authorizes REGEN-COV monoclonal antibody therapy for post-exposure prophylaxis (prevention) for COVID-19


... the Phase 3 trial results from Apr.

So yes.

Prophylaxis with REGEN-COV is not a substitute for vaccination against COVID-19

For post-exposure prophylaxis, either intravenous infusion or subcutaneous injection is appropriate. For individuals who remain at high risk of exposure to another individual with SARS-CoV-2 for longer than 4 weeks, and who are not expected to mount an adequate immune response to full SARS-CoV-2 vaccination, following an initial dose of 600 mg of casirivimab and 600 mg of imdevimab, repeat doses of 300 mg of casirivimab and 300 mg of imdevimab once every 4 weeks are appropriate for the duration of ongoing exposure.

[Sooner or later]

The development and manufacturing of REGEN-COV have been funded in part with federal funds from the Biomedical Advanced Research and Development Authority (BARDA), part of the U.S. Department of Health and Human Services' Office of the Assistant Secretary for Preparedness and Response, under OT number: HHSO100201700020C.

REGEN-COV Supply Update
The U.S. government will purchase all REGEN-COV doses delivered by June 30, 2021 and may accept additional doses through September 30, 2021 at its discretion, up to a maximum amount of 1.25 million doses. Regeneron expects to deliver at least 1 million REGEN-COV doses to the U.S. government in the second quarter. The specific quantity of doses delivered will be impacted by the timeliness of manufacturing operations.

REGEN-COV can be administered by IV infusion (as short as 20 minutes) or by SC injection (four injections), which is an alternative when IV infusion is not feasible and would lead to a delay in treatment

[Chocaholic]

So, anyone “not-fully-vaccinated”…may walk into a hospital and demand a Regen infusion following an asymptomatic positive nasal swab. Correct?

Is “not-fully-vaccinated” clearly defined? Since no one knows (or is telling) how long vaccine immunity lasts, at what point does one become not fully vaccinated?

[Sooner or later]

Originally Posted by Chocaholic

So, anyone “not-fully-vaccinated”…may walk into a hospital and demand a Regen infusion following an asymptomatic positive nasal swab. Correct?

Is “not-fully-vaccinated” clearly defined? Since no one knows (or is telling) how long vaccine immunity lasts, at what point does one become not fully vaccinated?

authorizing REGEN-COV for emergency use as post-exposure prophylaxis (prevention) for COVID-19 in adults and pediatric individuals (12 years of age and older weighing at least 40 kg) who are at high risk for progression to severe COVID-19, including hospitalization or death.

REGEN-COV also remains authorized for the treatment of mild-to-moderate COVID-19 in adults and pediatric patients (12 years of age and older weighing at least 40 kg) with positive results of direct SARS-CoV-2 viral testing, and who are at high risk for progression to severe COVID-19, including hospitalization or death.

[Chocaholic]

REGEN-COV should only be used as post-exposure prophylaxis for individuals who are:

not fully vaccinated or who are not expected to mount an adequate immune response to complete SARS-CoV-2 vaccination (for example, people with immunocompromising conditions,

See the bold above. And your point is exactly mine. After all this time, all the $$$$$ spent we have a vaccine of unconfirmed usefulness and still absolutely nothing anyone can do who is diagnosed with CV19 early.

[Sooner or later]

Did not miss it. It clearly states you must be at high risk.

You ain't gonna go into a hospital and demand a specific treatment and expect to get that treatment.

[Sooner or later]

Pfizer

https://www.fool.com/investing/2021/08/03/this-could-be-pfizers-next-covid-blockbuster-and-i/
This Could Be Pfizer's Next COVID Blockbuster -- and It Isn't a Vaccine

https://clinicaltrials.gov/ct2/show/NCT04960202
Brief Summary:
The purpose of this study is to determine whether PF-07321332/ritonavir is safe and effective for the treatment of adults who are ill with COVID-19 and do not need to be in the hospital, but are at an increased risk of developing severe illness. Throughout the study period, provision will be made to allow study visits to be conducted at a participant's home or another non-clinic location if available. The total study duration is up to 24 weeks.

[Sooner or later]

I don't believe this has been mentioned.
Lilly

https://www.wishtv.com/news/medical/lilly-coronavirus-treatment-offers-powerful-defense-against-virus-complications/

Aug 2nd, 2021
Scientists at Eli Lilly and Company have been investigating one particular drug they say is a powerful defense against virus complications. And now they have the research to back it up.

The drug is called baricitinib. It was originally designed to fight inflammation associated with rheumatoid arthritis. Lilly scientists have since re-purposed the drug and are using it to combat the inflammation-related complications of COVID-19.

Initially, they researched a combination treatment of baricitinib with the antiviral drug remdesivir in over 1,000 hospitalized patients. Findings showed the combination significantly reduced the number of days to hospital discharge compared to the control group. Now, they’ve found baricitinib can successfully reduce coronavirus-related inflammation without remedesivir.

“Most complications of patients in the hospital are from inflammation,” Dr. Ana Cardoso, a scientist at Lilly, said. “Inflammation is driving this virus. It’s what the body does in response [to infection]. That leads to complications and unfortunately deaths. So the motivation behind using baricitinib is [to target] hyperinflammation and reduce disease.”

Baricitinib reduced the risk of death by 39% in patients requiring supplemental oxygen and ventilators. The drug is now under emergency use authorization as a stand-alone treatment for adults and pediatric patients over two years old.

“Baricitinib in combination with remdesivir has already provided many people with a treatment option that could help prevent progression to ventilation or death and increase recovery speed for certain hospitalized patients with COVID-19 under it’s currently authorized use,” Ilya Yuffa, senior vice president and president of Lilly Bio-Medicines, said in a news release. “[The] FDA’s action provides physicians additional treatment regimen options for baricitinib to continue to meet the urgent medical need posed by this pandemic.”

Cardoso says Lilly has been in communication with the FDA. The two are currently in discussions about a path to full approval.