The COVID-19 Treatment Guidelines Panel’s Statement on the Emergency Use Authorization of Bamlanivimab for the Treatment of COVID-19

National Institute of Health ^ | November 18, 2020 | Anonymous

[ProtectOurFreedom]

Bamlanivimab (also known as LY-CoV555 and LY3819253) is a neutralizing monoclonal antibody that targets the receptor-binding domain of the spike protein of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Because this drug may block SARS-CoV-2 entry into host cells, it is being evaluated for the treatment of COVID-19.

On November 9, 2020, FDA issued an Emergency Use Authorization (EUA) to make bamlanivimab available for the treatment of nonhospitalized patients with mild to moderate COVID-19 who are at high risk for progressing to severe disease and/or hospitalization.

• At this time, there are insufficient data to recommend either for or against the use of bamlanivimab for the treatment of outpatients with mild to moderate COVID-19.
• Bamlanivimab should not be considered the standard of care for the treatment of patients with COVID-19.
• An interim analysis of the BLAZE-1 study, a Phase 2, randomized, placebo-controlled trial, suggested a potential clinical benefit of bamlanivimab for outpatients with mild to moderate COVID-19. However, the relatively small number of participants and the low number of hospitalizations or emergency department visits make it difficult to draw definitive conclusions about the clinical benefit of bamlanivimab.
• More data are needed to assess the impact of bamlanivimab on the disease course of COVID-19 and to identify those people who are most likely to benefit from the drug. Health care providers are encouraged to discuss participation in bamlanivimab clinical trials with their patients.
• Patients who are hospitalized for COVID-19 should not receive bamlanivimab outside of a clinical trial.

[ProtectOurFreedom]

I didn't see anything on FR about the use of Bamlanivimab in treating COVID or the EUA by the FDA on November 9. More from NIH follows. Unfortunately, I didn't see anything dealing with the Standard of Care treatment protocol used in conjunction with Bamlanivimab (i.e., nothing about combined therapy with zinc, steroids, antibiotics, Ivermectin, Vit C, Vit D, famotidine, melatonin, et al).

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Clinical Trial Data

The Blocking Viral Attachment and Cell Entry with SARS-CoV-2 Neutralizing Antibodies (BLAZE-1) trial is a randomized, double-blind, placebo-controlled, Phase 2 trial conducted at 41 centers in the United States to evaluate the safety and efficacy of bamlanivimab for the treatment of mild to moderate COVID-19 in an outpatient setting. Participants received a single intravenous infusion of bamlanivimab within 3 days of having a positive SARS-CoV-2 virologic test result. Participants were excluded if they had a saturation of oxygen (SpO2) ≤93% on room air, respiratory rate ≥30 breaths/minute, or heart rate ≥125 beats/minute. According to a published interim analysis of the trial, a total of 452 participants were randomized to receive one of three doses of bamlanivimab (700 mg, 2,800 mg, or 7,000 mg) or placebo.

Among the study participants, the median age was 45 years (range: 18–86 years) in the pooled bamlanivimab groups and 46 years (range: 18–77 years) in the placebo group. Although 69.6% (215/309) of the participants in the bamlanivimab groups and 66.4% (95/143) in the placebo group reportedly had risk factors for severe COVID-19, the study population included only a small percentage of participants aged >65 years (10.7% [33/309] in the bamlanivimab groups vs. 14.0% [20/143] in the placebo group). The median time from symptom onset to infusion of bamlanivimab or placebo was 4 days across the groups.

The mean decrease in nasopharyngeal SARS-CoV-2 level from baseline to Day 11 (the primary endpoint) was significantly greater among participants who received the 2,800 mg dose of bamlanivimab than among the placebo-treated participants. The decline in viral load was not significantly different between those who received the 700 mg or 7,000 mg dose of bamlanivimab and those who received placebo.

In a post hoc analysis of participants at high-risk for progression to severe COVID-19 (defined as aged ≥65 years or having a body mass index [BMI] ≥35), four of 95 participants (4.2%) in the combined bamlanivimab arms versus seven of 48 (14.6%) participants in the placebo group were hospitalized or had emergency department visits.

[Pollard]

hcq or ivermectin, zinc and an antibiotic

[ProtectOurFreedom]

There are LOTS of existing drugs waiting to be evaluated. The HCQ or Ivermectin based protocols are not the final say.

[EarlyBird]

Great news!

But who in the hell names these drugs?

I’m supposed to remember the name of this drug when I’m talking to my doctor? Can I have the Bam Bam thank you Ma’am drug, please doc?

[gas_dr]

Anything that ends -mab is considered a biologic and autoimmune therapy. Hence the reason for this study is that this class of drug will decrease interleukins that are circulating and thought to contribute to SARS secondary to autoimmune attack of the lungs (some call this this cytokine storm).