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A monoclonal antibody given to patients with mild COVID-19 reduced symptom severity and the odds of needing hospitalization.

About 10 days ago the hospital where I work started giving intravenous antibodies to COVID-19 patients in the emergency department. These are folks with COVID-19 symptoms and a positive COVID PCR test within the last three days but they’re not sick enough to warrant admission. My impression is that the infusion is monoclonal antibodies, different from the convalescent plasma we were offering to inpatients several months ago.

The antibody used in the study at hand is “LY-CoV555 (also known as LY3819253), a potent antispike neutralizing monoclonal antibody that binds with high affinity to the receptor-binding domain of SARS-CoV-2,” and “was derived from convalescent plasma obtained from a patient with Covid-19.” I assume scientists figured out a way to synthesize that antibody in a lab.

Click on Abstract for full details.

Abstract

BACKGROUND

Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) causes coronavirus disease 2019 (Covid-19), which is most frequently mild yet can be severe and life-threatening. Virus-neutralizing monoclonal antibodies are predicted to reduce viral load, ameliorate symptoms, and prevent hospitalization.

This was a very small study; only a little over a hundred patients in each of three treatment groups (three different doses) and the placebo group.

METHODS

In this ongoing phase 2 trial involving outpatients with recently diagnosed mild or moderate Covid-19, we randomly assigned 452 patients to receive a single intravenous infusion of neutralizing antibody LY-CoV555 in one of three doses (700 mg, 2800 mg, or 7000 mg) or placebo and evaluated the quantitative virologic end points and clinical outcomes. The primary outcome was the change from baseline in the viral load at day 11. The results of a preplanned interim analysis as of September 5, 2020, are reported here.

RESULTS

At the time of the interim analysis, the observed mean decrease from baseline in the log viral load for the entire population was −3.81, for an elimination of more than 99.97% of viral RNA. For patients who received the 2800-mg dose of LY-CoV555, the difference from placebo in the decrease from baseline was −0.53 (95% confidence interval [CI], −0.98 to −0.08; P=0.02), for a viral load that was lower by a factor of 3.4. Smaller differences from placebo in the change from baseline were observed among the patients who received the 700-mg dose (−0.20; 95% CI, −0.66 to 0.25; P=0.38) or the 7000-mg dose (0.09; 95% CI, −0.37 to 0.55; P=0.70). On days 2 to 6, the patients who received LY-CoV555 had a slightly lower severity of symptoms than those who received placebo. The percentage of patients who had a Covid-19–related hospitalization or visit to an emergency department was 1.6% in the LY-CoV555 group and 6.3% in the placebo group.

CONCLUSIONS

In this interim analysis of a phase 2 trial, one of three doses of neutralizing antibody LY-CoV555 appeared to accelerate the natural decline in viral load over time, whereas the other doses had not by day 11. (Funded by Eli Lilly; BLAZE-1 ClinicalTrials.gov number, NCT04427501. opens in new tab

Another study looked at the use of a cocktail containing two monoclonal antibodies in non-hospitalized patients. Researchers concluded:

In this interim analysis, the REGN-COV2 antibody cocktail reduced viral load, with a greater effect in patients whose immune response had not yet been initiated or who had a high viral load at baseline. Safety outcomes were similar in the combined REGN-COV2 dose groups and the placebo group. (Funded by Regeneron Pharmaceuticals and the Biomedical and Advanced Research and Development Authority of the Department of Health and Human Services; ClinicalTrials.gov number, NCT04425629. opens in new tab.)

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Their report indicated that those who received the antibodies were less likely to need subsequent medical visits. But they didn’t put that in their concluding paragraph so I will assume it didn’t reach statistical significance.

Neither of these studies reported reduction in death rates.

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Obesity, particularly BMI 35 or higher, is risk factor for serious COVID-19 disease. If obese, you’ve had almost a year to work on it. How ya doin’? I can help if needed. See the book below.

Steve Parker, M.D.

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Melatonin is a commonly-available over-the-counter sleep aid. In 2020, the Cleveland Clinic did epidemiological study that linked melatonin usage with a 30% reduced risk of contracting COVID-19. Clinical psychologist Michael J Breus, Ph D has an article at Psychology Today on the use of melatonin as a preventative or treatment for COVID-19.

Melatonin, of course, is best known as a sleep regulator. But melatonin also plays an important role in regulating the immune system. One way it does so is by influencing the production of small proteins known as cytokines, which act as signalers from the immune system to cells around the body. Cytokines can be inflammation producing (pro-inflammatory cytokines) or inflammation restricting (anti-inflammatory cytokines). Melatonin has been shown to reduce the production of pro-inflammatory cytokines. Melatonin also is well known to be an antioxidant, neutralizing free radical cells and limiting oxidative stress and damage, which contribute inflammation.

Pro-inflammatory cytokines serve an important purpose, in marshaling the inflammatory response that fights off viruses, bacteria, and other pathogens. That’s the protective mechanism of inflammation at work. But for the pro-inflammatory cytokine response to be beneficial, it must be proportional to the threat. A too vigorous response of pro-inflammatory cytokines creates a dangerous amount of inflammation—and can actually serve to spread the viral infection, rather than tamping it down. It is this inflammatory overreaction and viral spread that appears to take place in the most serious cases of COVID-19.

I spent 10 minutes on the Internet trying to find the appropriate dose of melatonin for its possible preventative and treatment powers. But no luck. It’s likely in the range of 1 to 10 mg/day, typically taken at night or bedtime. For insomnia in my hospitalized patients, I start at 1.5 mg. Most of my colleagues use a much higher dose. Dr Josh Farkas at emcrit.org suggests that the treatment dose is 5 mg/day.

As always, check with your personal physician first.

Steve Parker, M.D.

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