This was March 2020: Highlights • A
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Posted On: 07/17/2022 6:22:21 PM
This was March 2020:
Highlights
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Anti-CCR5 humanized monoclonal antibody restored CD8 counts in COVID patients.
•
Inversely correlated with decreases in plasma viral load (pVL) by day 14.
•
CCL5/RANTES up 3–5-fold in mild/moderate patients and >100-fold in critical ones.
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First report of highly sensitive, quantitative pVL by ddPCR in COVID patients.
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Statistically significant drop in IL-6 by day 14 of treatment.
Abstract
Objective
Infection with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is now a global pandemic. Emerging results indicate a dysregulated immune response. Given the role of CCR5 in immune cell migration and inflammation, we investigated the impact of CCR5 blockade via the CCR5-specific antibody leronlimab on clinical, immunological, and virological parameters in severe COVID-19 patients.
Methods
In March 2020, 10 terminally ill, critical COVID-19 patients received two doses of leronlimab via individual emergency use indication. We analyzed changes in clinical presentation, immune cell populations, inflammation, as well as SARS-CoV-2 plasma viremia before and 14 days after treatment.
Results
Over the 14-day study period, six patients survived, two were extubated, and one discharged. We observed complete CCR5 receptor occupancy in all donors by day 7. Compared with the baseline, we observed a concomitant statistically significant reduction in plasma IL-6, restoration of the CD4/CD8 ratio, and resolution of SARS-CoV2 plasma viremia (pVL). Furthermore, the increase in the CD8 percentage was inversely correlated with the reduction in pVL (r = −0.77, p = 0.0013).
Conclusions
Our study design precludes clinical efficacy inferences but the results implicate CCR5 as a therapeutic target for COVID-19 and they form the basis for ongoing randomized clinical trials.
So how did we end up with the FDA hit piece on Leronlimab that says it does nothing for Covid????
Highlights
•
Anti-CCR5 humanized monoclonal antibody restored CD8 counts in COVID patients.
•
Inversely correlated with decreases in plasma viral load (pVL) by day 14.
•
CCL5/RANTES up 3–5-fold in mild/moderate patients and >100-fold in critical ones.
•
First report of highly sensitive, quantitative pVL by ddPCR in COVID patients.
•
Statistically significant drop in IL-6 by day 14 of treatment.
Abstract
Objective
Infection with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is now a global pandemic. Emerging results indicate a dysregulated immune response. Given the role of CCR5 in immune cell migration and inflammation, we investigated the impact of CCR5 blockade via the CCR5-specific antibody leronlimab on clinical, immunological, and virological parameters in severe COVID-19 patients.
Methods
In March 2020, 10 terminally ill, critical COVID-19 patients received two doses of leronlimab via individual emergency use indication. We analyzed changes in clinical presentation, immune cell populations, inflammation, as well as SARS-CoV-2 plasma viremia before and 14 days after treatment.
Results
Over the 14-day study period, six patients survived, two were extubated, and one discharged. We observed complete CCR5 receptor occupancy in all donors by day 7. Compared with the baseline, we observed a concomitant statistically significant reduction in plasma IL-6, restoration of the CD4/CD8 ratio, and resolution of SARS-CoV2 plasma viremia (pVL). Furthermore, the increase in the CD8 percentage was inversely correlated with the reduction in pVL (r = −0.77, p = 0.0013).
Conclusions
Our study design precludes clinical efficacy inferences but the results implicate CCR5 as a therapeutic target for COVID-19 and they form the basis for ongoing randomized clinical trials.
So how did we end up with the FDA hit piece on Leronlimab that says it does nothing for Covid????
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