Page 10 of the trial paper Nov. 19th, 2021 on the
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Posted On: 07/15/2025 10:11:15 PM
Page 10 of the trial paper Nov. 19th, 2021 on the website:
To determine the performance of the clinical-grade CCR5 RO assay, we obtained blinded clinical samples from eight participants enrolled in a phase 2, two-arm, randomized, double blind, placebo-controlled study on the effects of Leronlimab treatment in long COVID-19 (ClinicalTrials.gov Identifier: NCT04678830).
Enrolled participants were randomized to receive either weekly 700 mg SC Leronlimab injections or placebo throughout an eight-week study period, with a total of three clinical visits at weeks 0, 4, and 8 after the first Leronlimab initiation.
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" Furthermore, the CCR5 RO
assay correctly identified individuals treated with Leronlimab versus placebo following unblinding, as treated individuals presented at baseline with no CCR5 RO, but then achieved full CCR5 RO on peripheral blood CD4+ T cells at the two follow-up
clinical visits, while placebo-treated participants never presented with CCR5 RO (Figure 5B). In line with the preclinical macaque results, we observed increased frequencies of circulating CCR5+CD4+ T cells following Leronlimab dosing. After Leronlimab initiation, frequencies of CCR5+CD4+ T cells
circulating in the peripheral blood in Leronlimab-treated participants were statistically higher than in untreated participants (Figure 5C). Thus, the longitudinal CD4+ T cell CCR5 RO in Leronlimab-treated participants and lack of measurable CCR5 RO in Leronlimab-untreated participants demonstrates the robustness and sensitivity of the clinical CCR5 RO assay."
Being the design of the CCR5 RO assay was used with 8 LH patients:
1. Test was designed after the Hiv trial of 556
2. We can add Cytodyn also has LL / CD4+ T Cell results on 8 LH patients
To determine the performance of the clinical-grade CCR5 RO assay, we obtained blinded clinical samples from eight participants enrolled in a phase 2, two-arm, randomized, double blind, placebo-controlled study on the effects of Leronlimab treatment in long COVID-19 (ClinicalTrials.gov Identifier: NCT04678830).
Enrolled participants were randomized to receive either weekly 700 mg SC Leronlimab injections or placebo throughout an eight-week study period, with a total of three clinical visits at weeks 0, 4, and 8 after the first Leronlimab initiation.
Continues within ----
" Furthermore, the CCR5 RO
assay correctly identified individuals treated with Leronlimab versus placebo following unblinding, as treated individuals presented at baseline with no CCR5 RO, but then achieved full CCR5 RO on peripheral blood CD4+ T cells at the two follow-up
clinical visits, while placebo-treated participants never presented with CCR5 RO (Figure 5B). In line with the preclinical macaque results, we observed increased frequencies of circulating CCR5+CD4+ T cells following Leronlimab dosing. After Leronlimab initiation, frequencies of CCR5+CD4+ T cells
circulating in the peripheral blood in Leronlimab-treated participants were statistically higher than in untreated participants (Figure 5C). Thus, the longitudinal CD4+ T cell CCR5 RO in Leronlimab-treated participants and lack of measurable CCR5 RO in Leronlimab-untreated participants demonstrates the robustness and sensitivity of the clinical CCR5 RO assay."
Being the design of the CCR5 RO assay was used with 8 LH patients:
1. Test was designed after the Hiv trial of 556
2. We can add Cytodyn also has LL / CD4+ T Cell results on 8 LH patients
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