COVID-19 Update #44 for 10/7/2020

COVID-19 Vaccines
 
The EMA has started a rolling review of AstraZeneca’s COVID-19 vaccine with early non-clinical data, while the FDA still has a hold in place for the U.S. Phase III trial.
 
The EMA has also started a rolling review of BioNTech’s and Pfizer’s  COVID-19 vaccine with early non-clinical data, a few days after initiating the rolling review for AstraZeneca’s vaccine.
 
 The National Academies of Sciences, Engineering, and Medicine have made recommendations to NIH regarding the distribution of a COVID-19 vaccine (s), when one or more are available.

• Phase 1a - healthcare workers and first responders 
• Phase 1b – high risk patients (two or more comorbid conditions) and older adults in overcrowded settings
• Phase 2 - teachers, school staff, and daycare workers; critical workers in high-risk settings; moderately risk patients; people in homeless shelters, group homes, prisons and their staff; and unvaccinated older adults 
• Phase 3 - young adults, children, essential workers at increased risk, not already immunized
• Phase 4 – all other patients

COVID-19 Monoclonal Antibodies
 
VIR and GSK announced the initiation of the 1,300 patient, Phase III portion of the COMET-ICE trial to evaluate whether VIR-7831 prevents mild or moderate COVID-19 patients from worsening as indicated by an increase in hospitalizations or death.
 
CPI-006
 
CPI-006 is a monoclonal antibody for CD73 that activates lymphocytes, induces the production of antigen-specific immunoglobulin from B cells and increases production of CD4+ and CD8+ cells. CPI-006 is being developed by Corvus Pharmaceuticals as a cancer treatment.

• Corvus is evaluating a single dose of CPI-006 as a treatment of mild to moderate COVID-19, in a 30 patient, Phase I, dose-ranging trial (NCT03454451).
  • An unpublished report describes how CPI-006 induced a rise in anti-SARS-CoV-2 antibodies at 7-days that continued to increase through day 56 in 10 patients. 
  • Corvus announced data from 15 patients in the study that supported an increase in anti-SARS-CoV-2 antibodies through day 56 and an increase in B cell activation.

Lopinavir-Ritonavir
 
The 11,000 patient RECOVERY trial has several arms testing lopinavir-ritonavir, dexamethasone, hydroxychloroquine, azithromycin, tocilizumab, REGN-COV2 and convalescent plasma. In the lopinavir-ritonavir arm of the RECOVERY trial (NCT04381936), 1,616 patients that received lopinavir-ritonavir were compared to 3,424 patients that received only usual care. Lopinavir-ritonavir did not improve mortality at 28-days compared to usual care (23% vs 22%), nor did the drugs decrease the duration of hospital stay, or the risk of progressing to invasive mechanical ventilation.