Accelerated development and clinical evaluation of immunotherapies for SARS-CoV-2/COVID-19
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Key facts
Disease
COVID-19Principal Investigator
Professor Anthony KelleherResearch Location
AustraliaLead Research Institution
UNSW SydneyResearch Priority Alignment
N/A
Research Category
Pathogen: natural history, transmission and diagnostics
Research Subcategory
Diagnostics
Special Interest Tags
N/A
Study Type
Clinical
Clinical Trial Details
Clinical Trial, Phase II
Broad Policy Alignment
Pending
Age Group
Unspecified
Vulnerable Population
Unspecified
Occupations of Interest
Unspecified
Abstract
1) Laboratory: Establishment and support for critical PC3 laboratory infrastructure to take at least two complementary, immunotherapies, that can be rapidly scaled up, from bench to bedside through development of a suite of vital viral assays for assessing in vitro efficacy of candidate approaches including: developing hyperimmune Ig; neutralising monoclonal antibodies with the Garvan; and thereafter small molecule inhibitors of SARS-CoV-2 from UNSW collaborators. 2) Clinical: Establishment of clinical trial capacity to design, develop and conduct early phase and Phase 2a/b and 3 clinical trials of leading approaches through both local and international networks such as INSIGHT. Outcomes: Completed Phase 1b/2a trial of Hyperimmune Ig by Oct 2020, commence phase 2B/3 trial by Jan 2021 Identification of lead monoclonal antibody and preparation of clinical grade batch for clinical trial by Dec 2020, Commence Phase 1a trial Jan 2021 Provide a platform for rapid PC3 in vitro screening of lead antiviral candidates: e.g. si/shRNAs, and other small molecules from across campus