Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV), a public-private partnership, will start its first trials in June on repurposed immune-modulators and anticoagulants.
In July, two separate trials of monoclonal antibodies (mAbs) will be launched in hospitalized and outpatient COVID-19 patients.
ACTIV, which is led by NIH and managed by the Foundation for NIH, includes 18 biopharma companies, FDA, CDC and the HHS Office of the Assistant Secretary for Preparedness and Response (ASPR). BARDA, the U.S. biodefense preparedness funding agency, is part of ASPR (see “Collaborating to Clobber COVID-19”).
ACTIV is working in parallel with Operation Warp Speed, the U.S. government program that is accelerating the development, manufacturing, procurement and deployment of drugs, vaccines and diagnostics to combat COVID-19.
The scale and urgency of the COVID-19 pandemic are pushing government and industry to collaborate more intensively than has ever been previously attempted.
ACTIV has operated at extraordinary speed, with government officials and corporate scientists collaborating seamlessly, individuals involved in the initiative told BioCentury.
Biopharma executives who are not involved in the effort, however, have complained that it has not been transparent about the criteria for selecting agents to study or its selections.
ACTIV has not publicly disclosed which agents it has selected to test, the timing of its trials, or when readouts can be expected. The documents BioCentury obtained identify classes, but not the specific agents, the consortium plans to test. First wave of therapies selected
ACTIV has created a process for prioritizing clinical agents for rapid testing and culled through hundreds of agents, including agents submitted by investigators and in surveys conducted by the consortium, as well as from public databases, including databases collated by BioCentury (see BioCentury Coronavirus Resource Center).
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