This Notice of Special Interest encourages cooperative agreement applications for implementation of investigator-initiated high-risk clinical trials, as defined by NIAID in PAR-18-633 and NOT-AI-16-084, that will augment ongoing and planned clinical trials of therapeutic and vaccine candidates directed against SARS-CoV-2 to evaluate:
- SARS-CoV-2 candidate vaccines
- non-vaccine biomedical prevention of SARS-CoV-2 infection and/or COVID-19
- therapeutic approaches to treat COVID-19
Please note, studies evaluating behavioral interventions (e.g., impact of face masks, hand- washing, social distancing) and those focused on disinfecting surfaces and equipment are not responsive and will not be considered for this NOSI initiative.
Investigators interested in responding to this NOSI are strongly encouraged to submit a written request for prior consultation to the email address listed below prior to submission of an NIAID Clinical Trial Implementation (U01) Cooperative Agreement application in response to PAR-18-633 to discuss the proposed project in the context of the needs identified above. This request should be as succinct as possible and include the study title and a brief description of the study and product to be evaluated; study PI; primary institution and potential collaborating sites; industry partners, if applicable; and a cost estimate. As a reminder, per NIH policy, applicants requesting $500,000 or more in direct costs in any year (excluding consortium F&A) must contact NIAID staff listed below no later than 6 weeks before submission and follow the Policy on the Acceptance for Review of Unsolicited Applications that Request $500,000 or More in Direct Costs as described in the SF424 (R&R) Application Guide.