Development of Treatments for COVID-19
The pandemic COVID-19, a disease caused by a novel coronavirus, continues to spread worldwide. As of March 23, 334,981 confirmed cases of COVID-19 have been reported worldwide, with 14,652 deaths from the disease (www.who.int), the total number of COVID-19 cases in the United States is 33,404 and total number of deaths is 400 (www.cdc.gov). Currently, there are currently no FDA-approved vaccines or treatments for COVID-19.
The goal of this RPP is to develop prototype countermeasures for the treatment of COVID-19.
- • The expected technology readiness level (TRL) at start of the period of performance (POP) is 3/4 and at the end of the POP is TRL 6 [TRL definitions: https://mtec-sc.org/wp-content/uploads/2016/12/TRL-definitions.pdf]
- • The Offeror is expected to have at the onset a candidate therapeutic with non-clinical data (in vitro, tox, pre-clinical data, etc.) suggesting safety and/or efficacy
- • The Offeror should have demonstrated manufacturing feasibility of the candidate therapeutic
- • Offerors who have had at least one meeting with the FDA to discuss the regulatory strategy for their candidate(s) are preferred
- • Repurposing commercially available, approved products or products in clinical development for related indications with demonstrated safety in humans are preferred
- • Partnering with DoD investigators on pre-clinical testing in animal models is encouraged, where appropriate.
The expected deliverable at the end of the POP is a final technical report to support a Go/No go decision for the product to enter Phase II clinical trials for the treatment of COVID-19. The research project award recipients were selected from the Offerors who responded to MTEC’s Request for Project Proposals (20-09-COVID-19_Treatment_MIDRP).