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Congressionally Directed Medical Research Programs (CDMRP) -- Peer Reviewed Medical Research Program (PRMRP) -- Clinical Trial Award for Emerging Viral Diseases and Respiratory Health
The PRMRP Clinical Trial Award supports the rapid implementation of clinical trials with the potential to have a significant impact in one or more of the Focus Areas published in this funding opportunity for the FY20 PRMRP Congressionally specified Topic Areas of Emerging Viral Diseases and Respiratory Health. Clinical trials may be designed to evaluate promising new products, pharmacologic agents (drugs or biologics), devices, clinical guidance, and/or emerging approaches and technologies. Proposed projects may range from small proofof-concept trials (e.g., pilot, first in human, Phase 0), to demonstrate feasibility or inform the design of more advanced trials, through large-scale trials to determine efficacy in relevant patient populations.
• Required Pre-Application Deadline: June 8, 2020
• Application Submission Deadline: June 22, 2020
Areas of Interest
Emerging Viral Diseases • On demand identification, isolation, characterization and manufacturing of antibodies (monoclonal or polyclonal) from peripheral blood mononuclear cells (PBMCs) collected from patients with coronavirus disease 2019 (COVID-19). • Development of a wearable sensor that provides real-time diagnostics that can be used as a point of care for emerging viral diseases to predict illness before onset of symptoms. The diagnostic platform should be applicable to COVID-19. Virus-specific markers that can identify viruses at the genus level can be included, with an emphasis on SARS-CoV-2, the virus that causes COVID-19. • Surveillance and predictive modeling tools that leverage artificial intelligence approaches to predict outbreaks and epidemics and support strategies for mitigating the threat of COVID-19. • Triage of care for COVID-19 patients requiring access to resource-intensive interventions. • Research to understand novel molecular and biological mechanisms of COVID-19 health impacts (e.g., microbiome) and identification/validation of biochemical, physiological, or combined biomarkers for evaluating short- and long-term health impacts from COVID-19. • Research to determine direct and indirect impacts of COVID-19 on military readiness and unit climate; interpersonal/family dynamics; behavioral and mental health issues such as depression, suicide, anxiety, and loneliness and other key risk factors such as substance abuse and risky health-related behaviors. The aim of such research should be to inform, develop, and test potential behavioral countermeasures (e.g., knowledge and information products, preparedness training, support resources, self-care and team-care recommendations) to mitigate negative impacts and maximize Service member and family readiness/resilience to stressors related to pandemics and disasters.
Respiratory Health • Research on the etiology and prevention of acute respiratory distress syndrome (ARDS) caused by host responses to coronaviruses, particularly COVID-19. • Development of improved methods for assessing and treating lung injury due to coronaviruses, particularly COVID-19. • Novel and/or innovative detection technologies or therapeutics to reduce the incidence and/or severity of ARDS and/or other lung injury secondary to coronaviruses, particularly COVID19. • Development of biomarker metrics to associate the long-term health outcomes of virusinduced ARDS with degradation of physiological and physical performance. • Ventilation and Extracorporeal Life Support approaches and technologies to support lung function or airway management in response to COVID-19 that increase survivability and/or minimize care provider burden or exposure. • Pharmacological and biologic interventions for COVID-19 induced complications, including ARDS and related sequelae. • Research on the short- and long-term health impacts of COVID-19 diagnosed Service members on readiness, deployability, fitness for duty (e.g., ability to complete the Army Combat Fitness Test), and operationally relevant respiratory challenges such as challenges in fixed-wing aviation, diving, and high-altitude ground operations. • Research on the prevention of COVID-19 (and other respiratory pathogens) in aircraft, ships, and submarines, specifically focused on ventilation systems and ease of transport of airborne pathogens (i.e., risk characterizations).
Investigators at or above the level of Assistant Professor (or equivalent) may be named by the organization as the PI on the application. There are no limitations on the number of applications for which an investigator may be named as a PI. An eligible PI, regardless of ethnicity, nationality, or citizenship status, must be employed by, or affiliated with, an eligible organization.
The CDMRP expects to allot up to $30M to fund approximately five Clinical Trial Award applications for Emerging Viral Diseases and/or Respiratory Health.