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CDMRP PRMRP Clinical Trial Award for Emerging Viral Diseases and Respiratory Health

Grants to USA, Canada, and International IHEs, For-Profits, and Agencies
for COVID-19 Clinical Trials in the Military Community

Agency Type:

Federal

Funding Source:

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U.S. Department of Defense (DoD) - U.S. Army Medical Research Acquisition Activity (USAMRAA)

LOI Date:

06/08/20

Deadline Date:

06/22/20 11:59 PM ET

Description:

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Grants to USA, Canada, and International IHEs, biotechnology companies, foundations, government agencies, research institutes, and military-related institutions for Coronavirus (COVID-19) related health research. A letter of intent is required before submitting a full application. Specific approvals may be required by the FDA prior to application submission deadline. Funding is intended to support expedited human clinical trials in emerging viral diseases or respiratory health.

All applications for this Program Announcement must specifically address at least one of the following Focus Areas and must be of clear scientific merit and direct relevance to military health.

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 virus-induced 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).

GrantWatch ID#:

GrantWatch ID#: 189616

Estimated Total Program Funding:

$30,000,000

Number of Grants:

Approximately five Clinical Trial Awards

Term of Contract:

The proposed clinical trial is expected to begin no later than 9 months after the award date. The maximum period of performance is 4 years.

Additional Eligibility Criteria:

All organizations, including international organizations, are eligible to apply.

Government Agencies Within the United States: Local, state, and Federal Government agencies are eligible to the extent that applications do not overlap with their fully funded internal programs. Such agencies are required to explain how their applications do not overlap with their internal programs.

As applications for this Program Announcement may be submitted by extramural and intramural organizations, these terms are defined below.

Extramural Organization: An eligible non-DoD organization. Examples of extramural
organizations include academic institutions, biotechnology companies, foundations, Federal Government organizations other than the DoD, and research institutes.

Intramural DoD Organization: A DoD laboratory, DoD military treatment facility, and/or
DoD activity embedded within a civilian medical center. Intramural Submission: Application submitted by a DoD organization for an intramural investigator working within a DoD laboratory or military treatment facility or in a DoD activity embedded within a civilian medical center.

USAMRAA makes awards to eligible organizations, not to individuals.

Organizations must be able to access .gov and .mil websites in order to fulfill the financial and technical deliverable requirements of the award and submit invoices for payment.

Funding from this award mechanism must support a clinical trial and cannot be used for animal studies.

Pre-Application Information:

Submission and Review Dates and Times:
- Pre-Application Submission Deadline: 5:00 p.m. Eastern time (ET), June 8, 2020
- Application Submission Deadline: 11:59 p.m. ET, June 22, 2020.
- End of Application Verification Period: 5:00 p.m. ET, June 29, 2020
- Peer Review: July 2020
- Programmatic Review: August 2020

For-profit organizations must obtain the Grants Officer’s approval prior to incurring any obligations and expenditures before the beginning date of the initial budget period of a new award.

eBRAP:
- PIs must be registered in eBRAP to submit a pre-application. PIs are encouraged to start the registration processes for eBRAP early to ensure that there is sufficient time for completion prior to the submission deadline. There is no grace period.
- During eBRAP registration, the PI must request to be affiliated with the organization from the list of organizations already registered with eBRAP. If the PI’s organization is not already registered with eBRAP, then the PI must invite an Authorized Organizational Representative (AOR) to register the organization. The AOR does not need to complete the organization registration in eBRAP prior to the pre-application submission deadline in order for the preapplication to be submitted.

The following steps are required as part of the Grants.gov registration process. Allow up to 8 weeks for the completion of the Grants.gov registration process. Registering early is advised.

- DUNS Number - Applicant organizations and all sub-recipient organizations must have a DUNS number to submit applications to Grants.gov. Register online for DUNS number at https://fedgov.dnb.com/webform.
- SAM Registry - The applicant organization must also be registered in the Entity Management functional area of the SAM with an “Active” status to submit applications through the Grants.gov portal. Allow several weeks to complete the entire SAM registration process at https://www.sam.gov/.
- Commercial and Government Entity (CAGE) Code. The applicant organization must have a CAGE code, which can be requested at: https://cage.dla.mil/Request
- Authorized Organizational Representative - Each organization must have an AOR who is registered with Grants.gov
- Applicants must create a Grants.gov Workspace

View this opportunity on Grants.gov at: https://www.grants.gov/web/grants/view-opportunity.html?oppId=326173

Information on human clinical trials: For more information, a Human Subject Resource Document is provided at https://ebrap.org/eBRAP/public/Program.htm.

Contact Information:

Before starting your grant application, please review the funding source's website listed below for updates/changes/addendums/conferences/LOIs.

All pre-applications for both extramural and intramural organizations must be submitted to: https://ebrap.org/eBRAP/public/index.htm

Full applications from extramural organizations must be submitted through Grants.gov.
Intramural DoD organizations may submit full applications to either eBRAP or Grants.gov.

Grants.gov application: https://apply07.grants.gov/apply/login.faces?oppId=326173&origin=vgo-apply

Help@ebrap.org - for program announcement related questions. Or call 301-682-5507.

Questions related to application submission through the Grants.gov portal should be directed to: support@grants.gov or call 800-518-4736.

CFDA Number:

12.420

Funding or Pin Number:

W81XWH-20-PRMRP-CTA-COV

URL for Full Text (RFP):

Geographic Focus:

USA: Alabama;   Alaska;   Arizona;   Arkansas;   California;   Colorado;   Connecticut;   Delaware;   Florida;   Georgia;   Hawaii;   Idaho;   Illinois;   Indiana;   Iowa;   Kansas;   Kentucky;   Louisiana;   Maine;   Maryland;   Massachusetts;   Michigan;   Minnesota;   Mississippi;   Missouri;   Montana;   Nebraska;   Nevada;   New Hampshire;   New Jersey;   New Mexico;   New York City;   New York;   North Carolina;   North Dakota;   Ohio;   Oklahoma;   Oregon;   Pennsylvania;   Rhode Island;   South Carolina;   South Dakota;   Tennessee;   Texas;   Utah;   Vermont;   Virginia;   Washington, DC;   Washington;   West Virginia;   Wisconsin;   Wyoming

USA Territories: American Samoa (USA)   Guam (USA)   Puerto Rico (USA)   Virgin Islands (USA)   Northern Mariana Islands (USA)

USA Compact Free Associations: The Federated States of Micronesia (USA)   Marshall Islands (USA)   Republic of Palau (USA)

Canada: Alberta   British Columbia   Manitoba   New Brunswick   Newfoundland and Labrador   Northwest Territories   Nova Scotia   Nunavut   Ontario   Prince Edward Island   Quebec   Saskatchewan   Yukon

Israel

International country outside of the USA, Israel and Canada.

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