Investigator Studies Program (MISP): SARS CoV-2/COVID-19
Effective April 2020, the Investigator Studies Program Review Committee (MISP-RC) will accept proposals within our current areas of interest (AOI) for SARS CoV-2/COVID-19. This is a competitive review process that will be conducted by the SARS CoV-2/COVID-19 MISP Review Committee. Decisions will be made on the basis of scientific merit and strategic fit within the AOI. Please review the critical activities and abide by the timelines as outlined below.

The following areas are of interest to Investigator Studies Program Committee:

Focus Area 1: Virology/Immunology
  • Understanding of viral evolution, resistance and immune evasion mechanisms, and models of viral pathogenesis
  • Preclinical assays and models to assess ADE
Focus Area 2: Host Immunology
  • Studies of patient clinical specimens to identify biomarkers of immunity and those that may predict disease progression. This may include but not limited to understanding SARS-COV2 specific cellular responses, antibody responses, or others and the durability of those responses; human genomics that may relate to susceptibility/resistance to novel coronavirus infections, such as ACE2 or CD26 receptor polymorphisms, immune response related polymorphisms
  • Studies of natural history of SARS-CoV2 infection, including longitudinal SARS-CoV2 RNA detection/viral kinetics and matched measurements of immune and clinical responses
Focus Area 3: Primary Epidemiology
  • Age-stratified, population-based sero-surveys conducted with an assay that has been or will be concurrently tested for appropriate performance characteristics in target populations
  • Studies to explore the preliminary biologic and/or physiologic and/or other factors associated with COVID-19 outcome and disease course with respect to key populations including but not limited to persons >65 yrs of age, gender, immune status (e.g., HIV+, transplant recipient, on DMARD or biologics for collagen vascular disease), DM, obesity.
Focus Area 4: Secondary Impact
  • Studies that characterize the epidemiology of secondary lung infections in persons with COVID19, including but not limited to:
    • The types of secondary pathogens recovered from patients across the spectrum of COVID19 disease that required therapeutic intervention
    • characterized population shifts in oropharyngeal colonization
    • The potential anti-infective pathways that were established for empiric or directed treatment of the presumed or proven secondary infection pathogens
  • Studies that describe the role of stewardship in the directed or empiric treatment of proven or presumed secondary pneumonias in patients with COVID19
Focus Area 5: Vaccine Confidence
  • Studies that evaluate the immediate impact of COVID-19 outbreak and response measures on:
    • population access to and uptake of recommended vaccines
    • confidence in vaccines, trust in health care providers and public health authorities
  • Studies that assess the potential long-term impacts of COVID-19 outbreak on immunization program functions, as well as a characterization of potential recovery of those programs.
  • Studies that explore perceptions toward potential COVID-19 vaccines among health care providers and key population subgroups

Please complete a full protocol and detailed budget via Visiontracker, the Company's on-line study management system (in US) or your MSD country representative (outside US). The proposals will be collectively reviewed and selected by the SARS CoV-2/COVID-19 MISP Committee.

Critical Activities and Timelines:
Activity 1st Review Cycle 2nd Review Cycle 3rd Review Cycle
Full Protocol Submission with Detailed Budget May 15, 2020 June 26, 2020 July 24, 2020
Target Review Committee Meeting Date June 10, 2020 July 23, 2020 August 20, 2020
Target Final Comments to Investigator July 3, 2020 August 21, 2020 September 18, 2020

MISP Information
This site is intended for US investigators only. Investigators outside of the US interested in submitting research proposals to the Investigator Studies Program should contact their local MSD office.