Merck Investigator Studies Program (MISP): SARS CoV-2/COVID-19 TREATMENT

Effective January 2022, the Merck Investigator Studies Program Review Committee (MISP-RC) for SARS CoV-2/COVID-19 TREATMENT will accept FUNDING ONLY, PRECLINICAL, and CLINICAL, NON-INTERVENTIONAL, submissions within our current areas of interest (AOI). This is a competitive review process that will be conducted by the 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. Clinical, interventional/treatment AOIs will be added at an upcoming date; until then any submission for use of molnupiravir in a treatment or prophylaxis study WILL NOT be reviewed.

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

• In vitro studies to assess the antiviral activity of NHC against RNA viruses of human significance
• Proof of concept studies demonstrating the antiviral activity and mechanism of action of molnupiravir in validated animal models of zoonotic RNA viral infections
• In vitro or animal studies to assess the development and mechanism of viral resistance to NHC/molnupiravir by RNA viruses of human significance
• In vitro or animal studies to assess the relationship between the number and type of accumulated errors in the viral genome and impact on viral infectivity
• Studies that may validate a standardized definition for post-acute SARS-COV2 (PASC) or long-COVID
• Studies that may provide clinical or biomarker predictors of infection severity in COVID-19 in children (<18 yr olds)
• Studies that may better characterize moderate/severe breakthrough infections and/or provide predictors of severe COVID-19 in high risk vaccinated populations such as the elderly, transplant recipients (solid organ or allogeneic stem cell transplant) and other immunocompromised/immunosuppressed patient populations, persons with BMI >30, DM, cardiopulmonary disease, and/or BIPOC, LatinX, native peoples.

Please complete the corresponding preclinical or clinical PROTOCOL and BUDGET templates via the Company's on-line study management system (in US) or your MSD country representative (outside US). The submissions will be collectively reviewed and selected by the MISP Committee.

 

Critical Activities and Timelines:

Activity	Review Cycle 1	Review Cycle 2	Review Cycle 3
SUBMISSION DEADLINES Full Protocol Dated CV (within 2-years) Detailed Budget on Merck Template	March 3, 2022	May 26, 2022	August 24, 2022

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.