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

Effective August 2022, the Merck Investigator Studies Program Review Committee (MISP-RC) for SARS CoV-2/COVID-19 TREATMENT will accept CLINICAL, NON-INTERVENTIONAL, and CLINICAL, INTERVENTIONAL, submissions within our current areas of interest (AOI). This remains 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.

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

CLINICAL , NON-INTERVENTIONAL
• Retrospective studies describing the use and efficacy of molnupiravir for the treatment of mild-moderate COVID-19 in under-represented populations. These may include: well-defined immunosuppressed or immunocompromised patients; persons with mild-moderate liver disease (Child-Pugh A or B); persons with late or end-stage renal disease
CLINICAL , INTERVENTIONAL

*IMPORTANT NOTE* - Because of the nature of the Emergency Use Authorizations (EUA) these can only be performed in the US, consistent with the terms of the US EUA Fact Sheet, and in countries where use of molnupiravir is authorized under the terms of the US EUA Fact Sheet. Proposals in this category must be proof-of-concept only; we will not consider any placebo controlled or blinded studies or studies anticipated to enroll large numbers of subjects. We are not considering any pre- or post- exposure prophylaxis studies in non-SARS-COV-2 infections.

• Proof of concept single center studies of the treatment of mild to moderate COVID-19 with molnupiravir in well-defined immunocompromised or immunosuppressed adult (> 18 years of age) patient populations, adults with late or end-stage renal disease, or adults requiring polypharmacy that could result in clinically significant drug-drug interactions by CYP3A4 boosters such as ritonavir for the management of chronic medical conditions.

Please complete the corresponding clinical PROTOCOL and BUDGET (NON-INTERVENTIONAL OR INTERVENTIONAL) 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 3
SUBMISSION DEADLINES Full Protocol Dated CV (within 2-years) Detailed Budget on Merck Template	October 31, 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.