Modification to Contract 75D30120C08008

The Centers for Disease Control and Prevention intends to award a sole source fixed-price modification to Rush University Medical Center “Rush” (1653 W Congress Prkwy Chicago, IL 60612).  Rush was awarded (1 September 2020) a contract (75D30120C08008; “Innovative Support for Patients with SARS-CoV-2 Infections (Inspire) Registry”) to conduct an 18-month study of 4,800 participants.  The study has two (2) primary aims: (1) determine the outcomes of SARS COV-2 infections among different age groups in the US population, and (2) determine if association of age with outcome varies among different populations, as defined by sex, race/ethnicity, presence of specific underlying conditions.   Using established protocols and procedures for recruitment, enrollment, and data collection, the Contractor provides interim analysis reports every two (2) weeks that synthesize the enrollees stratified by key factors, collaborates on publications, and will provide a final report and presentation of study results.  The Contractor uses the Hugo data management platform to integrate the eight (8) different sites’ clinical data and patient reported outcomes.  The period of performance of the contract is 1 September 2020 through 31 August 2022.

CDC requires a modification to expand the study population and extend the duration of follow-up to enhance the study design and generate knowledge about longer term outcomes and other questions of critical importance related to SARS-CoV-2.  The study enrollment will be expanded to include an additional 3,200 participants (8,000 total) which will result in a 1:1 ratio for cases and controls (4,000 each).  The study design will also be updated to follow all participants enrolled prior 1 November 2021 through a target of 24 months and follow all participants enrolled between 1 November 2021 through 30 April 2022 for a target of 18 months.  This results in an extension of the study period through 31 December 2023.  Additionally, the Hugo data management platform will be expanded to include additional EMR linkages for vaccination information and information on viral testing results.  The data collected from this modification will be integrated in the bi-weekly reports, scientific publications, final report and final presentation. The increased enrollment, extension of the study period, and enhanced data will provide critical, more statistically reliable study data than the current study design. It will also provide linkages to vaccine and variant information for CDC’s COVID-19 response.           

Rush has completed all of the INSPIRE work to date, completed the alignment of the Hugo data management platform across eight (8) sites and is working on the study activities with the current enrollment.  Therefore, Rush is the only contractor able to complete these study refinements including providing for a better comparison of cases to controls, achieving a higher target population, extending the current follow-up duration and study period, and using more robust Hugo data elements.   

This contract action (modification) is for supplies or services for which the Government intends to solicit and negotiate with only one source under the authority of FAR 6.302-1 and 41 U.S.C. 3304(a)(1).  Interested persons may identify their interest and capability to respond to the requirement or submit proposals. 

This notice of intent is not a request for competitive quotations; however, all quotations/responses received within fifteen (15) days of the issuance of this notice will be considered by the Government.  A determination by the Government to compete this proposed contract action (modification) based upon the responses to this notice is solely within the discretion of the Government.  Information received will normally be considered solely for the purpose of determining whether to conduct a competitive procurement.  Any quotation/response should be emailed to Mark Draluck at syq1@cdc.gov by 9:00 A.M. EST., 17 December 2021.