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October 23, 2020

The Clinical and Translational Research Facilitation Office Support of Rockefeller COVID-19 Research
By Donna Brassil, MA, RN, CCRC

The Clinical and Translational Research Facilitation Office (CTRFO) supported the development and operationalization of COVID studies under conditions of University closure. We assisted numerous investigators in developing both clinical and basic human research protocols and helped to guide them through rapid Advisory Committee for Clinical and Translational Science (ACCTS) and Institutional Review Board (IRB) reviews. We would like to highlight two of these studies.

Arlene Hurley, MA, ANP-BC, CCRC conducted Protocol Development Navigation of Davide Robbiani’s study, Peripheral Blood of Coronavirus Survivors to Identify Virus-Neutralizing Antibodies. This COVID-related study was the one that saw the most participants on campus during the University closure. Christian Gaebler, MD, a 3rd year Clinical Scholar, is the Principal Investigator of this study. There have been many study amendments since initial approval which have included the addition of 15 RU investigators from additional Labs on campus to share data and samples. To meet the enrollment goals of the study team, the four Facilitators joined the research team to participate in study implementation and conduct of this study by remote screening of the prescreened volunteers, and to conduct telephone consenting. We were assigned to contact 193 potential participants for remote screening, which included obtaining a medical history, including COVID-19 symptoms. We also obtained telephone consent and collectively conducted 63 of the 166 participant visits to Rockefeller University Hospital for the study (~38% of the screening visits). Arlene coordinated the study by preparing the medical records for each participant’s outpatient visit, coordinating with the Nursing Department on projected participant enrollment to ensure an adequate supply of equipment needed to collect the research samples, and arranging for campus parking for the study participants through coordination with the Hospital Facilities Specialist and University Security Department. Arlene performed internal monitoring of the 166 enrolled participants’ medical records, including monitoring data regarding the participants’ permission to share their research samples. This information was provided to Technology Transfer Office and Office of General Counsel to aid in their completion of a Material Transfer Agreement between the Nussenzweig Lab and a start-up company developing a Neutralizing Antibody assay.

The CTRFO Facilitators also guided Ohad Bentur, MD, a 3rd year Clinical Scholar in Dr. Coller’s Lab, through the Translational Navigation Process to rapidly develop and implement his study, Phase I Randomized Double Blind Placebo Controlled, Single-Dose, Dose Escalation Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Orally Inhaled Hydroxychloroquine Sulfate in Healthy Adult Volunteers. The time period from the initiation of Protocol Development Navigation to ACCTS/IRB approval and FDA review was less than 2 months, which is extraordinary for a Phase I study. Numerous experts within the Center for Clinical and Translational Science (CCTS), Hospital, and University participated in this Navigation process. IRB approval was granted on June 20th, the first participant was screened on June 24th, and enrollment was completed on August 10th. Richard Hutt, RN, BA, CCRC is coordinating this study, which includes strategizing goals with the sponsor, Pulmoquine Therapeutics, Inc., and the Contract Research Organization, Cliantha Research Ltd. Richard has been preparing for weekly external monitoring, which is being conducted virtually. This has necessitated the need for secure electronic platforms in which Richard has been uploading all source documents and essential regulatory documentation in addition to completing electronic Case Report Forms and answering data queries. Richard has also been performing Internal Monitoring. Dr. Bentur has been exemplary as Principal Investigator of this complex study, demonstrating outstanding team leadership.