COVID-19 Outpatient Clinical Research Unit

Due to the risk of transmission, outpatient research visits with persons under investigation for COVID-19 (PUIs) and persons with active COVID-19 cannot be scheduled in the Broadway Adult Outpatient Clinical Research Unit or seen in other Johns Hopkins clinical practice settings.

 

Research participants who are PUIs or have COVID-19 requiring isolation precautions must be scheduled at the COVID-19 Outpatient CRU, which provides a safe environment for study visits and procedures, including phlebotomy and upper respiratory sampling. Participant visits take place in specialized PODS, which have been modified for medical isolation with HEPA Filtered Negative Pressure Exhaust. Study team members must adhere to recommendations for the use of personal protective equipment (PPE) in ambulatory settings, which are updated regularly on the HEIC Intranet.

To determine if a research participant should be scheduled at the COVID-19 Outpatient CRU, study teams should consult the HEIC guidelines for the discontinuation of COVID-19 isolation precautions, which are updated regularly on the HEIC Intranet. Research protocols that can be expected to require visits to the COVID-10 Outpatient CRU include:

  • Studies enrolling patients with COVID-19 who are hospitalized and may require study visits or procedures after discharge
  • Studies enrolling persons in trials of COVID-19 prevention (medications or vaccine) who develop signs and symptoms of SARS-CoV-2 infection.
  • Studies enrolling patients with COVID-19 who are not hospitalized.

Research teams that anticipate the need for COVID-19 Outpatient CRU resources should contact the ICTR CRU before submission to COVID-19 Johns Hopkins Clinical Research Coordinating Committee and indicate the intent to conduct study visits in the COVID-19 CRU on the application for IRB review.

For more information, please contact us at ICTRcovidcru@jhmi.edu.