All current and enrolling active COVID clinical trials can be found here (scroll to bottom of linked page).
Due to a limited number of inpatients with COVID diagnoses at UC San Diego Health, along with multiple open and competing trials, the Committee is not currently reviewing any studies involving exclusively inpatients unless there is an exceptional circumstance. However, you are free to submit your proposal for future consideration. Once UC San Diego completes accrual on one of the trials involving UC San Diego inpatients, the Committee will then consider additional inpatient studies from those already submitted.
Approval Process of COVID-19 Research
All clinical trials must be reviewed and approved by the Clinical Trial Review Committee before submission to the IRB.
The COVID-19 Clinical Trials Review Committee is charged with reviewing all proposed clinical trials at UC San Diego Health that aim to enroll participants with diagnosed or suspected COVID-19 disease to determine appropriateness and feasibility for patient populations served by UC San Diego Health.
Submission Packet for Investigators
How to submit packet and overview of the COVID-19 Clinical Trials Review Committee
ACTRI COVID-19 Research Biobank
Additional COVID-19 Resources
STEP 1: Process Overview
- Principal Investigator will prepare Submission Packet outlining their proposed study and send to Dr. Constance Benson & Karlyle Lim. Once Submission Packet is downloaded and completed, please email to Dr. Constance Benson and Karlyle Lim.
- A Primary Reviewer will be assigned from the Committee.
- The COVID-19 Clinical Trials Review Committee will convene on the 1st and 3rd Thursdays of the month to discuss submissions.
- Review Decision will be communicated back to PI.
STEP 2: Review Decisions
- Approved: Protocol moves on to IRB for review
- Approved with Contingencies: Protocol may move on to IRB once contingencies are addressed, e.g. plan for coordination of enrollment with other ongoing trials
- Deferred: Review Committee may require further explanation, information or input about specific areas of the protocol study and implementation plans identified during the review. In this situation a decision is deferred until the Review Committee receives the requisite information.
- Disapproved: Protocol cannot be implemented at UC San Diego Health
- Investigators have the option to appeal; requests for appeal and the basis for the appeal should be forwarded to Dr. Constance Benson and Karlyle Lim.
Process Map for COVID-specific clinical research
Click image to display larger
General Criteria to Evaluation COVID-19/SARS-CoV-2 Clinical Trials for Implementation at UC San Diego Health
- Is there appropriate scientific justification for studying the intervention in question?
- Is the study design appropriate to test the hypotheses stated?
- Is the study feasible to conduct within inpatient or outpatient settings at UC San Diego Health?
- Is the funding available adequate to conduct the study?
- Are there other competing studies already underway or pending at UC San Diego Health that will impact the ability to recruit the proposed sample size and/or impact the staffing available to conduct the study?
- Do UCSD investigators play a key role in the development and implementation of the clinical trial that would be important for research objectives of UCSD Health?
- Constance A. Benson, MD – Chair
- Ezra Cohen, MD – Co-Chair
- Davey Smith, MD – Division Chief, Infectious Diseases & Global Public Health
- Atul Malhotra, MD – Division of Pulmonary/Critical Care & Sleep Medicine
- Susan Little, MD – Division of Infectious Diseases & Global Public Health
- Kimberly McConnell, PharmD – Investigational Drug Services
- Eric Mah – ACTRI (ex officio non-voting)
For additional questions regarding the COVID-19 Clinical Trials Review Committee, please contact Karlyle Lim at