COVID-19 Clinical Trials Process and Updates

April 6, 2020

All COVID-19 clinical trials must to be submitted to the COVID-19 Research Prioritization Committee and will be assigned as a high priority. Once the designation has been made, Anna Lok, M.D., Assistant Dean for Clinical Research will reach out to the Principal Investigator to offer logistical assistance. COVID-19 trials have now been fast-tracked to open in as little as two weeks from receiving the protocol.

Consent and sample collection is currently being managed by the ACCST CTSU and MCRU Lab. Some upcoming trials may be co-managed by staff from other CTSUs as appropriate. A committee including bioethicists and IRB is developing guiding principles for when a patient is eligible for more than one trial.

To date, we have opened three clinical trials, with four more opening within days. Current and upcoming trials are for patients with severe illness in the ICU, as well as those with mild to moderate illness looking to prevent progression. The CTSO is also supporting trials aimed at preventing infection in those at risk of exposure, such as healthcare workers. To learn more about current and upcoming COVID-19 clinical trials at the University of Michigan, view the COVID-19 Research Index

At this time, we would like to acknowledge all of the hard work that ACCST CTSU PIs and Staff have done to implement clinical trials at record speed at Michigan Medicine. Their diligence has laid the groundwork to offer the best care possible to our patients.