Table 1

Possible mitigation strategies for COVID-19 to permit reopening of immunomodulatory prevention and intervention studies in type 1 diabetes

COVID-19 rates* 14-day average positive rate <5%
Negative slope of positivity trend line
Subject selectionPrestudy questionnaire regarding school, sports, work, and ability to quarantine demonstrates subject/family commitment to risk mitigation
Preference for work from home or home school for at least 2 weeks post-infusion
MaskingWilling and able to wear mask at all times when outside of home for 2 weeks prior to and 2 weeks after study drug exposure
TravelTravel by personal vehicle to and from study site
No flights or use of public transportation (until travel/COVID-19 risk clarified)
Remote study visits performed when able
COVID-19 testingCOVID-19 PCR negative result within 72 h of study drug exposure
COVID-19 vaccination** For trial participants who are eligible for COVID-19 vaccination, complete vaccination course at least 2 weeks prior to study drug exposure
Quarantine*** Home quarantine other than essential activities with masking for 14 days following study drug
  • * Both the treatment site and subject’s home community.

  • ** Timing of vaccination recommended here is based on the currently available mRNA-based COVID-19 vaccines produced by Pfizer-BioNTech and Moderna, both of which require two doses administered 3 or 4 weeks apart, respectively. At the time of this writing, both vaccines are approved for use in people 16 years of age and older, precluding vaccination of many eligible type 1 diabetes trial participants. As additional COVID-19 vaccines may be approved going forward, these should be independently evaluated for timing prior to study drug infusion.

  • *** Specific metrics, timing, and duration of mitigation strategies may differ for different immune therapies based on their specific degree of immunosuppression and duration of biological activity. These suggestions are specific for the TrialNet low-dose ATG prevention study.