“
- REMAP-CAP independent Data Safety Monitoring Board (DSMB) conducted a scheduled
- interim safety assessment on available data to determine if the treatments in the RAS study domain were safe in patients with both severe and moderate COVID-19
- DSMB has communicated safety concerns related to the use of angiotensin converting enzyme (ACE) inhibitors and angiotensin receptor blockers (ARB) in patients with severe COVID-19
- The DSMB made no comment on the safety of the ARB + DMX-200 intervention
- The DSMB recommended that recruitment of patients with severe COVID-19 to all available interventions in this domain be suspended, and REMAP-CAP will temporarily pause enrolment of patients with moderate COVID-19 into this domain to allow review of additional data prior to potentially resuming enrolment
- Complete assessment of data from patients with severe disease will be undertaken and will be reported as soon as available
- he preliminary finding is unlikely to impact the CLARITY 2.0 study of DMX-200 and an ARB in patients with moderate COVID-19 respiratory complications
- The preliminary finding does not impact the ACTION3 study of DMX-200 in FSGS patients, where ARBs are part of existing standard of care”
Anouncement
