Announcements
January 22, 2021: Pause in enrollment in the ATTACC Trial
On January 21, after reviewing the results of interim analyses and safety reports, the ATTACC DSMB notified the ATTACC Primary Investigators that the therapeutic anticoagulation intervention has reached a prespecified threshold for superiority for moderate state patients with a >99% posterior probability of benefit.
Moderate state patients are the majority of ATTACC patients, defined by hospital admission for COVID-19 but no requirement for organ support in an intensive care environment. These are the only patients currently being enrolled in ATTACC and the multi-platform RCT.
To read more about the pause, you can visit our Media page. You can also contact us by visiting the Contact Us page.
January 4, 2021: Pause in enrollment of severe strata patients defined as patients admitted to an ICU AND receiving the organ support in the ATTACC trial.
After reviewing the results of interim data and safety reports from the multi-platform trials (ATTACC, Activ-4, and REMAP-CAP), the ATTACC Data Safety Monitoring Board (DSMB) notified the ATTACC Principal Investigators that the therapeutic anticoagulation intervention had reached a pre-specified threshold for severely ill patients defined as admitted to an ICU AND receiving the organ support.
At the same time, the DSMB also indicated concerns regarding the safety of therapeutic anticoagulation in admitted to an ICU AND receiving the organ support. All of the trial sites have paused enrollment of patients in the severely ill strata while the trials urgently work to undertake additional analyses which will be made available as soon as possible.
It should be noted that no safety concerns were identified in moderately ill (ward patients) patients randomized within the multi-platform trial. Randomization of moderately ill patients (not receiving ICU level of care) continues.
Please refer to our severe strata pause FAQs for any questions.
To read more about the pause, you can visit our Media page. You can also contact us by visiting the Contact Us page.