Methods
Thrombosis
LUNG, ASYMPTOMATIC COVID-19, THROMBOSIS, SECONDARY, BLOOD, HEART
The ACTIV4B Outpatient Thrombosis Clinical trial was funded by Operation Warp Speed and conducted as part of the National Heart, Lung, and Blood Institute (NHLBI) ACTIV platform of clinical trials. The enrollment methods, primary trial protocol, patient population, enrollment centers and outcome measurement methods are previously described [
Unadjusted and multivariable adjusted odds ratios for acute episodic care enrollment versus Minimal Contact enrollmentFor this secondary analysis we requested enrollment location data from the enrolling centers, information not originally collected as part of the ACTIV4B trial. Each site primary investigator and lead study coordinator completed a pre-populated table identifying each study participant as having been enrolled either at an AUEC setting, or through the MC process. AUEC enrolled patients included those COVID-19 positive patients (defined as having a positive PCR or antigen test within 14 days) seen and enrolled in an ED, urgent care, Monoclonal Antibody (MAB) clinic or acute care COVID-19 clinic for symptomatic COVID-19. Informed consent and enrollment occurred at or immediately following a visit at one of these settings. MC patients were those patients identified as COVID-19 positive via automated interrogation of the EHR that generated a COVID-19-positive test list, not otherwise meeting inclusion in the AUEC group. In the MC group each patient was contacted electronically via telephone, text message, or email, and the patient completed study orientation via an online video sent as a link in a text message or email. Inclusion/exclusion criteria were affirmed with a site investigator and signed consent was obtained. MC participants were also required to be COVID-19 test positive within 14 days of enrollment. Deidentified participant data from this trial will be made publicly available to researchers upon approval of use after 1 January 2023 by contacting the National Institutes of Health.
Risk of Key Endpoints for Acute Episodic Care and Minimal Contact Participants