Background The coronavirus disease 2019 (COVID-19) pandemic has challenged researchers performing clinical trials to develop innovative approaches to mitigate infectious risk while maintaining rigorous safety monitoring. Methods In this report we describe the implementation of a novel exclusively remote randomized clinical trial (ClinicalTrials.gov NCT04354428) of hydroxychloroquine and azithromycin for the treatment of the SARS-CoV-2–mediated COVID-19 disease which included cardiovascular safety monitoring. All study activities were conducted remotely. Self-collected vital signs (temperature, respiratory rate, heart rate, and oxygen saturation) and electrocardiographic (ECG) measurements were transmitted digitally to investigators while mid-nasal swabs for SARS-CoV-2 testing were shipped. ECG collection relied on a consumer device (KardiaMobile 6L, AliveCor Inc.) that recorded and transmitted six-lead ECGs via participants’ internet-enabled devices to a central core laboratory, which measured and reported QTc intervals that were then used to monitor safety. Results Two hundred and thirty-one participants uploaded 3245 ECGs. Mean daily adherence to the ECG protocol was 85.2% and was similar to the survey and mid-nasal swab elements of the study. Adherence rates did not differ by age or sex assigned at birth and were high across all reported race and ethnicities. QTc prolongation meeting criteria for an adverse event occurred in 28 (12.1%) participants, with 2 occurring in the placebo group, 19 in the hydroxychloroquine group, and 7 in the hydroxychloroquine + azithromycin group. Conclusions Our report demonstrates that digital health technologies can be leveraged to conduct rigorous, safe, and entirely remote clinical trials.

Background: The optimal local care of continuous-flow left ventricular-assisted device (CF-LVAD) exit site in unclear. We compared silver-coated wound dressing (Acticoat) with the conventional wound care method. Methods:A retrospective case-control study was conducted at Henry Ford Hospital, a tertiary teaching hospital in urban Detroit, between 11/1/2010 and 12/31/2011. Patients were divided into 2 groups based on Acticoatdressing use. Primary outcome was first CF-LVAD infection rate.Results: Forty-two patients were included in the study. Twenty patients used Acticoat-dressing, while 22 used the control dressing. Mean age was 60.3 ± 8.9 in the intervention group and 48.6 ± 4.8 in the control group (P: 0.004). Male patients were 15 (75%) in the intervention group and 15 (68.2%) in the control group (P: 0.74). Acticoat-dressing was used for a mean duration of 64.1 ± 122.9 days. The rate of first CF-LVAD infection was 15% (3) in the Acticoat group and 31.8% (7) in the control group (P: 0.25). Mortality at 200 days was 15% (3) in the intervention group; and 4.5% (1) in the control group (P: 0.25). Ten patients were infected in the whole study (23.8%); 9 of the infected patients (90%) required hospitalization after the first infection; while 3 patients (30%) required intensive-care unit admission. Mean time to the first infection was 276.3 ± 235.8 days in the intervention group and 276.3 ± 131.5 days in the control group (P: 0.99).

No abstract