A cluster randomized trial of interferon ß-1a for the reduction of transmission of SARS-Cov-2: protocol for the Containing Coronavirus Disease 19 trial (ConCorD-19).

BACKGROUND: SARS-CoV-2 infection rapidly spreads in populations due to the high rates of community transmission. Interrupting the shedding of SARS-CoV-2 may reduce the incidence of Coronavirus Disease 19 (COVID-19). Herein we provide a protocol for a cluster randomized trial that will examine the effectiveness of treatment with interferon (IFN) ß-1a compared to standard of care in limiting the transmission of SARS-CoV-2. Co-primary objectives are to determine whether IFN therapy reduces (a) the proportion of infected cases shedding SARS-CoV-2 at day 11 post randomization and (b) the incidence of transmission of SARS-CoV-2 infection from index cases to treatment-eligible household post-exposure contacts at day 11 after randomization. Secondary objectives include assessing the impact of IFN treatment on duration of viral clearance, hospitalizations and fatalities, and evaluating the safety of IFN treatment. METHODS: Three hundred and ten households, each including an index case with a recent COVID-19 diagnosis and at least one asymptomatic treatment-eligible household contact, will be randomized to receive 3 doses of 125 µg IFN ß-1a by subcutaneous administration (days 1, 6, and 11), or standard of care. All participants will be followed until day 29. DISCUSSION: The results from this trial will identify whether IFN ß treatment of mild or moderate COVID-19 cases accelerates viral clearance and prevents disease progression and whether IFN ß treatment of post-exposure contacts of COVID-19 cases reduces transmission of infection. TRIAL REGISTRATION: This trial is registered at ClinicalTrials.gov NCT04552379; date of registration September 17, 2020.

System-Wide Accelerated Implementation of Telemedicine in Response to COVID-19: Mixed Methods Evaluation.

BACKGROUND: As the COVID-19 pandemic disrupted medical practice, telemedicine emerged as an alternative to outpatient visits. However, it is not known how patients and physicians responded to an accelerated implementation of this model of medical care. OBJECTIVE: The aim of this study is to report the system-wide accelerated implementation of telemedicine, compare patient satisfaction between telemedicine and in-person visits, and report provider perceptions. METHODS: This study was conducted at the UC Christus Health Network, a large private academic health network in Santiago, Chile. The satisfaction of patients receiving telemedicine care in March and April 2020 was compared to those receiving in-person care during the same period (concurrent control group) as well as in March and April 2019 (retrospective control group). Patient satisfaction with in-person care was measured using the Net Promoter Score (NPS) survey. Patient satisfaction with telemedicine was assessed with an online survey assessing similar domains. Providers rated their satisfaction and responded to open-ended questions assessing challenges, strategies used to address challenges, the diagnostic process, treatment, and the patient-provider relationship. RESULTS: A total of 3962 patients receiving telemedicine, 1187 patients from the concurrent control group, and 1848 patients from the retrospective control group completed the surveys. Satisfaction was very high with both telemedicine and in-person services. Overall, 263 physicians from over 41 specialties responded to the survey. During telemedicine visits, most providers felt their clinical skills were challenged (61.8%). Female providers felt more challenged than male providers (70.7% versus 50.9%, P=.002). Surgeons, obstetricians, and gynecologists felt their clinical skills were challenged the least, compared to providers from nonsurgical specialties (P<.001). Challenges related to the delivery modality, diagnostic process, and patient-provider relationship differed by provider specialty (P=.046, P<.001, and P=.02, respectively). CONCLUSIONS: Telemedicine implemented in response to the COVID-19 pandemic produced high patient and provider satisfaction. Specialty groups perceived the impact of this new mode of clinical practice differently.