ABSTRACT
Rationale The ACTIV 4B (OWS/NHLBI supported) clinical trial addresses the use of anti-platelet and anticoagulant agents in symptomatic COVID-19 positive non-hospitalized patients with regards to safety and prevention of macro- and micro-thrombotic events using a composite outcome (symptomatic DVT/PE, arterial thromboembolism, MI, CVA, hospitalization for CV/pulmonary events, mortality). Concerns regarding SARS-CoV- 2 transmission risk to research staff and overburdened institutional environments create challenges for standard event monitoring. In addition, safety or outcome events often occur at other institutions rather than the enrollment site. Therefore, research methodology was adapted to effectively evaluate and categorize safety events using a remote low touch approach. Methods Trial over can be found at NCT04498273. Potential adverse events identified through patient electronic data capture survey or call center assessments are handled remotely by central clinical study staff. If an event is identified as a possible endpoint or SAE by the central study staff the electronic data collection (EDC) system notifies the central medical monitoring team, and the enrolling site coordinator if patient enrolled from an acute care setting, that additional source documents are necessary. The medical coordinator works with the site coordinator, or will reach out independently to treating institutions to obtain necessary source documents. Based on a review of clinical data from the EDC and all available source documents, final arbitration of seriousness, relatedness and expectedness is be made by the study's Medical Monitor, and appropriate study entities (NIH, FDA, IRB, study leadership, pharmaceutical co.) are notified.Results The process as described has been successfully and effectively implemented in >50 patients with anticipation of 7000 patient eventual enrollment. Events have been captured, source documentation has been procured and events have been reported as per established protocol processes. Conclusion We have effectively implemented a medical safety event monitoring methodology in a “low touch” study design to assess events in the complex COVID-19 outpatient space. Elements of our system can be effectively replicated in other COVID and non-COVID clinical trials. .
ABSTRACT
Aims: People with COPD and persons with HIV have been recognized as medically and socially vulnerable populations during the COVID-19 pandemic. Data on the impact of the pandemic and its response on the psychosocial wellbeing and medical care of persons living with HIV and COPD is lacking. We evaluated the mental health and health-care utilization consequences during the pandemic in this population. Methods: We surveyed Pittsburgh HIV Lung Cohort participants from May through July 2020. Demographic and clinical data included age, sex, race and smoking history. Anxiety, depression and insomnia during the pandemic were evaluated using the General Anxiety Disorder-7 scale, Patient Health Questionnaire- 9 and Insomnia Severity Index. The survey assessed for COVID-19 symptoms, health-care access/ utilization and risk/protective behaviours. Continuous variables were compared between participants with and without COPD using t-test and Mann-Whitney test as appropriate and categorical variables were compared using Fisher's exact test. Multiple and ordinal logistic regression was used to evaluate the association of COPD and any interaction effect by HIV status with anxiety, depression, insomnia, general health status, health-care utilization and risk/protective behaviours. All statistical tests were two-sided. Results: 136 individuals were included: age 57.9 ±9.5 years;76.5% male;60.3% Caucasian and 39% Black;47% current or former smokers. Forty-two (30.9%) respondents screened positive for anxiety disorders, 35 (25.7%) had major depressive disorder and 7 (5.1%) reported insomnia. Median scores and proportions across categories by severity of symptoms did not differ by COPD status. Of 22 participants with new or worsening symptoms that could be related to COVID-19, only 10 sought medical care. Participants with COPD reported similar levels of concern about seeking care due to potential COVID-19 exposures (50.0% versus 42.9%;P=0.64), interruptions in medical care (30.4% versus 27.4%;P=0.801) and a trend to less delay in diagnostic testing as those without COPD (8.7% versus 20.4%;P=0.247). Individuals with COPD were more likely to have sought emergent or urgent care since March (30.4% versus 8.0%;P=0.007). Although all respondents reported practicing social-distancing and masking, the majority (119;87.5%) had in fact continued interacting with people outside the household and 38 (27.9%) joined large gatherings. Those with COPD reported similar risk behaviour as those without. There was no interaction effect by HIV status. See Table 1. Conclusions: Anxiety, depression and concern of COVID-19 exposure were prevalent among persons with and without COPD or HIV. Many respondents experienced interruptions in medical care and diagnostic testing and concern about health-care-associated COVID-19 exposure, but this was not more severe inthose with COPD or HIV. Despite likely higher risk of poor outcome in those with COPD, individuals with COPD were not more likely to curtail social interactions than those without COPD. HIV status also did not seem to modify the impact of COVID-19 on behaviours in this group.