Background The uptake of nirmatrelvir plus ritonavir (NPR) in patients with COVID-19 has been limited by concerns around the rebound phenomenon despite the scarcity of evidence around its epidemiology. The purpose of this study was to prospectively compare the epidemiology of rebound in NPR-treated and untreated participants with acute COVID-19 infection. Methods We designed a prospective, observational study in which participants who tested positive for COVID-19 and were clinically eligible for NPR were recruited to be evaluated for either viral or symptom clearance and rebound. Participants were assigned to the treatment or control group based on their decision to take NPR. Following initial diagnosis, both groups were provided 12 rapid antigen tests and asked to test on a regular schedule for 16 days and answer symptom surveys. Viral rebound based on test results and COVID-19 symptom rebound based on patient-reported symptoms were evaluated. Results Viral rebound incidence was 14.2% in the NPR treatment group (n=127) and 9.3% in the control group (n=43). Symptom rebound incidence was higher in the treatment group (18.9%) compared to controls (7.0%). There were no notable differences in viral rebound by age, gender, pre-existing conditions, or major symptom groups during the acute phase or at the 1-month interval. Conclusion This preliminary report suggests that rebound after clearance of test positivity or symptom resolution is higher than previously reported. However, notably we observed a similar rate of rebound in both the NPR treatment and control groups. Large studies with diverse participants and extended follow-up are needed to better understand the rebound phenomena.
Introduction: The uptake of Paxlovid in individuals infected with COVID-19 has been significantly limited by concerns around the Paxlovid rebound phenomenon despite the scarcity of evidence around its epidemiology. The purpose of this study was to prospectively compare the epidemiology of Paxlovid rebound in treated and untreated participants with acute COVID-19 infection Methods: We designed a digital, prospective observational study, which included participants who tested positive for COVID-19 and were clinically eligible for Paxlovid. Participants were assigned to a Paxlovid or control group based on their decision to take the medication. Both groups were provided 12 rapid antigen tests and asked to test and answer symptom surveys on a regular frequent schedule for 16 days. Viral rebound based on test results and COVID-19 symptom rebound based on patient reported symptoms were evaluated. Results: Viral rebound incidence was 14.2% in the Paxlovid group (n=127) and 9.3% in the control group (n=43). COVID-19 symptom rebound incidence was higher in the Paxlovid group (18.9%) compared to the control group (7.0%). There were no notable differences in viral rebound by age, gender, pre-existing conditions, or major symptom groups during the acute phase or at the 1-month interval. Conclusion: This preliminary report of our prospective study suggests that rebound after clearance of test positivity or symptom resolution is higher than previously reported. However, we observed a similar rate of rebound in both in the Paxlovid and control groups. Large studies with diverse participants and extended follow-up are needed to better understand the rebound phenomena.
Electronic health record (EHR) technology has become a central digital health tool throughout health care. EHR systems are responsible for a growing number of vital functions for hospitals and providers. More recently, patient-facing EHR tools are allowing patients to interact with their EHR and connect external sources of health data, such as wearable fitness trackers, personal genomics, and outside health services, to it. As patients become more engaged with their EHR, the volume and variety of digital health information will serve an increasingly useful role in health care and health research. Particularly due to the COVID-19 pandemic, the ability for the biomedical research community to pivot to fully remote research, driven largely by EHR data capture and other digital health tools, is an exciting development that can significantly reduce burden on study participants, improve diversity in clinical research, and equip researchers with more robust clinical data. In this viewpoint, we describe how patient engagement with EHR technology is poised to advance the digital clinical trial space, an innovative research model that is uniquely accessible and inclusive for study participants.
UNSTRUCTURED Electronic health record (EHR) technology has become a central digital health tool throughout health care. EHR systems are responsible for a growing number of vital functions for hospitals and providers. More recently, patient-facing EHR tools are allowing patients to interact with their EHR and connect external sources of health data such as from wearable fitness trackers, personal genomics, and outside health services. As patients become more engaged with their EHR, the volume and variety of digital health information will serve an increasingly useful role in health care and health research. Particularly due to the Covid-19 pandemic, the ability for the biomedical research community to pivot to fully remote research, driven in large part by EHR data capture and other digital health tools, is an exciting development that can significantly reduce burden on study participants, improve diversity in clinical research, and equip researchers with more robust clinical data. In this article we describe how patient engagement with EHR technology is poised to advance the digital clinical trial space, an innovative research model that is uniquely accessible and inclusive for study participants.
BACKGROUND Maternal health outcomes have been under-researched due to pregnant people being underrepresented or excluded from studies based on their status as a vulnerable population. Medication use, safety, dosing, and efficacy have been particularly understudied in pregnant people, even though it has been shown up to 95% of pregnant people take medications. Utilization of medications and prenatal vitamins across under-represented pregnant populations is not well understood, particulary for communities that are underrepresented in biomedical research (UBR). OBJECTIVE We aimed to characterize and compare the use of prenatal vitamins, and commonly used over the counter and prescription medications, among pregnant people self-identifying as Black versus non-Black and those living in rural versus urban regions in the United States. METHODS We conducted a prospective, decentralized study of 4,130 pregnant study participants who answered survey questionnaires using a mobile research app. All pregnant people living in the U.S. comfortable with reading and writing in English were eligible. The study was conducted in a decentralized fashion with the use of a study app to facilitate enrollment using an eConsent and self-reported data collection. RESULTS Among the study population, there was significantly different utilization of prenatal vitamins, antiemetics, antidepressants, and pain medication across different UBR sub-populations. Black participants reported significantly lower frequencies of prenatal vitamin use compared to non-Black participants (p<0.0001). The frequency of participants who were currently receiving treatment for anxiety and depression also differed by both racial and rural/urban sub-groups. There was significantly lower use of antidepressants (p=0.002) and antiemetics (p=0.02) among Black compared to non-Black participants. CONCLUSIONS A prospective decentralized study demonstrated lower use of prenatal vitamins among Black, non-White, and rural pregnant participants and lower use of anti-emetics among Black pregnant participants. Additional research dedicated to identifying how and why these utilization disparities exist can help improve maternal health outcomes, specifically for diverse communities. CLINICALTRIAL NCT03085875
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