RESUMO
Importance: There is an urgent need to identify treatments for postacute sequelae of SARS-CoV-2 infection (PASC). Objective: To assess the efficacy of a 15-day course of nirmatrelvir-ritonavir in reducing the severity of select PASC symptoms. Design, Setting, and Participants: This was a 15-week blinded, placebo-controlled, randomized clinical trial conducted from November 2022 to September 2023 at Stanford University (California). The participants were adults with moderate to severe PASC symptoms of 3 months or longer duration. Interventions: Participants were randomized 2:1 to treatment with oral nirmatrelvir-ritonavir (NMV/r, 300 mg and 100 mg) or with placebo-ritonavir (PBO/r) twice daily for 15 days. Main Outcomes and Measures: Primary outcome was a pooled severity of 6 PASC symptoms (fatigue, brain fog, shortness of breath, body aches, gastrointestinal symptoms, and cardiovascular symptoms) based on a Likert scale score at 10 weeks. Secondary outcomes included symptom severity at different time points, symptom burden and relief, patient global measures, Patient-Reported Outcomes Measurement Information System (PROMIS) measures, orthostatic vital signs, and sit-to-stand test change from baseline. Results: Of the 155 participants (median [IQR] age, 43 [34-54] years; 92 [59%] females), 102 were randomized to the NMV/r group and 53 to the PBO/r group. Nearly all participants (n = 153) had received the primary series for COVID-19 vaccination. Mean (SD) time between index SARS-CoV-2 infection and randomization was 17.5 (9.1) months. There was no statistically significant difference in the model-derived severity outcome pooled across the 6 core symptoms at 10 weeks between the NMV/r and PBO/r groups. No statistically significant between-group differences were found at 10 weeks in the Patient Global Impression of Severity or Patient Global Impression of Change scores, summative symptom scores, and change from baseline to 10 weeks in PROMIS fatigue, dyspnea, cognitive function, and physical function measures. Adverse event rates were similar in NMV/r and PBO/r groups and mostly of low grade. Conclusions and Relevance: The results of this randomized clinical trial showed that a 15-day course of NMV/r in a population of patients with PASC was generally safe but did not demonstrate a significant benefit for improving select PASC symptoms in a mostly vaccinated cohort with protracted symptom duration. Further studies are needed to determine the role of antivirals in the treatment of PASC. Trial Registration: ClinicalTrials.gov Identifier: NCT05576662.
RESUMO
Introduction: The COVID-19 pandemic will have widespread health, economic, and psychological consequences. Reports indicate the Latino community is particularly vulnerable to the economic and health risks of this pandemic as a consequence of systemic oppression. Latina mothers, in particular, are navigating the pandemic from their racialized, gendered, and classed positions while caring for children and families. These factors are likely to have a significant psychological toll. Method: The sample consisted of 70 Latina mothers. The majority of the families (72%) contained at least one employed adult, of which 91.7% were essential workers. Factors associated with stress, depressive symptoms, and anxiety symptoms during the initial March 20 - June 1, 2020 California "shelter in place" mandate were assessed via phone survey using validated measures and Likert-scale items created for the study. Receipt of the federal stimulus check on stress, depressive symptoms, and anxiety symptoms was also assessed. Results: Due to the pandemic, 52.7% of the mothers reported being forced to engage in economic cutbacks. Mothers' experiences of stress during the outbreak stem from worries about themselves contracting the virus and making economic cutbacks. Economic cutbacks were also associated with greater reports of depressive and anxiety symptoms. Receiving the stimulus payment did not reduce economic cutbacks, contract worries, stress, or depressive and anxiety symptoms. Conclusion: Findings highlight the pandemic's immediate economic toll on Latino families. Further, these economic implications seem to be having downstream effects on mothers' psychological well-being, that were not alleviated by the stimulus payment.