ABSTRACT
PurposeThis small-scale, prospective cohort study nested within a randomized controlled trial aimed to investigate the possible associations between physical activity levels and clinical outcomes among hospitalized patients with severe COVID-19. MethodsHospitalized patients with severe COVID-19 were recruited from Clinical Hospital of the School of Medicine of the University of Sao Paulo (a quaternary referral teaching hospital), and from Ibirapuera Field Hospital, both located in Sao Paulo, Brazil. Physical activity levels were assessed by Baecke Questionnaire of Habitual Physical Activity. The primary outcome was hospital length of stay. The secondary outcomes were: mortality, admission to the intensive care unit (ICU), and mechanical ventilation requirement. ResultsMean hospital length of stay was 8.5 {+/-} 7.1 days; 3.3% of patients died, 13.8% were admitted to ICU, and 8.6% required mechanical ventilation. Linear regression models showed that physical activity indexes were not associated with hospital length of stay (work index: {beta}=-0.57 [95%CI: -1.80 to 0.65], p=0.355; sport index: {beta}=0.43 [95%CI: -0.94 to 1.80], p=0.536; leisure-time index: {beta}=1.18 [95%CI: -0.22 to 2.59], p=0.099; total activity index: {beta}=0.20 [95%CI: -0.48 to 0.87], p=0.563. Physical activity indexes were not associated with mortality, admission to ICU and mechanical ventilation requirement (all p>0.05). ConclusionsAmong hospitalized patients with COVID-19, physical activity did not associate with hospital length of stay or any other clinically-relevant outcomes. These findings suggest that previous physical activity levels may not change the prognosis of severe COVID-19.
Subject(s)
COVID-19ABSTRACT
Importance: Patients with COVID-19 may exhibit 25-hydroxyvitamin D deficiency, but the beneficial effects of vitamin D3 supplementation in this disease remain to be proven by randomized controlled trials. Objective: To investigate the efficacy and safety of vitamin D3 supplementation in patients with severe COVID-19. Design, Setting, and Participants: This is a multicenter, double-blind, randomized, placebo-controlled trial conducted in two centers (a quaternary hospital and a field hospital) in Sao Paulo, Brazil. The trial included 240 hospitalized patients with severe COVID-19. The study was conducted from June 2, 2020 to October 7, 2020. Interventions: Patients were randomly allocated (1:1 ratio) to receive either a single oral dose of 200,000 IU of vitamin D3 or placebo. Main Outcomes and Measures: The primary outcome was hospital length of stay, defined as hospital discharge from the date of randomization or death. Secondary outcomes were mortality, admission to ICU, mechanical ventilation requirement, and serum levels of 25-hydroxyvitamin D, creatinine, calcium, C-reactive protein, and D-dimer. Results: Of 240 randomized patients (mean age, 56 years; 56% men), 232 (96.7%) were included in the primary analysis. Log-rank test showed that hospital length of stay was comparable between the vitamin D3 supplementation and placebo groups (7.0 days [95% CI, 6.1 to 7.9] and 7.0 days [95% CI, 6.2 to 7.8 days]; hazard ratio, 1.12 [95% CI, 0.9 to 1.5]; P = .379; respectively). The rate of mortality (7.0% vs 5.1%; P = .590), admission to ICU (15.8% vs 21.2%; P = .314), and mechanical ventilation requirement (7.0% vs 14.4%; P = .090) did not significantly differ between groups. Vitamin D3 supplementation significantly increased serum 25-hydroxyvitamin D levels compared to placebo (difference, 24.0 ng/mL [95% CI, 21.0% to 26.9%]; P = .001). No adverse events were observed. Conclusions and Relevance: Among hospitalized patients with severe COVID-19, vitamin D3 supplementation was safe and increased 25-hydroxyvitamin D levels, but did not reduce hospital length of stay or any other relevant outcomes vs placebo. This trial does not support the use of vitamin D3 supplementation as an adjuvant treatment of patients with COVID-19.