RESUMEN
Background: Previous Randomised controlled trials (RCT) evaluating chloroquine and hydroxychloroquine in non-hospitalised COVID-19 patients have found no significant difference in hospitalisation rates. However, low statistical power precluded definitive answers. Methods: We conducted a multicenter, double-blind, RCT in 56 Brazilian sites. Adults with suspected or confirmed COVID-19 presenting with mild or moderate symptoms with ≤ 07 days prior to enrollment and at least one risk factor for clinical deterioration were randomised (1:1) to receive hydroxychloroquine 400 mg twice a day (BID) in the first day, 400 mg once daily (OD) thereafter for a total of seven days, or matching placebo. The primary outcome was hospitalisation due to COVID-19 at 30 days, which was assessed by an adjudication committee masked to treatment allocation and following the intention-to-treat (ITT) principle. An additional analysis was performed only in participants with SARS-CoV-2 infection confirmed by molecular or serology testing (modified ITT [mITT] analysis). This trial was registered at ClinicalTrials.gov, NCT04466540. Findings: From May 12, 2020 to July 07, 2021, 1372 patients were randomly allocated to hydroxychloroquine or placebo. There was no significant difference in the risk of hospitalisation between hydroxychloroquine and placebo groups (44/689 [6·4%] and 57/683 [8·3%], RR 0·77 [95% CI 0·52-1·12], respectively, p=0·16), and similar results were found in the mITT analysis with 43/478 [9·0%] and 55/471 [11·7%] events, RR 0·77 [95% CI 0·53-1·12)], respectively, p=0·17. To further complement our data, we conducted a meta-analysis which suggested no significant benefit of hydroxychloroquine in reducing hospitalisation among patients with positive testing (69/1222 [5·6%], and 88/1186 [7·4%]; RR 0·77 [95% CI 0·57-1·04]). Interpretation: In outpatients with mild or moderate forms of COVID-19, the use of hydroxychloroquine did not reduce the risk of hospitalisation compared to the placebo control. Our findings do not support the routine use of hydroxychloroquine for treatment of COVID-19 in the outpatient setting. Funding: COALITION COVID-19 Brazil and EMS.
RESUMEN
OBJECTIVE: To clarify whether, in healthy individuals, practicing yoga can modify maximal inspiratory pressure and spirometric indices when compared with the practice of aerobic exercise. MEYHODS: A controlled clinical trial. A total of 31 healthy volunteers were allocated to practice aerobic exercise (n = 15) or to practice yoga (n = 16). Those in the first group served as controls and engaged in aerobic exercise for 45-60 minutes, twice a week for three months. Those in the second group practiced selected yogic techniques, also in sessions of 45-60 minutes, twice a week for three months. Forced vital capacity, forced expiratory volume in one second and maximal inspiratory pressure were measured before and after the three months of training. RESULTS: No significant alterations were seen in the spirometric indices. A slight, although not significant, improvement in maximal inspiratory pressure was seen in both groups. However, there was a significant difference, seen in both genders, between the absolute delta (final value minus baseline value) of maximal inspiratory pressure for the group practicing yoga and that obtained for the group engaging in aerobic exercise (males: 19.5 cm H2O versus 2.8 cm H2O, p = 0.05; females: 20 cm H2O versus 3.9 cm H2O, p = 0.01). CONCLUSION: Neither yoga nor aerobic exercise provided a statistically significant improvement in maximal inspiratory pressure after three months. However, the absolute variation in maximal inspiratory pressure was greater among those practicing yoga.