Background Steroid use for COVID-19 is based on the possible role of these drugs in mitigating the inflammatory response, mainly in the lungs, triggered by SARS-CoV-2. This study aimed at evaluating at evaluating the efficacy of methylprednisolone (MP) among hospitalized patients with suspected COVID-19. Methods Parallel, double-blind, placebo-controlled, randomized, phase IIb clinical trial was performed with hospitalized patients aged ≥ 18 years with clinical, epidemiological and/or radiological suspected COVID-19, at a tertiary care facility in Manaus, Brazil. Patients were randomly allocated (1:1 ratio) to receive either intravenous MP (0.5 mg/kg) or placebo (saline solution), twice daily, for 5 days. A modified intention-to-treat (mITT) analysis was conducted. The primary outcome was 28-day mortality. ClinicalTrials Identifier NCT04343729. Findings From April 18 to June 16, 2020, 647 patients were screened, 416 randomized, and 393 analyzed as mITT, MP in 194 and placebo in 199 individuals. SARS-CoV-2 infection was confirmed by RT-PCR in 81.3%. Mortality at day 28 was not different between groups. A subgroup analysis showed that patients over 60 years in the MP group had a lower mortality rate at day 28. Patients in the MP arm tended to need more insulin therapy, and no difference was seen in virus clearance in respiratory secretion until day 7. Conclusion The findings of this study suggest that a short course of MP in hospitalized patients with COVID-19 did not reduce mortality in the overall population.
Background Relapses in vivax malaria have posed great challenges for malaria control, and they also account for a great proportion of reported cases. Knowing the real effectiveness of a 7-day primaquine (PQ) scheme is crucial in order to evaluate not only the cost-effectiveness of implementing new anti-hypnozoite drugs, but also how health education strategies can guarantee better compliance and be reinforced. This study aimed to evaluate the effect of daily treatment with chloroquine and PQ supervised by health workers versus prescription without supervision. Methods The outcome was the passive detection of new positive thick blood smears up to 180 days, based on the official data records from the National Malaria Control Programme. The recurrences seen in the real life were, therefore, used as a surrogate for true relapses. Results Patients under supervised treatment had a lower risk of recurrence up to day 180 when compared to the unsupervised treatment (17.9% vs. 36.1%; p = 0.027). Conclusions The lack of supervision in the non-supervised group (which followed standard of care in the real life) enabled proper comparison, as consent itself would have lead to greater compliance in this group. Future studies should scale such an analysis to different settings in the Brazilian Amazon.
BackgroundRelapses in vivax malaria have posed great challenges to malaria control, accounting for a great proportion of reported cases. Knowing the real effectiveness of 7 day primaquine (PQ) scheme is crucial to understand not only the cost-effectiveness of implementing new anti-hypnozoite drugs but how health education strategies can guarantee better compliance and be reinforced. This study aimed the evaluation of the daily supervised treatment effect with chloroquine and PQ (in consented patients) versus prescription without supervision (non-consented patients), and the outcome was the passive detection of new positive thick blood smears until 180 days, based on the official data records from the National Malaria Control Program. The recurrences seen in the real life were therefore used as a surrogate for true relapses. Patients under supervised treatment had a lower risk of recurrence until day 180 when compared to the unsupervised treatment (17.9% vs 36.1%; p=0.027). The lack of consent in the non-supervised group (which followed standard of care in the real life) enabled proper comparison, as consent itself could lead to better compliance in this group. Future studies should scale such analysis to different settings in the Brazilian Amazon.
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