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1.
Medicine (Baltimore) ; 100(51): e28288, 2021 Dec 23.
Article in English | MEDLINE | ID: covidwho-1591728

ABSTRACT

BACKGROUND: Coronavirus disease 2019 (COVID-19) is a viral respiratory disease that spreads rapidly, reaching pandemic status, causing the collapse of numerous health systems, and a strong economic and social impact. The treatment so far has not been well established and there are several clinical trials testing known drugs that have antiviral activity, due to the urgency that the global situation imposes. Drugs with specific mechanisms of action can take years to be discovered, while vaccines may also take a long time to be widely distributed while new virus variants emerge. Thus, drug repositioning has been shown to be a good strategy for defining new therapeutic approaches. Studies of the effect of enriched heparin in the replication of severe acute respiratory syndrome Coronavirus 2 (SARS-CoV-2) in vitro assays justify the advance for clinical tests. METHODS AND ANALYSIS: A phase I/II triple-blind parallel clinical trial will be conducted. Fifty participants with radiological diagnosis of grade IIA pneumonia will be selected, which will be allocated in 2 arms. Participants allocated in Group 1 (placebo) will receive nebulized 0.9% saline. Participants allocated in Group 2 (intervention) will receive nebulized enriched heparin (2.5 mg/mL 0.9% saline). Both groups will receive the respective solutions on a 4/4 hour basis, for 7 days. The main outcomes of interest will be safety (absence of serious adverse events) and efficacy (measured by the viral load).Protocols will be filled on a daily basis, ranging from day 0 (diagnosis) until day 8.


Subject(s)
COVID-19 Drug Treatment , Heparin/therapeutic use , Clinical Trials, Phase I as Topic , Clinical Trials, Phase II as Topic , Humans , Randomized Controlled Trials as Topic , Saline Solution , Treatment Outcome
3.
Psychiatry Res ; 296: 113669, 2021 02.
Article in English | MEDLINE | ID: covidwho-989071

ABSTRACT

This study aimed to analyze the possible impacts on the prison population's mental health in the context of the new COVID-19 pandemic. Qualitative study was carried out following a lexical and content analysis using the software IRaMuTeQ, version 0.7 alpha 2, in the speech of the short communication and headlines from newspapers. Three groups emerged from the analysis: "spatial conditions for infection" (39.2% of the text segments); "disease outbreaks in prisons" (30,4%) and "public responsibility" (30,4%). Precarious conditions of prisons, high rate of infections and psychiatric illnesses, and lack of government assistance are issues that should be given special attention in order to formulate health promotion and prevention policies focusing on mental health in prison population.


Subject(s)
COVID-19/epidemiology , Mental Disorders/epidemiology , Prisoners/statistics & numerical data , COVID-19/prevention & control , COVID-19/psychology , Comorbidity , Cross-Sectional Studies , Evaluation Studies as Topic , Health Promotion , Humans , Mental Disorders/prevention & control , Mental Disorders/psychology , Prisoners/psychology , Public Assistance , Risk Factors
4.
N Engl J Med ; 383(21): 2041-2052, 2020 11 19.
Article in English | MEDLINE | ID: covidwho-670007

ABSTRACT

BACKGROUND: Hydroxychloroquine and azithromycin have been used to treat patients with coronavirus disease 2019 (Covid-19). However, evidence on the safety and efficacy of these therapies is limited. METHODS: We conducted a multicenter, randomized, open-label, three-group, controlled trial involving hospitalized patients with suspected or confirmed Covid-19 who were receiving either no supplemental oxygen or a maximum of 4 liters per minute of supplemental oxygen. Patients were randomly assigned in a 1:1:1 ratio to receive standard care, standard care plus hydroxychloroquine at a dose of 400 mg twice daily, or standard care plus hydroxychloroquine at a dose of 400 mg twice daily plus azithromycin at a dose of 500 mg once daily for 7 days. The primary outcome was clinical status at 15 days as assessed with the use of a seven-level ordinal scale (with levels ranging from one to seven and higher scores indicating a worse condition) in the modified intention-to-treat population (patients with a confirmed diagnosis of Covid-19). Safety was also assessed. RESULTS: A total of 667 patients underwent randomization; 504 patients had confirmed Covid-19 and were included in the modified intention-to-treat analysis. As compared with standard care, the proportional odds of having a higher score on the seven-point ordinal scale at 15 days was not affected by either hydroxychloroquine alone (odds ratio, 1.21; 95% confidence interval [CI], 0.69 to 2.11; P = 1.00) or hydroxychloroquine plus azithromycin (odds ratio, 0.99; 95% CI, 0.57 to 1.73; P = 1.00). Prolongation of the corrected QT interval and elevation of liver-enzyme levels were more frequent in patients receiving hydroxychloroquine, alone or with azithromycin, than in those who were not receiving either agent. CONCLUSIONS: Among patients hospitalized with mild-to-moderate Covid-19, the use of hydroxychloroquine, alone or with azithromycin, did not improve clinical status at 15 days as compared with standard care. (Funded by the Coalition Covid-19 Brazil and EMS Pharma; ClinicalTrials.gov number, NCT04322123.).


Subject(s)
Antiviral Agents/administration & dosage , Azithromycin/administration & dosage , Coronavirus Infections/drug therapy , Hydroxychloroquine/administration & dosage , Pneumonia, Viral/drug therapy , Adult , Aged , Aged, 80 and over , Antiviral Agents/therapeutic use , Azithromycin/therapeutic use , Betacoronavirus , Brazil , COVID-19 , Drug Therapy, Combination , Female , Hospitalization , Humans , Hydroxychloroquine/therapeutic use , Male , Middle Aged , Pandemics , Patient Acuity , SARS-CoV-2 , Treatment Failure , COVID-19 Drug Treatment
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