- MeSH
- lidé MeSH
- management bolesti metody MeSH
- pooperační bolest * terapie MeSH
- Check Tag
- lidé MeSH
- Publikační typ
- směrnice pro lékařskou praxi MeSH
We collected a multi-centric retrospective dataset of patients (N = 213) who were admitted to ten hospitals in Czech Republic and tested positive for SARS-CoV-2 during the early phases of the pandemic in March-October 2020. The dataset contains baseline patient characteristics, breathing support required, pharmacological treatment received and multiple markers on daily resolution. Patients in the dataset were treated with hydroxychloroquine (N = 108), azithromycin (N = 72), favipiravir (N = 9), convalescent plasma (N = 7), dexamethasone (N = 4) and remdesivir (N = 3), often in combination. To explore association between treatments and patient outcomes we performed multiverse analysis, observing how the conclusions change between defensible choices of statistical model, predictors included in the model and other analytical degrees of freedom. Weak evidence to constrain the potential efficacy of azithromycin and favipiravir can be extracted from the data. Additionally, we performed external validation of several proposed prognostic models for Covid-19 severity showing that they mostly perform unsatisfactorily on our dataset.
- MeSH
- COVID-19 epidemiologie patologie terapie MeSH
- dospělí MeSH
- farmakoterapie COVID-19 MeSH
- hospitalizace * MeSH
- lidé středního věku MeSH
- lidé MeSH
- progrese nemoci * MeSH
- senioři MeSH
- statistické modely MeSH
- Check Tag
- dospělí MeSH
- lidé středního věku MeSH
- lidé MeSH
- mužské pohlaví MeSH
- senioři MeSH
- ženské pohlaví MeSH
- Publikační typ
- časopisecké články MeSH
- práce podpořená grantem MeSH
- Geografické názvy
- Česká republika MeSH
BACKGROUND: Novel coronavirus SARS-CoV-2 is known to be susceptible in vitro to exposure to hydroxychloroquine and its effect has been found to be potentiated by azithromycin. We hypothesise that early administration of hydroxychloroquine alone or in combination with azithromycin can prevent respiratory deterioration in patients admitted to intensive care due to rapidly progressive COVID-19 infection. METHODS: Design: Prospective, multi-centre, double-blind, randomised, controlled trial (RCT). PARTICIPANTS: Adult (> 18 years) within 24 h of admission to the intensive care unit with proven or suspected COVID-19 infection, whether or not mechanically ventilated. Exclusion criteria include duration symptoms of febrile disease for ≥ 1 week, treatment limitations in place or moribund patients, allergy or intolerance of any study treatment, and pregnancy. INTERVENTIONS: Patients will be randomised in 1:1:1 ratio to receive Hydroxychloroquine 800 mg orally in two doses followed by 400 mg daily in two doses and azithromycin 500 mg orally in one dose followed by 250 mg in one dose for a total of 5 days (HC-A group) or hydroxychloroquine + placebo (HC group) or placebo + placebo (C-group) in addition to the best standard of care, which may evolve during the trial period but will not differ between groups. Primary outcome is the composite percentage of patients alive and not on end-of-life pathway who are free of mechanical ventilation at day 14. SECONDARY OUTCOMES: The percentage of patients who were prevented from needing intubation until day 14, ICU length of stay, and mortality (in hospital) at day 28 and 90. DISCUSSION: Although both investigational drugs are often administered off label to patients with severe COVID-19, at present, there is no data from RCTs on their safety and efficacy. In vitro and observational trial suggests their potential to limit viral replication and the damage to lungs as the most common reason for ICU admission. Therefore, patients most likely to benefit from the treatment are those with severe but early disease. This trial is designed and powered to investigate whether the treatment in this cohort of patients leads to improved clinical patient-centred outcomes, such as mechanical ventilation-free survival. TRIAL REGISTRATION: Clinical trials.gov: NCT04339816 (Registered on 9 April 2020, amended on 22 June 2020); Eudra CT number: 2020-001456-18 (Registered on 29 March 2020).
- MeSH
- azithromycin aplikace a dávkování MeSH
- Betacoronavirus * MeSH
- dvojitá slepá metoda MeSH
- hydroxychlorochin aplikace a dávkování MeSH
- jednotky intenzivní péče MeSH
- kombinovaná farmakoterapie MeSH
- koronavirové infekce farmakoterapie mortalita MeSH
- lidé MeSH
- pandemie MeSH
- prospektivní studie MeSH
- randomizované kontrolované studie jako téma * MeSH
- virová pneumonie farmakoterapie mortalita MeSH
- Check Tag
- lidé MeSH
- Publikační typ
- časopisecké články MeSH
- multicentrická studie MeSH
- protokol klinické studie MeSH
- MeSH
- chronická bolest MeSH
- kliniky pro terapii bolesti MeSH
- kohortové studie MeSH
- lidé MeSH
- management bolesti MeSH
- měření bolesti MeSH
- pooperační bolest * MeSH
- průzkumy a dotazníky MeSH
- randomizované kontrolované studie jako téma MeSH
- retrospektivní studie MeSH
- rizikové faktory MeSH
- Check Tag
- lidé MeSH
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- MeSH
- dítě MeSH
- dospělí MeSH
- kojenec MeSH
- management bolesti metody trendy MeSH
- měření bolesti metody MeSH
- neopioidní analgetika aplikace a dávkování farmakologie MeSH
- opioidní analgetika aplikace a dávkování farmakologie MeSH
- pacientem kontrolovaná analgezie metody MeSH
- pooperační bolest * diagnóza klasifikace terapie MeSH
- pooperační péče MeSH
- senioři MeSH
- způsoby aplikace léků MeSH
- Check Tag
- dítě MeSH
- dospělí MeSH
- kojenec MeSH
- senioři MeSH
- Publikační typ
- přehledy MeSH
- Publikační typ
- abstrakt z konference MeSH
- Klíčová slova
- komplikace léčby pooperační bolesti, servis pro léčbu akutní bolesti,
- MeSH
- celková anestezie škodlivé účinky využití MeSH
- lidé MeSH
- management nemoci MeSH
- měření bolesti účinky léků MeSH
- pooperační bolest farmakoterapie klasifikace MeSH
- pooperační komplikace farmakoterapie MeSH
- Check Tag
- lidé MeSH
