ABSTRACT
Background: Repurposed drugs for treatment of new onset disease may be an effective therapeutic shortcut. We aimed to evaluate the efficacy of repurposed antivirals compared to placebo in lowering SARS-CoV2 viral load of COVID-19 patients. Methods: REVOLUTIOn is a randomised, parallel, blinded, multistage, superiority and placebo controlled randomised trial conducted in 35 centres in Brazil. We include patients aged 18 years or older admitted to hospital with laboratory-confirmed SARS-CoV-2 infection, symptoms onset 9 days or less and SpO2 94% or lower at room air were eligible. All participants were randomly allocated to receive either atazanavir, daclatasvir or sofosbuvir/daclatasvir or placebo for 10 days. The primary outcome was the decay rate (slope) of the SARS-CoV-2 viral load logarithm assessed in the modified intention to-treat population. This trial was registered with ClinicalTrials.gov, number NCT04468087. Findings: Between February 09, 2021, and August 04, 2021, 255 participants were enrolled and randomly assigned to atazanavir (n = 64), daclatasvir (n = 66), sofosbuvir/daclatasvir (n = 67) or placebo (n = 58). Compared to placebo group, the change from baseline to day 10 in log viral load was not significantly different for any of the treatment groups (0.05 [95% CI, -0.03 to 0.12], -0.02 [95% CI, -0.09 to 0.06], and -0.03 [95% CI, -0.11 to 0.04] for atazanavir, daclatasvir and sofosbuvir/daclatasvir groups respectively). There was no significant difference in the occurrence of serious adverse events between treatment groups. Interpretation: No significant reduction in viral load was observed from the use of atazanavir, daclatasvir or sofosbuvir/daclatasvir compared to placebo in hospitalised COVID-19 patients who need oxygen support with symptoms onset 9 days or less. Funding: Ministério da Ciência, Tecnologia e Inovação (MCTI) - Conselho Nacional de Desenvolvimento Científico e Tecnológico (CNPQ); Cia Latino-Americana de Medicamentos (Clamed); Cia Industrial H. Carlos Schneider (Ciser); Hospital Research Foundation Incorporation, Australia, HCor São Paulo; Blanver Farmoquímica; Instituto de Tecnologia em Fármacos (Farmanguinhos) da Fundação Oswaldo Cruz (Fiocruz); Coordenação Geral de Planejamento Estratégico (Cogeplan)/Fiocruz; and Fundação de apoio a Fiocruz (Fiotec, VPGDI-054-FIO-20-2-13).
ABSTRACT
PURPOSE: Little is known about how caregiving affects the quality of life (QoL) of older family carers and no dementia and age-specific QoL scale is available for use with this population. This study aimed to develop and validate a unique dementia caregiving- and age-specific tool - the 'Dementia Quality of Life Scale for Older Family Carers' (DQoL-OC). METHODS: The scale items were identified in focus groups with older family carers in the UK. Content and face validity were evaluated by a panel of six experts. A set of 100 items assessed on a 5-point Likert scale was tested with 182 older family carers. Test-re-test reliability was conducted with 18 individuals. Exploratory factor analysis was used to identify the QoL model and reduce the number of scale items. Convergent construct validity and internal consistency were also established. RESULTS: A one-factor solution containing 22 items was obtained. Test-re-test reliability (lower bound r = 0.835; p < 0.001), internal consistency (Cronbach's α = 0.936), and convergent construct validity were established. Significantly lower levels of QoL were found in female older carers; those who perceived their relatives with dementia as being at the earlier stages of the disease and with unstable dementia symptoms; those providing care more hours per day and more days per week; and those in younger-old age. CONCLUSIONS: The DQoL-OC is a valid and reliable scale that will be useful for research and in clinical practice with older family carers of people with dementia. These study results will inform future health and social care aiming to improve life quality for this overlooked population of carers.
