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BackgroundObservational studies have reported an association between use of eye protection and reduced risk of SARS-CoV-2 infection and other respiratory viruses, but as for most non-pharmaceutical interventions for infection control, no randomized trials have been conducted. We conducted a randomized trial to evaluate the effectiveness of recommending the use of glasses in public as protection against being infected with SARS-CoV-2 and other respiratory viruses. Methods and findingsThis was a pragmatic, randomized, trial in Norway from 2 February to 24 April 2022 where all adult members of the public who did not regularly wear glasses, had no symptoms of COVID-19 and no COVID-19 in the last 6 weeks, were eligible. Participants randomized to the intervention group were asked to wear glasses (e.g. sunglasses) for 2 weeks when close to others in public spaces. The primary outcome was positive COVID-19 test result notified to the Norwegian Surveillance System for Communicable Diseases (MSIS). Secondary outcomes included positive COVID-19 test result based on self-report and episode of respiratory infection based on self-report of symptoms. We randomized 3717 participants. All were identified and followed up in the registries and 87% responded to the end of study-questionnaire. The proportions with a notified positive COVID-19 test in the national registry were 3.7% in the intervention group (68/1852) and 3.5% (65/1865) in the control group (95% CI for risk difference -1.0% to 1.4%; relative risk 1.10, 95% CI 0.75 to 1.50). The proportions with a positive COVID-19 test based on self-report were 9.6% and 11.5% (95% CI for risk difference -3.9% to 0.1%; relative risk 0.83, 95% CI 0.69 to 1.00). The risk of respiratory infections based on self-reported symptoms was lower in the intervention group (31% vs. 34%; 95% CI for risk difference -3.3% to -0.3%; relative risk 0.90, 95% CI 0.82 to 0.99). ConclusionsOur results indicate that asking people to wear glasses may protect the public against respiratory infections, but the findings are not certain, and the study needs replication. Although the evidence is uncertain, and the effect probably modest at best, wearing glasses may be worth considering as one component in the infection control toolbox since it is a simple, low burden, and low-cost intervention, with few negative consequences. Trial registrationClinicalTrials.gov Identifier: NCT05217797 FundingThe costs of running the trial were covered by the Centre for Epidemic Interventions Research (CEIR), Norwegian Institute of Public Health. The authors received no specific funding for this work
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ImportanceThere is concern that post-acute SARS-CoV-2 infection health outcomes ("post-COVID syndrome") in children could be a serious problem but at the same time there is concern about the validity of reported associations between infection and long-term outcomes. ObjectiveTo systematically assess the validity of reported post-acute SARS-CoV-2 infection health outcomes in children. Evidence ReviewA search on PubMed and Web of Science was conducted to identify studies published up to January 22, 2022, that reported on post-acute SARS-CoV-2 infection health outcomes in children (<18 years) with follow-up of [≥]2 months since detection of infection or [≥]1 month since recovery from acute illness. We assessed the consideration of confounding bias and causality, and the risk of bias. Findings21 studies including 81,896 children reported up to 97 symptoms with follow-up periods of 2-11.5 months. Fifteen studies had no control group. The reported proportion of children with post-COVID syndrome was between 0% and 66.5% in children with SARS-CoV-2 infection (n=16,986) and 2% to 53.3% in children without SARS-CoV-2 infection (n=64,910). Only 2 studies made a clear causal interpretation of an association of SARS-CoV-2 infection and the main outcome of "post-COVID syndrome" and provided recommendations regarding prevention measures. Two studies mentioned potential limitations in the conclusion of the main text but none of the 21 studies mentioned any limitations in the abstract nor made a clear statement for cautious interpretation. The validity of all 21 studies was seriously limited due to an overall critical risk of bias (critical risk for confounding bias [n=21]; serious or critical risk for selection bias [n=19]; serious risk for misclassification bias [n=3], for bias due to missing data [n=14] and for outcome measurement [n=12]; and critical risk for selective reporting bias [n=16]). Conclusions and RelevanceThe validity of reported post-acute SARS-CoV-2 infection health outcomes in children is critically limited. None of the studies provided evidence with reasonable certainty on whether SARS-CoV-2 infection has an impact on post-acute health outcomes, let alone to what extent. Children and their families urgently need much more reliable and methodologically robust evidence to address their concerns and improve care. KEY POINTSO_ST_ABSQuestionC_ST_ABSHow valid are the reported results on health outcomes in children after acute SARS-CoV-2 infection? FindingsWe identified 21 studies with only 6 using a controlled design. Reported post-acute health-outcomes were numerous and heterogeneous. The reported proportion of children with post-COVID syndrome was up to 66.5% in children with and 53.3% in children without SARS-CoV-2 infection. All studies had seriously limited validity due to critical and serious risk of bias in multiple domains. MeaningThe validity of reported post-acute SARS-CoV-2 infection health outcomes in children is critically limited and methodological robust evidence is urgently needed.
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BackgroundA systematic review of observational studies indicated that eye protection may be an effective measure to prevent SARS-CoV-2 infections. Randomized trials are needed to assess whether the observed associations are caused by protection of the eye or confounding factors such as other systematic differences between users and non-users of eye protection, co-interventions, or changes in COVID-19 incidence when comparisons were done over time. MethodsPragmatic, virtual, parallel group, 1:1 randomized, superiority trial. We will recruit and randomize participants via an online portal. The trial will be fully remote and virtual without any personal interaction between investigators and participants. All members of the public are eligible who confirm that they are at least 18 years of age, do not regularly wear glasses, have not contracted COVID-19 since December 15th 2021, and are willing to be randomized to wear, or not wear glasses in public when close to other people, for a 2-week period. Persons who are dependent on visual aids but typically use contact lenses are eligible. The participants will be randomized (1:1) to wear glasses (sunglasses or other types of glasses) in public spaces when close to others (public transport, shopping centers etc.), or to the control group. The control group will be asked not to wear glasses in public spaces when close to others. The primary outcome is positive test for COVID-19. We aim to include about 25,000 participants to have a statistical power of 80% to detect a relative risk reduction of 25% for the primary outcome. DiscussionMany have easy access to sunglasses or other glasses. Wearing glasses may provide eye protection and repurposing sunglasses for infection control could be a simple, readily available, environmentally friendly, safe, and sustainable infection prevention measure. Trial registrationNCT05217797 (Clinicaltrials.gov)
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BackgroundNumerous non-pharmaceutical interventions (NPIs) were taken worldwide to contain the spread of the COVID-19 pandemic. We aimed at providing an overview of randomized trials assessing NPIs to prevent COVID-19. MethodsWe included all randomized trials assessing NPIs to prevent COVID-19 in any country and setting registered in ClinicalTrials.gov and the World Health Organization International Clinical Trials Registry Platform using the COVID-evidence platform (until 17 August 2021). We searched for corresponding publications in MEDLINE/PubMed, Google Scholar, the Living Overview of Evidence platform (L-OVE), and the Cochrane COVID-19 registry as well as for results posted in registries. ResultsWe identified 41 randomized trials. Of them, 11 were completed (26.8%) including 7 with published results. The 41 trials planned to recruit a median of 1,700 participants (IQR, 588 to 9,500, range 30 to 35,256,399) with a median planned duration of 8 months (IQR, 3 to 14, range 1 to 24). Most came from the United States (n=11, 26.8%). The trials mostly assessed protective equipment (n=11, 26.8%), COVID-19-related information and education programs (n=9, 22.0%), access to mass events under specific safety measures (n=5, 12.2%), testing and screening strategies (n=5, 12.2%), and hygiene management (n=5, 12.2%). ConclusionsWorldwide, 41 randomized trials assessing NPIs have been initiated with published results available to inform policy decisions for only 7 of them. A long-term research agenda including behavioral, environmental, social, and systems level interventions is urgently needed to guide policies and practices in the current and future public health emergencies.
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Substantial COVID-19 research investment has been allocated to randomized clinical trials (RCTs) on hydroxychloroquine/chloroquine, which currently face recruitment challenges or early discontinuation. We aimed to estimate the effects of hydroxychloroquine and chloroquine on survival in COVID-19 from all currently available RCT evidence, published and unpublished. We conducted a rapid meta-analysis of ongoing, completed, or discontinued RCTs on hydroxychloroquine or chloroquine treatment for any COVID-19 patients (protocol: https://osf.io/QESV4/). We systematically identified unpublished RCTs (ClinicalTrials.gov, WHO International Clinical Trials Registry Platform, Cochrane COVID-registry up to June 11, 2020), and published RCTs (PubMed, medRxiv and bioRxiv up to October 16, 2020). All-cause mortality was extracted (publications/preprints) or requested from investigators and combined in random-effects meta-analyses, calculating odds ratios (ORs) with 95% confidence intervals (CIs), separately for hydroxychloroquine and chloroquine. Prespecified subgroup analyses included patient setting, diagnostic confirmation, control type, and publication status. Sixty-three trials were potentially eligible. We included 14 unpublished trials (1308 patients) and 14 publications/preprints (9011 patients). Results for hydroxychloroquine are dominated by RECOVERY and WHO SOLIDARITY, two highly pragmatic trials, which employed relatively high doses and included 4716 and 1853 patients, respectively (67% of the total sample size). The combined OR on all-cause mortality for hydroxychloroquine was 1.11 (95% CI: 1.02, 1.20; I2=0%; 26 trials; 10,012 patients) and for chloroquine 1.77 (95%CI: 0.15, 21.13, I2=0%; 4 trials; 307 patients). We identified no subgroup effects. We found that treatment with hydroxychloroquine was associated with increased mortality in COVID-19 patients, and there was no benefit of chloroquine. Findings have unclear generalizability to outpatients, children, pregnant women, and people with comorbidities.