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1.
Pediatrics ; 2021 Dec 06.
Article in English | MEDLINE | ID: covidwho-1622403
2.
Lancet Reg Health Am ; 6: 100161, 2022 Feb.
Article in English | MEDLINE | ID: covidwho-1587082
5.
Academic pediatrics ; 2021.
Article in English | EuropePMC | ID: covidwho-1564303

ABSTRACT

Objectives : The purpose of our study is to evaluate the feasibility and reliability of a comprehensive set of preventive measures in limiting secondary transmission of COVID-19 in schools. Methods : A prospective cohort study was conducted to evaluate SARS-CoV-2 transmission in an independent K-8 school in San Mateo County, California. The research was conducted between September 14, 2020 through March 22, 2021 and consisted of: (1) demographic and epidemiological questionnaires;(2) daily symptom reporting;(3) weekly RT-PCR testing;and (4) periodic on-site qualitative observations. Results : 180 (79%) students and 63 (74%) on-site staff/contractors were enrolled. Participants reported symptoms in 144 (<1%) daily surveys of the 19,409 collected. Among those who reported symptoms and exposures, none tested positive during the 22-week study period. Of all participants, a total of 6 tested positive for SARS-CoV-2 at least once by RT-PCR;all were asymptomatic at time of testing. No in-school transmission occurred. Mask adherence was high among all grades, and incidents of improper mask use mostly occurred during non-instruction time. Physical distancing was well-enforced during class time and snack breaks, although adherence during non-instruction time waned as the school year progressed. Conclusion : Our comprehensive, prospective study following COVID-19 transmission over 22 weeks in a K-8 school demonstrates that: (1) surveillance testing is important for detecting asymptomatic infections in schools;(2) monitoring symptoms may not be necessary and/or sufficient for COVID-19;and (3) younger children can adhere to key mitigation measures (e.g., masking) which have the potential to limit transmission.

6.
Open forum infectious diseases ; 8(Suppl 1):293-293, 2021.
Article in English | EuropePMC | ID: covidwho-1563806

ABSTRACT

Background While pediatric cases of COVID-19 are at low risk for adverse events, schoolchildren should be considered for surveillance as they can become infected at school and serve as sources of household or community transmission. Our team assessed the feasibility of young children self-collecting SARS-CoV-2 samples for surveillance testing in an educational setting. Methods Students at a K-8 school were tested weekly for SARS-CoV-2 from September 2020 - June 2021. Error rates were collected from September 2020 - January 2021. Clinical staff provided all students with instructions for anterior nares specimen self-collection and then observed them to ensure proper technique. Instructions included holding the sterile swab while making sure not to touch the tip, inserting the swab into their nostril until they start to feel resistance, and rubbing the swab in four circles before repeating the process in their other nostril. An independent observer timed random sample self-collections from April - June 2021. Results 2,590 samples were collected from 209 students during the study period when data on error rates were collected. Errors occurred in 3.3% of all student encounters (n=87). Error rates over time are shown in Figure 1, with the highest rate occurring on the first day of testing (n=20/197, 10.2%) and the lowest in January 2021 (n=1/202, 0.5%). 2,574 visits for sample self-collection occurred during the study period when independent timing data was collected (April - June 2021). Of those visits, 7.5% (n=193) were timed. The average duration of each visit was 70 seconds. Figure 1. Swab Error Rates Over Time Conclusion Pediatric self-collected lower nasal swabs are a viable and easily tolerated specimen collection method for SARS-CoV-2 surveillance in school settings, as evidenced by the low error rate and short time window of sample self-collection during testing. School administrators should expect errors to drop quickly after implementing testing. Disclosures All Authors: No reported disclosures

7.
Open forum infectious diseases ; 8(Suppl 1):S302-S302, 2021.
Article in English | EuropePMC | ID: covidwho-1563805

ABSTRACT

Background In order to mitigate the spread of SARS-CoV-2 and the COVID-19 pandemic, public health officials have recommended self-isolation, self-quarantine of exposed household contacts (HHC), and mask use to limit viral spread within households and communities. While household transmission of SARS-CoV-2 is common, risk factors for HHC transmission are poorly understood. Methods In this prospective cohort study, we enrolled 37 households with at least one reverse transcription polymerase chain reaction-confirmed (RT-PCR) COVID-19 index case from March 2020 - March 2021, in order to calculate secondary attack rates (SAR) and define risk factors for secondary infections. Participants were tested daily for SARS-CoV-2 via RT-PCR, using self-collected lower nasal samples. Households were followed until all members tested negative for seven consecutive days. We collected demographics, medical conditions, relationship to index case, and socioeconomic indicators. Subgroup data analysis was conducted and stratified by positivity status. Results Of 99 enrolled participants, 37 were index cases and 62 were household contacts (HHC), of whom 25 HHC were infected (40.3%). Secondary attack rate (SAR) was highest among adults caring for a parent (n=4/4, 100%) and parents of index cases (5/10, 50%). Households whose income came from service work had greater risk of transmission compared to households whose primary income was technology (n=5/7;71.4% vs 3/8;37.5% respectively). Pediatric contacts were at lower risk of infection when compared to adult contacts (n=5/18, 27.8% vs n=20/44, 45.5% respectively). Conclusion This study suggests that household transmission represents a key source of community-based infection of SARS-CoV-2. Allocating resources for education/training regarding prevention among infected individuals and their close contacts will be critical for control of future outbreaks of SARS-CoV-2. Disclosures All Authors: No reported disclosures

8.
Vaccines (Basel) ; 9(12)2021 Nov 29.
Article in English | MEDLINE | ID: covidwho-1542830

ABSTRACT

OBJECTIVE: The study was designed to compare intentions to receive COVID-19 vaccination by race-ethnicity, to identify beliefs that may mediate the association between race-ethnicity and intention to receive the vaccine and to identify the demographic factors and beliefs most strongly predictive of intention to receive a vaccine. DESIGN: Cross-sectional survey conducted from November 2020 to January 2021, nested within a longitudinal cohort study of the prevalence and incidence of SARS-CoV-2 among a general population-based sample of adults in six San Francisco Bay Area counties (called TrackCOVID). Study Cohort: In total, 3161 participants among the 3935 in the TrackCOVID parent cohort responded. RESULTS: Rates of high vaccine willingness were significantly lower among Black (41%), Latinx (55%), Asian (58%), Multi-racial (59%), and Other race (58%) respondents than among White respondents (72%). Black, Latinx, and Asian respondents were significantly more likely than White respondents to endorse lack of trust of government and health agencies as a reason not to get vaccinated. Participants' motivations and concerns about COVID-19 vaccination only partially explained racial-ethnic differences in vaccination willingness. Concerns about a rushed government vaccine approval process and potential bad reactions to the vaccine were the two most important factors predicting vaccination intention. CONCLUSIONS: Vaccine outreach campaigns must ensure that the disproportionate toll of COVID-19 on historically marginalized racial-ethnic communities is not compounded by inequities in vaccination. Efforts must emphasize messages that speak to the motivations and concerns of groups suffering most from health inequities to earn their trust to support informed decision making.

9.
Preprint in English | EuropePMC | ID: ppcovidwho-292965

ABSTRACT

Background: Favipiravir is an oral, RNA–dependent RNA polymerase inhibitor with in vitro activity against SARS–CoV2. Despite limited data, favipiravir is administered to patients with COVID-19 in several countries. Methods: We conducted a phase 2 double–blind randomized controlled outpatient trial of favipiravir in asymptomatic or mildly symptomatic adults with a positive SARS–CoV2 RT–PCR within 72 hours of enrollment. Participants were randomized 1:1 to receive placebo or favipiravir (1800 mg BID Day 1, 800mg BID Days 2–10). The primary outcome was SARS–CoV2 shedding cessation in a modified intention-to-treat (mITT) cohort of participants with positive enrollment RT–PCRs. Using SARS–CoV2 deep sequencing, we assessed the impact of favipiravir on mutagenesis. Results: From July 8, 2020 to March 23, 2021, we randomized 149 participants with 116 included in the mITT cohort. The mean age was 43 years (SD 12.5) and 57 (49%) were women. We found no difference in time to shedding cessation by treatment arm overall (HR 0.76 favoring placebo, 95% confidence interval [CI] 0.48 – 1.20) or in sub-group analyses (age, sex, high-risk comorbidities, seropositivity or symptom duration at enrollment). We observed no difference in time to symptom resolution (initial: HR 0.84, 95% CI 0.54 – 1.29;sustained: HR 0.87, 95% CI 0.52 – 1.45). We detected no difference in accumulation of transition mutations in the viral genome during treatment. Conclusions: Our data do not support favipiravir use at commonly used doses in outpatients with uncomplicated COVID-19. Further research is needed to ascertain if higher doses of favipiravir are effective and safe for patients with COVID-19.

10.
Infectious Diseases in Children ; 33(6):18, 2020.
Article in English | ProQuest Central | ID: covidwho-1525100

ABSTRACT

According to the release, the funding also will support mass vaccination campaigns and the rebuilding of health systems to help address damage done by the pandemic. According to the release, as of March, routine childhood immunization services decreased in 53% of the 129 countries for which data were available. According to the release, dozens of countries have postponed vaccination campaigns against polio, meningitis, yellow fever, typhoid, cholera, tetanus and measles, mumps and rubella.

11.
Lancet ; 2021 Nov 15.
Article in English | MEDLINE | ID: covidwho-1521624

ABSTRACT

Since the first case of COVID-19 was identified in the USA in January, 2020, over 46 million people in the country have tested positive for SARS-CoV-2 infection. Several COVID-19 vaccines have received emergency use authorisations from the US Food and Drug Administration, with the Pfizer-BioNTech vaccine receiving full approval on Aug 23, 2021. When paired with masking, physical distancing, and ventilation, COVID-19 vaccines are the best intervention to sustainably control the pandemic. However, surveys have consistently found that a sizeable minority of US residents do not plan to get a COVID-19 vaccine. The most severe consequence of an inadequate uptake of COVID-19 vaccines has been sustained community transmission (including of the delta [B.1.617.2] variant, a surge of which began in July, 2021). Exacerbating the direct impact of the virus, a low uptake of COVID-19 vaccines will prolong the social and economic repercussions of the pandemic on families and communities, especially low-income and minority ethnic groups, into 2022, or even longer. The scale and challenges of the COVID-19 vaccination campaign are unprecedented. Therefore, through a series of recommendations, we present a coordinated, evidence-based education, communication, and behavioural intervention strategy that is likely to improve the success of COVID-19 vaccine programmes across the USA.

12.
Ann Epidemiol ; 2021 Nov 17.
Article in English | MEDLINE | ID: covidwho-1517026

ABSTRACT

PURPOSE: We describe the design of a longitudinal cohort study to determine SARS-CoV-2 incidence and prevalence among a population-based sample of adults living in six San Francisco Bay Area counties. METHODS: Using an address-based sample, we stratified households by county and by census-tract risk. Risk strata were determined by using regression models to predict infections by geographic area using census-level sociodemographic and health characteristics. We disproportionately sampled high and medium risk strata, which had smaller population sizes, to improve precision of estimates, and calculated a desired sample size of 3400. Participants were primarily recruited by mail and were followed monthly with PCR testing of nasopharyngeal swabs, testing of venous blood samples for antibodies to SARS-CoV-2 spike and nucleocapsid antigens, and testing of the presence of neutralizing antibodies, with completion of questionnaires about socio-demographics and behavior. Estimates of incidence and prevalence will be weighted by county, risk strata and sociodemographic characteristics of non-responders, and will take into account laboratory test performance. RESULTS: We enrolled 3842 adults from August to December, 2020, and completed follow-up March 31, 2021. We reached target sample sizes within most strata. CONCLUSIONS: Our stratified random sampling design will allow us to recruit a robust general population cohort of adults to determine the incidence of SARS-CoV-2 infection. Identifying risk strata was unique to the design and will help ensure precise estimates, and high-performance testing for presence of virus and antibodies will enable accurate ascertainment of infections.

13.
N Engl J Med ; 2021 Nov 09.
Article in English | MEDLINE | ID: covidwho-1506999

ABSTRACT

BACKGROUND: Safe, effective vaccines against coronavirus disease 2019 (Covid-19) are urgently needed in children younger than 12 years of age. METHODS: A phase 1, dose-finding study and an ongoing phase 2-3 randomized trial are being conducted to investigate the safety, immunogenicity, and efficacy of two doses of the BNT162b2 vaccine administered 21 days apart in children 6 months to 11 years of age. We present results for 5-to-11-year-old children. In the phase 2-3 trial, participants were randomly assigned in a 2:1 ratio to receive two doses of either the BNT162b2 vaccine at the dose level identified during the open-label phase 1 study or placebo. Immune responses 1 month after the second dose of BNT162b2 were immunologically bridged to those in 16-to-25-year-olds from the pivotal trial of two 30-µg doses of BNT162b2. Vaccine efficacy against Covid-19 at 7 days or more after the second dose was assessed. RESULTS: During the phase 1 study, a total of 48 children 5 to 11 years of age received 10 µg, 20 µg, or 30 µg of the BNT162b2 vaccine (16 children at each dose level). On the basis of reactogenicity and immunogenicity, a dose level of 10 µg was selected for further study. In the phase 2-3 trial, a total of 2268 children were randomly assigned to receive the BNT162b2 vaccine (1517 children) or placebo (751 children). At data cutoff, the median follow-up was 2.3 months. In the 5-to-11-year-olds, as in other age groups, the BNT162b2 vaccine had a favorable safety profile. No vaccine-related serious adverse events were noted. One month after the second dose, the geometric mean ratio of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) neutralizing titers in 5-to-11-year-olds to those in 16-to-25-year-olds was 1.04 (95% confidence interval [CI], 0.93 to 1.18), a ratio meeting the prespecified immunogenicity success criterion (lower bound of two-sided 95% CI, >0.67; geometric mean ratio point estimate, ≥0.8). Covid-19 with onset 7 days or more after the second dose was reported in three recipients of the BNT162b2 vaccine and in 16 placebo recipients (vaccine efficacy, 90.7%; 95% CI, 67.7 to 98.3). CONCLUSIONS: A Covid-19 vaccination regimen consisting of two 10-µg doses of BNT162b2 administered 21 days apart was found to be safe, immunogenic, and efficacious in children 5 to 11 years of age. (Funded by BioNTech and Pfizer; ClinicalTrials.gov number, NCT04816643.).

15.
Open Forum Infect Dis ; 8(7): ofab310, 2021 Jul.
Article in English | MEDLINE | ID: covidwho-1322651

ABSTRACT

Background: Given the persistence of viral RNA in clinically recovered coronavirus disease 2019 (COVID-19) patients, subgenomic RNAs (sgRNAs) have been reported as potential molecular viability markers for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). However, few data are available on their longitudinal kinetics, compared with genomic RNA (gRNA), in clinical samples. Methods: We analyzed 536 samples from 205 patients with COVID-19 from placebo-controlled, outpatient trials of peginterferon Lambda-1a (Lambda; n = 177) and favipiravir (n = 359). Nasal swabs were collected at 3 time points in the Lambda (days 1, 4, and 6) and favipiravir (days 1, 5, and 10) trials. N-gene gRNA and sgRNA were quantified by quantitative reverse transcription polymerase chain reaction. To investigate the decay kinetics in vitro, we measured gRNA and sgRNA in A549ACE2+ cells infected with SARS-CoV-2, following treatment with remdesivir or dimethylsulfoxide control. Results: At 6 days in the Lambda trial and 10 days in the favipiravir trial, sgRNA remained detectable in 51.6% (32/62) and 49.5% (51/106) of the samples, respectively. Cycle threshold (Ct) values for gRNA and sgRNA were highly linearly correlated (marginal R 2 = 0.83), and the rate of increase did not differ significantly in the Lambda trial (1.36 cycles/d vs 1.36 cycles/d; P = .97) or the favipiravir trial (1.03 cycles/d vs 0.94 cycles/d; P = .26). From samples collected 15-21 days after symptom onset, sgRNA was detectable in 48.1% (40/83) of participants. In SARS-CoV-2-infected A549ACE2+ cells treated with remdesivir, the rate of Ct increase did not differ between gRNA and sgRNA. Conclusions: In clinical samples and in vitro, sgRNA was highly correlated with gRNA and did not demonstrate different decay patterns to support its application as a viability marker.

16.
Contemp Clin Trials ; 108: 106509, 2021 09.
Article in English | MEDLINE | ID: covidwho-1312964

ABSTRACT

More than 3000 clinical trials related to COVID-19 have been registered through clinicaltrials.gov. With so many trials, there is a risk that many will be inconclusive due to being underpowered or due to an inability to recruit patients. At academic medical centers, multiple trials are competing for the same resources; the success of one may come at the expense of another. The COVID-19 Outpatient Pragmatic Protocol Study (COPPS) is a flexible phase 2, multi-site, randomized, blinded trial based at Stanford University designed to overcome these issues by simultaneously evaluating multiple COVID-19 treatments in the outpatient setting in one common platform with shared controls. This approach reduces the overall number of patients required for statistical power, while improving the likelihood that any enrolled patient receives active treatment. The platform study has two main domains designed to evaluate COVID-19 treatments by assessing their ability to reduce viral shedding (Viral Domain), measured with self-collected nasal swabs, or improve clinical outcomes (Clinical Domain), measured through self-reported symptomology data. Data are collected on both domains for all participants enrolled. Participants are followed over a 28-day period. COPPS has the advantage of pragmatism created around its workflow that is also appealing to potential participants because of a lower probability of inactive treatment. At the conclusion of this clinical trial we expect to have identified potentially effective therapeutic strategy/ies for treating COVID-19 in the outpatient setting, which will have a transformative impact on medicine and public health.


Subject(s)
COVID-19 , Humans , Outpatients , Research Design , SARS-CoV-2 , Treatment Outcome
18.
Nat Commun ; 12(1): 1967, 2021 03 30.
Article in English | MEDLINE | ID: covidwho-1159789

ABSTRACT

Type III interferons have been touted as promising therapeutics in outpatients with coronavirus disease 2019 (COVID-19). We conducted a randomized, single-blind, placebo-controlled trial (NCT04331899) in 120 outpatients with mild to moderate COVID-19 to determine whether a single, 180 mcg subcutaneous dose of Peginterferon Lambda-1a (Lambda) within 72 hours of diagnosis could shorten the duration of viral shedding (primary endpoint) or symptoms (secondary endpoint). In both the 60 patients receiving Lambda and 60 receiving placebo, the median time to cessation of viral shedding was 7 days (hazard ratio [HR] = 0.81; 95% confidence interval [CI] 0.56 to 1.19). Symptoms resolved in 8 and 9 days in Lambda and placebo, respectively, and symptom duration did not differ significantly between groups (HR 0.94; 95% CI 0.64 to 1.39). Both Lambda and placebo were well-tolerated, though liver transaminase elevations were more common in the Lambda vs. placebo arm (15/60 vs 5/60; p = 0.027). In this study, a single dose of subcutaneous Peginterferon Lambda-1a neither shortened the duration of SARS-CoV-2 viral shedding nor improved symptoms in outpatients with uncomplicated COVID-19.


Subject(s)
Antiviral Agents/administration & dosage , COVID-19/drug therapy , Interleukins/administration & dosage , Polyethylene Glycols/administration & dosage , Adult , Aged , COVID-19/virology , Female , Humans , Injections, Subcutaneous , Male , Middle Aged , Outpatients , SARS-CoV-2/drug effects , SARS-CoV-2/physiology , Single-Blind Method , Treatment Failure , Virus Shedding/drug effects , Young Adult
19.
Acad Med ; 96(10): 1389-1392, 2021 10 01.
Article in English | MEDLINE | ID: covidwho-998488

ABSTRACT

Health care professionals and the institutions in which they work are being stretched to their limits amidst the current COVID-19 pandemic. At the same time, a second longstanding pandemic has been brought to the fore: the entrenched system of racial injustice and oppression. The first pandemic is new, and to date, substantial resources have been allocated to urgently addressing its mitigation; the second has a long history with inconsistent attention and resources but has recently been spotlighted more intensely than at any time in the nation's recent past. The authors contend that these 2 simultaneous pandemics have brought forth the need for institutions in the United States to make a renewed commitment to respect, wellness, diversity, and inclusion. While investment and leadership in these domains have always been essential, these have largely been viewed as a "nice-to-have" option. The events of much of 2020 (most notably) have illustrated that committing to and investing in policies, programs, centers, and leadership to drive change in these domains are essential and a "need-to-have" measure. The authors outline the necessity of investing in the promotion of cultures of inclusive excellence at both individual and organizational levels to coordinate a united response to the simultaneous pandemics. It is in the interests of health care systems to consider the wellness of the workforce to overcome the longer-term economic, systemic, and social trauma that will likely occur for years to come at both the individual and institutional levels. Maintaining or augmenting investment is necessary despite the economic challenges the nation faces. Now is the time to cultivate resilience and wellness through a renewed commitment to cultures of respect, diversity, and inclusion. This commitment is urgently needed to support and sustain the health care workforce and maintain outstanding health care systems for future generations.


Subject(s)
COVID-19/therapy , Courage , Delivery of Health Care/organization & administration , Health Personnel/psychology , Health Personnel/statistics & numerical data , Organizational Culture , Racism/psychology , Adult , Female , Humans , Male , Middle Aged , Pandemics/prevention & control , SARS-CoV-2 , United States
20.
Infect Control Hosp Epidemiol ; 42(9): 1053-1059, 2021 09.
Article in English | MEDLINE | ID: covidwho-989631

ABSTRACT

OBJECTIVE: We assessed the magnitude of unidentified coronavirus disease 2019 (COVID-19) in our healthcare personnel (HCP) early in the COVID-19 pandemic, and we evaluated risk factors for infection to identify areas for improvement in infection control practice in a northern California academic medical center. METHODS: We reviewed anti-severe acute respiratory coronavirus virus 2 (SARS-CoV-2) receptor-binding domain (RBD) IgG serologic test results and self-reported risk factors for seropositivity among 10,449 asymptomatic HCP who underwent voluntary serology testing between April 20 and May 20, 2020. RESULTS: In total, 136 employees (1.3%) tested positive for SARS-CoV-2 IgG. This included 41 individuals (30.1%) who had previously tested positive for SARS-CoV-2 by nasopharyngeal reverse-transcription polymerase chain reaction (RT-PCR) between March 13 and April 16, 2020. In multivariable analysis, employees of Hispanic ethnicity (odds ratio [OR], 2.01; 95% confidence interval [CI], 1.22-3.46) and those working in environmental services, food services, or patient transport (OR, 4.81; 95% CI, 2.08-10.30) were at increased risk for seropositivity compared to other groups. Employees reporting a household contact with COVID-19 were also at higher risk for seropositivity (OR, 3.25; 95% CI, 1.47-6.44), but those with a work, exposure alone were not (OR, 1.27; 95% CI, 0.58-2.47). Importantly, one-third of seropositive individuals reported no prior symptoms, no suspected exposures, and no prior positive RT-PCR test. CONCLUSION: In this study, SARS-CoV-2 seropositivity among HCP early in the northern California epidemic appeared to be quite low and was more likely attributable to community rather than occupational exposure.


Subject(s)
COVID-19 , Pandemics , California/epidemiology , Delivery of Health Care , Humans , SARS-CoV-2 , Seroepidemiologic Studies
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