Serious adverse events of special interest following mRNA COVID-19 vaccination in randomized trials in adults
In 2020, prior to COVID-19 vaccine rollout, the Brighton Collaboration created a priority list, endorsed by the World Health Organization, of potentia…
SARS-CoV-2 infection causes immunodeficiency in recovered patients by downregulating CD19 expression in B cells via enhancing B-cell metabolism
Signal Transduction and Targeted Therapy - SARS-CoV-2 infection causes immunodeficiency in recovered patients by downregulating CD19 expression in B cells via enhancing B-cell metabolism
Recent SARS-CoV-2 infection abrogates antibody and B-cell responses to booster vaccination
SARS-CoV-2 mRNA booster vaccines provide protection from severe disease, eliciting strong immunity that is further boosted by previous infection. However, it is unclear whether these immune responses are affected by the interval between infection and vaccination. Over a two-month period, we evaluated antibody and B-cell responses to a third dose mRNA vaccine in 66 individuals with different infection histories. Uninfected and post-boost but not previously infected individuals mounted robust ancestral and variant spike-binding and neutralizing antibodies, and memory B cells. Spike-specific B-cell responses from recent infection were elevated at pre-boost but comparatively less so at 60 days post-boost compared to uninfected individuals, and these differences were linked to baseline frequencies of CD27lo B cells. Day 60 to baseline ratio of BCR signaling measured by phosphorylation of Syk was inversely correlated to days between infection and vaccination. Thus, B-cell responses to booster vaccines are impeded by recent infection. ### Competing Interest Statement The authors have declared no competing interest. ### Funding Statement This study was funded by the Intramural Research Programs of the Vaccine Research Center and the Division of Intramural Research, National Institutes of Allergy and Infectious Diseases, National Institutes of Health. ### Author Declarations I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained. Yes The details of the IRB/oversight body that provided approval or exemption for the research described are given below: The IRB of the National Institutes of Health gave ethical approval for this work I confirm that all necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived, and that any patient/participant/sample identifiers included were not known to anyone (e.g., hospital staff, patients or participants themselves) outside the research group so cannot be used to identify individuals. Yes I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance). Yes I have followed all appropriate research reporting guidelines and uploaded the relevant EQUATOR Network research reporting checklist(s) and other pertinent material as supplementary files, if applicable. Yes All data produced in the present study are available upon reasonable request to the authors
Wie gut OP-Masken und FFP2- bzw. KN95-Masken vor einer Infektion mit dem Coronavirus Sars-CoV2 schützen, hat ein Team des Max-Planck-Instituts für Dynamik und Selbstorganisation analysiert. Demnach senkt ein solcher Mund-Nase-Schutz das Risiko einer Ansteckung deutlich.
Comparison of Persistent Symptoms Following SARS-CoV-2... : The Pediatric Infectious Disease Journal
ratory syndrome coronavirus 2 (SARS-CoV-2) antibody status. Methods: Data were collected between October 2020 and May 2022 from the Texas Coronavirus Antibody REsponse Survey, a statewide prospective population-based survey among 5-90 years old. Serostatus was assessed by the Roche Elecsys Anti-SARS-CoV-2 Immunoassay for detection of antibodies to the SARS-CoV-2 nucleocapsid protein. Self-reported antigen/polymerase chain reaction COVID-19 test results and persistent COVID symptom status/type/duration were collected simultaneously. Risk ratios for persistent COVID symptoms were calculated versus adults and by age group, antibody status, symptom presence/severity, variant, body mass index and vaccine status. Results: A total of 82 (4.5% of the total sample [n = 1813], 8.0% pre-Delta, 3.4% Delta and beyond) participants reported persistent COVID symptoms (n = 27 [1.5%] 4–12 weeks, n = 58 [3.3%] 12 weeks). Compared with adults, all pediatric age groups had a lower risk for persistent COVID symptoms regardless of length of symptoms reported. Additional increased risk for persistent COVID symptoms 12 weeks included severe symptoms with initial infection, not being vaccinated and having unhealthy weight (body mass index ≥85th percentile for age and sex). Conclusions: These findings highlight the existence of nonhospitalized youth who may also experience persistent COVID symptoms. Children and adolescents are less likely to experience persistent COVID symptoms than adults and more likely to be symptomatic, experience severe symptoms and have unhealthy weight compared with children/adolescents without persistent COVID symptoms....
Boston – In Bezirken des US-Staats Massachusetts, in denen die Maskenpflicht an den Schulen Ende Februar aufgehoben wurde, kam es in den folgenden Wochen... #medRxiv #Studie #COVID19
Pediatric Infectious Disease Group (GPIP) position paper on the immune debt of the COVID-19 pandemic in childhood, how can we fill the immunity gap?
Since the beginning of the COVID-19 pandemic, reduced incidence of many viral and bacterial infections has been reported in children: bronchiolitis, v…
Infectiousness of SARS-CoV-2 breakthrough infections and reinfections during the Omicron wave
With more recent SARS-CoV-2 variants, breakthrough infections in vaccinated individuals and reinfections among previously infected individuals are increasingly common, especially during the Omicron wave. Such infections have led to concerns about controlling transmission and underscore a broader need to understand the contribution of vaccination, including booster doses, and natural immunity to the infectiousness of persons with SARS-CoV-2 infections, especially in high-risk populations with intense transmission such as prisons. Here, we show that both vaccine-derived and naturally acquired immunity independently reduce the infectiousness of persons with Omicron variant SARS-CoV-2 infections in a prison setting. Analyzing data from system-wide SARS-CoV-2 surveillance across 35 California state prisons, we estimate that Omicron variant infections among unvaccinated cases had a 36% (95% confidence interval (CI): 30-42%) risk of transmitting to close contacts, as compared to 27% (24-30%) risk among vaccinated cases. In adjusted analyses, we estimated that any vaccination, prior infection alone, and both vaccination and prior infection reduced an index case’s risk of transmitting to close contacts by 24% (9-37%), 21% (4-36%) and 41% (23-54%), respectively. Receipt of booster doses and more recent vaccination further reduced infectiousness among vaccinated cases. These findings suggest that although vaccinated and/or previously infected individuals remain highly infectious upon SARS-CoV-2 infection in this prison setting, their infectiousness is reduced compared to individuals without any history of vaccination or infection. ### Competing Interest Statement JAL has received grants, honoraria, and speaker fees from Pfizer; grants and honoraria from Merck, Sharp, & Dohme; and honoraria from VaxCyte; all unrelated to the subject of this work. ATK and DS received funding from California Prison Health Care Receivership. The remaining authors have no disclosures. ### Funding Statement The study was funded by the University of California, San Francisco Department of Medicine. ### Author Declarations I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained. Yes The details of the IRB/oversight body that provided approval or exemption for the research described are given below: Ethics committee/IRB of the University of California, San Francisco gave approval for this work. I confirm that all necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived, and that any patient/participant/sample identifiers included were not known to anyone (e.g., hospital staff, patients or participants themselves) outside the research group so cannot be used to identify individuals. Yes I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance). Yes I have followed all appropriate research reporting guidelines and uploaded the relevant EQUATOR Network research reporting checklist(s) and other pertinent material as supplementary files, if applicable. Yes Data requests may be made to California Correctional Health Care Services (CCHCS) and are subject to controlled access. All analytic code is publicly available.
Single-cell gene expression links SARS-CoV-2 infection and gut serotonin
We read with great interest the paper by Ha et al 1 demonstrating that circulating levels of serotonin (5-hydroxytryptamine, 5-HT) are increased in COVID-19 and correlate with disease severity and gastrointestinal symptoms such as diarrhoea. Another recent paper by Lin et al 2 in this journal demonstrated that diarrhoea is the most common GI symptom in patients with COVID-19. Almost all 5-HT in our body is produced by enterochromaffin (EC) cells within the epithelium of the GI tract, which constitute approximately half of all enteroendocrine (EE) cells. Gut-derived 5-HT modulates gut peristalsis and exacerbates inflammatory responses by acting as a chemotactic molecule for various immune cells and by triggering cytokine release.3 While most gut epithelial cell types are susceptible to SARS-CoV-2 infection, EE cells have the greatest proportion of cells infected at 12 hours after viral exposure.4 In addition, the use of selective serotonin reuptake inhibitors (SSRI), normally prescribed to treat mental health conditions such as depression, is reported to reduce COVID-19 severity in humans.5 The GI tract is a route of SARS-CoV-2;6 however, its unknown if EC …
Long-term cardiac pathology in individuals with mild initial COVID-19 illness
Nature Medicine - In individuals with long-term cardiac symptoms after an initially mild course of COVID-19 illness, magnetic resonance imaging and measurement of cardiac injury biomarkers commonly...
Class switch towards non-inflammatory IgG isotypes after repeated SARS-CoV-2 mRNA vaccination
Repeated mRNA vaccinations are an efficient tool to combat the SARS-CoV-2
pandemic. High levels of neutralizing SARS-CoV-2-antibodies are an important
component of vaccine-induced immunity. Shortly after the first or second mRNA
vaccine dose, the IgG response mainly consists of the pro-inflammatory isotypes IgG1
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(which was not certified by peer review) is the author/funder, who has granted medRxiv a license to display the preprint in perpetuity.
The copyright holder for this preprintthis version posted July 10, 2022.;https://doi.org/10.1101/2022.07.05.22277189doi:medRxiv preprint
NOTE: This preprint reports new research that has not been certified by peer review and should not be used to guide clinical practice.
and IgG3 and is driven by T helper (Th) 1 cells. Here, we report that several months
after the second vaccination, SARS-CoV-2-specific antibodies were increasingly
composed of non-inflammatory IgG2 and particularly IgG4, which were further boosted
by a third mRNA vaccination and/or SARS-CoV-2 variant breakthrough infections.
While IgG antibodies were affinity matured and of high neutralization capacity, the
switch in constant domains caused changes in fragment crystallizable (Fc)-receptor
mediated effector functions, including a decreased capacity to facilitate phagocytosis.
IgG4 induction was neither induced by Th2 cells nor observed after homologous or
heterologous SARS-CoV-2 vaccination with adenoviral vectors. In addition, IgG2- and
IgG4-producing memory B cells were phenotypically indistinguishable from IgG1- or
IgG3-producing cells. Since Fc-mediated effector functions are critical for antiviral
immunity, the described class switch towards non-inflammatory IgG isotypes, which
otherwise rarely occurs after vaccination or viral infection, may have consequences for
the choice and timing of vaccination regimens using mRNA vaccines.
Children’s Risk of Suicide Increases on School Days
Unlike in adults, suicide risk among children is lowest during the summer and higher during the school year. Understanding these patterns can help prevent and treat suicidality
More data suggesting higher rates of heart attacks and strokes following COVID19 infections in the U.K. @FT .Certainly something our health service can’t cope with this winter pic.twitter.com/k15sXPQ907— Tim Spector MD (Prof) (@timspector) September 3, 2022
outbreak.info is a standardized, searchable platform to discover and explore COVID-19 and SARS-CoV-2 data from the Center for Viral Systems Biology (cvisb.org) at Scripps Research. It contains three parts: a standardized searchable database of COVID-19 research; customizable real-time surveillance reports on SARS-CoV-2 variants and mutations; and an explorable interface to examine changes in epidemiological data.
Risk of Reinfection, Vaccine Protection, and Severity of Infection with the BA.5 Omicron Subvariant: A Danish Nation-Wide Population-Based Study
Background: Estimates of immunity and severity for the SARS-CoV-2 omicron subvariant BA.5 are important to assess the public health impact associated with its
Protection of SARS-CoV-2 natural infection against reinfection with the Omicron BA.4 or BA.5 subvariants
This study estimates the effectiveness of previous infection with SARS-CoV-2 in preventing reinfection with Omicron BA.4/BA.5 subvariants using a test-negative, case–control study design. Cases (SARS-CoV-2-positive test results) and controls (SARS-CoV-2-negative test results) were matched according to sex, 10-year age group, nationality, comorbid condition count, calendar week of testing, method of testing, and reason for testing. Effectiveness was estimated using the S-gene “target failure” (SGTF) infections between May 7, 2022-July 4, 2022. SGTF status provides a proxy for BA.4/BA.5 infections, considering the negligible incidence of other SGTF variants during the study. Effectiveness was also estimated using all diagnosed infections between June 8, 2022-July 4, 2022, when BA.4/BA.5 dominated incidence. Effectiveness of a previous pre-Omicron infection against symptomatic BA.4/BA.5 reinfection was 15.1% (95% CI: -47.1-50.9%), and against any BA.4/BA.5 reinfection irrespective of symptoms was 28.3% (95% CI: 11.4-41.9%). Effectiveness of a previous Omicron infection against symptomatic BA.4/BA.5 reinfection was 76.1% (95% CI: 54.9-87.3%), and against any BA.4/BA.5 reinfection was 79.7% (95% CI: 74.3-83.9%). Results using all diagnosed infections when BA.4/BA.5 dominated incidence confirmed the same findings. Sensitivity analyses adjusting for vaccination status confirmed study results. Protection of a previous infection against BA.4/BA.5 reinfection was modest when the previous infection involved a pre-Omicron variant, but strong when the previous infection involved the Omicron BA.1 or BA.2 subvariants. Protection of a previous infection against BA.4/BA.5 was lower than that against BA.1/BA.2, consistent with BA.4/BA.5’s greater capacity for immune-system evasion than that of BA.1/BA.2. ### Competing Interest Statement The authors have declared no competing interest. ### Funding Statement The authors are grateful for institutional salary support from the Biomedical Research Program and the Biostatistics, Epidemiology, and Biomathematics Research Core, both at Weill Cornell Medicine-Qatar, as well as for institutional salary support provided by the Ministry of Public Health, Hamad Medical Corporation, and Sidra Medicine. The authors are also grateful for the Qatar Genome Programme and Qatar University Biomedical Research Center for institutional support for the reagents needed for the viral genome sequencing. The funders of the study had no role in study design, data collection, data analysis, data interpretation, or writing of the article. Statements made herein are solely the responsibility of the authors. ### Author Declarations I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained. Yes The details of the IRB/oversight body that provided approval or exemption for the research described are given below: The study was approved by the Hamad Medical Corporation and Weill Cornell Medicine-Qatar Institutional Review Boards with waiver of informed consent. I confirm that all necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived, and that any patient/participant/sample identifiers included were not known to anyone (e.g., hospital staff, patients or participants themselves) outside the research group so cannot be used to identify individuals. Yes I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance). Yes I have followed all appropriate research reporting guidelines and uploaded the relevant EQUATOR Network research reporting checklist(s) and other pertinent material as supplementary files, if applicable. Yes The dataset of this study is a property of the Qatar Ministry of Public Health that was provided to the researchers through a restricted-access agreement that prevents sharing the dataset with a third party or publicly. Future access to this dataset can be considered through a direct application for data access to Her Excellency the Minister of Public Health (https://www.moph.gov.qa/english/Pages/default.aspx). Aggregate data are available within the manuscript and its Supplementary information.
Lack of effects on female fertility and prenatal and postnatal offspring development in rats with BNT162b2, a mRNA-based COVID-19 vaccine
BNT162b2 is a vaccine developed to prevent coronavirus disease 2019 (COVID-19). BNT162b2 is a lipid nanoparticle formulated nucleoside-modified messenger RNA (mRNA) encoding the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) spike protein ...
Effectiveness of the COVID-19 vaccines against severe disease with Omicron sub-lineages BA.4 and BA.5 in England
The Omicron sub-lineages BA.4 and BA.5 were first detected in England in April 2022. A case surge followed despite England having recently experienced waves with BA.1 and BA.2. This study used a whole population test-negative case-control study design to estimate the effectiveness of the vaccines currently in use as part of the UK COVID-19 vaccination programme against hospitalisation following infection with BA.4 and BA.5 as compared to BA.2 during a period of co-circulation. Incremental VE was estimated in those vaccinated with either a third or fourth dose as compared to individuals with waned immunity who had received their second dose at least 25 weeks prior. Vaccination status was included as an independent variable and effectiveness was defined as 1-odds of vaccination in cases/odds of vaccination in controls. During the study period, there were 32,845 eligible tests from hospitalised individuals. Of these, 25,862 were negative (controls), 3,432 were BA.2, 273 were BA.4, 947 were BA.5 and 2,331 were either BA.4 or BA.5 cases. There was no evidence of reduced VE against hospitalisation for BA.4 or BA.5 as compared to BA.2. The incremental VE was 56.8% (95% C.I.; 24.0-75.4%), 59.9% (95% C.I.; 45.6-70.5%) and 52.4% (95% C.I.; 43.2-60.1%) for BA.4, BA.5 and BA.2, respectively, at 2 to 14 weeks after a third or fourth dose. VE against hospitalisation with BA.4/5 or BA.2 was slightly higher for the mRNA-1273 booster than the BNT162b2 booster at all time-points investigated, but confidence intervals overlapped. These data provide reassuring evidence of the protection conferred by the current vaccines against severe disease with BA.4 and BA.5. ### Competing Interest Statement The authors have declared no competing interest. ### Funding Statement None ### Author Declarations I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained. Yes The details of the IRB/oversight body that provided approval or exemption for the research described are given below: PHE Research Ethics and Governance Group Statement: Surveillance of COVID-19 testing and vaccination is undertaken under Regulation 3 of The Health Service (Control of Patient Information) Regulations 2002 to collect confidential patient information (http://www.legislation.gov.uk/uksi/2002/1438/regulation/3/made) under Sections 3(i) (a) to (c), 3(i)(d) (i) and (ii) and 3(3). The study protocol was subject to an internal review by the PHE Research Ethics and Governance Group and was found to be fully compliant with all regulatory requirements. As no regulatory issues were identified, and ethical review is not a requirement for this type of work, it was decided that a full ethical review would not be necessary. All necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived. I confirm that all necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived, and that any patient/participant/sample identifiers included were not known to anyone (e.g., hospital staff, patients or participants themselves) outside the research group so cannot be used to identify individuals. Yes I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance). Yes I have followed all appropriate research reporting guidelines and uploaded the relevant EQUATOR Network research reporting checklist(s) and other pertinent material as supplementary files, if applicable. Yes All data produced in the present work are contained in the manuscript. Data cannot be made publicly available for ethical and legal reasons, i.e. public availability would compromise patient confidentiality as data tables list single counts of individuals rather than aggregated data
There was no evidence of reduced VE against hospitalisation for BA.4 or BA.5 as compared to BA.2. In those who had received their 3rd or 4th dose 2 to 14 weeks ago, the incremental VE as compared to those who were 25 or more weeks post their 2nd dose was 50-60%. pic.twitter.com/QCmPyMqPlr— Freja Kirsebom (@freja_kirsebom) September 2, 2022
Assessment of pulmonary arterial circulation 3 months after hospitalization for SARS-CoV-2 pneumonia: Dual-energy CT (DECT) angiographic study in 55 patients - PubMed
DECT depicted proximal arterial thrombosis in 5.4% of patients and perfusion abnormalities suggestive of widespread microangiopathy in 65.5% of patients. Lung microcirculation was abnormal in 4 patients with normal lung parenchyma.
A nationwide questionnaire study of post-acute symptoms and health problems after SARS-CoV-2 infection in Denmark
Nature Communications - The health impacts associated with SARS-CoV-2 infection are still not well understood. Here, the authors report findings from a survey of ~150,000 people in Denmark, and...
Rapid initiation of nasal saline irrigation to reduce severity in high-risk COVID+ outpatients: a randomized clinical trial compared to a national dataset observational arm
Importance SARS-CoV-2 enters the nasopharynx to replicate; nasal irrigation soon after diagnosis could reduce viral load and inhibit furin cleavage necessary for cell entry, thereby reducing morbidity and mortality. Objective To determine whether initiating nasal irrigation after COVID-19 diagnosis reduces hospitalizations and death in high-risk outpatients, and whether irrigant composition impacts severity. Design Unblinded randomized clinical trial of two nasal irrigation protocols in older outpatients PCR positive for SARS-CoV-2, with an observational arm using laboratory-confirmed cases in the CDC COVID-19 Case Surveillance dataset. Setting Single-lab community testing facility associated with the emergency department (ED) in Augusta, GA. Participants A consecutive sample of high-risk adults were enrolled within 24 hours of a positive COVID-19 test between September 24 and December 21 of 2020. Patients aged 55 and older were remotely consented. Among 826 screened, 321 of 694 eligible patients were unable to be reached, 294 refused participation, and 79 participants were enrolled. Interventions Participants were randomly assigned adding 2.5 mL povidone-iodine 10% or 2.5 mL sodium bicarbonate to 240 mL of isotonic nasal irrigation twice daily for 14 days. Main Outcomes and Measures The primary outcome was hospitalization or death from COVID-19 within 28 days of enrollment by daily self-report confirmed with phone calls and hospital records, compared to the CDC Surveillance Dataset covering the same time. Secondary outcomes compared symptom resolution by irrigant additive. Results Seventy-nine high-risk participants were enrolled (mean [SD] age, 64 [8] years; 36 [46%] women; 71% Non-Hispanic White), with mean BMI 30.3. Analyzed by intention-to-treat, by day 28, COVID-19 symptoms resulted in one ED visit and no hospitalizations in 42 irrigating with alkalinization, one hospitalization of 37 in the povidone-iodine group, (1.27%) and no deaths. Of nearly three million CDC cases, 9.47% were known to be hospitalized, with an additional 1.5% mortality in those without hospitalization data. The total risk of hospitalization or death (11%) was 8.57 times that of enrolled patients (SE=2.74; P=.006). 62 completed daily surveys (78%), averaging 1.8 irrigations/day. Eleven had irrigation complaints, and four discontinued. There were no significant differences by additive. Conclusion SARS-CoV-2+ participants initiating nasal irrigation were over 8 times less likely to be hospitalized than the national rate. Trial Registration [ClinicalTrial.gov][1] Identifier: [NCT04559035][2] Author Approval All authors have filled out ICMJE and approved submission. Conflict of Interest Statement Materials were provided by Neilmed Inc. and Rhinosystems Inc. The study was supported by funding from the Bernard and Anne Gray Donor Advised Fund Community Foundation for Greater Atlanta, Neilmed Inc., and Rhinosystems. No authors have conflict of interest. Question After testing positive for COVID-19, will rapidly initiating nasal irrigation reduce the risk of morbidity and mortality compared to a national dataset? Findings A consecutive sample of 79 high-risk adults (mean age 64, BMI 30.3) were randomized to initiate one of two nasal irrigation protocols within 24 hours of a positive COVID-19 test. Compared to a CDC COVID-19 National Dataset observational arm, 1.27% of participants initiating twice daily nasal irrigation were hospitalized or died, compared to 11%, a significant difference. Meaning In high-risk outpatients testing positive for SARS-CoV-2 who initiated nasal irrigation rapidly after diagnosis, risk of hospitalization or death was eight times lower than national rates reported by the CDC. ### Competing Interest Statement The authors have declared no competing interest. ### Clinical Trial NCT04559035 ### Funding Statement Materials were provided by Neilmed Inc. and Rhinosystems Inc. The investigator-initiated study was supported by funding from the Bernard and Anne Gray Donor Advised Fund Community Foundation for Greater Atlanta, Neilmed Inc., and Rhinosystems. No authors received payment or services from a third party for any aspect of the submitted work. ### Author Declarations I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained. Yes The details of the IRB/oversight body that provided approval or exemption for the research described are given below: Institutional Review Board Office Augusta University 1120 15th St., CJ-2103 Augusta GA 30912-7621 Email: IRB{at}augusta.edu Phone: 706-721-3110 I confirm that all necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived, and that any patient/participant/sample identifiers included were not known to anyone (e.g., hospital staff, patients or participants themselves) outside the research group so cannot be used to identify individuals. Yes I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance). Yes I have followed all appropriate research reporting guidelines and uploaded the relevant EQUATOR Network research reporting checklist(s) and other pertinent material as supplementary files, if applicable. Yes Data is available from the University of Augusta Department of Emergency Medicine Research Office, and online from the CDC COVID-19 Case Surveillance Public Use Data [1]: http://ClinicalTrial.gov [2]: /lookup/external-ref?link_type=CLINTRIALGOV&access_num=NCT04559035&atom=%2Fmedrxiv%2Fearly%2F2021%2F12%2F08%2F2021.08.16.21262044.atom