PCR-confirmed COVID-19 Infections Research Articles

Donepezil-associated survival benefits among Alzheimer's disease patients are retained but not enhanced during COVID-19 infections.

Donepezil is a front-line treatment for Alzheimer's disease. Donepezil treatment is associated with decreased risk of all-cause mortality. Specific protection is observed in pneumonia and cardiovascular disease. We hypothesized that donepezil treatment would improve mortality among Alzheimer's patients following infection with COVID-19. The objective of this study is to assess the influence of ongoing donepezil treatment on survival in Alzheimer's disease patients after polymerase chain reaction (PCR)-confirmed COVID-19 infection. This is a retrospective cohort study. We conducted a national survey of Veterans with Alzheimer's disease to assess the influence of ongoing donepezil treatment on survival in Alzheimer's disease patients after PCR-confirmed COVID-19 infection. We assessed all-cause 30-day mortality stratified by COVID-19 infection and donepezil use, estimating odds ratios using multivariate logistic regression. Among people with Alzheimer's disease and COVID-19, all-cause 30-day mortality was 29% (47/163) for people taking donepezil compared with 38% (159/419) for those who were not. Among people with Alzheimer's disease without COVID-19, all-cause 30-day mortality was 5% (189/4189) for people taking donepezil compared with 7% (712/10,241) for those who were not. Adjusting for covariates, the decrease in mortality associated with donepezil did not differ between people with and without COVID-19 (interaction p = 0.710). The known survival benefits of donepezil were retained but not found to be specific to COVID-19 among people with Alzheimer's disease.

Clinical Outcomes and Survival Analysis of Remdesivir as a Treatment Option for Moderate to Severe COVID-19 Patients

Background: Remdesivir is a broad-spectrum antiviral that has been approved as promising medicine worldwide for the fatal pandemic COVID-19 disease. There is a debate over its efficacy, with different studies taking into account a variety of factors. Therefore, we conducted this study to evaluate the primary composite outcome of mortality rate, need for mechanical ventilation (MV), and escalation of care among Remdesivir (RDV) and non-Remdesivir (NoRDV) groups. Methods: Patients with moderate and severe PCR-confirmed COVID-19 infection were observed retrospectively, before and after including RDV in the treatment protocol during the period from August 2020 to February 2021. Result: From the 509 hospitalized patients, 35% received Remdesivir, with 64% being severe patients. The median age in both groups was 59 years old, and there was no significant difference between the two groups regarding gender, baseline characteristics, and comorbidities. In contrast, the median hospital length of stay in the RDV group was lower (8 days) than the NoRDV (9 days), p = 0.004. The composite outcome was 17.7% in the RDV group and 22.2% in the NoRDV group, but the difference was statistically insignificant (p-value 0.289). Adjusted logistic regression demonstrated a non-significant lower association of the composite outcome with RDV use (OR 0.623, 95CI% 0.37–1.02), and a significant reduction occurred in patients <60 years old (OR 0.39, 95%CI 0.17–0.83). However, survival analysis for mortality, MV, and transfer to a higher level revealed insignificant differences in the median time between groups. Subgroup analyses showed that RDV utilization had a non-significant effect on the risk of all three outcomes across different groups. Conclusion: Despite controlling all patient characteristics, treatment with RDV did not improve patient outcomes over other antivirals and standard care. There is an urgent need for further studies to investigate and evaluate new therapeutic approaches or combinations.

Pancreatic Steatosis Evaluated by Automated Volumetric CT Fat Fraction of the Pancreas: Association with Severity in COVID-19 Pneumonia

This study investigated the relationship between the severity of pneumonia based on chest CT findings and that of pancreatic steatosis assessed using an automated volumetric measurement of the CT fat volume fraction (CT-FVF) of the pancreas, using unenhanced three-dimensional CT in polymerase chain reaction (PCR)-confirmed COVID-19 patients. The study population consisted of 128 patients with PCR-confirmed COVID-19 infection who underwent CT examinations. The CT-FVF of the pancreas was calculated using a histogram analysis for the isolation of fat-containing voxels in the pancreas. The CT-FVF (%) of the pancreas had a significantly positive correlation with the lung severity score on CT (ρ = 0.549, p < 0.01). CT-FVF (%) of the pancreas in the severe pneumonia group was significantly higher than that of the non-severe pneumonia group (21.7% vs. 7.8%, p < 0.01). The area under the curve of CT-FVF (%) of the pancreas in predicting the severity of pneumonia on CT was calculated to be 0.82, with a sensitivity of 88% and a specificity of 68% at a threshold for the severity score of 12.3. The automated volumetric measurement of the CT-FVF of the pancreas using unenhanced CT can help estimate disease severity in patients with COVID-19 pneumonia based on chest CT findings.

Rate of True-Positive Findings of COVID-19 Typical Appearance at Chest CT per RSNA Consensus Guidelines in an Increasingly Vaccinated Population.

BackgroundRSNA COVID-19 chest CT consensus guidelines are widely used, but their true positive rate for COVID-19 pneumonia has not been assessed among vaccinated patients.PurposeTo assess true positive rate of RSNA typical chest CT findings of COVID-19 among fully vaccinated subjects with PCR-confirmed COVID-19 infection compared with unvaccinated subjects.Materials and MethodsPatients with COVID Typical chest CT findings and one positive or two negative PCR tests for COVID-19 within 7 days of their chest CT between January 2021 – January 2022 at a quaternary academic medical center were included. True positives were defined as chest CTs interpreted as COVID Typical and PCR-confirmed COVID-19 infection within 7 days. Logistic regression models were constructed to quantify the association between PCR results and vaccination status, vaccination status and COVID-19 variants, and vaccination status and months.Results652 subjects (median age 59, [IQR, 48–72]); 371 [57%] men) with CT scans classified as COVID Typical were included. 483 (74%) were unvaccinated and 169 (26%) were fully vaccinated. The overall true positive rate of COVID Typical CTs was lower among vaccinated versus unvaccinated (70/169 [41%; 95% CI: 34, 49%] vs 352/483 [73%; 69, 77%]; OR (95% CI): 3.8 (2.6, 5.5); P < .001). Unvaccinated subjects were more likely to have true positive CTs compared with fully vaccinated subjects during the peaks of COVID-19 variants Alpha (OR, 16 [95% CI: 6.1, 42]; P < .001) and Delta (OR, 8.3 [95% CI: 4.2, 16]; P < .001), but no statistical differences were found during the peak of Omicron variant (OR, 1.7 [95% CI: 0.27, 11]; P = .56)ConclusionFully vaccinated subjects with confirmed COVID-19 breakthrough infections had lower true positive rates of COVID Typical chest CT findings.

Amyloidosis and COVID-19: experience from an amyloid program in Canada.

Severe acute respiratory syndrome coronavirus (SARS-CoV2) and associated COVID-19 infection continue to impact patients globally. Patients with underlying health conditions are at heightened risk of adverse outcomes from COVID-19; however, research involving patients with rare health conditions remains scarce. The amyloidoses are a rare grouping of protein deposition diseases. Light-chain and transthyretin amyloidosis are the most common disease forms, often present with systemic involvement of vital organs including the heart, nerves, kidneys, and GI tracts of affected individuals. The Amyloidosis Program of Calgary examined 152 ATTR patients and 103 AL patients analyzing rates of vaccination, COVID-19 testing, infection outcomes, influence referrals, and excess deaths. Results showed 15 total PCR-confirmed COVID-19 infections in the tested population of amyloid patients, with a higher frequency of infections among patient with AL compared to the ATTR cohort (26.2% vs 5.1%). Four patients (26.6%) required hospital admission for COVID-19 infection, 2 ATTR, and 2 AL patients. Of the confirmed cases, 1 (0.07%) unvaccinated ATTR patient died of a COVID-19 infection. An excess of deaths was found in both the ATTR and AL cohorts when comparing pre-pandemic years 2018 and 2019 to the pandemic years of 2020 and 2021. The finding suggests that amyloidosis patients are likely at a high risk for severe COVID-19 infection and mortality, especially those of advanced age, those on an active treatment with chemotherapy, and those with concomitant B-cell or plasma cell disorder. The impact of virtual healthcare visits and pandemic measures on the excess of deaths observed requires further research.

COVID-19 in cancer patients with diabetes in Pakistan: Clinical features and management.

Diabetes and cancer are the leading causes of mortality all over the world. Infectious diseases are more common and/or life-threatening in patients with diabetes. Cancer patients with diabetes are individuals that are more susceptible to the current COVID-19 pandemic. We investigated the clinical features of survivor and non-survivor COVID-19-infected cancer patients with diabetes. We did a retrospective study of 43 diabetic cancer patients with PCR-confirmed COVID-19 infection from Shaukat Khanum Memorial Cancer Hospital and Research Centre, Lahore, Pakistan between March 03, 2020, and May 18, 2021. These patients either were discharged from the hospital or had died by Jun 16, 2021. Clinicopathological and radiological features were compared between survivors and non-survivors by fisher's exact test and chi-square test. Forty-three diabetic cancer patients with SARS-CoV-2 infection were enrolled and the majority were males 26 (60.5%). The overall mean age was 61.67 ± 11.80. 39 (90.7%) had solid tumors and 3 (7.0%) had hematological malignancies. Fever (74.4%) and dyspnea (58.1%) were the most common symptoms. Complications were reported in 36 (83.7%) patients; during the course of the disease. Additionally, all the deceased patients (n=15) had acquired the complications. 11 (25.6%) patients were admitted to an intensive care unit (ICU). Furthermore, 29 (67.4%) out of 43 patients showed abnormal features in the radiological findings. We found significantly elevated levels of C-reactive protein (P=0.005), serum lactate (P=0.01), albumin (P=0.02), alkaline phosphate (P=0.03), and neutrophil count (P=0.04) in the non-survivors as compared to the survivors. Cancer patients with diabetes are a vulnerable population in the current pandemic. Identifying how diabetes in cancer patients affects the severity of SARS-CoV-2 infection is crucial for the clinical management of these patients. Rigorous scrutiny of clinicopathological features of COVID-19 infected cancer patients with diabetes especially values of C-reactive protein, lactate, albumin, alkaline phosphate, neutrophils, and regular monitoring of blood glucose levels may play a critical role in the outcome of the disease.

Humoral and cellular response in convalescent COVID-19 lupus patients

In SLE, underlying immune dysregulation and immunosuppression may increase the susceptibility to COVID-19 and impair the humoral and adaptive response. We aimed to characterize COVID-19 infection, identifying susceptibility and severity risk factors, assessing the presence of SARS-CoV-2 IgG antibodies and analyzing the cellular response. We established a prospective cohort of lupus patients to estimate the COVID-19 incidence compared to the reference general population. Data were collected via telephone interviews and medical record review. SARS-CoV-2 IgG antibodies were measured cross-sectionally as part of routine surveillance. Longitudinal changes in antibody titers and immunological profile from convalescent COVID-19 patients were evaluated at 6, 12 and 24 week after symptom onset. From immunological studies, PBMCs from convalescent patients were extracted and analyzed by flow cytometry and gene expression analysis. We included 725 patients, identifying 29 with PCR-confirmed COVID-19 infection and 16 with COVID-19-like symptoms without PCR-testing. Of the 29 confirmed cases, 7 had severe disease, 8 required hospital admission (27.6%), 4 intensive care, and 1 died. COVID-19 accumulated incidence was higher in lupus patients. Health care workers and anti-SSA/Ro52 antibody positivity were risk factors for COVID-19 susceptibility, and hypocomplementemia for severity. SARS-CoV-2 IgG antibodies were detected in 8.33% of patients. Three fourths of confirmed COVID-19 cases developed antibodies. High prednisone doses were associated with lack of antibody response. Antibody titers declined over time (39%). Convalescent patients at week 12 after symptom onset displayed a CD8+T cell reduction and predominant Th17 with a mild Th2 response, more pronounced in severe COVID-19 disease. Longitudinal immune response analysis showed a progressive sustained increase in CD8+ T and B memory cells with a decrease of Th17 signaling. Lupus patients are at higher risk of COVID-19 infection and new susceptibility and severity risk factors were identified. Lupus patients were able to mount humoral and cellular responses despite immunosuppressive therapy.

A pre-vaccine exploratory survey of SARS-CoV-2 humoral immunity among Egyptian general population

BackgroundPopulation-based studies on COVID-19 have important implications for modeling the pandemic and determining vaccination policies. Limited data are available from such surveys in Egypt.MethodsThis cross-sectional was conducted throughout the period between January and June 2021, which coincided with the second and third waves of the COVID-19 pandemic in Egypt. At that time, vaccines against COVID-19 were not available to the general population. The study was carried out in eight Egyptian governorates and included 2360 participants, who were recruited through a multistage stratified cluster sample technique, based on gender, age, and district followed by a random sample within each district. Socio-demographic data were recorded and serum samples were collected and tested for SARS-Co-V2 spike (S) antibodies.ResultsThe overall adjusted prevalence of anti-S was 46.3% (95% CI 44.2–48.3%), with significant differences between governorates. Factors associated with anti-S seropositivity were: being female (p = 0.001), living in a rural area (p = 0.008), and reporting a history of COVID-19 infection (p = 0.001). Higher medians of anti-S titers were significantly associated with: extremes of age (p < 0.001), living in urban areas, having primary education (p = 0.009), and reporting a history of COVID-19 infection, especially if based on chest CT or PCR (p < 0.001).ConclusionsHigh seroprevalence rates indicate increased COVID-19 infection and immune response among a considerable percentage of the community. Age, gender, residence, educational level, and previous PCR-confirmed COVID-19 infections were all determinants of the immune response.

Performance of the APOP-screener for predicting in-hospital mortality in older COVID-19 patients: a retrospective study

BackgroundA variety of prediction models concerning COVID-19 have been proposed since onset of the pandemic, but to this date no gold standard exists. Mortality rates show a sharp increase with advancing age but with the large heterogeneity of this population in terms of comorbidities, vulnerability and disabilities, identifying risk factors is difficult. Therefore, we aimed to research the multidimensional concept of frailty, measured by the Acute Presenting Older Patient (APOP)-screener, as a risk factor for in-hospital mortality in older COVID-19 patients.MethodsAll consecutive patients of 70 years or older, with a PCR confirmed COVID-19 infection and a completed APOP-score, presenting at the Emergency Department (ED) of the Jeroen Bosch Hospital, the Netherlands, between February 27th 2020 and February 1st 2021 were retrospectively included. We gathered baseline characteristics and scored the CCI and CFS from patient records. The primary outcome was in-hospital mortality.ResultsA total of 292 patients met the inclusion criteria. Approximately half of the patients were considered frail by the APOP or CFS. 127 patients (43.5%) scored frail on the CFS, 158 (54.1%) scored high risk on the APOP-screener. 79 patients (27.1%) died during their hospital admission. The APOP-screener showed a significantly elevated risk of in-hospital mortality when patients scored both high risk of functional and evidence of cognitive impairment (OR 2.24, 95% 1.18–4.25). Significant elevation of in-hospital mortality was found for the high CCI-scores (≥ 5)(OR 1.78, 95% 1.02–3.11), but not for the highest CFS category (5–9, frail) (OR 1.35, 95% 0.75–2.47). The discriminatory performance of the APOP, CFS and CCI were comparable (AUC resp. 0.59 (0.52–0.66), 0.54 (0.46–0.62) and 0.58 (0.51–0.65)).ConclusionAlthough the elevated risk for in-hospital mortality found for the most frail patients as scored by the APOP, this instrument has poor discriminatory value. Additionally, the CFS did not show significance in predicting in-hospital mortality and had a poor discriminatory value as well. Therefore, treatment decisions based on frailty or comorbidities alone should be made with caution. Approaching the heterogeneity of the older population by adding frailty as assessed by the APOP-score to existing prediction models may enhance the predictive value of these models.

Functional activity of peripheral blood mononuclear cells in patients with non-Hodgkin's lymphomas receiving treatment after COVID-19 disease.

e19564 Background: Patients with non-Hodgkin's lymphomas (NHL) develop abnormalities in the structural and functional organization of the immune system leading to immune deficiency. Chemotherapy (CT) in patients after SARS-CoV infection is associated with a more severe disease course affecting the treatment results. The cytokine-producing activity (CPA) of blood cells is poorly studied, while it determines the effectiveness of antitumor and anti-infective functions of the immune system. The purpose of this study was to evaluate CPA of peripheral blood mononuclear cells in patients receiving treatment for NHL after COVID-19. Methods: The study included 8 patients with large B-cell NHL with PCR-confirmed COVID-19 infection in past medical history. All patients received from 3 to 4 chemotherapy cycles. K2EDTA blood samples obtained before and after 3-4 CT cycles were divided into 2 parts after dilution with a sterile nutrient medium solution: part 1, to assess spontaneous CPA; part 2, with addition of a sterile mitogen (phytohemagglutinin 4 μg, concanavalin A 4 μg, and lipopolysaccharide 2 μg) to assess stimulated CPA. The samples were incubated for 24 hours at 370C, and the levels of IL-1β, IL-6, IL-8, IL-10, IL-18, IL-4, IL-2, TNF- α, INF-ɣ, INF-α were determined in the obtained plasma. The stimulation coefficient (SC) was calculated as the ratio of stimulated CPA to spontaneous CPA. Results: 3-4 CT cycles in patients after COVID-19 was accompanied by an elevation of spontaneous CPA of the blood cells IL-6, INF-ɣ, TNF-α, IL-8, compared to the initial levels, by 678%, 127%, 64% and 57%, respectively. The ability of cells to spontaneous production of IL-10 and INF-α decreased by 30% and 100%. The mitogen-induced CPA of mononuclear cells in relation to IL-10, IL-6, IL-2, IL-1β and INF-α increased by 300%, 130%, 92%, 52% and 52%, respectively. Stimulated CPA in relation to INF-ɣ decreased by 21% compared to initial levels. As a result of the revealed CPA changes, SC in NHL patients after COVID-19 receiving CT increased, compared to the initial levels, by 465%, 92% and 48% respectively for IL-10, IL-2, IL-1β, as well as the appearing ability to INF-α production. SC for IL-6, INF-ɣ, TNF-α, and IL-8 decreased by 70%, 66%, 33% and 27% respectively. Conclusions: Certain features of spontaneous and mitogen-activated CPA of blood mononuclear cells were revealed in NHL patients after COVID-19, indicating a change in the functional activity of immune cells which could affect the development of the disease and the effectiveness of the therapy. The data obtained require additional studies and can be used to assess the condition of patients, as well as to predict the therapy efficacy.

CE-541-04 CARDIAC ARRHYTHMIAS IN POST-ACUTE SEQUELAE OF SARS-COV-2 INFECTION ASSESSED BY AMBULATORY RHYTHM MONITORING

Many COVID-19 survivors report ongoing cardiopulmonary symptoms and organ dysfunction in a poorly understood syndrome known as post-acute sequelae of COVID-19 (PASC). Risk of arrhythmias is elevated in acute COVID-19 infection, especially in hospitalized patients with severe infection. In the post-acute period, palpitations are commonly reported, but little is known about the risk of arrhythmias in patients with PASC. To characterize the burden of arrhythmias in individuals with PASC at least 1 year after SARS-CoV-2 infection and the correlation between symptoms and clinically significant arrhythmias. As part of the LIINC COVID-19 recovery cohort (NCT04362150), we conducted ambulatory rhythm monitoring using the Bardy Diagnostics Carnation Ambulatory Monitor (CAM) for up to 14 days on participants at least 1 year after PCR-confirmed COVID-19 infection without prior CVD. Cardiopulmonary symptoms were assessed through interviews at the time of enrollment, at the time of initiation of rhythm monitoring, and through a journal used during the rhythm monitoring period. Among 27 participants, 13 reported cardiopulmonary symptoms. Median age was 56 and 48% were female (Table 1); monitoring was performed at a median of 16.5 months after infection. Those with PASC pushed the symptom button 4.2 more times on average (95% CI -1.4 to 10.3; p=0.13). After adjustment for age and sex, cardiopulmonary symptoms were not associated with an increased burden of PACs (β = -0.04, 95%CI -0.15 to 0.07, p = 0.47), PVCs (β = 0.21, 95%CI -0.22 to 0.65, p = 0.31), or supraventricular tachycardia episodes (β = 3.0 per week, 95%CI -3.1 to 9.2, p = 0.31). Average HR (β = -1.66, 95%CI -12.8 to 9.5, p = 0.076) and HR variability (β = 2.5, 95%CI -10.3 to 15.3, p = 0.69) were not significantly different between those with and without symptoms. Similar results were found after adjusting for LVEF, LV strain, and LA volume index. Button pushes correlated with SVT in only one participant who had PASC and none without PASC. In the first study to assess cardiac arrhythmia burden in patients with PASC through ambulatory rhythm monitoring, we did not find significant associations between the presence of cardiopulmonary symptoms after COVID-19 and PAC burden, PVC burden, SVT episodes, average HR, or HR variability.

What is the association of renin–angiotensin–aldosterone system inhibitors with COVID-19 outcomes: retrospective study of racially diverse patients?

ObjectiveTo describe the clinical outcomes of COVID-19 in a racially diverse sample from the US Southeast and examine the association of renin–angiotensin–aldosterone system (RAAS) inhibitor use with COVID-19 outcome.Design, Setting,...

Effects of blood group types on risk of infection, disease severity, and mortality in COVID-19 patients

Aim: COVID-19 is an epidemic communicable disease that has been declared as a pandemic caused by severe acute respiratory syndrome coronavirus 2. Clinical studies have demonstrated that advanced age and comorbid conditions enhance the severity of the infection. The objective of this study was to examine the of effects of blood group types on risk of infection, disease severity, and mortality in COVID-19 patients.&#x0D; Material and Method: Included in this study were 1618 patients who had been diagnosed with PCR confirmed COVID-19 infection. The age, gender, blood type, disease severity, need for intensive care, and deaths of the patients were analyzed retrospectively. For the distribution of the blood types in a healthy population, statistics for the blood types of individuals in Ankara for 2020 were obtained from the Republic of Turkey Red Crescent Blood Services and used as a healthy control group for comparison with the data of the patients included in the study.&#x0D; Results: Among the COVID-19 patients, blood type A was the most common type at a rate of 46.2%. This was followed by blood type O at a rate of 28.4%. The least common blood type was found to be type AB at a rate of 9%. When compared to the healthy population, blood type A was determined to be statistically significantly more common in COVID-19 infection (p=0.07,). In contrast, blood type O was determined to be less common when compared to the healthy population (p

Ivermectin for the prevention of COVID-19: addressing potential bias and medical fraud.

BackgroundIvermectin is an antiparasitic drug being investigated in clinical trials for the prevention of COVID-19. However, there are concerns about the quality of some of these trials.ObjectivesTo conduct a meta-analysis with randomized controlled trials of ivermectin for the prevention of COVID-19, while controlling for the quality of data. The primary outcome was RT–PCR-confirmed COVID-19 infection. The secondary outcome was rate of symptomatic COVID-19 infection.MethodsWe conducted a subgroup analysis based on the quality of randomized controlled trials evaluating ivermectin for the prevention of COVID-19. Quality was assessed using the Cochrane risk of bias measures (RoB 2) and additional checks on raw data, where possible.ResultsFour studies were included in the meta-analysis. One was rated as being potentially fraudulent, two as having a high risk of bias and one as having some concerns for bias. Ivermectin did not have a significant effect on preventing RT–PCR-confirmed COVID-19 infection. Ivermectin had a significant effect on preventing symptomatic COVID-19 infection in one trial with some concerns of bias, but this result was based on post hoc analysis of a multi-arm study.ConclusionsIn this meta-analysis, the use of ivermectin was not associated with the prevention of RT–PCR-confirmed or symptomatic COVID-19. The currently available randomized trials evaluating ivermectin for the prevention of COVID-19 are insufficient and of poor quality.

Headache, anosmia, ageusia and other neurological symptoms in COVID-19: a cross-sectional study

BackgroundNeurological symptoms are frequent among patients with COVID-19. Little is known regarding the repercussions of neurological symptoms for patients and how these symptoms are related to one another.ObjectivesTo determine whether there is an association between the neurological symptoms in patients with COVID-19, and to characterize the headache.MethodThis was a cross-sectional study. All hospital inpatients and health workers at the Hospital Universitario Oswaldo Cruz with a PCR-confirmed COVID-19 infection between March and June 2020 were considered for the study and were interviewed by telephone at least 2-months after the acute phase of the disease. These patients were identified by the hospital epidemiological surveillance department. A semi-structured questionnaire was used containing sociodemographic and clinical data and the ID-Migraine.ResultsA total of 288 patients was interviewed; 53.1% were male; with a median age of 49.9 (41.5–60.5) years; 91.7% presented some neurological symptom; 22.2% reported some neurological symptom as the symptom that troubled them most during COVID-19. Neurological symptoms were: ageusia (69.8%), headache (69.1%), anosmia (67%), myalgia (44.4%), drowsiness (37.2%), agitation (20.8%); mental confusion (14.9%), syncope (4.9%) and epileptic seizures (2.8%). Females, those who presented with fever, sore throat, anosmia/ageusia and myalgia also presented significantly more with headache (logistic regression). The most frequent headache phenotype was a non-migraine phenotype, was of severe intensity and differed from previous headaches. This persisted for more than 30 days in 18% and for more than 90 days in 10% of patients. Thirteen percent of those with anosmia and 11% with ageusia continued with these complaints after more than 90 days of the acute phase of the disease. Aged over 50 years, agitation and epileptic seizures were significantly associated with mental confusion (logistic regression).ConclusionHeadache is frequent in COVID-19, is associated with other symptoms such as fever, sore throat, anosmia, ageusia, and myalgia, and may persist beyond the acute phase of the disease.

A comparison of antibody response in kidney transplant recipients and healthcare workers who had PCR-confirmed COVID-19 infection.

Data on antibody response following COVID-19 in kidney transplant recipients is scarce. This crosssectional study aims to investigate the antibody response to COVID-19 among kidney transplant recipients. We recruited 46 kidney transplant recipients with RT-PCR-confirmed COVID-19 and 45 recipients without COVID-19 history. We also constructed two control groups (COVID-19 positive and negative) from a historical cohort of healthcare workers. We used age and sex-based propensity score matching to select the eligible subjects to the control groups. We measured the SARS-CoV-2 IgG levels quantitatively using the Abbott ARCHITECT system. An antibody level above 1.4 S/C was defined as positivity. Transplant recipients with COVID-19 had a higher BMI, and COVID-19 history in a household member was more common than that of the transplant recipient without COVID-19. IgG seropositivity rate (69.6% vs. 78.3%, p = 0.238) and the median IgG level (3.28 [IQR: 0.80-5.85] vs. 4.59 [IQR: 1.61-6.06], p = 0.499) were similar in COVID-19-positive transplant recipients and controls. Kidney transplant recipients who had a longer duration between RT-PCR and antibody testing had lower antibody levels (r = -0.532, p < 0.001). At the early post-COVID-19 period, kidney transplant recipients have a similar antibody response to controls. However, these patients' antibody levels and immunity should be closely monitored in the long term.

Final efficacy analysis, interim safety analysis, and immunogenicity of a single dose of recombinant novel coronavirus vaccine (adenovirus type 5 vector) in adults 18 years and older: an international, multicentre, randomised, double-blinded, placebo-controlled phase 3 trial

BackgroundThe Ad5-nCoV vaccine is a single-dose adenovirus type 5 (Ad5) vectored vaccine expressing the SARS-CoV-2 spike protein that was well-tolerated and immunogenic in phase 1 and 2 studies. In this study, we report results on the final efficacy and interim safety analyses of the phase 3 trial.MethodsThis double-blind, randomised, international, placebo-controlled, endpoint-case driven, phase 3, clinical trial enrolled adults aged 18 years older at study centres in Argentina, Chile, Mexico, Pakistan, and Russia. Participants were eligible for the study if they had no unstable or severe underlying medical or psychiatric conditions; had no history of a laboratory-confirmed SARS-CoV-2 infection; were not pregnant or breastfeeding; and had no previous receipt of an adenovirus-vectored, coronavirus, or SARS-CoV-2 vaccine. After informed consent was obtained, 25 mL of whole blood was withdrawn from all eligible participants who were randomised in a 1:1 ratio to receive a single intramuscular dose of 0·5 mL placebo or a 0·5 mL dose of 5 × 1010 viral particle (vp)/mL Ad5-nCoV vaccine; study staff and participants were blinded to treatment allocation. All participants were contacted weekly by email, telephone, or text message to self-report any symptoms of COVID-19 illness, and laboratory testing for SARS-CoV-2 was done for all participants with any symptoms. The primary efficacy objective evaluated Ad5-nCoV in preventing symptomatic, PCR-confirmed COVID-19 infection occurring at least 28 days after vaccination in all participants who were at least 28 days postvaccination on Jan 15, 2021. The primary safety objective evaluated the incidence of any serious adverse events or medically attended adverse events postvaccination in all participants who received a study injection. This trial is closed for enrolment and is registered with ClinicalTrials.gov (NCT04526990).FindingsStudy enrolment began on Sept 22, 2020, in Pakistan, Nov 6, 2020, in Mexico, Dec 2, 2020, in Russia and Chile, and Dec 17, 2020, in Argentina; 150 endpoint cases were reached on Jan 15, 2021, triggering the final primary efficacy analysis. One dose of Ad5-nCoV showed a 57·5% (95% CI 39·7–70·0, p=0·0026) efficacy against symptomatic, PCR-confirmed, COVID-19 infection at 28 days or more postvaccination (21 250 participants; 45 days median duration of follow-up [IQR 36–58]). In the primary safety analysis undertaken at the time of the efficacy analysis (36 717 participants), there was no significant difference in the incidence of serious adverse events (14 [0·1%] of 18 363 Ad5-nCoV recipients and 10 [0·1%] of 18 354 placebo recipients, p=0·54) or medically attended adverse events (442 [2·4%] of 18 363 Ad5-nCoV recipients and 411 [2·2%] of 18 354 placebo recipients, p=0·30) between the Ad5-nCoV or placebo groups, or any serious adverse events considered related to the study product (none in both Ad5-nCoV and placebo recipients). In the extended safety cohort, 1004 (63·5%) of 1582 of Ad5-nCoV recipients and 729 (46·4%) of 1572 placebo recipients reported a solicited systemic adverse event (p<0·0001), of which headache was the most common (699 [44%] of Ad5-nCoV recipients and 481 [30·6%] of placebo recipients; p<0·0001). 971 (61·3%) of 1584 Ad5-nCoV recipients and 314 (20·0%) of 1573 placebo recipients reported an injection-site adverse event (p<0·0001), of which pain at the injection site was the most frequent; reported by 939 (59%) Ad5-nCoV recipients and 303 (19%) placebo recipients.InterpretationOne dose of Ad5-nCoV is efficacious and safe in healthy adults aged 18 years and older.FundingCanSino Biologics and the Beijing Institute of Biotechnology.

ОСОБЕННОСТИ УЛЬТРАЗВУКОВЫХ ХАРАКТЕРИСТИК СОСТОЯНИЯ МЕЗЕНТЕРИАЛЬНЫХ ЛИМФАТИЧЕСКИХ УЗЛОВ ПРИ COVID-19-ИНФЕКЦИИ У ДЕТЕЙ С ОСТРЫМ АБДОМИНАЛЬНЫМ СИНДРОМОМ: ОПИСАНИЕ КЛИНИЧЕСКИХ НАБЛЮДЕНИЙ

The authors describe clinical observations of children with acute mesenteric adenitis with PCRconfirmed COVID-19 infection. Attention during ultrasound diagnostics is drawn to the condition of the lymph nodes – mesenteric adenitis in COVID-19 infection was manifested by a significant increase in the size of the nodes – more than 15 mm, a large number of nodes in the cut with a tendency to form a conglomerate, a more rounded shape, significantly increased blood flow, a reaction of the peritoneum in the form its thickening and the presence of free fluid in the abdominal cavity. Unusual for a «ordinary» respiratory viral or intestinal infection type of lymph nodes was the only sign that distinguishes the manifestations of mesenteric infection in COVID-19 infection.

146. Intact Sense of Taste and Smell During COVID-19 Infection Is Associated with Absence of of SARS-CoV-2 Spike Protein Antibody Responses within 3 Months of Symptomatic Illness

BackgroundAlthough studies show most COVID-19 survivors have post-infection immunity against SARS-CoV-2 that could prevent re-infection, there is still a need to identify the breadth of antibody (Ab) responses associated with clinical phenotypes. We characterized Ab profiles at the estimated peak of Ab diversity among adults with recovered SARS-CoV-2 infections and determined their relationships with clinical factors.MethodsFrom April-June 2020, 41 health system employees with PCR-confirmed symptomatic COVID-19 infection enrolled 8-10 weeks after symptom onset. Symptom questionnaires including baseline demographics, COVID-19 symptoms, disease severity, and disease duration were collected and plasma samples were assayed using a custom Luminex Multiplex platform (Figure 1) to measure the antibody response against 20 COVID-19 related antigens (Figure 2). Differences in Ab profile titers among different groups were tested using nonparametric t test and Benjamini-Hochberg adjustment for multiplicity. Associations were considered significant at FDR< 0.05. Figure 1: Description of the Luminex Serology Assay Figure 2: List of the COVID-19 Related Antigens and Controls MeasuredResultsMean age was 48 years (range 27-68), with 51% female, 37% White, 32% Black, 29% Asian, and 17% LatinX. Ab profiles (Figure 3) showed 100% cross-reactivity with related alpha and beta coronavirus, and 95% with SARS-CoV-1. 78% had Abs against SARS-CoV-2 nucleocapsid protein (NCP). However, 29% of patients had no immune response against the four spike protein epitopes. These participants also reported fewer symptoms, including no cases of anosmia/ageusia, suggesting mild illness. Anosmia/ageusia, fever, and cough associated significantly with higher Ab titers (Figure 4). ConclusionBroad immune responses to various SARS-CoV-2 and related antigens were found among a heterogeneous patient population. However, less than 3 months after symptom onset, protective Ab responses to SARS-CoV-2 spike proteins were not detected in nearly one-third of recovered patients, primarily with mild infection. Intact sense of smell and taste demonstrated the greatest association with loss of seroprotective SARS-CoV-2 Ab responses, which may be clinically useful to predict post-infection immunity. Next steps include comparing the magnitude of Ab responses following full series completion with mRNA vaccination among this cohort.Disclosures Robert Bencshop, PhD, Eli Lilly (Employee) Josh Poorbaugh, PhD, Eli Lilly (Employee) Ajay Nirula, MD/PhD, Eli Lilly (Employee, Shareholder) Lin Zhang, PhD, Eli Lilly and Company (Employee, Shareholder) Stephanie Beasley, BA, Eli Lilly (Employee)

MOG antibody-associated encephalitis secondary to Covid-19: case report

BackgroundWhile Covid-19 predominantly affects the respiratory system, neurological manifestations including encephalitis occur in some patients, possibly affecting the course and outcome of the disease. Here, we describe a unique case of a young man with Covid-19 and transient MOG-positive encephalitis, with a benign course.Case presentationA 22-year-old male, with PCR confirmed Covid-19 infection was admitted because of persistent headache. The clinical examination was normal. Neuropsychological testing revealed distinct executive deficits. Brain MRI and cerebrospinal fluid (CSF) analysis were suggestive for encephalitis. Further laboratory examination revealed a serum MOG antibody titre. The headache improved with analgetic treatment and i.v. methylprednisolone. Consequently, the MOG antibody titer decreased and MRI lesions were resolving. The patient made a full recovery, with no signs of deterioration over the following months.ConclusionsCovid-19 manifestations in the CNS include encephalitis with variable course and prognosis. This case highlights a possible association between inflammation due to COVID-19 and transient secondary autoimmunity with transient MOG antibodies and atypical clinical presentation.