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2.
Eur Rev Med Pharmacol Sci ; 25(21): 6767-6774, 2021 11.
Article in English | MEDLINE | ID: covidwho-1524864

ABSTRACT

OBJECTIVE: We aimed to test the efficiency of CHA2DS2-VASc, CHA2DS2-VASc-HS, R2CHA2DS2-VASc score systems on the prediction of mortality in the patients with COVID-19. PATIENTS AND METHODS: The data were collected from 508 hospitalized patients with COVID-19. Comorbidity features including coronary artery disease, peripheral arterial disease, congestive heart failure, hypertension, atrial fibrillation, diabetes mellitus, hyperlipidemia, smoking, chronic obstructive pulmonary disease, cerebrovascular event, cancer status, and renal disease were recorded. The patients were divided as surviving group (n=440) and non-survivors (n=68). RESULTS: The in-hospital mortality rate of the patients with COVID-19 was 13.4%. Factors found to be associated with mortality in univariate analysis were CHA2DS2-VASc, CHA2DS2-VASc-HS, R2CHA2DS2-VASc, cancer state, atrial fibrillation, hemoglobin, lymphocyte count, CRP, albumin and ferritin. Model 1 multivariate cox regression analysis revealed CHA2DS2-VASc, hemoglobin, CRP and ferritin levels to be independently associated with mortality. Factors that were found to be independently associated with in-hospital mortality in Model 2 analysis were CHA2DS2-VASc-HS, R2CHA2DS2-VASc, hemoglobin, CRP and ferritin whereas except hemoglobin in Model 3 analysis, the other variables had been the same. Predictive power of R2CHA2DS2-VASc was better than of both CHA2DS2-VASc (p=0.002) and CHA2DS2-VASc-HS (p=0.034) in determining the in-hospital mortality. Patients with higher R2CHA2DS2-VASc (> 3 points), CHA2DS2-VASc-HS (> 3 points) and CHA2DS2-VASc (> 2 points) scores exhibited the highest mortality rate in survival analysis by using Kaplan-Meier and long-rank tests. CONCLUSIONS: CHA2DS2-VASc, CHA2DS2-VASc-HS, and R2CHA2DS2-VASc were found to be independent predictors of mortality in hospitalized COVID-19 patients. The current study revealed that the predictive ability of R2CHA2DS2-VASc was better than the both of CHA2DS2-VASc and CHA2DS2-VASc-HS score.


Subject(s)
COVID-19/mortality , Comorbidity , Severity of Illness Index , Adult , Aged , Aged, 80 and over , Area Under Curve , COVID-19/pathology , COVID-19/virology , Female , Hemoglobins/analysis , Hospital Mortality , Hospitalization , Humans , Kaplan-Meier Estimate , Lymphocyte Count , Male , Middle Aged , Proportional Hazards Models , ROC Curve , SARS-CoV-2/isolation & purification
4.
Front Public Health ; 9: 646863, 2021.
Article in English | MEDLINE | ID: covidwho-1512060

ABSTRACT

Countries are recording health information on the global spread of COVID-19 using different methods, sometimes changing the rules after a few days. All of them are publishing the number of new individuals infected, recovered and dead individuals, along with some supplementary material. These data are often recorded in a non-uniform manner and do not conform the standard definitions of these variables. In this paper we show that, using data from the first wave of the epidemic (February-June), Kaplan-Meier curves calculated with them could provide useful information on the dynamics of the disease in different countries. We developed our scheme based on the cumulative total number of infected, recovered and dead individuals provided by the countries. We present a robust and simple model to show certain characteristics of the evolution of the dynamic process, showing that the differences in evolution between countries are reflected in the corresponding Kaplan-Meier-type curves. We compare the curves obtained for the most affected countries at that time, with the corresponding interpretation of the properties that distinguish them. The model is revealed as a practical tool for countries in the management of the Healthcare System.


Subject(s)
COVID-19 , Epidemics , Humans , Kaplan-Meier Estimate , SARS-CoV-2
5.
J Am Soc Nephrol ; 32(3): 639-653, 2021 03.
Article in English | MEDLINE | ID: covidwho-1496657

ABSTRACT

BACKGROUND: CKD is a heterogeneous condition with multiple underlying causes, risk factors, and outcomes. Subtyping CKD with multidimensional patient data holds the key to precision medicine. Consensus clustering may reveal CKD subgroups with different risk profiles of adverse outcomes. METHODS: We used unsupervised consensus clustering on 72 baseline characteristics among 2696 participants in the prospective Chronic Renal Insufficiency Cohort (CRIC) study to identify novel CKD subgroups that best represent the data pattern. Calculation of the standardized difference of each parameter used the cutoff of ±0.3 to show subgroup features. CKD subgroup associations were examined with the clinical end points of kidney failure, the composite outcome of cardiovascular diseases, and death. RESULTS: The algorithm revealed three unique CKD subgroups that best represented patients' baseline characteristics. Patients with relatively favorable levels of bone density and cardiac and kidney function markers, with lower prevalence of diabetes and obesity, and who used fewer medications formed cluster 1 (n=1203). Patients with higher prevalence of diabetes and obesity and who used more medications formed cluster 2 (n=1098). Patients with less favorable levels of bone mineral density, poor cardiac and kidney function markers, and inflammation delineated cluster 3 (n=395). These three subgroups, when linked with future clinical end points, were associated with different risks of CKD progression, cardiovascular disease, and death. Furthermore, patient heterogeneity among predefined subgroups with similar baseline kidney function emerged. CONCLUSIONS: Consensus clustering synthesized the patterns of baseline clinical and laboratory measures and revealed distinct CKD subgroups, which were associated with markedly different risks of important clinical outcomes. Further examination of patient subgroups and associated biomarkers may provide next steps toward precision medicine.


Subject(s)
Renal Insufficiency, Chronic/classification , Adult , Aged , Algorithms , Bone Density , Cohort Studies , Disease Progression , Female , Heart Function Tests , Humans , Kaplan-Meier Estimate , Kidney Function Tests , Male , Middle Aged , Prognosis , Prospective Studies , Renal Insufficiency, Chronic/physiopathology , Risk Factors , Unsupervised Machine Learning , Young Adult
6.
Sci Rep ; 11(1): 21297, 2021 10 29.
Article in English | MEDLINE | ID: covidwho-1493220

ABSTRACT

The COVID-19 outbreak has caused over three million deaths worldwide. Understanding the pathology of the disease and the factors that drive severe and fatal clinical outcomes is of special relevance. Studying the role of the respiratory microbiota in COVID-19 is especially important as the respiratory microbiota is known to interact with the host immune system, contributing to clinical outcomes in chronic and acute respiratory diseases. Here, we characterized the microbiota in the respiratory tract of patients with mild, severe, or fatal COVID-19, and compared it to healthy controls and patients with non-COVID-19-pneumonia. We comparatively studied the microbial composition, diversity, and microbiota structure between the study groups and correlated the results with clinical data. We found differences in the microbial composition for COVID-19 patients, healthy controls, and non-COVID-19 pneumonia controls. In particular, we detected a high number of potentially opportunistic pathogens associated with severe and fatal levels of the disease. Also, we found higher levels of dysbiosis in the respiratory microbiota of patients with COVID-19 compared to the healthy controls. In addition, we detected differences in diversity structure between the microbiota of patients with mild, severe, and fatal COVID-19, as well as the presence of specific bacteria that correlated with clinical variables associated with increased risk of mortality. In summary, our results demonstrate that increased dysbiosis of the respiratory tract microbiota in patients with COVID-19 along with a continuous loss of microbial complexity structure found in mild to fatal COVID-19 cases may potentially alter clinical outcomes in patients. Taken together, our findings identify the respiratory microbiota as a factor potentially associated with the severity of COVID-19.


Subject(s)
Bacteria/genetics , COVID-19/microbiology , COVID-19/mortality , Dysbiosis/microbiology , Microbiota/genetics , Respiratory System/microbiology , SARS-CoV-2/genetics , Severity of Illness Index , Adolescent , Adult , Aged , COVID-19/pathology , Case-Control Studies , Female , Humans , Kaplan-Meier Estimate , Male , Middle Aged , Phylogeny , RNA, Ribosomal, 16S/genetics , Young Adult
7.
J Clin Invest ; 131(20)2021 10 15.
Article in English | MEDLINE | ID: covidwho-1470551

ABSTRACT

BACKGROUNDCOVID-19 convalescent plasma (CCP) has been considered a treatment option for COVID-19. This trial assessed the efficacy of a neutralizing antibody containing high-dose CCP in hospitalized adults with COVID-19 requiring respiratory support or intensive care treatment.METHODSPatients (n = 105) were randomized 1:1 to either receive standard treatment and 3 units of CCP or standard treatment alone. Control group patients with progress on day 14 could cross over to the CCP group. The primary outcome was a dichotomous composite outcome of survival and no longer fulfilling criteria for severe COVID-19 on day 21.ResultsThe primary outcome occurred in 43.4% of patients in the CCP group and 32.7% in the control group (P = 0.32). The median time to clinical improvement was 26 days in the CCP group and 66 days in the control group (P = 0.27). The median time to discharge from the hospital was 31 days in the CCP group and 51 days in the control group (P = 0.24). In the subgroup that received a higher cumulative amount of neutralizing antibodies, the primary outcome occurred in 56.0% of the patients (vs. 32.1%), with significantly shorter intervals to clinical improvement (20 vs. 66 days, P < 0.05) and to hospital discharge (21 vs. 51 days, P = 0.03) and better survival (day-60 probability of survival 91.6% vs. 68.1%, P = 0.02) in comparison with the control group.ConclusionCCP added to standard treatment was not associated with a significant improvement in the primary and secondary outcomes. A predefined subgroup analysis showed a significant benefit of CCP among patients who received a larger amount of neutralizing antibodies.Trial registrationClinicalTrials.gov NCT04433910.FundingBundesministerium für Gesundheit (German Federal Ministry of Health): ZMVI1-2520COR802.


Subject(s)
COVID-19/therapy , SARS-CoV-2 , Aged , Antibodies, Neutralizing/administration & dosage , Antibodies, Neutralizing/therapeutic use , Antibodies, Viral/administration & dosage , Antibodies, Viral/therapeutic use , COVID-19/immunology , COVID-19/physiopathology , Combined Modality Therapy , Cross-Over Studies , Female , Humans , Immunization, Passive/adverse effects , Immunization, Passive/methods , Kaplan-Meier Estimate , Male , Middle Aged , Pandemics , Prospective Studies , SARS-CoV-2/immunology , Severity of Illness Index , Treatment Outcome
8.
PLoS One ; 16(10): e0257641, 2021.
Article in English | MEDLINE | ID: covidwho-1448573

ABSTRACT

BACKGROUND: Given the rapid increased in confirmed coronavirus disease 2019 (COVID-19) and related mortality, it is important to identify vulnerable patients. Immunocompromised status is considered a risk factor for developing severe COVID-19. We aimed to determine whether immunocompromised patients with COVID-19 have an increased risk of mortality. METHOD: The groups' baseline characteristics were balanced using a propensity score-based inverse probability of treatment weighting approach. Odds ratios (ORs) and their 95% confidence intervals (CIs) were calculated for the risks of in-hospital mortality and other outcomes according to immunocompromised status using a multivariable logistic regression model. We identified immunocompromised status based on a diagnosis of malignancy or HIV/AIDS, having undergone organ transplantation within 3 years, prescriptions for corticosteroids or oral immunosuppressants for ≥30 days, and at least one prescription for non-oral immunosuppressants during the last year. RESULTS: The 6,435 COVID-19 patients (≥18 years) included 871 immunocompromised (13.5%) and 5,564 non-immunocompromised (86.5%). Immunocompromised COVID-19 patients were older (60.1±16.4 years vs. 47.1±18.7 years, absolute standardized mean difference: 0.738). The immunocompromised group had more comorbidities, a higher Charlson comorbidity index, and a higher in-hospital mortality rate (9.6% vs. 2.3%; p < .001). The immunocompromised group still had a significantly higher in-hospital mortality rate after inverse probability of treatment weighting (6.4% vs. 2.0%, p < .001). Multivariable analysis adjusted for baseline imbalances revealed that immunocompromised status was independently associated with a higher risk of mortality among COVID-19 patients (adjusted odds ratio [aOR]: 2.09, 95% CI: 1.62-2.68, p < .001). CONCLUSIONS: Immunocompromised status among COVID-19 patients was associated with a significantly increased risk of mortality.


Subject(s)
COVID-19/diagnosis , Immunocompromised Host , Adolescent , Adult , Age Factors , Aged , Aged, 80 and over , COVID-19/epidemiology , COVID-19/mortality , COVID-19/virology , Comorbidity , Female , Hospital Mortality , Humans , Kaplan-Meier Estimate , Male , Middle Aged , Odds Ratio , Republic of Korea/epidemiology , Retrospective Studies , Risk Factors , SARS-CoV-2/isolation & purification , Young Adult
9.
Sci Rep ; 11(1): 19458, 2021 09 30.
Article in English | MEDLINE | ID: covidwho-1447326

ABSTRACT

Efficacious therapeutics for Ebola virus disease are in great demand. Ebola virus infections mediated by mucosal exposure, and aerosolization in particular, present a novel challenge due to nontypical massive early infection of respiratory lymphoid tissues. We performed a randomized and blinded study to compare outcomes from vehicle-treated and remdesivir-treated rhesus monkeys in a lethal model of infection resulting from aerosolized Ebola virus exposure. Remdesivir treatment initiated 4 days after exposure was associated with a significant survival benefit, significant reduction in serum viral titer, and improvements in clinical pathology biomarker levels and lung histology compared to vehicle treatment. These observations indicate that remdesivir may have value in countering aerosol-induced Ebola virus disease.


Subject(s)
Adenosine Monophosphate/analogs & derivatives , Alanine/analogs & derivatives , Antiviral Agents/pharmacology , Ebolavirus/drug effects , Hemorrhagic Fever, Ebola/drug therapy , Adenosine Monophosphate/administration & dosage , Adenosine Monophosphate/pharmacology , Administration, Intravenous , Aerosols , Alanine/administration & dosage , Alanine/pharmacology , Animals , Antiviral Agents/administration & dosage , Disease Models, Animal , Female , Hemorrhagic Fever, Ebola/blood , Kaplan-Meier Estimate , Liver/drug effects , Liver/virology , Lung/pathology , Lung/virology , Lymph Nodes/drug effects , Lymph Nodes/pathology , Lymph Nodes/virology , Macaca mulatta , Male , Random Allocation , Systemic Inflammatory Response Syndrome/drug therapy , Systemic Inflammatory Response Syndrome/virology , Viral Load/drug effects , Viremia/drug therapy
11.
JAMA ; 326(11): 1013-1023, 2021 09 21.
Article in English | MEDLINE | ID: covidwho-1441906

ABSTRACT

Importance: In patients who require mechanical ventilation for acute hypoxemic respiratory failure, further reduction in tidal volumes, compared with conventional low tidal volume ventilation, may improve outcomes. Objective: To determine whether lower tidal volume mechanical ventilation using extracorporeal carbon dioxide removal improves outcomes in patients with acute hypoxemic respiratory failure. Design, Setting, and Participants: This multicenter, randomized, allocation-concealed, open-label, pragmatic clinical trial enrolled 412 adult patients receiving mechanical ventilation for acute hypoxemic respiratory failure, of a planned sample size of 1120, between May 2016 and December 2019 from 51 intensive care units in the UK. Follow-up ended on March 11, 2020. Interventions: Participants were randomized to receive lower tidal volume ventilation facilitated by extracorporeal carbon dioxide removal for at least 48 hours (n = 202) or standard care with conventional low tidal volume ventilation (n = 210). Main Outcomes and Measures: The primary outcome was all-cause mortality 90 days after randomization. Prespecified secondary outcomes included ventilator-free days at day 28 and adverse event rates. Results: Among 412 patients who were randomized (mean age, 59 years; 143 [35%] women), 405 (98%) completed the trial. The trial was stopped early because of futility and feasibility following recommendations from the data monitoring and ethics committee. The 90-day mortality rate was 41.5% in the lower tidal volume ventilation with extracorporeal carbon dioxide removal group vs 39.5% in the standard care group (risk ratio, 1.05 [95% CI, 0.83-1.33]; difference, 2.0% [95% CI, -7.6% to 11.5%]; P = .68). There were significantly fewer mean ventilator-free days in the extracorporeal carbon dioxide removal group compared with the standard care group (7.1 [95% CI, 5.9-8.3] vs 9.2 [95% CI, 7.9-10.4] days; mean difference, -2.1 [95% CI, -3.8 to -0.3]; P = .02). Serious adverse events were reported for 62 patients (31%) in the extracorporeal carbon dioxide removal group and 18 (9%) in the standard care group, including intracranial hemorrhage in 9 patients (4.5%) vs 0 (0%) and bleeding at other sites in 6 (3.0%) vs 1 (0.5%) in the extracorporeal carbon dioxide removal group vs the control group. Overall, 21 patients experienced 22 serious adverse events related to the study device. Conclusions and Relevance: Among patients with acute hypoxemic respiratory failure, the use of extracorporeal carbon dioxide removal to facilitate lower tidal volume mechanical ventilation, compared with conventional low tidal volume mechanical ventilation, did not significantly reduce 90-day mortality. However, due to early termination, the study may have been underpowered to detect a clinically important difference. Trial Registration: ClinicalTrials.gov Identifier: NCT02654327.


Subject(s)
Carbon Dioxide/blood , Extracorporeal Circulation , Respiration, Artificial/methods , Respiratory Insufficiency/therapy , Aged , Early Termination of Clinical Trials , Extracorporeal Circulation/adverse effects , Female , Humans , Kaplan-Meier Estimate , Male , Middle Aged , Respiration, Artificial/adverse effects , Respiratory Distress Syndrome/therapy , Respiratory Insufficiency/mortality , Tidal Volume
12.
Front Endocrinol (Lausanne) ; 12: 727419, 2021.
Article in English | MEDLINE | ID: covidwho-1444039

ABSTRACT

Background: Blood parameters, such as neutrophil-to-lymphocyte ratio, have been identified as reliable inflammatory markers with diagnostic and predictive value for the coronavirus disease 2019 (COVID-19). However, novel hematological parameters derived from high-density lipoprotein-cholesterol (HDL-C) have rarely been studied as indicators for the risk of poor outcomes in patients with severe acute respiratory syndrome-related coronavirus 2 (SARS-CoV-2) infection. Here, we aimed to assess the prognostic value of these novel biomarkers in COVID-19 patients and the diabetes subgroup. Methods: We conducted a multicenter retrospective cohort study involving all hospitalized patients with COVID-19 from January to March 2020 in five hospitals in Wuhan, China. Demographics, clinical and laboratory findings, and outcomes were recorded. Neutrophil to HDL-C ratio (NHR), monocyte to HDL-C ratio (MHR), lymphocyte to HDL-C ratio (LHR), and platelet to HDL-C ratio (PHR) were investigated and compared in both the overall population and the subgroup with diabetes. The associations between blood parameters at admission with primary composite end-point events (including mechanical ventilation, admission to the intensive care unit, or death) were analyzed using Cox proportional hazards regression models. Receiver operating characteristic curves were used to compare the utility of different blood parameters. Results: Of 440 patients with COVID-19, 67 (15.2%) were critically ill. On admission, HDL-C concentration was decreased while NHR was high in patients with critical compared with non-critical COVID-19, and were independently associated with poor outcome as continuous variables in the overall population (HR: 0.213, 95% CI 0.090-0.507; HR: 1.066, 95% CI 1.030-1.103, respectively) after adjusting for confounding factors. Additionally, when HDL-C and NHR were examined as categorical variables, the HRs and 95% CIs for tertile 3 vs. tertile 1 were 0.280 (0.128-0.612) and 4.458 (1.817-10.938), respectively. Similar results were observed in the diabetes subgroup. ROC curves showed that the NHR had good performance in predicting worse outcomes. The cutoff point of the NHR was 5.50. However, the data in our present study could not confirm the possible predictive effect of LHR, MHR, and PHR on COVID-19 severity. Conclusion: Lower HDL-C concentrations and higher NHR at admission were observed in patients with critical COVID-19 than in those with noncritical COVID-19, and were significantly associated with a poor prognosis in COVID-19 patients as well as in the diabetes subgroup.


Subject(s)
COVID-19/blood , Cholesterol, HDL/blood , Diabetes Mellitus/blood , Aged , Biomarkers/blood , COVID-19/diagnosis , COVID-19/mortality , China , Diabetes Mellitus/diagnosis , Diabetes Mellitus/mortality , Female , Humans , Kaplan-Meier Estimate , Leukocytes/cytology , Male , Middle Aged , Prognosis , ROC Curve , Retrospective Studies , Severity of Illness Index
13.
Clin Appl Thromb Hemost ; 27: 10760296211045902, 2021.
Article in English | MEDLINE | ID: covidwho-1443743

ABSTRACT

INTRODUCTION: Diabetes is the most common of comorbidity in patients with SARS-COV-2 pneumonia. Coagulation abnormalities with D-dimer levels are increased in this disease. OBJECTIFS: We aimed to compare the levels of D-dimer in diabetic and non-diabetic patients with COVID 19. A link between D-dimer and mortality has also been established. MATERIALS: A retrospective study was carried out at the University Hospital Center of Oujda (Morocco) from November 01st to December 01st, 2020. Our study population was divided into two groups: a diabetic group and a second group without diabetes to compare clinical and biological characteristics between the two groups. In addition, the receiver operator characteristic curve was used to assess the optimal D-dimer cut-off point for predicting mortality in diabetics. RESULTS: 201 confirmed-COVID-19-patients were included in the final analysis. The median age was 64 (IQR 56-73), and 56% were male. Our study found that D-dimer levels were statistically higher in diabetic patients compared to non-diabetic patients. (1745 vs 845 respectively, P = 0001). D-dimer level > 2885 ng/mL was a significant predictor of mortality in diabetic patients with a sensitivity of 71,4% and a specificity of 70,7%. CONCLUSION: Our study found that diabetics with COVID-19 are likely to develop hypercoagulation with a poor prognosis.


Subject(s)
COVID-19/blood , Diabetes Mellitus/blood , Fibrin Fibrinogen Degradation Products/analysis , SARS-CoV-2 , Thrombophilia/blood , Aged , Area Under Curve , Biomarkers , C-Reactive Protein/analysis , COVID-19/complications , COVID-19/epidemiology , Comorbidity , Diabetes Complications/blood , Diabetes Complications/epidemiology , Diabetes Mellitus/epidemiology , Female , Hospital Mortality , Humans , Hypertension/epidemiology , Inflammation/immunology , Kaplan-Meier Estimate , Male , Middle Aged , Oxidative Stress , Prognosis , ROC Curve , Retrospective Studies , Risk Factors , Thrombophilia/etiology , Thrombophilia/immunology
14.
J Med Virol ; 93(10): 5880-5885, 2021 Oct.
Article in English | MEDLINE | ID: covidwho-1432421

ABSTRACT

This study is done to estimаte in-hоsрitаl mоrtаlity in раtients with severe асute resрirаtоry syndrоme соrоnаvirus 2 (SАRS-СоV-2) strаtified by Vitamin-D (Vit-D) levels. Раtients were strаtified ассоrding tо by serum 25-hydroxy-vitamin D (25(OH)Vit-D) levels intо twо grоuрs, that is, 25(OH)Vit-D less thаn 40 nmol/L аnd 25(OH)Vit-D greаter thаn 40 nmol/L. А tоtаl оf 231 раtients were inсluded. Оf these, 120 (50.2%) оf the раtients hаd 25(OH)Vit-D levels greаter thаn 40 nmol/L. The meаn аge wаs 49 ± 17 yeаrs, аnd 67% оf the раtients were mаles. The mediаn length оf оverаll hоsрitаl stаy wаs 18 [6; 53] dаys. The remаining 119 (49.8%) раtients hаd а 25(OH)Vit-D less thаn 40 nmol/L. Vitamin D levels were seen as deficient in 63% of patients, insufficient in 25% and normal in 12%. Оverаll mоrtаlity wаs 17 раtients (7.1%) but statistically not signifiсаnt among the grоuрs (p = 0.986). The Kарlаn-Meier survivаl аnаlysis shоwed no significance based on an alpha of 0.05, LL = 0.36, df = 1, p = 0.548, indicating Vitamin_D_Levels was not able to adequately predict the hazard of Mortality. In this study, serum 25(OH)Vit-D levels were found have no significance in terms of predicting the in-hоsрitаl mortality in раtients with SАRS-СоV-2.


Subject(s)
COVID-19/mortality , Vitamin D/analogs & derivatives , Adult , Aged , COVID-19/blood , COVID-19/diagnosis , Female , Hospital Mortality , Humans , Intensive Care Units , Kaplan-Meier Estimate , Length of Stay , Male , Middle Aged , Retrospective Studies , SARS-CoV-2 , Vitamin D/blood
15.
JAMA ; 326(8): 728-735, 2021 08 24.
Article in English | MEDLINE | ID: covidwho-1427006

ABSTRACT

Importance: Data on BNT162b2 messenger RNA (mRNA) vaccine (Pfizer-BioNTech) effectiveness and safety in pregnancy are currently lacking because pregnant women were excluded from the phase 3 trial. Objective: To assess the association between receipt of BNT162b2 mRNA vaccine and risk of SARS-CoV-2 infection among pregnant women. Design, Setting, and Participants: This was a retrospective cohort study within the pregnancy registry of a large state-mandated health care organization in Israel. Pregnant women vaccinated with a first dose from December 19, 2020, through February 28, 2021, were 1:1 matched to unvaccinated women by age, gestational age, residential area, population subgroup, parity, and influenza immunization status. Follow-up ended on April 11, 2021. Exposures: Exposure was defined by receipt of the BNT162b2 mRNA vaccine. To maintain comparability, nonexposed women who were subsequently vaccinated were censored 10 days after their exposure, along with their matched pair. Main Outcomes and Measures: The primary outcome was polymerase chain reaction-validated SARS-CoV-2 infection at 28 days or more after the first vaccine dose. Results: The cohort included 7530 vaccinated and 7530 matched unvaccinated women, 46% and 33% in the second and third trimester, respectively, with a mean age of 31.1 years (SD, 4.9 years). The median follow-up for the primary outcome was 37 days (interquartile range, 21-54 days; range, 0-70). There were 118 SARS-CoV-2 infections in the vaccinated group and 202 in the unvaccinated group. Among infected women, 88 of 105 (83.8%) were symptomatic in the vaccinated group vs 149 of 179 (83.2%) in the unvaccinated group (P ≥ .99). During 28 to 70 days of follow-up, there were 10 infections in the vaccinated group and 46 in the unvaccinated group. The hazards of infection were 0.33% vs 1.64% in the vaccinated and unvaccinated groups, respectively, representing an absolute difference of 1.31% (95% CI, 0.89%-1.74%), with an adjusted hazard ratio of 0.22 (95% CI, 0.11-0.43). Vaccine-related adverse events were reported by 68 patients; none was severe. The most commonly reported symptoms were headache (n = 10, 0.1%), general weakness (n = 8, 0.1%), nonspecified pain (n = 6, <0.1%), and stomachache (n = 5, <0.1%). Conclusions and Relevance: In this retrospective cohort study of pregnant women, BNT162b2 mRNA vaccination compared with no vaccination was associated with a significantly lower risk of SARS-CoV-2 infection. Interpretation of study findings is limited by the observational design.


Subject(s)
COVID-19 Vaccines/administration & dosage , COVID-19/epidemiology , Pregnancy Complications, Infectious/epidemiology , Pregnant Women , Adult , COVID-19/immunology , COVID-19/prevention & control , COVID-19 Vaccines/adverse effects , COVID-19 Vaccines/immunology , Case-Control Studies , Confidence Intervals , Female , Gestational Age , Humans , Incidence , Israel/epidemiology , Kaplan-Meier Estimate , Pregnancy , Pregnancy Complications, Infectious/immunology , Pregnancy Complications, Infectious/prevention & control , Regression Analysis , Retrospective Studies , Risk , Time Factors , Vaccination/statistics & numerical data
16.
PLoS One ; 16(9): e0257647, 2021.
Article in English | MEDLINE | ID: covidwho-1430547

ABSTRACT

INTRODUCTION: Despite the exalted status of sputum mycobacterial load for gauging pulmonary tuberculosis treatment and progress, Chest X-rays supplement valuable information for taking instantaneous therapeutic decisions, especially during the COVID-19 pandemic. Even though literature on individual parameters is overwhelming, few studies have explored the interaction between radiographic parameters denoting severity with mycobacterial burden signifying infectivity. By using a sophisticated approach of integrating Chest X-ray parameters with sputum mycobacterial characteristics, evaluated at all the three crucial time points of TB treatment namely pre-treatment, end of intensive phase and completion of treatment, utilizing the interactive Cox Proportional Hazards model, we aimed to precisely deduce predictors of unfavorable response to TB treatment. MATERIALS AND METHOD: We extracted de-identified data from well characterized clinical trial cohorts that recruited rifampicin-sensitive Pulmonary TB patients without any comorbidities, taking their first spell of anti-tuberculosis therapy under supervision and meticulous follow up for 24 months post treatment completion, to accurately predict TB outcomes. Radiographic data independently obtained, interpreted by two experienced pulmonologists was collated with demographic details and, sputum smear and culture grades of participants by an independent statistician and analyzed using the Cox Proportional Hazards model, to not only adjust for confounding factors including treatment effect, but also explore the interaction between radiological and bacteriological parameters for better therapeutic application. RESULTS: Of 667 TB patients with data available, cavitation, extent of involvement, lower zone involvement, smear and culture grade at baseline were significant parameters predisposing to an unfavorable TB treatment outcome in the univariate analysis. Reduction in radiological lesions in Chest X-ray by at least 50% at 2 months and 75% at the end of treatment helped in averting unfavorable responses. Smear and Culture conversion at the end of 2 months was highly significant as a predictor (p<0.001). In the multivariate analysis, the adjusted hazards ratios (HR) for an unfavorable response to TB therapy for extent of involvement, baseline cavitation and persistence (post treatment) were 1.21 (95% CI: 1.01-1.44), 1.73 (95% CI: 1.05-2.84) and 2.68 (95% CI: 1.4-5.12) respectively. A 3+ smear had an HR of 1.94 (95% CI: 0.81-4.64). Further probing into the interaction, among patients with 3+ and 2+ smears, HRs for cavitation were 3.26 (95% CI: 1.33-8.00) and 1.92 (95% CI: 0.80-4.60) while for >2 zones, were 3.05 (95% CI: 1.12-8.23) and 1.92 (95% CI: 0.72-5.08) respectively. Patients without cavitation, zonal involvement <2, and a smear grade less than 2+ had a better prognosis and constituted minimal disease. CONCLUSION: Baseline Cavitation, Opacities occupying >2 zones and 3+ smear grade individually and independently forecasted a poorer TB outcome. The interaction model revealed that Zonal involvement confined to 2 zones, without a cavity and smear grade up to 2+, constituting "minimal disease", had a better prognosis. Radiological clearance >50% along with smear conversion at the end of intensive phase of treatment, observed to be a reasonable alternative to culture conversion in predicting a successful outcome. These parameters may potentially take up key positions as stratification factors for future trials contemplating on shorter TB regimens.


Subject(s)
Mycobacterium tuberculosis/physiology , Rifampin/therapeutic use , Sputum/microbiology , Tuberculosis, Pulmonary/diagnostic imaging , Tuberculosis, Pulmonary/drug therapy , Adult , Female , Humans , Kaplan-Meier Estimate , Male , Multivariate Analysis , Proportional Hazards Models , Rifampin/pharmacology , Treatment Outcome , Tuberculosis, Pulmonary/microbiology , Young Adult
18.
Respir Med ; 188: 106606, 2021 11.
Article in English | MEDLINE | ID: covidwho-1401832

ABSTRACT

BACKGROUND: In this study, we report clinical outcomes in COVID-19 infection in a large cohort of people with cystic fibrosis (pwCF) and compare these outcomes to a propensity score matched cohort of people without CF. METHODS: Analysis of a multicenter research network TriNETX was performed including patients more than 16 years of age diagnosed with COVID-19. Outcomes in COVID-19 positive pwCF were compared with a propensity-matched cohort of people without CF. RESULTS: A total of 507,810 patients with COVID-19 were included (422 patients, 0.08% with CF; 507,388 patients, 99.92% without CF. Mean age at COVID-19 diagnosis in CF cohort was 46.6 ± 19.3 years, with female predominance (n = 225, 53.32%). Majority of the participants were Caucasian (n = 309, 73.22%). In the crude, unmatched analysis, mortality, hospitalization, critical care need, mechanical ventilation, acute kidney injury and composite (combination of intubation and mortality) outcome at 30 days was higher in the pwCF. Following robust propensity matching, pwCF had higher hospitalization rate (RR 1.56, 95% CI 1.20-2.04), critical care need (RR 1.78, 95% CI 1.13-2.79), and acute renal injury (RR 1.60, 95% CI 1.07-2.39) as compared to patients without CF. CONCLUSION: People with CF are at risk of poor outcomes with COVID-19.5.2% of these patients died within one month of COVID-19 diagnosis, and more than one in 10 patients required critical care. Therefore, the relatively young median age of cystic fibrosis patients, and lower prevalence of obesity do not protect these patients from severe disease contrary to prior reports.


Subject(s)
COVID-19/complications , COVID-19/mortality , Cystic Fibrosis/complications , Adult , Aged , COVID-19/therapy , Critical Care , Cystic Fibrosis/mortality , Cystic Fibrosis/therapy , Female , Hospitalization , Humans , Kaplan-Meier Estimate , Male , Middle Aged , Propensity Score , Respiration, Artificial , Retrospective Studies , Survival Rate
19.
Sci Rep ; 11(1): 17791, 2021 09 07.
Article in English | MEDLINE | ID: covidwho-1397897

ABSTRACT

The purpose of this study is to explore whether uric acid (UA) can independently act as a prognostic factor and critical marker of the 2019 novel corona virus disease (COVID-19). A multicenter, retrospective, and observational study including 540 patients with confirmed COVID-19 was carried out at four designated hospitals in Wuhan. Demographic, clinical, laboratory data were collected and analyzed. The primary end point was in-hospital death of patients with COVID-19. The concentration of admission UA (adUA) and the lowest concentration of uric acid during hospitalization (lowUA) in the dead patients were significantly lower than those in the survivors. Multivariate logistic regression analysis showed the concentration of lowUA (OR 0.986, 95% CI 0.980-0.992, p < 0.001) was able to independently predict the risk of in-hospital death. The mean survival time in the low-level group of lowUA was significantly lower than other groups. When lowUA was ≤ 166 µmol/L, the sensitivity and specificity in predicting hospital short-term mortality were 76.9%, (95% CI 68.5-85.1%) and 74.9% (95% CI 70.3-78.9%). This retrospective study determined that the lowest concentration of UA during hospitalization can be used as a prognostic indicator and a marker of disease severity in severe patients with COVID-19.


Subject(s)
COVID-19/mortality , Uric Acid/blood , Adult , Aged , Biomarkers/blood , COVID-19/blood , COVID-19/diagnosis , China/epidemiology , Feasibility Studies , Female , Hospital Mortality , Humans , Kaplan-Meier Estimate , Male , Middle Aged , Prognosis , Retrospective Studies , Risk Assessment/methods , Risk Factors , Sensitivity and Specificity , Severity of Illness Index
20.
PLoS One ; 16(9): e0256977, 2021.
Article in English | MEDLINE | ID: covidwho-1394551

ABSTRACT

INTRODUCTION: Coronavirus disease (COVID-19) is caused by severe acute respiratory syndrome coronavirus 2. Although most patients with COVID-19 develop asymptomatic or mild disease, some patients develop severe disease. The effectiveness of various therapeutic agents, including antiviral drugs, steroids, and anti-inflammatories for COVID-19, have been being confirmed. The effect of administering steroids in early disease is unclear. This study therefore aimed to evaluate the effectiveness and risk of exacerbation of steroids administered preceding antiviral drugs in patients with COVID-19 pneumonia. METHODS: This retrospective, single-center, observational study included consecutive patients with COVID-19 between March 2020 and March 2021. Patients were divided into a steroids-first group and antiviral-drugs-first group. Mortality, duration of hospitalization, incidence rate and duration of intensive care unit (ICU) admission, intubation, and extracorporeal membrane oxygenation (ECMO) induction of the two groups were compared. RESULTS: A total of 258 patients were admitted during the study period. After excluding patients who received symptomatic treatment only, who were taking immunosuppressive drugs, or who were administered antiviral drugs only, 68 patients were included in the analysis, 16 in the steroids-first group and 52 in the antiviral-drugs-first group. The rate of intubation, ICU admission and ECMO induction were significantly higher in the steroids-first group than in the antiviral-drugs-first group (81.3% vs. 33.3, p<0.001, 75.0% vs. 29.4%, p = 0.001, and 31.3% vs. 7.8%, p = 0.017, respectively). Furthermore, patients who received steroids within ten days after starting antiviral drugs had significantly lower rates of ICU admission, intubation, and ECMO induction. (81.3% vs. 42.9% p = 0.011, 75.0% vs. 37.1% p = 0.012, and 31.3% vs. 8.6% p = 0.039, respectively). CONCLUSIONS: Administering steroids prior to antiviral drugs soon after symptom onset can aggravate disease severity. When administration of steroids is considered soon after symptom onset, it may be safer to initiate antiviral drugs first.


Subject(s)
Antiviral Agents/therapeutic use , COVID-19/drug therapy , Dexamethasone/therapeutic use , Hospitalization/statistics & numerical data , Respiratory Distress Syndrome/drug therapy , SARS-CoV-2/drug effects , Aged , Antiviral Agents/administration & dosage , COVID-19/physiopathology , COVID-19/virology , Dexamethasone/administration & dosage , Drug Administration Schedule , Female , Glucocorticoids/administration & dosage , Glucocorticoids/therapeutic use , Hospital Mortality , Humans , Intensive Care Units/statistics & numerical data , Kaplan-Meier Estimate , Male , Middle Aged , Respiratory Distress Syndrome/physiopathology , Retrospective Studies , SARS-CoV-2/physiology , Severity of Illness Index , Treatment Outcome
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