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1.
Eur J Radiol ; 130: 109202, 2020 Sep.
Article in English | MEDLINE | ID: covidwho-684452

ABSTRACT

BACKGROUND: So far, only a few studies evaluated the correlation between CT features and clinical outcome in patients with COVID-19 pneumonia. PURPOSE: To evaluate CT ability in differentiating critically ill patients requiring invasive ventilation from patients with less severe disease. METHODS: We retrospectively collected data from patients admitted to our institution for COVID-19 pneumonia between March 5th-24th. Patients were considered critically ill or non-critically ill, depending on the need for mechanical ventilation. CT images from both groups were analyzed for the assessment of qualitative features and disease extension, using a quantitative semiautomatic method. We evaluated the differences between the two groups for clinical, laboratory and CT data. Analyses were conducted on a per-protocol basis. RESULTS: 189 patients were analyzed. PaO2/FIO2 ratio and oxygen saturation (SaO2) were decreased in critically ill patients. At CT, mixed pattern (ground glass opacities (GGO) and consolidation) and GGO alone were more frequent respectively in critically ill and in non-critically ill patients (p < 0.05). Lung volume involvement was significantly higher in critically ill patients (38.5 % vs. 5.8 %, p < 0.05). A cut-off of 23.0 % of lung involvement showed 96 % sensitivity and 96 % specificity in distinguishing critically ill patients from patients with less severe disease. The fraction of involved lung was related to lactate dehydrogenase (LDH) levels, PaO2/FIO2 ratio and SaO2 (p < 0.05). CONCLUSION: Lung disease extension, assessed using quantitative CT, has a significant relationship with clinical severity and may predict the need for invasive ventilation in patients with COVID-19.


Subject(s)
Betacoronavirus , Coronavirus Infections/diagnostic imaging , Image Interpretation, Computer-Assisted/methods , Pneumonia, Viral/diagnostic imaging , Tomography, X-Ray Computed/methods , Aged , Critical Illness , Evaluation Studies as Topic , Female , Humans , Lung/diagnostic imaging , Male , Middle Aged , Pandemics , Research Design , Retrospective Studies , Risk Factors , Sensitivity and Specificity
2.
Nan Fang Yi Ke Da Xue Xue Bao ; 40(8): 1112-1118, 2020 Aug 30.
Article in Chinese | MEDLINE | ID: covidwho-749265

ABSTRACT

OBJECTIVE: To analyze the clinical features of severe or critical ill adult patients with coronavirus disease (COVID-19). METHODS: The clinical data of 75 patients with severe or critical COVID-19 in Honghu People's Hospital from January to March in 2020 were collected. RESULTS: Of the 75 patients with COVID-19 pneumonia, 41 were male (54.67%) and 34 were female (45.33%) with a mean age of 67.53 ±12.37 years; 43 patients had severe and 32 had critical COVID-19, and 49.3% of the patients had underlying diseases. The main clinical manifestations included fever (78.67%) and coughing (70.67%). Compared with the severe patients, the critically ill patients had higher proportions of patients over 60 years old with elevated white blood cell count, increased prothrombin time, and higher levels of hsCRP, PCT, D-dimer, ALT, LDH, cTnI and NT-proBNP. Univariate logistic regression analysis showed that an age over 60 years, leukocytosis, hs-CRP elevation, prolonged prothrombin time, and increased levels of D-dimer, NT-proBNP and cTnI were associated with severe COVID-19. Multivariate logistic regression showed that an age over 60 years (OR=8.165, 95% CI: 1.483-45.576, P=0.017), prolonged prothrombin time (OR=7.516, 95% CI: 2.568-21.998, P=0.006) and elevated NT-proBNP (OR=6.194, 95% CI: 1.305-29.404, P=0.022) were independent risk factors for critical type of COVID-19. CONCLUSIONS: An age over 60 years, a prolonged prothrombin time and elevated NT-proBNP level are important clinical features of critically ill patients with COVID-19, and can be deemed as early warning signals for critical conditions of the disease.


Subject(s)
Betacoronavirus , Coronavirus Infections , Pandemics , Pneumonia, Viral , Aged , Critical Illness , Female , Humans , Male , Middle Aged , Retrospective Studies
3.
Nan Fang Yi Ke Da Xue Xue Bao ; 40(6): 778-785, 2020 Jun 30.
Article in Chinese | MEDLINE | ID: covidwho-749262

ABSTRACT

OBJECTIVE: To explore the clinical characteristics and outcomes of adult critically ill patients with COVID-19 and identify the risk factors correlated with in-hospital deaths. METHODS: This study was conducted among 20 confirmed adult cases of COVID-19 in the Intensive Care Unit (ICU) of Honghu People's Hospital in Jingzhou City, Hubei Province. According to the final outcome, the patients were divided into survivor group and death group with 10 patients each. The demographic data, clinical manifestations and signs, laboratory findings, treatment measures and clinical outcomes were obtained from electronic medical records to compare the clinical characteristics and outcomes between the two groups. Univariate logistic analysis was used to analyze the risk factors associated with in-hospital death. RESULTS: The mean age of patients with confirmed COVID-19 was 70 ± 12 years, and 40% of them were male. The patients were admitted to ICU 11 ± 9 days after symptom onset. The most common symptoms on admission were cough (19 cases), fatigue or myalgia (18 cases), fever (17 cases) and dyspnea (16 cases). Eleven (55%) of the patients had underlying diseases, among which hypertension was the most common (11 cases), followed by cardiovascular disease (4 cases) and diabetes (3 cases). Six (30%) of the patients received invasive mechanical ventilation and continued renal replacement therapy but eventually died. Acute cardiac injury was the most common complication (19 cases). Half of the patients died between the 2nd and 19th day after ICU admission. Compared with dead patients, the surviving patients had a lower average body weight (61.70±2.36 vs 68.60±7.15 kg, P=0.01) and a higher Glasgow Coma Index (14.69 ± 0.70 vs 12.70 ± 2.45, P=0.03), and were less likely to develop shock (2 vs 10, P=0.001) or acute respiratory distress syndrome (2 vs 10, P=0.001). CONCLUSIONS: Critically ill patients with COVID-19 are generally older. A higher body weight and a lower lymphocyte count are potentially associated with a greater likeliness of fatality in ICU patients with COVID-19.


Subject(s)
Betacoronavirus , Coronavirus Infections , Critical Illness , Pandemics , Pneumonia, Viral , Aged , Aged, 80 and over , Female , Humans , Male , Middle Aged , Retrospective Studies
4.
Zhonghua Jie He He Hu Xi Za Zhi ; 43(9): 737-743, 2020 Sep 12.
Article in Chinese | MEDLINE | ID: covidwho-749117

ABSTRACT

The critically illsurvivors with COVID-19 have Post-Intensive Care Syndrome (PICS) manifestations of varying degrees of physical, cognitive, and mental disorders after discharge from the Intensive Care Unit. Comprehensive respiratory rehabilitation interventions for patients are essential to minimize disability rate, reduce medical costs, and increase social participation. Integrated the existing treatment experience and relevant literature evidence, we recommend the evaluation and intervention of respiratory rehabilitation in the two stages of discharge ICUto ward and home. Based on Chinese experience, a PCCM physician-led multidisciplinary team management process was constructed. Personal protection recommendations were made based on the potential risk of infection among critically ill COVID-19 survivors.


Subject(s)
Betacoronavirus , Coronavirus Infections , Critical Care , Critical Illness , Pandemics , Pneumonia, Viral , Humans , Intensive Care Units
5.
Trials ; 21(1): 769, 2020 Sep 07.
Article in English | MEDLINE | ID: covidwho-748922

ABSTRACT

OBJECTIVES: To assess the effect of anticoagulation with bivalirudin administered intravenously on gas-exchange in patients with COVID-19 and respiratory failure using invasive mechanical ventilation. TRIAL DESIGN: This is a single centre parallel group, superiority, randomized (1:1 allocation ratio) controlled trial. PARTICIPANTS: All patients admitted to the Hamad Medical Corporation -ICU in Qatar for COVID-19 associated respiratory distress and in need of mechanical ventilation are screened for eligibility. INCLUSION CRITERIA: all adult patients admitted to the ICU who test positive for COVID-19 by PCR-test and in need for mechanical ventilation are eligible for inclusion. Upon crossing the limit of D-dimers (1.2 mg/L) these patients are routinely treated with an increased dose of anticoagulant according to our local protocol. This will be the start of randomization. EXCLUSION CRITERIA: pregnancy, allergic to the drug, inherited coagulation abnormalities, no informed consent. INTERVENTION AND COMPARATOR: The intervention group will receive the anticoagulant bivalirudin intravenously with a target aPTT of 45-70 sec for three days while the control group will stay on the standard treatment with low-molecular-weight heparins /unfractionated heparin subcutaneously (see scheme in Additional file 1). All other treatment will be unchanged and left to the attending physicians. MAIN OUTCOMES: As a surrogate parameter for clinical improvement and primary outcome we will use the PaO2/FiO2 (P/F) ratio. RANDOMISATION: After inclusion, the patients will be randomized using a closed envelope method into the conventional treatment group, which uses the standard strategy and the experimental group which receives anticoagulation treatment with bivalirudin using an allocation ratio of 1:1. BLINDING (MASKING): Due to logistical and safety reasons (assessment of aPTT to titrate the study drug) only the data-analyst will be blinded to the groups. NUMBERS TO BE RANDOMISED (SAMPLE SIZE): We performed a sample size calculation and assumed the data for P/F ratio (according to literature) is normally distributed and used the mean which would be: 160 and SD is 80. We expect the treatment will improve this by 30%. In order to reach a power of 80% we would need 44 patients per group (in total 88 patients). Taking approximately 10% of dropout into account we will include 100 patients (50 in each group). TRIAL STATUS: The local registration number is MRC-05-082 with the protocol version number 2. The date of approval is 18th June 2020. Recruitment started on 28th June and is expected to end in November 2020. TRIAL REGISTRATION: The protocol is registered before starting subject recruitment under the title: "Anticoagulation in patients suffering from COVID-19 disease. The ANTI-CO Trial" in ClinicalTrials.org with the registration number: NCT04445935 . Registered on 24 June 2020. FULL PROTOCOL: The full protocol is attached as an additional file, accessible from the Trials website (Additional file 2). In the interest in expediting dissemination of this material, the familiar formatting has been eliminated; this Letter serves as a summary of the key elements of the full protocol.


Subject(s)
Antithrombins/therapeutic use , Coronavirus Infections/drug therapy , Peptide Fragments/therapeutic use , Pneumonia, Viral/drug therapy , Respiration, Artificial , Respiratory Distress Syndrome, Adult/therapy , Anticoagulants/therapeutic use , Betacoronavirus , Coronavirus Infections/blood , Critical Illness , Fibrin Fibrinogen Degradation Products/metabolism , Heparin/therapeutic use , Heparin, Low-Molecular-Weight/therapeutic use , Hirudins , Humans , Pandemics , Partial Thromboplastin Time , Pneumonia, Viral/blood , Qatar , Recombinant Proteins/therapeutic use
7.
Zhong Nan Da Xue Xue Bao Yi Xue Ban ; 45(5): 530-535, 2020 May 28.
Article in English, Chinese | MEDLINE | ID: covidwho-745312

ABSTRACT

OBJECTIVES: To describe the clinical characteristics and outcomes of severely ill patients with coronavirus disease 2019, and to investigate the relationship between plasma glucose level and the prognosis of severely ill patients with coronavirus disease 2019. METHODS: We enrolled 52 severely ill patients with coronavirus disease 2019. Among them, 12 cases progressed to critical illness. The clinical and biochemical characteristics of severely and critically ill patients were compared. RESULTS: Compared with the severely ill patients, critically ill patients had higher white blood cell and neutrophil counts, as well as higher levels of D-dimer, IL-6 and C-reactive protein (all P<0.05). Before treatment, the fasting plasma glucose (FPG) levels were significantly higher in the critically ill patient's group [(10.23±3.71) mmol/L] compared to those in the severely ill patients [(7.12±3.35) mmol/L, P<0.05]. After adjusting for age, gender, and course of the disease, fasting blood glucose at admission (OR=1.308, 95% CI 1.066 to 1.606, P=0.01) and hyperglycemia at admission (OR=29.198, 95% CI 2.903 to 293.639, P=0.004) were closely related to whether severely ill patients progressed to critical patients with coronavirus disease 2019. In our study, 15 (34.8%) of the severely ill and 10 (83.3%) critically ill patients received the steroid treatment. Compared with the severely ill patients, the FPG levels in critically ill patients were higher (P<0.05). CONCLUSIONS: Fasting hyperglycemia at admission is a significant predictor for the prognosis of severely ill patients with coronavirus disease 2019. Closely monitoring and the optimal management of hyperglycemia may improve the prognosis of patients with coronavirus disease 2019.


Subject(s)
Blood Glucose , Coronavirus Infections/blood , Hyperglycemia/complications , Pneumonia, Viral/blood , Betacoronavirus , Coronavirus Infections/diagnosis , Critical Illness , Humans , Leukocyte Count , Pandemics , Pneumonia, Viral/diagnosis , Prognosis
8.
Yonsei Med J ; 61(9): 826-830, 2020 Sep.
Article in English | MEDLINE | ID: covidwho-745127

ABSTRACT

We retrospectively reviewed patients with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infections who were admitted to an intensive care unit in Daegu, South Korea. The outcomes of patients who did (cases) or did not (controls) receive darunavir-cobicistat (800-150 mg) therapy were compared. Fourteen patients received darunavir-cobicistat treatment, and 96 received other antiviral therapy (controls). Overall, the darunavir-cobicistat group comprised patients with milder illness, and the crude mortality rate of all patients in the darunavir-cobicistat group was lower than that in the controls [odds ratio (OR) 0.20, 95% confidence interval (CI) 0.04-0.89, p=0.035]. After 1:2 propensity-score matching, there were 14 patients in the darunavir-cobicistat group, and 28 patients in the controls. In propensity score-matched analysis, the darunavir-cobicistat group had lower mortality than the controls (OR 0.07, 95% CI 0.01-0.52, p=0.009). In conclusion, darunavir-cobicistat therapy was found to be associated with a significant survival benefit in critically ill patients with SARS-CoV-2 infection.


Subject(s)
Anti-HIV Agents/therapeutic use , Cobicistat/therapeutic use , Coronavirus Infections/drug therapy , Darunavir/therapeutic use , HIV Protease Inhibitors/therapeutic use , Pneumonia, Viral/drug therapy , Adult , Anti-HIV Agents/administration & dosage , Anti-HIV Agents/adverse effects , Betacoronavirus , Case-Control Studies , Cobicistat/administration & dosage , Cobicistat/adverse effects , Coronavirus Infections/diagnosis , Coronavirus Infections/mortality , Critical Illness , Darunavir/administration & dosage , Darunavir/adverse effects , Female , HIV Protease Inhibitors/administration & dosage , HIV Protease Inhibitors/adverse effects , Humans , Intensive Care Units , Male , Middle Aged , Pandemics , Pneumonia, Viral/diagnosis , Pneumonia, Viral/mortality , Republic of Korea/epidemiology , Retrospective Studies , Severity of Illness Index , Treatment Outcome
9.
Biomed Res Int ; 2020: 2721381, 2020.
Article in English | MEDLINE | ID: covidwho-744899

ABSTRACT

Introduction: Emergency department (ED) triage regarding infection with severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) is challenging. During the coronavirus disease 2019 (COVID-19) outbreak in Germany, the diagnostic outcomes of critically ill patients admitted to the resuscitation room in the ED of our academic 754-bed hospital should be analyzed. Methods: All resuscitation room patients between March 1st and April 15th 2020 were included in this retrospective study. Every patient with suspicion of SARS-CoV-2 infection received a pharyngeal swab for real-time polymerase chain reaction (rt-PCR), divided in the clinical subgroups of "highly suspicious for COVID-19" and "COVID-19 as differential diagnosis." All respiratory and infectious symptoms were included as at least "differential diagnosis" as an expanded suspicion strategy. Results: Ninety-five patients were included (trauma n = 14, critically ill n = 81). Of 3 highly suspicious patients, 2 had rt-PCR positive pharyngeal swabs. In 39 patients, COVID-19 was defined as differential diagnosis, and 3 were positive for SARS-CoV-2. Of them, pharyngeal swabs were positive in 1 case, while in 2 cases, only tracheal fluid was rt-PCR positive while the pharyngeal swabs were negative. In one of these 2 cases, chest computed tomography (CT) was also negative for ground-glass opacities but showed a pulmonary abscess and pulmonary embolism. Conclusion: We recommend an expanded suspicion strategy for COVID-19 due to unexpected diagnostic outcomes. Personal protective equipment should be used in every resuscitation room operation due to unexpected cases and initial knowledge gaps. Furthermore, tracheal fluid should be tested for SARS-CoV-2 in every intubated patient due to cases with negative pharyngeal swabs and negative chest CT.


Subject(s)
Betacoronavirus , Clinical Laboratory Techniques/methods , Coronavirus Infections/diagnosis , Pneumonia, Viral/diagnosis , Aged , Aged, 80 and over , Coronavirus Infections/diagnostic imaging , Coronavirus Infections/epidemiology , Critical Illness , Diagnosis, Differential , Disease Outbreaks , Emergency Service, Hospital , False Negative Reactions , Female , Germany/epidemiology , Humans , Male , Middle Aged , Pandemics , Pneumonia, Viral/diagnostic imaging , Pneumonia, Viral/epidemiology , RNA, Viral/genetics , RNA, Viral/isolation & purification , Real-Time Polymerase Chain Reaction , Resuscitation , Retrospective Studies , Tomography, X-Ray Computed , Triage
13.
Medicine (Baltimore) ; 99(34): e21874, 2020 Aug 21.
Article in English | MEDLINE | ID: covidwho-733315

ABSTRACT

BACKGROUND: Coronavirus disease 2019 (COVID-19) has caused serious damage to public health. COVID-19 has no vaccine or specific therapy; its mortality rate increases significantly once patients deteriorate. Furthermore, intensive monitoring of COVID-19 is limited by insufficient medical resources and increased risks of exposure to medical staff. We therefore aim to build an early warning and rapid response system (EWRRS) to address these problems. METHOD: The research is designed as a prospective cohort study, to verify a dynamic and interactive evaluation system; it includes patient self-reporting, active monitoring, early alarming and treatment recommendations. Adult patients diagnosed with COVID-19 will be recruited from Sept 2020 to Aug 2021 at a tertiary contagious hospital. Patients with life expectancy <48 hours, pregnant or lactating, in immunosuppression states or end-stage diseases will be excluded. The intervention is implementation of EWRRS to detect early signs of clinical deterioration of COVID-19 patients, to provide timely and efficient treatment suggestions by the system. EWRRS can determine the classification and interactive evaluation of patient information; the determination is based on the application of 3 different scenario modules, separately driven by patients, nurses, and physicians. The primary outcome is change in disease severity category after treatment. Secondary outcomes include the proportion of patients with different disease severity types; critical deterioration events; patients who had unplanned transfers to an intensive care unit (ICU) and required critical care interventions; intervals from warning to implementation of clinical interventions; hospital mortality; length of ICU and hospital stay; workload of medical staff and risks of exposure to COVID-19. DISCUSSION: Our hypothesis is that EWRRS provides an example of an early identification, warning, and response system for COVID-19. In addition, EWRRS can potentially be extended to use as a grading metric for general critically ill patients in an ICU setting.


Subject(s)
Clinical Deterioration , Coronavirus Infections/physiopathology , Critical Illness , Pneumonia, Viral/physiopathology , Betacoronavirus , Humans , Intensive Care Units , Monitoring, Physiologic , Pandemics , Prospective Studies , Research Design , Risk Assessment , Severity of Illness Index
16.
J Med Case Rep ; 14(1): 134, 2020 Aug 24.
Article in English | MEDLINE | ID: covidwho-727299

ABSTRACT

BACKGROUND: Novel coronavirus disease 2019 presents with fever, dry cough, fatigue, and shortness of breath in most cases; however, some rare manifestations in other organs have also been reported so far. CASE PRESENTATION: Here, the case of a 69-year-old Iranian man with coronavirus disease 2019 is presented who suffered from frequent episodes of vasopressor-resistant hypotension during intensive care unit admission, which was finally attributed to the occurrence of acute adrenal insufficiency. CONCLUSIONS: As this is a rare complication, adrenal insufficiency might be easily overlooked. However, early detection of this disease among critically ill patients infected with coronavirus disease 2019 could be lifesaving, especially among those unresponsive to vasopressor agents.


Subject(s)
Adrenal Insufficiency/etiology , Betacoronavirus , Coronavirus Infections/complications , Critical Illness , Intensive Care Units , Pneumonia, Viral/complications , Acute Disease , Adrenal Insufficiency/diagnosis , Aged , Coronavirus Infections/epidemiology , Humans , Male , Pandemics , Pneumonia, Viral/epidemiology , Tomography, X-Ray Computed
17.
Trials ; 21(1): 738, 2020 Aug 24.
Article in English | MEDLINE | ID: covidwho-727297

ABSTRACT

OBJECTIVES: This study aims to determine the protection provided by Shenfu injection (a traditional Chinese medicine) against development of organ dysfunction in critically ill patients with coronavirus disease 2019 (COVID-19). TRIAL DESIGN: This study is a multicenter, randomized, controlled, open-label, two-arm ratio 1:1, parallel group clinical trial. PARTICIPANTS: The patients, who are aged from 18 to 75 years old, with a confirmed or suspected diagnosis of severe or critical COVID-19, will be consecutively recruited in the study, according to the guideline on diagnosis and treatment of COVID-19 (the 7th version) issued by National Health Commission of the People's Republic of China. Exclusion criteria include pregnant and breastfeeding women, atopy or allergies to Shenfu Injection (SFI), severe underlying disease (malignant tumor with multiple metastases, uncontrolled hemopathy, cachexia, severe malnutrition, HIV), active bleeding, obstructive pneumonia caused by lung tumor, severe pulmonary interstitial fibrosis, alveolar proteinosis and allergic alveolitis, continuous use of immunosuppressive drugs in last 6 months, organ transplantation, expected death within 48 hours, the patients considered unsuitable for this study by researchers. The study is conducted in 11 ICUs of designated hospitals for COVID-19, located in 5 cities of China. INTERVENTION AND COMPARATOR: The enrolled patients will randomly receive 100 ml SFI (study group) or identical volume of saline (control group) twice a day for seven consecutive days. Patients in the both groups will be given usual care and the necessary supportive therapies as recommended by the latest edition of the management guidelines for COVID-19 (the 7th version so far). MAIN OUTCOMES: The primary endpoint is a composite of newly developed or exacerbated organ dysfunction. This is defined as an increase in the sequential organ failure assessment (SOFA) score of two or more, indicating sepsis and involvement of at least one organ. The SOFA score will be measured for the 14 days after enrolment from the baseline (the score at randomization). The secondary endpoints are shown below: • SOFA score in total • Pneumonia severity index score • Dosage of vasoactive drugs • Ventilation free days within 28 days • Length of stay in intensive care unit • Total hospital costs to treat the patient • 28-day mortality • The incidence of adverse drug events related to SFI RANDOMISATION: The block randomization codes were generated by SAS V.9.1 for allocation of participants in this study. The ratio of random distribution is 1:1. The sealed envelope method is used for allocation concealment. BLINDING (MASKING): The patients and statistical personnel analyzing study data are both blinded. The blinding of group assignment is not adopted for the medical staff. NUMBERS TO BE RANDOMISED (SAMPLE SIZE): This study is expected to recruit 300 patients with COVID-19, (150 in each group). TRIAL STATUS: Protocol version 2.0, February 15, 2020. Patient recruitment started on February 25, and will end on August 31, 2020. TRIAL REGISTRATION: Chinese Clinical Trial Registry: ChiCTR2000030043. Registered February 21, 2020, http://www.chictr.org.cn/showprojen.aspx?proj=49866 FULL PROTOCOL: The full protocol is attached as an additional file, accessible from the Trials website (Additional file 1). In the interest in expediting dissemination of this material, the familiar formatting has been eliminated; this letter serves as a summary of the key elements of the full protocol.


Subject(s)
Coronavirus Infections/drug therapy , Drugs, Chinese Herbal/therapeutic use , Organ Dysfunction Scores , Pneumonia, Viral/drug therapy , Betacoronavirus , China , Coronavirus Infections/physiopathology , Critical Illness , Humans , Pandemics , Pneumonia, Viral/physiopathology
18.
Trials ; 21(1): 734, 2020 Aug 24.
Article in English | MEDLINE | ID: covidwho-727295

ABSTRACT

OBJECTIVES: Primary objective: To estimate the effect of corticosteroids compared with usual care or placebo on mortality up to 28 days after randomization. Secondary objectives: To examine whether the effect of corticosteroids compared with usual care or placebo on mortality up to 28 days after randomization varies between subgroups related to treatment characteristics, disease severity at the time of randomization, patient characteristics, or risk of bias. To examine the effect of corticosteroids compared with usual care or placebo on serious adverse events. STUDY DESIGN: Prospective meta-analysis of randomized controlled trials. Both placebo-controlled and open-label trials are eligible. PARTICIPANTS: Hospitalised, critically ill patients with suspected or confirmed COVID-19. INTERVENTION AND COMPARATOR: Intervention groups will have received therapeutic doses of a steroid (dexamethasone, hydrocortisone or methylprednisolone) with IV or oral administration immediately after randomization. The comparator groups will have received standard of care or usual care or placebo. MAIN OUTCOME: All-cause mortality up to 28 days after randomization. SEARCH METHODS: Systematic searching of clinicaltrials.gov , EudraCT, the WHO ISRCTN registry, and the Chinese clinical trials registry. Additionally, research and WHO networks will be asked for relevant trials. RISK OF BIAS ASSESSMENTS: These will be based on the Cochrane RoB 2 tool, and will use structured information provided by the trial investigators on a form designed for this prospective meta-analysis. We will use GRADE to assess the certainty of the evidence. STATISTICAL ANALYSES: Trial investigators will provide data on the numbers of participants who did and did not experience each outcome according to intervention group, overall and in specified subgroups. We will conduct fixed-effect (primary analysis) and random-effects (Paule-Mandel estimate of heterogeneity and Hartung-Knapp adjustment) meta-analyses. We will quantify inconsistency in effects between trials using I2 statistics. Evidence for subgroup effects will be quantified by ratios of odds ratios comparing effects in the subgroups, and corresponding interaction p-values. Comparisons between subgroups defined by trial characteristics will be made using random-effects meta-regression. Comparisons between subgroups defined by patient characteristics will be made by estimating trial-specific ratios of odds ratios comparing intervention effects between subgroups then combining these using random-effects meta-analysis. Steroid interventions will be classified as high or low dose according to whether the dose is greater or less than or equal to 400 mg hydrocortisone per day or equivalent. We will use network meta-analysis methods to make comparisons between the effects of high and low dose steroid interventions (because one trial randomized participants to both low and high dose steroid arms). PROSPERO REGISTRATION NUMBER: CRD42020197242 FULL PROTOCOL: The full protocol for this prospective meta-analysis is attached as an additional file, accessible from the Trials website (Additional file 1). To expedite dissemination of this material, the familiar formatting has been eliminated; this Letter serves as a summary of the key elements of the full protocol for the systematic review.


Subject(s)
Coronavirus Infections/drug therapy , Glucocorticoids/therapeutic use , Pneumonia, Viral/drug therapy , Adrenal Cortex Hormones/therapeutic use , Betacoronavirus , Critical Illness , Dexamethasone/therapeutic use , Humans , Hydrocortisone/therapeutic use , Methylprednisolone/therapeutic use , Pandemics , Prospective Studies , Randomized Controlled Trials as Topic
19.
J Am Soc Nephrol ; 31(9): 2205-2221, 2020 09.
Article in English | MEDLINE | ID: covidwho-725838

ABSTRACT

BACKGROUND: The incidence, severity, and outcomes of AKI in COVID-19 varied in different reports. In patients critically ill with COVID-19, the clinicopathologic characteristics of AKI have not been described in detail. METHODS: This is a retrospective cohort study of 81 patients critically ill with COVID-19 in an intensive care unit. The incidence, etiologies, and outcomes of AKI were analyzed. Pathologic studies were performed in kidney tissues from ten deceased patients with AKI. RESULTS: A total of 41 (50.6%) patients experienced AKI in this study. The median time from illness to AKI was 21.0 (IQR, 9.5-26.0) days. The proportion of Kidney Disease Improving Global Outcomes (KDIGO) stage 1, stage 2, and stage 3 AKI were 26.8%, 31.7%, and 41.5%, respectively. The leading causes of AKI included septic shock (25 of 41, 61.0%), volume insufficiency (eight of 41, 19.5%), and adverse drug effects (five of 41, 12.2%). The risk factors for AKI included age (per 10 years) (HR, 1.83; 95% CI, 1.24 to 2.69; P=0.002) and serum IL-6 level (HR, 1.83; 95% CI, 1.23 to 2.73; P=0.003). KDIGO stage 3 AKI predicted death. Other potential risk factors for death included male sex, elevated D-dimer, serum IL-6 level, and higher Sequential Organ Failure Assessment score. The predominant pathologic finding was acute tubular injury. Nucleic acid tests and immunohistochemistry failed to detect the virus in kidney tissues. CONCLUSIONS: AKI was a common and multifactorial complication in patients critically ill with COVID-19 at the late stage of the disease course. The predominant pathologic finding was acute tubular injury. Older age and higher serum IL-6 level were risk factors of AKI, and KDIGO stage 3 AKI independently predicted death.


Subject(s)
Acute Kidney Injury/pathology , Betacoronavirus , Coronavirus Infections/complications , Kidney/pathology , Pneumonia, Viral/complications , Acute Kidney Injury/etiology , Aged , Aged, 80 and over , Coronavirus Infections/pathology , Creatinine/blood , Critical Illness , Female , Humans , Intensive Care Units , Interleukin-6/blood , Kidney/ultrastructure , Kidney/virology , Male , Middle Aged , Pandemics , Pneumonia, Viral/pathology , Retrospective Studies , Risk Factors
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