PROTOCOL: A retrospective, multicentre cohort study for adult inpatients in Wuhan, China

Authors: Alexandra Freeman
Date added: 13th April 2020, 16:45:52

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Here, we present details of all patients admitted to the two designated hospitals in Wuhan—Jinyintan Hospital and Wuhan Pulmonary Hospital—with laboratory-confirmed COVID-19 and a definite clinical outcome (death or discharge) as of Jan 31, 2020. We aim to explore risk factors of in-hospital death for patients and describe the clinical course of symptoms, viral shedding, and temporal changes of laboratory findings during hospitalisation.

Study design and participants

This retrospective cohort study included two cohorts of adult inpatients (≥18 years old) from Jinyintan Hospital and Wuhan Pulmonary Hospital (Wuhan, China). All adult patients who were diagnosed with COVID-19 according to WHO interim guidance were screened, and those who died or were discharged between Dec 29, 2019 (ie, when the first patients were admitted), and Jan 31, 2020, were included in our study. Since these two hospitals were the only designated hospitals for transfer of patients with COVID-19 from other hospitals in Wuhan until Feb 1, 2020, our study enrolled all adult inpatients who were hospitalised for COVID-19 and had a definite outcome (dead or discharged) at the early stage of the outbreak.

Before Jan 11, 2020, SARS-CoV-2 RNA detection results were not available in the electronic medical records, from which data for this study were obtained retrospectively; therefore, this study includes 29 of the 41 patients originally reported on.5

The study was approved by the Research Ethics Commission of Jinyintan Hospital (KY-2020–01.01) and the requirement for informed consent was waived by the Ethics Commission as described previously.5

Data collection

Epidemiological, demographic, clinical, laboratory, treatment, and outcome data were extracted from electronic medical records using a standardised data collection form, which was a modified version of the WHO/International Severe Acute Respiratory and Emerging Infection Consortium case record form for severe acute respiratory infections. All data were checked by two physicians (FZ and ZL) and a third researcher (GF) adjudicated any difference in interpretation between the two primary reviewers.

Laboratory procedures

Methods for laboratory confirmation of SARS-CoV-2 infection have been described elsewhere.5 Briefly, four institutions—the Chinese Center for Disease Control and Prevention, the Chinese Academy of Medical Science, the Academy of Military Medical Sciences, and the Wuhan Institute of Virology, Chinese Academy of Sciences—were responsible for SARS-CoV-2 detection in respiratory specimens by next-generation sequencing or real-time RT-PCR methods. From Jan 11, 2020, SARS-CoV-2 RNA were detected by local Centers for Disease Control and Prevention, local health institutions, and Jingyintan Hospital and Wuhan Pulmonary Hospital. Throat-swab specimens were obtained for SARS-CoV-2 PCR re-examination every other day after clinical remission of symptoms, including fever, cough, and dyspnoea, but only qualitative data were available. The criteria for discharge were absence of fever for at least 3 days, substantial improvement in both lungs in chest CT, clinical remission of respiratory symptoms, and two throat-swab samples negative for SARS-CoV-2 RNA obtained at least 24 h apart.

Routine blood examinations were complete blood count, coagulation profile, serum biochemical tests (including renal and liver function, creatine kinase, lactate dehydrogenase, and electrolytes), myocardial enzymes, interleukin-6 (IL-6), serum ferritin, and procalcitonin. Chest radiographs or CT scan were also done for all inpatients. Frequency of examinations was determined by the treating physician.

Definitions

Fever was defined as axillary temperature of at least 37·3°C. Sepsis and septic shock were defined according to the 2016 Third International Consensus Definition for Sepsis and Septic Shock.5 Secondary infection was diagnosed when patients showed clinical symptoms or signs of pneumonia or bacteraemia and a positive culture of a new pathogen was obtained from lower respiratory tract specimens (qualified sputum, endotracheal aspirate, or bronchoalveolar lavage fluid) or blood samples after admission.5 Ventilator-associated pneumonia was diagnosed according to the guidelines for treatment of hospital-acquired and ventilator-associated pneumonia.8 Acute kidney injury was diagnosed according to the KDIGO clinical practice guidelines9 and acute respiratory distress syndrome (ARDS) was diagnosed according to the Berlin Definition.10 Acute cardiac injury was diagnosed if serum levels of cardiac biomarkers (eg, high-sensitivity cardiac troponin I) were above the 99th percentile upper reference limit, or if new abnormalities were shown in electrocardiography and echocardiography.5 The illness severity of COVID-19 was defined according to the Chinese management guideline for COVID-19 (version 6.0).11 Coagulopathy was defined as a 3-second extension of prothrombin time or a 5-second extension of activated partial thromboplastin time. Hypoproteinaemia was defined as blood albumin of less than 25 g/L. Exposure history was defined as exposure to people with confirmed SARS-CoV-2 infection or to the Wuhan seafood market.





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