COVIDNCT04371562
Predicting Death and ICU Admission in COVID-19 Patients in ED
An observational study of COVID, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
Trial summary
INTRODUCTION. The novel coronavirus designated SARS-CoV-2, has determined an international outbreak of respiratory illness named Covid-19. Patients with Covid-19 present primarily with fever, myalgia or fatigue, and dry cough. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID
- How many people
- 300 participants
- Where
- 1 siteItaly
- Study dates
- 1 Mar 2020to 15 Apr 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Consecutive COVID-19 patients admitted to ED
Who may be able to join
- COVID 19 confirmed patients.
Who cannot join
- <18 years
- Pregnant women
- Asymptomatic and normal x-ray findings subjects
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Predicting ICU Admission and Death for COVID-19 Patients in the Emergency Department. Comparison of Five Scoring Systems.
INTRODUCTION. The novel coronavirus designated SARS-CoV-2, has determined an international outbreak of respiratory illness named Covid-19. Patients with Covid-19 present primarily with fever, myalgia or fatigue, and dry cough. Based on available data from 5% to 10% among hospitalized patients will require ICU admission.
In this context of overflow of critically ill patients, it is mandatory to establish clear and objective criteria to assess and predict a Covid-19 patient's need for ICU admission, and potentially predict death occurrence. Early Warning Scores (EWS) are used in hospitalized patients to predict clinical deterioration. Several study demonstrate the utility of EWS in ED to predict patient outcome.
Read more
AIM. The objective of this study is to evaluate five EWSs, to predict the need for ICU admission and the mortality in patients admitted in ED with COVID-19.
METHODS. This is a single-center, retrospective observational study. We will review the clinical records of all the patients consecutively admitted to our ED for Covid-19 over a three-weeks period (March 1 to 21, 2020). We will exclude from study cohort patients aged <18 years old and pregnant women, and patients already on oro-tracheal intubation at ED arrival. Based on clinical records five EWS will be calculated: NEWS, NEWS2, qSOFA, MEWS, REMS.
Study endpoints. The primary study endpoints will be death at 7 days, and need for ICU at 7 days, since ED admission. As secondary endpoints we will evaluate need for ICU and death at 24 and 48 hours since ED admission.
Statistical Analysis Receiver operating characteristic (ROC) curve analysis will be used to evaluate the overall performance of the selected EWSs in predicting the defined adverse outcomes. According to Youden's index we will estimate the optimal cut-off points and corresponding sensitivity and specificity at selected score threshold values. The comparison between the ROC AUCs will be made according to DeLong method.
Read the detailed description
INTRODUCTION After the first cases identified in Wuhan city (China) on December 2019, the novel coronavirus designated SARS-CoV-2 has caused a global epidemic of respiratory illness named COVID-191. To date, more than, 3,000,000 cases have been reported worldwide, including more than 300,000 deaths.
Typical COVID-19 patients present with fever, myalgia or fatigue, and dry cough. Severe cases progress to severe dyspnoea and hypoxemia within one week after the onset of symptoms 3-5. In hospitalized COVID-19 patients, the prevalence of hypoxemic respiratory failure is around 20%, and more than 25% of them may require intensive care treatment.
The increasing number of COVID-19 cases has challenged the healthcare systems worldwide. Given the current overflow of critically ill patients in the Emergency Departments (EDs), an early identification of patients who need admittance to an intensive care unit (ICU) because of an increased risk of unfavourable outcome is necessary. Although general guidelines for ICU admission and triage exist, only limited guidance is available for the specific setting of COVID-19 patients.
In this context of overwhelming demand for medical assessment and triage in ED, early warning scores (EWS) may be useful. EWS are based on a rapid and quantitative assessment of changes in vital signs, and were developed to identify and track patients at risk of deterioration in non-critical areas of the hospital in order to ensure an early stabilisation and ICU transfer when appropriate and prevent avoidable cardiac arrest. However, in recent years these scores have been used in ED to predict ICU admission and mortality. Use of EWS has recently been proposed for the triage of COVID-19 patients in ED. However, their usefulness has not been demonstrated yet.
METHODS Study design This is a retrospective observational study conducted in the ED of the largest urban teaching hospital in Rome, a referral center for COVID-19 in central Italy. The participants reviewed the electronic medical records (EMR) of all adults (>18y) patients admitted to ED for suspected COVID-19 over three consecutive weeks from March 1 to March 21, 2020, tested for COVID-19 according to the WHO interim guidance.
Inclusion and exclusion criteria Study will include only patients whose diagnosis is confirmed with real-time reverse-transcriptase-polymerase-chain-reaction assay of nasal and pharyngeal swab specimens.
Will be excluded from the study cohort pregnant women, patients discharged from ED with normal chest x-ray findings, and patients who were already mechanically ventilated on ED arrival. For patients with more than one access to our ED, only the latest access will be included in the analysis.
Study variables The following information will be extracted from digital clinical records: age, sex, clinical history and presentation, temperature, heart rate (HR), respiratory rate (RR), arterial blood pressure (BP), Glasgow Coma Scale (GCS) score, oxygen therapy, peripheral oxygen saturation (SpO2), and chest x-ray findings.Clinical signs, including SpO2, will be assessed on arrival at the ED. National Early Warning Score (NEWS), National Early Warning Score 2 (NEWS2), Quick Sepsis Related Organ Failure Assessment (qSOFA), Modified Early Warning Score (MEWS), and Rapid Emergency Medicine Score (REMS) will be calculated for each patient. For NEWS2 calculation, patient will be considered at risk of type 2 respiratory failure if had a confirmed history of chronic obstructive pulmonary disease (COPD).
Study endpoints The primary study endpoints considered will be death or ICU admission within 7 days from arrival at the ED. Secondary endpoints will be death or ICU admission within 24 and 48 hours from ED arrival.
Criteria for ICU admission The criteria for ICU admission of COVID-19 patients in include need for invasive respiratory support, or extra-pulmonary organ failure such as circulatory shock requiring vasopressors, or renal failure. These criteria are expected to be consistent throughout the study period.
Statistical Analysis and sample size Continuous variables will be reported as median [interquartile range], and will be compared at univariate analysis by Mann-Whitney U test. Categorical variables will be reported as absolute number (percentage), and will be compared by Chi-square test (with Fisher's test if appropriate).
Receiver operating characteristic (ROC) curve analysis will be used to estimate the overall performance of the evaluated scores in predicting the defined adverse outcomes. For each score threshold values will be calculated sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV), positive likelihood ratio (+LR), and negative likelihood ratio (-LR). The Youden index will be used to estimate the optimal cut-off points for sensitivity and specificity. The comparison between the ROC AUCs will be made according to DeLong method. A p value ≤ 0.05 will be regarded as significant. Data will be analyzed by IBM SPSS statistics v25® (IBM, IL, USA).
Sample size. For a correct estimation of ROC Curve a minimum of 50 patients for each endpoint should be included in the analysis. Given the estimate flow of at least 300 COVID-19 confirmed patients in the study period, and the actual rate of ICU admission in these patients (about 20%), the sample should be adequate for statistical estimation.
Aim of the study The objective of the present study is to assess the ability of EWS to predict ICU admission and mortality in COVID-19 patients in the emergency department.
Ethical considerations All the patients accessing the "COVID" ED signs a comprehensive ethical agreement for collection of blood samples and clinical data, for bio-bank and research purposes (Informative mod 147 25/06/2019).
- Conditions
- COVID
- Keywords
- Early -Warning Scores, NEWS, NEWS2, qSOFA, REMS, MEWS
What is being measured
The primary outcome is the main question the study is designed to answer.
7-day death
Death by seven day from ED access
Measured: 7 day
7-day ICU
Admission to ICU by seven day from ED access
Measured: 7 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2020
- Study start1 Mar 2020
- Primary completion31 Mar 2020
- Study completion15 Apr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for COVIDStudies of the same condition, open and under way.
- More trials run by Fondazione Policlinico Universitario Agostino Gemelli IRCCSThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Francesco Franceschi, MD PhD, Study chair, Fondazione Policlinico Universitario A. Gemelli, IRCCS, Roma
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04371562
- Sponsor's protocol ID
- 0017055/20
- Status last verified
- Apr 2020
- First submitted
- 30 Apr 2020
- Last updated
- 5 May 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Guan WJ, Ni ZY, Hu Y, Liang WH, Ou CQ, He JX, Liu L, Shan H, Lei CL, Hui DSC, Du B, Li LJ, Zeng G, Yuen KY, Chen RC, Tang CL, Wang T, Chen PY, Xiang J, Li SY, Wang JL, Liang ZJ, Peng YX, Wei L, Liu Y, Hu YH, Peng P, Wang JM, Liu JY, Chen Z, Li G, Zheng ZJ, Qiu SQ, Luo J, Ye CJ, Zhu SY, Zhong NS; China Medical Treatment Expert Group for Covid-19. Clinical Characteristics of Coronavirus Disease 2019 in China. N Engl J Med. 2020 Apr 30;382(18):1708-1720. doi: 10.1056/NEJMoa2002032. Epub 2020 Feb 28.
PubMed 32109013Huang C, Wang Y, Li X, Ren L, Zhao J, Hu Y, Zhang L, Fan G, Xu J, Gu X, Cheng Z, Yu T, Xia J, Wei Y, Wu W, Xie X, Yin W, Li H, Liu M, Xiao Y, Gao H, Guo L, Xie J, Wang G, Jiang R, Gao Z, Jin Q, Wang J, Cao B. Clinical features of patients infected with 2019 novel coronavirus in Wuhan, China. Lancet. 2020 Feb 15;395(10223):497-506. doi: 10.1016/S0140-6736(20)30183-5. Epub 2020 Jan 24.
PubMed 31986264Chen N, Zhou M, Dong X, Qu J, Gong F, Han Y, Qiu Y, Wang J, Liu Y, Wei Y, Xia J, Yu T, Zhang X, Zhang L. Epidemiological and clinical characteristics of 99 cases of 2019 novel coronavirus pneumonia in Wuhan, China: a descriptive study. Lancet. 2020 Feb 15;395(10223):507-513. doi: 10.1016/S0140-6736(20)30211-7. Epub 2020 Jan 30.
PubMed 32007143Wang D, Hu B, Hu C, Zhu F, Liu X, Zhang J, Wang B, Xiang H, Cheng Z, Xiong Y, Zhao Y, Li Y, Wang X, Peng Z. Clinical Characteristics of 138 Hospitalized Patients With 2019 Novel Coronavirus-Infected Pneumonia in Wuhan, China. JAMA. 2020 Mar 17;323(11):1061-1069. doi: 10.1001/jama.2020.1585.
PubMed 32031570Jin Y, Yang H, Ji W, Wu W, Chen S, Zhang W, Duan G. Virology, Epidemiology, Pathogenesis, and Control of COVID-19. Viruses. 2020 Mar 27;12(4):372. doi: 10.3390/v12040372.
PubMed 32230900Livingston E, Bucher K. Coronavirus Disease 2019 (COVID-19) in Italy. JAMA. 2020 Apr 14;323(14):1335. doi: 10.1001/jama.2020.4344. No abstract available.
PubMed 32181795Wu C, Chen X, Cai Y, Xia J, Zhou X, Xu S, Huang H, Zhang L, Zhou X, Du C, Zhang Y, Song J, Wang S, Chao Y, Yang Z, Xu J, Zhou X, Chen D, Xiong W, Xu L, Zhou F, Jiang J, Bai C, Zheng J, Song Y. Risk Factors Associated With Acute Respiratory Distress Syndrome and Death in Patients With Coronavirus Disease 2019 Pneumonia in Wuhan, China. JAMA Intern Med. 2020 Jul 1;180(7):934-943. doi: 10.1001/jamainternmed.2020.0994.
PubMed 32167524Nates JL, Nunnally M, Kleinpell R, Blosser S, Goldner J, Birriel B, Fowler CS, Byrum D, Miles WS, Bailey H, Sprung CL. ICU Admission, Discharge, and Triage Guidelines: A Framework to Enhance Clinical Operations, Development of Institutional Policies, and Further Research. Crit Care Med. 2016 Aug;44(8):1553-602. doi: 10.1097/CCM.0000000000001856.
PubMed 27428118Swiss Society Of Intensive Care Medicine. Recommendations for the admission of patients with COVID-19 to intensive care and intermediate care units (ICUs and IMCUs). Swiss Med Wkly. 2020 Mar 24;150:w20227. doi: 10.4414/smw.2020.20227. eCollection 2020 Mar 23. No abstract available.
PubMed 32208493Smith GB, Prytherch DR, Meredith P, Schmidt PE, Featherstone PI. The ability of the National Early Warning Score (NEWS) to discriminate patients at risk of early cardiac arrest, unanticipated intensive care unit admission, and death. Resuscitation. 2013 Apr;84(4):465-70. doi: 10.1016/j.resuscitation.2012.12.016. Epub 2013 Jan 4.
PubMed 23295778Singer M, Deutschman CS, Seymour CW, Shankar-Hari M, Annane D, Bauer M, Bellomo R, Bernard GR, Chiche JD, Coopersmith CM, Hotchkiss RS, Levy MM, Marshall JC, Martin GS, Opal SM, Rubenfeld GD, van der Poll T, Vincent JL, Angus DC. The Third International Consensus Definitions for Sepsis and Septic Shock (Sepsis-3). JAMA. 2016 Feb 23;315(8):801-10. doi: 10.1001/jama.2016.0287.
PubMed 26903338Olsson T, Terent A, Lind L. Rapid Emergency Medicine score: a new prognostic tool for in-hospital mortality in nonsurgical emergency department patients. J Intern Med. 2004 May;255(5):579-87. doi: 10.1111/j.1365-2796.2004.01321.x.
PubMed 15078500Subbe CP, Kruger M, Rutherford P, Gemmel L. Validation of a modified Early Warning Score in medical admissions. QJM. 2001 Oct;94(10):521-6. doi: 10.1093/qjmed/94.10.521.
PubMed 11588210
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predicting ICU Admission and Death for COVID-19 Patients in the Emergency Department. Comparison of Five Scoring Systems.
- ClinicalTrials.gov ID
- NCT04371562
- Acronym / sponsor ID
- 0017055/20
- Conditions
- COVID
- Keywords
- Early -Warning Scores, NEWS, NEWS2, qSOFA, REMS, MEWS
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSUniversity, hospital or other
- Study start
- 1 Mar 2020 (actual)
- Primary completion
- 31 Mar 2020 (actual)
- Study completion
- 15 Apr 2020 (actual)
- First posted
- 1 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
INTRODUCTION. The novel coronavirus designated SARS-CoV-2, has determined an international outbreak of respiratory illness named Covid-19. Patients with Covid-19 present primarily with fever, myalgia or fatigue, and dry cough. Based on available data from 5% to 10% among hospitalized patients will require ICU admission.
In this context of overflow of critically ill patients, it is mandatory to establish clear and objective criteria to assess and predict a Covid-19 patient's need for ICU admission, and potentially predict death occurrence. Early Warning Scores (EWS) are used in hospitalized patients to predict clinical deterioration. Several study demonstrate the utility of EWS in ED to predict patient outcome.
AIM. The objective of this study is to evaluate five EWSs, to predict the need for ICU admission and the mortality in patients admitted in ED with COVID-19.
METHODS. This is a single-center, retrospective observational study. We will review the clinical records of all the patients consecutively admitted to our ED for Covid-19 over a three-weeks period (March 1 to 21, 2020). We will exclude from study cohort patients aged <18 years old and pregnant women, and patients already on oro-tracheal intubation at ED arrival. Based on clinical records five EWS will be calculated: NEWS, NEWS2, qSOFA, MEWS, REMS.
Study endpoints. The primary study endpoints will be death at 7 days, and need for ICU at 7 days, since ED admission. As secondary endpoints we will evaluate need for ICU and death at 24 and 48 hours since ED admission.
Statistical Analysis Receiver operating characteristic (ROC) curve analysis will be used to evaluate the overall performance of the selected EWSs in predicting the defined adverse outcomes. According to Youden's index we will estimate the optimal cut-off points and corresponding sensitivity and specificity at selected score threshold values. The comparison between the ROC AUCs will be made according to DeLong method.
Detailed description
INTRODUCTION After the first cases identified in Wuhan city (China) on December 2019, the novel coronavirus designated SARS-CoV-2 has caused a global epidemic of respiratory illness named COVID-191. To date, more than, 3,000,000 cases have been reported worldwide, including more than 300,000 deaths.
Typical COVID-19 patients present with fever, myalgia or fatigue, and dry cough. Severe cases progress to severe dyspnoea and hypoxemia within one week after the onset of symptoms 3-5. In hospitalized COVID-19 patients, the prevalence of hypoxemic respiratory failure is around 20%, and more than 25% of them may require intensive care treatment.
The increasing number of COVID-19 cases has challenged the healthcare systems worldwide. Given the current overflow of critically ill patients in the Emergency Departments (EDs), an early identification of patients who need admittance to an intensive care unit (ICU) because of an increased risk of unfavourable outcome is necessary. Although general guidelines for ICU admission and triage exist, only limited guidance is available for the specific setting of COVID-19 patients.
In this context of overwhelming demand for medical assessment and triage in ED, early warning scores (EWS) may be useful. EWS are based on a rapid and quantitative assessment of changes in vital signs, and were developed to identify and track patients at risk of deterioration in non-critical areas of the hospital in order to ensure an early stabilisation and ICU transfer when appropriate and prevent avoidable cardiac arrest. However, in recent years these scores have been used in ED to predict ICU admission and mortality. Use of EWS has recently been proposed for the triage of COVID-19 patients in ED. However, their usefulness has not been demonstrated yet.
METHODS Study design This is a retrospective observational study conducted in the ED of the largest urban teaching hospital in Rome, a referral center for COVID-19 in central Italy. The participants reviewed the electronic medical records (EMR) of all adults (>18y) patients admitted to ED for suspected COVID-19 over three consecutive weeks from March 1 to March 21, 2020, tested for COVID-19 according to the WHO interim guidance.
Inclusion and exclusion criteria Study will include only patients whose diagnosis is confirmed with real-time reverse-transcriptase-polymerase-chain-reaction assay of nasal and pharyngeal swab specimens.
Will be excluded from the study cohort pregnant women, patients discharged from ED with normal chest x-ray findings, and patients who were already mechanically ventilated on ED arrival. For patients with more than one access to our ED, only the latest access will be included in the analysis.
Study variables The following information will be extracted from digital clinical records: age, sex, clinical history and presentation, temperature, heart rate (HR), respiratory rate (RR), arterial blood pressure (BP), Glasgow Coma Scale (GCS) score, oxygen therapy, peripheral oxygen saturation (SpO2), and chest x-ray findings.Clinical signs, including SpO2, will be assessed on arrival at the ED. National Early Warning Score (NEWS), National Early Warning Score 2 (NEWS2), Quick Sepsis Related Organ Failure Assessment (qSOFA), Modified Early Warning Score (MEWS), and Rapid Emergency Medicine Score (REMS) will be calculated for each patient. For NEWS2 calculation, patient will be considered at risk of type 2 respiratory failure if had a confirmed history of chronic obstructive pulmonary disease (COPD).
Study endpoints The primary study endpoints considered will be death or ICU admission within 7 days from arrival at the ED. Secondary endpoints will be death or ICU admission within 24 and 48 hours from ED arrival.
Criteria for ICU admission The criteria for ICU admission of COVID-19 patients in include need for invasive respiratory support, or extra-pulmonary organ failure such as circulatory shock requiring vasopressors, or renal failure. These criteria are expected to be consistent throughout the study period.
Statistical Analysis and sample size Continuous variables will be reported as median [interquartile range], and will be compared at univariate analysis by Mann-Whitney U test. Categorical variables will be reported as absolute number (percentage), and will be compared by Chi-square test (with Fisher's test if appropriate).
Receiver operating characteristic (ROC) curve analysis will be used to estimate the overall performance of the evaluated scores in predicting the defined adverse outcomes. For each score threshold values will be calculated sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV), positive likelihood ratio (+LR), and negative likelihood ratio (-LR). The Youden index will be used to estimate the optimal cut-off points for sensitivity and specificity. The comparison between the ROC AUCs will be made according to DeLong method. A p value ≤ 0.05 will be regarded as significant. Data will be analyzed by IBM SPSS statistics v25® (IBM, IL, USA).
Sample size. For a correct estimation of ROC Curve a minimum of 50 patients for each endpoint should be included in the analysis. Given the estimate flow of at least 300 COVID-19 confirmed patients in the study period, and the actual rate of ICU admission in these patients (about 20%), the sample should be adequate for statistical estimation.
Aim of the study The objective of the present study is to assess the ability of EWS to predict ICU admission and mortality in COVID-19 patients in the emergency department.
Ethical considerations All the patients accessing the "COVID" ED signs a comprehensive ethical agreement for collection of blood samples and clinical data, for bio-bank and research purposes (Informative mod 147 25/06/2019).
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Consecutive COVID-19 patients admitted to ED
Key inclusion criteria (1 listed)
- COVID 19 confirmed patients.
Key exclusion criteria (3 listed)
- <18 years
- Pregnant women
- Asymptomatic and normal x-ray findings subjects
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
7-day death
Time frame: 7 day
Death by seven day from ED access
7-day ICU
Time frame: 7 day
Admission to ICU by seven day from ED access
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2020.
- Background: PubMed 32109013Guan WJ, Ni ZY, Hu Y, Liang WH, Ou CQ, He JX, Liu L, Shan H, Lei CL, Hui DSC, Du B, Li LJ, Zeng G, Yuen KY, Chen RC, Tang CL, Wang T, Chen PY, Xiang J, Li SY, Wang JL, Liang ZJ, Peng YX, Wei L, Liu Y, Hu YH, Peng P, Wang JM, Liu JY, Chen Z, Li G, Zheng ZJ, Qiu SQ, Luo J, Ye CJ, Zhu SY, Zhong NS; China Medical Treatment Expert Group for Covid-19. Clinical Characteristics of Coronavirus Disease 2019 in China. N Engl J Med. 2020 Apr 30;382(18):1708-1720. doi: 10.1056/NEJMoa2002032. Epub 2020 Feb 28.
- Background: PubMed 31986264Huang C, Wang Y, Li X, Ren L, Zhao J, Hu Y, Zhang L, Fan G, Xu J, Gu X, Cheng Z, Yu T, Xia J, Wei Y, Wu W, Xie X, Yin W, Li H, Liu M, Xiao Y, Gao H, Guo L, Xie J, Wang G, Jiang R, Gao Z, Jin Q, Wang J, Cao B. Clinical features of patients infected with 2019 novel coronavirus in Wuhan, China. Lancet. 2020 Feb 15;395(10223):497-506. doi: 10.1016/S0140-6736(20)30183-5. Epub 2020 Jan 24.
- Background: PubMed 32007143Chen N, Zhou M, Dong X, Qu J, Gong F, Han Y, Qiu Y, Wang J, Liu Y, Wei Y, Xia J, Yu T, Zhang X, Zhang L. Epidemiological and clinical characteristics of 99 cases of 2019 novel coronavirus pneumonia in Wuhan, China: a descriptive study. Lancet. 2020 Feb 15;395(10223):507-513. doi: 10.1016/S0140-6736(20)30211-7. Epub 2020 Jan 30.
- Background: PubMed 32031570Wang D, Hu B, Hu C, Zhu F, Liu X, Zhang J, Wang B, Xiang H, Cheng Z, Xiong Y, Zhao Y, Li Y, Wang X, Peng Z. Clinical Characteristics of 138 Hospitalized Patients With 2019 Novel Coronavirus-Infected Pneumonia in Wuhan, China. JAMA. 2020 Mar 17;323(11):1061-1069. doi: 10.1001/jama.2020.1585.
- Background: PubMed 32230900Jin Y, Yang H, Ji W, Wu W, Chen S, Zhang W, Duan G. Virology, Epidemiology, Pathogenesis, and Control of COVID-19. Viruses. 2020 Mar 27;12(4):372. doi: 10.3390/v12040372.
- Background: PubMed 32181795Livingston E, Bucher K. Coronavirus Disease 2019 (COVID-19) in Italy. JAMA. 2020 Apr 14;323(14):1335. doi: 10.1001/jama.2020.4344. No abstract available.
- Background: PubMed 32167524Wu C, Chen X, Cai Y, Xia J, Zhou X, Xu S, Huang H, Zhang L, Zhou X, Du C, Zhang Y, Song J, Wang S, Chao Y, Yang Z, Xu J, Zhou X, Chen D, Xiong W, Xu L, Zhou F, Jiang J, Bai C, Zheng J, Song Y. Risk Factors Associated With Acute Respiratory Distress Syndrome and Death in Patients With Coronavirus Disease 2019 Pneumonia in Wuhan, China. JAMA Intern Med. 2020 Jul 1;180(7):934-943. doi: 10.1001/jamainternmed.2020.0994.
- Background: PubMed 27428118Nates JL, Nunnally M, Kleinpell R, Blosser S, Goldner J, Birriel B, Fowler CS, Byrum D, Miles WS, Bailey H, Sprung CL. ICU Admission, Discharge, and Triage Guidelines: A Framework to Enhance Clinical Operations, Development of Institutional Policies, and Further Research. Crit Care Med. 2016 Aug;44(8):1553-602. doi: 10.1097/CCM.0000000000001856.
- Background: PubMed 32208493Swiss Society Of Intensive Care Medicine. Recommendations for the admission of patients with COVID-19 to intensive care and intermediate care units (ICUs and IMCUs). Swiss Med Wkly. 2020 Mar 24;150:w20227. doi: 10.4414/smw.2020.20227. eCollection 2020 Mar 23. No abstract available.
- Background: PubMed 23295778Smith GB, Prytherch DR, Meredith P, Schmidt PE, Featherstone PI. The ability of the National Early Warning Score (NEWS) to discriminate patients at risk of early cardiac arrest, unanticipated intensive care unit admission, and death. Resuscitation. 2013 Apr;84(4):465-70. doi: 10.1016/j.resuscitation.2012.12.016. Epub 2013 Jan 4.
- Background: PubMed 26903338Singer M, Deutschman CS, Seymour CW, Shankar-Hari M, Annane D, Bauer M, Bellomo R, Bernard GR, Chiche JD, Coopersmith CM, Hotchkiss RS, Levy MM, Marshall JC, Martin GS, Opal SM, Rubenfeld GD, van der Poll T, Vincent JL, Angus DC. The Third International Consensus Definitions for Sepsis and Septic Shock (Sepsis-3). JAMA. 2016 Feb 23;315(8):801-10. doi: 10.1001/jama.2016.0287.
- Background: PubMed 15078500Olsson T, Terent A, Lind L. Rapid Emergency Medicine score: a new prognostic tool for in-hospital mortality in nonsurgical emergency department patients. J Intern Med. 2004 May;255(5):579-87. doi: 10.1111/j.1365-2796.2004.01321.x.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Francesco Franceschi, MD PhD study chair
Fondazione Policlinico Universitario A. Gemelli, IRCCS, Roma
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COVID, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
7-day death (time frame: 7 day). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04371562, which also lists 13 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 May 2020.