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Prognostic Factors Keeping Track for COVID-19 Pneumonia (NIKE_C19)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT04324684
Recruitment Status : Completed
First Posted : March 27, 2020
Last Update Posted : May 14, 2020
Information provided by (Responsible Party):
Geltrude Mingrone, Catholic University of the Sacred Heart

Brief Summary:

It has been reported that nearly half of the patients who are hospitalized for Covid-19 pneumonia have on admission old age or comorbidities.

In particular, hypertension was present in 30% of the cases, diabetes in 19%, coronary heart disease in 8% and chronic obstructive lung disease in 3% of the patients.

Amazingly, in the two major studies published in the Lancet (Zhou F et al Lancet 2020) and in the New England Journal of Medicine (Guan W et al 2020), the weight of the subjects as well their body mass index (BMI) were omitted. However, obesity, alone or in association with diabetes, can be a major predisposition factor for Covid-19 infection.

The primary end-point of our prospective, observational study is to assess the recovery rate in patients with diagnosis of Covid-19 pneumonia. Among the other secondary end-points, we intend to find the predictors of the time to clinical improvement or hospital discharge in patients affected by Covid-19 pneumonia.

Condition or disease
Pneumonia, Viral Hypertension Diabetes Mellitus Obesity Cardiovascular Diseases Obstructive Lung Disease

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Study Type : Observational
Actual Enrollment : 198 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Time of Recovery and Prognostic Factors of COVID-19 Pneumonia
Actual Study Start Date : March 31, 2020
Actual Primary Completion Date : May 7, 2020
Actual Study Completion Date : May 7, 2020

Resource links provided by the National Library of Medicine

Covid19 pneumonia with comorbidities

Patients with pneumonia from Covid 19 with at least one of the following comorbidities:

  1. Hypertension
  2. Obesity and/or type 2 diabetes
  3. Cardiovascular disease
  4. Chronic obstructive lung disease
Covid2 pneumonia without comorbidities
Without any of the following comorbidities

Primary Outcome Measures :
  1. rate of recovery [ Time Frame: 3 weeks ]
    mean rate of recovery in patients with diagnosis of Covid-19 pneumonia, who present with complications at the time of hospital admission (such as diabetes, obesity, cardiovascular disease, hypertension or respiratory failure), with the mean recovery rate in patients without any of the above-mentioned complications.

Secondary Outcome Measures :
  1. time to improvement [ Time Frame: 3 weeks ]
    comparison of the survival curves (times to improvement) in the two groups (patients with and without complications) and among patients presenting with different types of complications

  2. efficacy of treatments [ Time Frame: 3 weeks ]
    the efficacy of different pharmaceutical treatment against Covid-19

  3. organ failure [ Time Frame: 3 weeks ]
    liver, kidney or multiorgan failure, cardiac failure

Biospecimen Retention:   Samples Without DNA
Plasma samples

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Subjects hospitalized for Covid19 pneumonia

Inclusion Criteria:

diagnosis of pneumonia; Covid-19 test positive; hospitalized subjects; both sexes aged; given informed consent.

Exclusion Criteria:

age lower than 18 years; pregnancy; breast-feeding.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04324684

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Fondazione Policlinico Universitario A. Gemelli IRCCS
Roma, Italy
Sponsors and Collaborators
Catholic University of the Sacred Heart
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Principal Investigator: Geltrude Mingrone, MD PhD Fondazione Policlinico Universitario A. Gemelli, IRCCS

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Responsible Party: Geltrude Mingrone, Associate Professor of Internal Medicine, Catholic University of the Sacred Heart
ClinicalTrials.gov Identifier: NCT04324684    
Other Study ID Numbers: 20202503
First Posted: March 27, 2020    Key Record Dates
Last Update Posted: May 14, 2020
Last Verified: May 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Pneumonia, Viral
Lung Diseases
Lung Diseases, Obstructive
Cardiovascular Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Virus Diseases