Prognostic Factors Keeping Track for COVID-19 Pneumonia (NIKE_C19)
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|ClinicalTrials.gov Identifier: NCT04324684|
Recruitment Status : Completed
First Posted : March 27, 2020
Last Update Posted : May 14, 2020
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|
|Study Type :||Observational|
|Actual Enrollment :||198 participants|
|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|
Covid19 pneumonia with comorbidities
Patients with pneumonia from Covid 19 with at least one of the following comorbidities:
Covid2 pneumonia without comorbidities
Without any of the following comorbidities
- 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.
- 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
- efficacy of treatments [ Time Frame: 3 weeks ]the efficacy of different pharmaceutical treatment against Covid-19
- organ failure [ Time Frame: 3 weeks ]liver, kidney or multiorgan failure, cardiac failure
Biospecimen Retention: Samples Without DNA
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
|Fondazione Policlinico Universitario A. Gemelli IRCCS|
|Principal Investigator:||Geltrude Mingrone, MD PhD||Fondazione Policlinico Universitario A. Gemelli, IRCCS|