Obesity Clinical Trial
— NIKE_C19Official title:
Time of Recovery and Prognostic Factors of COVID-19 Pneumonia
NCT number | NCT04324684 |
Other study ID # | 20202503 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | March 31, 2020 |
Est. completion date | May 7, 2020 |
Verified date | May 2020 |
Source | Catholic University of the Sacred Heart |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 198 |
Est. completion date | May 7, 2020 |
Est. primary completion date | May 7, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 100 Years |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
Italy | Fondazione Policlinico Universitario A. Gemelli IRCCS | Roma |
Lead Sponsor | Collaborator |
---|---|
Catholic University of the Sacred Heart |
Italy,
Bornstein SR, Dalan R, Hopkins D, Mingrone G, Boehm BO. Endocrine and metabolic link to coronavirus infection. Nat Rev Endocrinol. 2020 Apr 2. doi: 10.1038/s41574-020-0353-9. [Epub ahead of print] — View Citation
Guan W, Ni Z,Hu Y et al. Clinical characteristics of coronavirus disease 2019 in China. N Engl J Med. 2020; (published online Feb 28.)
Masters SL, Dunne A, Subramanian SL, Hull RL, Tannahill GM, Sharp FA, Becker C, Franchi L, Yoshihara E, Chen Z, Mullooly N, Mielke LA, Harris J, Coll RC, Mills KH, Mok KH, Newsholme P, Nuñez G, Yodoi J, Kahn SE, Lavelle EC, O'Neill LA. Activation of the NLRP3 inflammasome by islet amyloid polypeptide provides a mechanism for enhanced IL-1ß in type 2 diabetes. Nat Immunol. 2010 Oct;11(10):897-904. doi: 10.1038/ni.1935. Epub 2010 Sep 12. — View Citation
Qu D, Liu J, Lau CW, Huang Y. IL-6 in diabetes and cardiovascular complications. Br J Pharmacol. 2014 Aug;171(15):3595-603. doi: 10.1111/bph.12713. Review. — View Citation
Zhou F, Yu T, Du R, Fan G, Liu Y, Liu Z, Xiang J, Wang Y, Song B, Gu X, Guan L, Wei Y, Li H, Wu X, Xu J, Tu S, Zhang Y, Chen H, Cao B. Clinical course and risk factors for mortality of adult inpatients with COVID-19 in Wuhan, China: a retrospective cohort study. Lancet. 2020 Mar 28;395(10229):1054-1062. doi: 10.1016/S0140-6736(20)30566-3. Epub 2020 Mar 11. Erratum in: Lancet. 2020 Mar 28;395(10229):1038. Lancet. 2020 Mar 28;395(10229):1038. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | rate of recovery | 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. | 3 weeks | |
Secondary | time to improvement | 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 | 3 weeks | |
Secondary | efficacy of treatments | the efficacy of different pharmaceutical treatment against Covid-19 | 3 weeks | |
Secondary | organ failure | liver, kidney or multiorgan failure, cardiac failure | 3 weeks |
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