COVID-19 Virus InfectionRF-COVIDNCT04786808
Risk Factors for COVID-19 Mortality
An observational study of COVID-19 Virus Infection and Population at Risk, run by Teodoro Marcianò at 1 site in Italy.
Trial summary
COVID-19 pandemic has deeply burdened hospitals all over the world. A two-stage disease has been hypothesized due to quick worsening of clinical status after 7-10 days from the beginning of first symptoms, generally flu-like symptoms. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID-19 Virus Infection, Population at Risk, Acute Respiratory Distress Syndrome
- How many people
- 200 participants
- Where
- 1 siteItaly
- Study dates
- 15 Jan 2021to 7 Nov 2021
- 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: All patients admitted to the ward from the Emergency Department are proposed to participate to the study. Patients admitted to the Emergency Medicine Ward have a COVID-19 pneumonia with respiratory failure at any stage of severity, with a PaO2/FiO2 ratio approximately between 100 and 300. Prevalence of severe cases changes according to the number of cases diagnosed in the community and consequently to the global number of admissions to the hospital. The study is intended to be conducted over a period of 1 year.
Who may be able to join
- Admission to the Emergency Medicine Ward from the Emergency Department of Piacenza Hospital (Italy)
- Confirmed COVID-19 diagnosis through molecular test obtained from nasal-pharyngeal swabs in the Emergency Department
- Age above 18
Who cannot join
- inability to obtain an informed consent due to neurological conditions.
- patient's refusal to sign the informed consent
- inability of researchers to recruit the patient in the first 24 hours from the admission.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Risk Factors for COVID-19 Mortality: a Prospective Observational Study
COVID-19 pandemic has deeply burdened hospitals all over the world. A two-stage disease has been hypothesized due to quick worsening of clinical status after 7-10 days from the beginning of first symptoms, generally flu-like symptoms. Predicting clinical worsening could help to address major efforts towards higher risk patients.
During the last year most observational studies, generally retrospective, has been conducted, identifying some risk factors such as age, obesity, male gender, cardiovascular disease, COPD, diabetes etc.
The study goal is to collect systematically a variegate amount of clinical, biometric, laboratory and radiological data from patients admitted to the Emergency Medicine Ward of Piacenza Hospital (Italy), in order to prospectively analyze what characteristics are associated to higher risk of mortality.
- Medical subject headings
- COVID-19, Respiratory Distress Syndrome
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality rate
Number of patients who die for any cause in the first 28 days after admission
Measured: 28 days after admission
Secondary outcomes (1)
Need of invasive ventilation
Number of patients who need invasive ventilation in the first 15 days after admission
Measured: 15 days after admission
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2021
- Study start15 Jan 2021
- Primary completion7 Nov 2021
- Study completion7 Nov 2021
Why it stopped: Not enough participants recruited (about 30% at october 2021).
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19 Virus InfectionStudies of the same condition, open and under way.
- 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
- Prospective
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Teodoro Marcianò
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Teodoro Marcianò, Azienda Unita Sanitaria Locale di Piacenza
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04786808
- Sponsor's protocol ID
- RF-COVID-AUSLPC
- Acronym
- RF-COVID
- Status last verified
- Nov 2021
- First submitted
- 5 Mar 2021
- Last updated
- 15 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Risk Factors for COVID-19 Mortality: a Prospective Observational Study
- ClinicalTrials.gov ID
- NCT04786808
- Acronym / sponsor ID
- RF-COVID / RF-COVID-AUSLPC
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Not enough participants recruited (about 30% at october 2021).
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Teodoro MarcianòUniversity, hospital or other
- Study start
- 15 Jan 2021 (actual)
- Primary completion
- 7 Nov 2021 (actual)
- Study completion
- 7 Nov 2021 (actual)
- First posted
- 8 Mar 2021 (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.
COVID-19 pandemic has deeply burdened hospitals all over the world. A two-stage disease has been hypothesized due to quick worsening of clinical status after 7-10 days from the beginning of first symptoms, generally flu-like symptoms. Predicting clinical worsening could help to address major efforts towards higher risk patients.
During the last year most observational studies, generally retrospective, has been conducted, identifying some risk factors such as age, obesity, male gender, cardiovascular disease, COPD, diabetes etc.
The study goal is to collect systematically a variegate amount of clinical, biometric, laboratory and radiological data from patients admitted to the Emergency Medicine Ward of Piacenza Hospital (Italy), in order to prospectively analyze what characteristics are associated to higher risk of mortality.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients admitted to the ward from the Emergency Department are proposed to participate to the study. Patients admitted to the Emergency Medicine Ward have a COVID-19 pneumonia with respiratory failure at any stage of severity, with a PaO2/FiO2 ratio approximately between 100 and 300. Prevalence of severe cases changes according to the number of cases diagnosed in the community and consequently to the global number of admissions to the hospital. The study is intended to be conducted over a period of 1 year.
Key inclusion criteria (3 listed)
- Admission to the Emergency Medicine Ward from the Emergency Department of Piacenza Hospital (Italy)
- Confirmed COVID-19 diagnosis through molecular test obtained from nasal-pharyngeal swabs in the Emergency Department
- Age above 18
Key exclusion criteria (3 listed)
- inability to obtain an informed consent due to neurological conditions.
- patient's refusal to sign the informed consent
- inability of researchers to recruit the patient in the first 24 hours from the admission.
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
Mortality rate
Time frame: 28 days after admission
Number of patients who die for any cause in the first 28 days after admission
1 secondary outcome
Need of invasive ventilation
Time frame: 15 days after admission
Results and safety
The study was stopped early (reason given: Not enough participants recruited (about 30% at october 2021).). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Nov 2021.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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-19 Virus Infection and Population at Risk, run by Teodoro Marcianò 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 3 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: stopped early, as of the sponsor's last update on 15 Nov 2021. 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 was stopped early (reason given: Not enough participants recruited (about 30% at october 2021).). Results are not available in the source record.
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?
Mortality rate (time frame: 28 days after admission). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Nov 2021.