covid19MI-COVIDNCT04427345
Predictive Factors COVID-19 Patients
An observational study of covid19, run by University of Milano Bicocca at 1 site in Italy.
Trial summary
This is a monocentric retro-prospective observational study that will be conducted on all COVID19 positive patients hospitalized at the S. Gerardo Hospital in Monza. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- covid19
- What is being tested?
- Predictive factors for clinical response in patients with COVID-19.
- How many people
- 0 participants
- Where
- 1 siteItaly
- Study dates
- 30 Apr 2020to 12 May 2022
- 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: The study involves patients admitted to San Gerardo Hospital from March 1, 2020 to May 31, 2020. The minimum expected follow-up will be one year for all patients. Given the nature of the study, no formal calculation of the sample size was made, nor was a sample size predefined. However, given the recruiting potential of the center which in March saw on average 30-60 hospitalizations due to SARS-CoV-2 per day, even considering a progressive decrease in access, it is assumed that the proportion of patients who will be included in the study will exceed 1000 units.
Who may be able to join
- Patients 18 years old or above
- Diagnosis of SARS-CoV-2 pneumonia
Who cannot join
- Explicit refusal to participate in the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Predictive Clinical Response Factors in COVID-19 Patients
This is a monocentric retro-prospective observational study that will be conducted on all COVID19 positive patients hospitalized at the S. Gerardo Hospital in Monza.
Read the detailed description
BACKGROUND:
The Severe Acute Respiratory Syndrome-Coronavirus-2 (SARS-CoV-2) pandemic is severely testing the health systems of the most advanced countries. Clinicians are faced with a new pathology of an emerging virus. There is therefore an urgent need to collect real-time clinical data that informs about outcome predictive variables. Furthermore, there are currently no antiviral drugs approved for the treatment of SARS-CoV-2 infection, off-label therapies are being used with drugs already in use for other pathologies that have shown some efficacy in vitro, and some treatments obtained for compassionate use with other drugs that are being tested.
It is more than ever necessary to collect clinical practice data both retrospectively on the work done so far, and in a longitudinal perspective, and analyze them quickly to optimize current treatments and define protocols for the future. Having a good clinical data base also offers the possibility of collaborating with numerous international networks on translational research, which aims to correlate clinical data with virological and immunological data, aimed at the rapid identification of possible specific viral virulence factors, or particular immune structures of the guests who once again define the final clinical outcome.
STUDY DESIGN:
All COVID19 positive patients admitted to San Gerardo Hospital will be enrolled in the study.
After patient signs the informed consent, the following data will be collected:
- birth data
- sex
- demographic data
- comorbidity
- blood chemistry data at the entrance
A series of variables will then be collected relating to the treatment procedure, the therapies, the team's choice to maximize the care ceiling in the individual patient and the entire clinical study of the patient.
STATISTICAL ANALISYS:
Central tendency and dispersion measurements will be used for descriptive analysis of continuous variables while absolute and relative frequencies will be used to describe categorical variables.
- Conditions
- covid19
- Being tested
- Predictive factors for clinical response in patients with COVID-19.
- Keywords
- Coronavirus, sars-covid-2, coronavirus infection
- Medical subject headings
- COVID-19, Coronavirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Predictive factors for clinical response in patients with COVID-19.Other
Identify the risk factors for intra-hospital mortality in patients hospitalized in the COVID + hospital wards of the San Gerardo hospital and build a prognostic score through which it is possible to define a stratification that immediately guides the therapeutic choices and the intensity of care .
| Study group | Role | What they receive |
|---|---|---|
| Covid19 infection related patients | Patients admitted to COVID wards of the S. Gerardo Hospital of Monza, including Intensive Care wards. Receives: Other: Predictive factors for clinical response in patients with COVID-19. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Identify risk factors for intra-hospital mortality.
Identify risk factors for intra-hospital mortality in patients admitted to the COVID + hospital wards of San Gerardo hospital.
Measured: Until patient discharge from the hospital (approximately 1 year)
Identify risk factors to build a prognostic score.
Identify the risk factors to build a prognostic score through which it is possible to define a stratification that immediately guides the therapeutic choices.
Measured: Until patient discharge from the hospital (approximately 1 year)
Identify risk factors to build a prognostic score.
Identify the risk factors to build a prognostic score through which it is possible to define a stratification that immediately directs towards the right intensity of care.
Measured: Until patient discharge from the hospital (approximately 1 year)
Secondary outcomes (5)
Predictive factors for the hospitalization duration.
Description of the predictive factors for the hospitalization duration.
Measured: Until patient discharge from the hospital (approximately 1 year)
Predictive factors for clinical status patients based on "Ordinal Scale for Clinical Improvement"
Description of the predictive factors for the clinical status of patients based on "Ordinal Scale for Clinical Improvement" defined by OMS (
Measured: Until patient discharge from the hospital (approximately 1 year)
Describe the anti-viral therapies used commonly in this emergency in terms of efficacy
Description of efficacy of the anti-viral therapies used today without particular restrictions, but on which solid clinical functioning tests are lacking.
Measured: Until patient discharge from the hospital (approximately 1 year).
Describe the anti-viral therapies used commonly used in this emergency in terms of safety
Description of safety of the anti-viral therapies used today without particular restrictions, but on which solid clinical functioning tests are lacking.
Measured: Until patient discharge from the hospital (approximately 1 year).
Monitor the clinical course of the disease in discharged patients.
Description of the disease clinical course in patients 12 months after discharge (mortality, neurological, respiratory and cardiac outcomes).
Measured: 12 month after discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2020
- Study start30 Apr 2020
- Primary completionMay 2021 (estimated)
- Study completion12 May 2022
Why it stopped: This study has been included in another trial within the same Sponsor
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for covid19Studies 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
- Retrospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Milano Bicocca
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04427345
- Sponsor's protocol ID
- MI-COVID
- Acronym
- MI-COVID
- Status last verified
- May 2022
- First submitted
- 4 Jun 2020
- Last updated
- 26 May 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Rosenbaum L. Facing Covid-19 in Italy - Ethics, Logistics, and Therapeutics on the Epidemic's Front Line. N Engl J Med. 2020 May 14;382(20):1873-1875. doi: 10.1056/NEJMp2005492. Epub 2020 Mar 18. No abstract available.
PubMed 32187459Chen 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 32031570Wu 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 32167524Wu Z, McGoogan JM. Characteristics of and Important Lessons From the Coronavirus Disease 2019 (COVID-19) Outbreak in China: Summary of a Report of 72 314 Cases From the Chinese Center for Disease Control and Prevention. JAMA. 2020 Apr 7;323(13):1239-1242. doi: 10.1001/jama.2020.2648. No abstract available.
PubMed 32091533Guan 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 32109013
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predictive Clinical Response Factors in COVID-19 Patients
- ClinicalTrials.gov ID
- NCT04427345
- Acronym / sponsor ID
- MI-COVID / MI-COVID
- Conditions
- covid19
- Keywords
- Coronavirus, sars-covid-2, coronavirus infection
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: This study has been included in another trial within the same Sponsor
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of Milano BicoccaUniversity, hospital or other
- Study start
- 30 Apr 2020 (actual)
- Primary completion
- May 2021 (estimated)
- Study completion
- 12 May 2022 (actual)
- First posted
- 11 Jun 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.
This is a monocentric retro-prospective observational study that will be conducted on all COVID19 positive patients hospitalized at the S. Gerardo Hospital in Monza.
Detailed description
BACKGROUND:
The Severe Acute Respiratory Syndrome-Coronavirus-2 (SARS-CoV-2) pandemic is severely testing the health systems of the most advanced countries. Clinicians are faced with a new pathology of an emerging virus. There is therefore an urgent need to collect real-time clinical data that informs about outcome predictive variables. Furthermore, there are currently no antiviral drugs approved for the treatment of SARS-CoV-2 infection, off-label therapies are being used with drugs already in use for other pathologies that have shown some efficacy in vitro, and some treatments obtained for compassionate use with other drugs that are being tested.
It is more than ever necessary to collect clinical practice data both retrospectively on the work done so far, and in a longitudinal perspective, and analyze them quickly to optimize current treatments and define protocols for the future. Having a good clinical data base also offers the possibility of collaborating with numerous international networks on translational research, which aims to correlate clinical data with virological and immunological data, aimed at the rapid identification of possible specific viral virulence factors, or particular immune structures of the guests who once again define the final clinical outcome.
STUDY DESIGN:
All COVID19 positive patients admitted to San Gerardo Hospital will be enrolled in the study.
After patient signs the informed consent, the following data will be collected:
- birth data
- sex
- demographic data
- comorbidity
- blood chemistry data at the entrance
A series of variables will then be collected relating to the treatment procedure, the therapies, the team's choice to maximize the care ceiling in the individual patient and the entire clinical study of the patient.
STATISTICAL ANALISYS:
Central tendency and dispersion measurements will be used for descriptive analysis of continuous variables while absolute and relative frequencies will be used to describe categorical variables.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Covid19 infection related patients | – | Other: Predictive factors for clinical response in patients with COVID-19.Patients admitted to COVID wards of the S. Gerardo Hospital of Monza, including Intensive Care wards. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study involves patients admitted to San Gerardo Hospital from March 1, 2020 to May 31, 2020. The minimum expected follow-up will be one year for all patients. Given the nature of the study, no formal calculation of the sample size was made, nor was a sample size predefined. However, given the recruiting potential of the center which in March saw on average 30-60 hospitalizations due to SARS-CoV-2 per day, even considering a progressive decrease in access, it is assumed that the proportion of patients who will be included in the study will exceed 1000 units.
Key inclusion criteria (2 listed)
- Patients 18 years old or above
- Diagnosis of SARS-CoV-2 pneumonia
Key exclusion criteria (1 listed)
- Explicit refusal to participate in the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Predictive factors for clinical response in patients with COVID-19.Identify the risk factors for intra-hospital mortality in patients hospitalized in the COVID + hospital wards of the San Gerardo hospital and build a prognostic score through which it is possible to define a stratification that immediately guides the therapeutic choices and the intensity of care . | Other | Covid19 infection related patients |
Primary outcome
Identify risk factors for intra-hospital mortality.
Time frame: Until patient discharge from the hospital (approximately 1 year)
Identify risk factors for intra-hospital mortality in patients admitted to the COVID + hospital wards of San Gerardo hospital.
Identify risk factors to build a prognostic score.
Time frame: Until patient discharge from the hospital (approximately 1 year)
Identify the risk factors to build a prognostic score through which it is possible to define a stratification that immediately guides the therapeutic choices.
Identify risk factors to build a prognostic score.
Time frame: Until patient discharge from the hospital (approximately 1 year)
Identify the risk factors to build a prognostic score through which it is possible to define a stratification that immediately directs towards the right intensity of care.
5 secondary outcomes
Predictive factors for the hospitalization duration.
Time frame: Until patient discharge from the hospital (approximately 1 year)
Predictive factors for clinical status patients based on "Ordinal Scale for Clinical Improvement"
Time frame: Until patient discharge from the hospital (approximately 1 year)
Describe the anti-viral therapies used commonly in this emergency in terms of efficacy
Time frame: Until patient discharge from the hospital (approximately 1 year).
Describe the anti-viral therapies used commonly used in this emergency in terms of safety
Time frame: Until patient discharge from the hospital (approximately 1 year).
Monitor the clinical course of the disease in discharged patients.
Time frame: 12 month after discharge
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 May 2022.
- Background: PubMed 32187459Rosenbaum L. Facing Covid-19 in Italy - Ethics, Logistics, and Therapeutics on the Epidemic's Front Line. N Engl J Med. 2020 May 14;382(20):1873-1875. doi: 10.1056/NEJMp2005492. Epub 2020 Mar 18. No abstract available.
- 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 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 32091533Wu Z, McGoogan JM. Characteristics of and Important Lessons From the Coronavirus Disease 2019 (COVID-19) Outbreak in China: Summary of a Report of 72 314 Cases From the Chinese Center for Disease Control and Prevention. JAMA. 2020 Apr 7;323(13):1239-1242. doi: 10.1001/jama.2020.2648. No abstract available.
- 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.
- Individual participant dataSharing planned: No
Related trials for covid19
Not yet recruitingPhase 1
A Safety, Reactogenicity and Immunogenicity Trial of RVX-sCPD9 Booster Intranasal COVID-19 Vaccine
COVID -19
Not yet recruitingPhase 3
Dapagliflozin for Long COVID Syndrome
COVID - 19, Long COVID Syndrome
RecruitingPhase 1
A Safety and Immunogenicity Trial of OCU500, ChAd36 Vector Encoding SARS-CoV-2 Spike Vaccine Via Intranasal and Inhalational Routes in Previously Vaccinated Adults
COVID-19
Active, not recruitingObservational study
Analysis of Coronavirus Disease 19 (COVID-19) Convalescent Plasma
Asymptomatic COVID-19 Infection Laboratory-Confirmed, Symptomatic COVID-19 Infection Laboratory-Confirmed
Not yet recruitingPhase 1
Phase I Open-Label Safety Trial of Pembrolizumab for Neurological Post- Acute Sequelae of SARS-CoV-2 (PD1-PASC I)
Post-Acute COVID-19 Syndrome
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 covid19, run by University of Milano Bicocca 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 2 inclusion and 1 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: withdrawn, as of the sponsor's last update on 26 May 2022. 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 withdrawn before enrolling participants, so there are no results.
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?
Identify risk factors for intra-hospital mortality. (time frame: Until patient discharge from the hospital (approximately 1 year)). The study lists 3 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 NCT04427345, which also lists 6 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 26 May 2022.