COVID-19UroCovidNCT04409899
The Utility of Enhanced Pre and Post-surgical Work-out to Prevent the Spread of COVID-19 in a Large Urology Department
An observational study of COVID-19 and Urologic Diseases, run by Fundacio Puigvert at 1 site in Spain.
Trial summary
Since the outbreak of COVID-19 hit Spain in March 2020, most of the elective surgeries have been canceled everywhere. As soon as the epidemiology phase of the pandemic changed and the restrictions have been eased, different protocols have been put in place to screen patients for SARS-CoV-2 before surgery in order to… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- COVID-19, Urologic Diseases, Surgery--Complications
- What is being tested?
- Blood tests
- How many people
- 300 participants
- Where
- 1 siteSpain
- Study dates
- 20 Mar 2020to 31 Dec 2020
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients in a waiting list for a urological surgery and selected to undertake the intervention during COVID-19 pandemic according to priority and risk/benefit assessment
Who may be able to join
- Patients selected for urological surgery during COVID-19 pandemic
Who cannot join
- Patients admitted in the hospital not undergoing surgical intervention
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Utility of Enhanced Pre- and Post-surgical Protocols to Prevent the Spread of COVID-19 in a Large Urological Department (UroCovid Study)
Since the outbreak of COVID-19 hit Spain in March 2020, most of the elective surgeries have been canceled everywhere. As soon as the epidemiology phase of the pandemic changed and the restrictions have been eased, different protocols have been put in place to screen patients for SARS-CoV-2 before surgery in order to reduce the spreading of the disease in hospitalized patients. To the best of the current state of knowledge, no recommendations or protocols have been established to guide surgeons in dealing with patients developing unspecific symptoms after surgeries, which could sign either of a post-op complication or COVID-19. The investigators have developed an enhanced pre and post-surgical protocol both to screen patients for COVID-19 before surgery and to promptly identify those patients suspicious for the viral infection during the post-op.
Read the detailed description
The pandemic outbreak of SARS-CoV-2 has put significant strain on the hospitals of many countries around the world. Spain has been one of the countries most affected by the COVID-19, with nearly 30 thousands of confirmed deaths as by 23rd of May 2020.
While the state of emergency was declared by the Spanish government at the beginning of March 2020, the Intensive Care Units of the larger Spanish cities were overwhelmed by the number of patients in need of invasive respiratory supports. Moreover, data from China revealed that patients undergoing surgery and being SARS-CoV-2 carriers were at higher risk for complications and fatalities. As a result, most of the elective surgeries have been canceled in all surgical disciplines. As far as it concerned the urology patients, recommendations were provided by the European Association of Urology in order to guide the selection of the surgeries to be prioritized. Further recommendations on how to screen patients before surgeries were released by other national and international scientific societies and regulatory boards.
However, regardless of a successful pre-operative screening with patients being cleared of COVID-19, there might be still the possibility the patients could incubate the virus during hospitalization or getting it in the hospital from other patients, visitors or professionals.
To the best of the current state of knowledge, no recommendations have been published on how to guide the decision-making process on patients developing postoperatively unspecific symptoms (fever, chest pain, oxygen desaturation, etc) which could raise suspicions for COVID-19 during the outbreak of the disease.
The Institutional site of the investigators is a monographic hospital fully dedicated to urology and nephrology, and work in close cooperation with one of the four larger public hospitals in Barcelona; this latter has been one of those hospitals under significant strain for the COVID-19 emergency, while the former was marginally involved by the pandemic wave. The urological surgical activities never stopped during the outbreak, though initially were severely reduced; after experiencing some post-operative severe complications in patients developing concomitantly the SARS-CoV-2 infection, the investigators developed an enhanced pre and post-surgical protocol having a twofold objective: 1) to limit the risk to intervene patients harbouring the SARS-CoV-2 by undertaking an RT-PCR test 48 hours before surgery, and screening for symptoms compatible with COVID-19 and/or for strict contacts with infected people; furthermore, an X-ray thorax, and serum D-dimer and C-Reactive Protein were undertaken to establish baseline values. 2) to establish a post-surgical algorithm to guide surgeons on the nature of unspecific (and common) symptoms that could overlook for COVID-19 or rather raise unnecessary alarms for the viral infection, by performing serum/blood and imaging tests.
As soon as the protocol was put in action, data have been recorded prospectively in a registry in order to evaluate the utility of such a strategy. The recruitment period has been planned to embrace only the acute phase of the pandemic; the investigators hypothesize that such enhanced work-out may reduce the hospital contamination and optimal patient care in the acute phase of the COVID-19 pandemic as well as in its future waves, especially in those urological or surgical sites where activities have not been discontinued.
- Conditions
- COVID-19, Urologic Diseases, Surgery--Complications, Epidemic Disease
- Being tested
- Blood tests
- Keywords
- Pre-surgical screening, Post-surgical work out, Urological surgery, Nosocomial COVID-19 incidence
- Medical subject headings
- COVID-19, Urologic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood testsDiagnostic test
Also called RT-PCR
RT-PCR, D-dimer, CRP, procalcitonin, ferritin, complete haemogram
| Study group | Role | What they receive |
|---|---|---|
| Urological surgical patients during COVID-19 pandemic | During the COVID-19 pandemic, the urological patients in the need of a surgical intervention have been screened on the basis of the underline conditions, the priority of surgery, and risk-benefit assessment. A pre-surgical work-out was performed in the selected patients, with some of them being detected of COVID-19 at RT-PCR or suspected for it according to the risk-assessment survey. Enhanced blood tests and X-rays of the thorax were performed as baseline assessments. In case of development of post-surgical unspecific symptoms, clinical and laboratory work-out were performed before to expedite a new RT-PCR, which would have required preventive isolation of a patient in a COVID-19 ward. We evaluated the impact of COVID-19 in this selected cohort and the complications eventually associated with the viral infection. Receives: Diagnostic Test: Blood tests |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of SARS-CoV-2/COVID-19 in a selected cohort of urological patients undergoing surgery
Measured: Day 1 pre-op up to day-30 post-op
Post-operative COVID-19 related complication rates
Measured: Day 1 pre-op up to day-30 post-op
Secondary outcomes (1)
Association between post-surgery inflammatory indexes and COVID-19 diagnosis during hospitalization
Measured: Up to day-30 post-op
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2020
- Study start20 Mar 2020
- Primary completion30 Jun 2020
- Study completion31 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for COVID-19Studies 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
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fundacio Puigvert
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Francesco Sanguedolce, Fundacio Puigvert
- Investigators
- Francesco Sanguedolce, MD, PhD, Principal investigator, Fundacio Puigvert
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04409899
- Sponsor's protocol ID
- FundacióPuigvert
- Acronym
- UroCovid
- Status last verified
- Jul 2020
- First submitted
- 26 May 2020
- Last updated
- 21 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: At the moment there is no plan to share data, but it could be considered in case of need
Publications
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.
PubMed 32171076Shang W, Dong J, Ren Y, Tian M, Li W, Hu J, Li Y. The value of clinical parameters in predicting the severity of COVID-19. J Med Virol. 2020 Oct;92(10):2188-2192. doi: 10.1002/jmv.26031. Epub 2020 Jun 2.
PubMed 32436996Lippi G, Plebani M. Procalcitonin in patients with severe coronavirus disease 2019 (COVID-19): A meta-analysis. Clin Chim Acta. 2020 Jun;505:190-191. doi: 10.1016/j.cca.2020.03.004. Epub 2020 Mar 4. No abstract available.
PubMed 32145275Stensland KD, Morgan TM, Moinzadeh A, Lee CT, Briganti A, Catto JWF, Canes D. Considerations in the Triage of Urologic Surgeries During the COVID-19 Pandemic. Eur Urol. 2020 Jun;77(6):663-666. doi: 10.1016/j.eururo.2020.03.027. Epub 2020 Apr 9.
PubMed 32279903Lei S, Jiang F, Su W, Chen C, Chen J, Mei W, Zhan LY, Jia Y, Zhang L, Liu D, Xia ZY, Xia Z. Clinical characteristics and outcomes of patients undergoing surgeries during the incubation period of COVID-19 infection. EClinicalMedicine. 2020 Apr 5;21:100331. doi: 10.1016/j.eclinm.2020.100331. eCollection 2020 Apr.
PubMed 32292899
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Utility of Enhanced Pre- and Post-surgical Protocols to Prevent the Spread of COVID-19 in a Large Urological Department (UroCovid Study)
- ClinicalTrials.gov ID
- NCT04409899
- Acronym / sponsor ID
- UroCovid / FundacióPuigvert
- Conditions
- COVID-19, Urologic Diseases, Surgery--Complications, Epidemic Disease
- Keywords
- Pre-surgical screening, Post-surgical work out, Urological surgery, Nosocomial COVID-19 incidence
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Fundacio PuigvertUniversity, hospital or other
- Study start
- 20 Mar 2020 (actual)
- Primary completion
- 30 Jun 2020 (actual)
- Study completion
- 31 Dec 2020 (estimated)
- First posted
- 1 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.
Since the outbreak of COVID-19 hit Spain in March 2020, most of the elective surgeries have been canceled everywhere. As soon as the epidemiology phase of the pandemic changed and the restrictions have been eased, different protocols have been put in place to screen patients for SARS-CoV-2 before surgery in order to reduce the spreading of the disease in hospitalized patients. To the best of the current state of knowledge, no recommendations or protocols have been established to guide surgeons in dealing with patients developing unspecific symptoms after surgeries, which could sign either of a post-op complication or COVID-19. The investigators have developed an enhanced pre and post-surgical protocol both to screen patients for COVID-19 before surgery and to promptly identify those patients suspicious for the viral infection during the post-op.
Detailed description
The pandemic outbreak of SARS-CoV-2 has put significant strain on the hospitals of many countries around the world. Spain has been one of the countries most affected by the COVID-19, with nearly 30 thousands of confirmed deaths as by 23rd of May 2020.
While the state of emergency was declared by the Spanish government at the beginning of March 2020, the Intensive Care Units of the larger Spanish cities were overwhelmed by the number of patients in need of invasive respiratory supports. Moreover, data from China revealed that patients undergoing surgery and being SARS-CoV-2 carriers were at higher risk for complications and fatalities. As a result, most of the elective surgeries have been canceled in all surgical disciplines. As far as it concerned the urology patients, recommendations were provided by the European Association of Urology in order to guide the selection of the surgeries to be prioritized. Further recommendations on how to screen patients before surgeries were released by other national and international scientific societies and regulatory boards.
However, regardless of a successful pre-operative screening with patients being cleared of COVID-19, there might be still the possibility the patients could incubate the virus during hospitalization or getting it in the hospital from other patients, visitors or professionals.
To the best of the current state of knowledge, no recommendations have been published on how to guide the decision-making process on patients developing postoperatively unspecific symptoms (fever, chest pain, oxygen desaturation, etc) which could raise suspicions for COVID-19 during the outbreak of the disease.
The Institutional site of the investigators is a monographic hospital fully dedicated to urology and nephrology, and work in close cooperation with one of the four larger public hospitals in Barcelona; this latter has been one of those hospitals under significant strain for the COVID-19 emergency, while the former was marginally involved by the pandemic wave. The urological surgical activities never stopped during the outbreak, though initially were severely reduced; after experiencing some post-operative severe complications in patients developing concomitantly the SARS-CoV-2 infection, the investigators developed an enhanced pre and post-surgical protocol having a twofold objective: 1) to limit the risk to intervene patients harbouring the SARS-CoV-2 by undertaking an RT-PCR test 48 hours before surgery, and screening for symptoms compatible with COVID-19 and/or for strict contacts with infected people; furthermore, an X-ray thorax, and serum D-dimer and C-Reactive Protein were undertaken to establish baseline values. 2) to establish a post-surgical algorithm to guide surgeons on the nature of unspecific (and common) symptoms that could overlook for COVID-19 or rather raise unnecessary alarms for the viral infection, by performing serum/blood and imaging tests.
As soon as the protocol was put in action, data have been recorded prospectively in a registry in order to evaluate the utility of such a strategy. The recruitment period has been planned to embrace only the acute phase of the pandemic; the investigators hypothesize that such enhanced work-out may reduce the hospital contamination and optimal patient care in the acute phase of the COVID-19 pandemic as well as in its future waves, especially in those urological or surgical sites where activities have not been discontinued.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Urological surgical patients during COVID-19 pandemic | – | Diagnostic Test: Blood testsDuring the COVID-19 pandemic, the urological patients in the need of a surgical intervention have been screened on the basis of the underline conditions, the priority of surgery, and risk-benefit assessment. A pre-surgical work-out was performed in the selected patients, with some of them being detected of COVID-19 at RT-PCR or suspected for it according to the risk-assessment survey. Enhanced blood tests and X-rays of the thorax were performed as baseline assessments. In case of development of post-surgical unspecific symptoms, clinical and laboratory work-out were performed before to expedite a new RT-PCR, which would have required preventive isolation of a patient in a COVID-19 ward. We evaluated the impact of COVID-19 in this selected cohort and the complications eventually associated with the viral infection. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients in a waiting list for a urological surgery and selected to undertake the intervention during COVID-19 pandemic according to priority and risk/benefit assessment
Key inclusion criteria (1 listed)
- Patients selected for urological surgery during COVID-19 pandemic
Key exclusion criteria (1 listed)
- Patients admitted in the hospital not undergoing surgical intervention
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 |
|---|---|---|
| Blood testsAlso: RT-PCRRT-PCR, D-dimer, CRP, procalcitonin, ferritin, complete haemogram | Diagnostic test | Urological surgical patients during COVID-19 pandemic |
Primary outcome
Rate of SARS-CoV-2/COVID-19 in a selected cohort of urological patients undergoing surgery
Time frame: Day 1 pre-op up to day-30 post-op
Post-operative COVID-19 related complication rates
Time frame: Day 1 pre-op up to day-30 post-op
1 secondary outcome
Association between post-surgery inflammatory indexes and COVID-19 diagnosis during hospitalization
Time frame: Up to day-30 post-op
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2020.
- Background: PubMed 32171076Zhou 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.
- Background: PubMed 32436996Shang W, Dong J, Ren Y, Tian M, Li W, Hu J, Li Y. The value of clinical parameters in predicting the severity of COVID-19. J Med Virol. 2020 Oct;92(10):2188-2192. doi: 10.1002/jmv.26031. Epub 2020 Jun 2.
- Background: PubMed 32145275Lippi G, Plebani M. Procalcitonin in patients with severe coronavirus disease 2019 (COVID-19): A meta-analysis. Clin Chim Acta. 2020 Jun;505:190-191. doi: 10.1016/j.cca.2020.03.004. Epub 2020 Mar 4. No abstract available.
- Background: PubMed 32279903Stensland KD, Morgan TM, Moinzadeh A, Lee CT, Briganti A, Catto JWF, Canes D. Considerations in the Triage of Urologic Surgeries During the COVID-19 Pandemic. Eur Urol. 2020 Jun;77(6):663-666. doi: 10.1016/j.eururo.2020.03.027. Epub 2020 Apr 9.
- Background: PubMed 32292899Lei S, Jiang F, Su W, Chen C, Chen J, Mei W, Zhan LY, Jia Y, Zhang L, Liu D, Xia ZY, Xia Z. Clinical characteristics and outcomes of patients undergoing surgeries during the incubation period of COVID-19 infection. EClinicalMedicine. 2020 Apr 5;21:100331. doi: 10.1016/j.eclinm.2020.100331. eCollection 2020 Apr.
- World Health Organization. COVID-19 Situation ReportLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided. At the moment there is no plan to share data, but it could be considered in case of need
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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.
Francesco Sanguedolce, MD, PhD principal investigator
Fundacio Puigvert
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 and Urologic Diseases, run by Fundacio Puigvert at 1 site in Spain.
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 1 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: status not confirmed, as of the sponsor's last update on 21 Jul 2020. 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 Spain. 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?
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?
Rate of SARS-CoV-2/COVID-19 in a selected cohort of urological patients undergoing surgery (time frame: Day 1 pre-op up to day-30 post-op). The study lists 2 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 NCT04409899, which also lists 5 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 21 Jul 2020.