SARS-CoV 2DECORENCT04401033
Increased Risk of SARS-CoronaVirus-2 (SARS-CoV-2) Infection Associated With Endoscopy (DECORE Study)
An observational study of SARS-CoV 2 and COVID, run by Hospital del Rio Hortega at 1 site in Spain.
Trial summary
The aim of our study to compare the proportion of patients who develop SARS-CoV-2 disease in 3 groups: patients undergoing a abdominal ultrasound examination in a Specialty Center, patients undergoing endoscopic procedure in a third level hospital with CoronaVirus Disease (COVID-19) hospitalization plants and patients… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- SARS-CoV 2, COVID
- What is being tested?
- Telephonic medical visit, Gastrointestinal endoscopy and Abdominal ultrasound
- Type of treatment
- Surgery or procedure, Lifestyle or therapy programme
- How many people
- 450 participants
- Where
- 1 siteSpain
- Study dates
- 11 May 2020to 30 Jun 2020
- How long will I take part?
- 2 Months
- 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: Patients scheduled for an ambulatory endoscopy, an ambulatory abdominal ultrasound, or a telephonic visit
Who may be able to join
- Patients scheduled for an ambulatory endoscopy, an ambulatory abdominal ultrasound, or a telephonic visit Age younger than 18 years.
Who cannot join
- Refusal to sign the informed consent Immunosuppression (steroid treatment with a dose of 20 mg or more of prednisone daily, azathioprine, cyclosporine, mercaptopurine, methotrexate, mycophenolate, tacrolimus, everolimus, chemotherapeutic agents, anti-tumoral necrosis factor (TNF)-α drugs or other biological treatments for inflammatory bowel disease) Immunodeficiency due to a non-pharmacological cause (HIV, hematological dyscrasias, primary immunodeficiencies ...) Previous confirmed diagnosis (by PCR or serology) of SARS-CoV-2 disease. Diagnosis of previous suspicion (documented in the medical history by a physician) of SARS-CoV-2 disease.
- Previous clinical picture compatible with SARS-CoV-2 in the previous 2 months (defined as any positive response to the check-list questionnaire contained in Annex III) Cognitive impairment or hearing impairment preventing the phone visit Habitual residence outside the province of Valladolid Ultrasound interventionism (liver biopsy, ultrasound-guided paracentesis, biliary drainage ...)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective Observational Study Evaluating the Increased Risk of SARS-CoronaVirus-2 (SARS-CoV-2) Infection Associated With Endoscopic Procedures (DECORE Study)
The aim of our study to compare the proportion of patients who develop SARS-CoV-2 disease in 3 groups: patients undergoing a abdominal ultrasound examination in a Specialty Center, patients undergoing endoscopic procedure in a third level hospital with CoronaVirus Disease (COVID-19) hospitalization plants and patients who make a telephonic visit (do not go to the hospital) in the digestive system service.
Read the detailed description
Patients will undergo a telephonic interview 48-96h before the procedure where will ask about the presence of symptoms suggestive of SARS-CoV-2 infection. Optionally, they will also be carried out a scan (PCR) to detect infection 48-96h before procedure, withdrawing from the study patients with positive PCR or infection suspected by clinical data according to the questionnaire, after evaluating the responses to the questionnaire by one of the members of the research team.
Endoscopic examinations will be carried out according to the recommendations of the Spanish Society for Digestive Endoscopy (SEED). The patient will perform a hand wash with solution hydroalcoholic before entering the endoscopy room, and you will be placed a surgical mask and gloves. Staff close to the patient will carry FFP2 mask, exceptionally surgical mask, gown (waterproof in high-risk examinations as established in the SEED guidelines), hat, nitrile gloves and face shield or safety glasses (reusable) and shim covers. The examinations will be carried out using sedation guided by endoscopist according to current clinical guidelines.
Ultrasonographic examinations (US) will be carried out according to clinical guideline. The examinator will wear a filtering face pieces 2 (FFP2) mask, exceptionally surgical mask, gown, cap, nitrile gloves and face shield or goggles safety (reusable) and shoe covers. The gel bottle, the transducer and the gurney will be washed before each US with low level disinfectant.
Patients who meet the inclusion criteria and do not have any exclusion criteria will be invited to participate in the study. The patients who agree to participate will complete the informed consent according to the law 41/2002 of patient autonomy without for that reason alter the relationship with your doctor or cause any harm to your treatment. The monitoring period will have a maximum duration of 17 days. It will consist of a telephone control through a pre-established checklist. In case of any positive answer to the questionnaire, it will be completed the study through the consultation of the investigators by means of a polymerase chain reaction (PCR).
- Conditions
- SARS-CoV 2, COVID
- Being tested
- Telephonic medical visit, Gastrointestinal endoscopy, Abdominal ultrasound
- Keywords
- COVID, SARS-CoV 2, Endoscopy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Telephonic medical visitBehavioural
The patient will receive a telephonic call passing a medical visit
Gastrointestinal endoscopyProcedure or surgery
Upper or lower GI endoscopy according to clinical practice and current guidelines
Abdominal ultrasoundProcedure or surgery
Diagnostic abdominal ultrasound according to the current guidelines
| Study group | Role | What they receive |
|---|---|---|
| Endoscopic cohort | Endoscopic examinations: They will be carried out according to the recommendations of the Spanish society for digestive endoscopy (SEED). In summary, the patient will perform a hand wash with hydroalcoholic solution before entering the endoscopy room, and will put on a surgical mask and gloves. Personnel close to the patient will wear an FFP2 mask, exceptionally a surgical mask, a gown (waterproof in high-risk examinations as established in the SEED guidelines), a cap, nitrile gloves and face shield or safety glasses (reusable) and shoe covers. The examinations will be performed by endoscopist-guided sedation in accordance with current clinical guidelines. Receives: Procedure: Gastrointestinal endoscopy | |
| Ultrasonography cohort | Abdominal ultrasound: They will be carried out according to international clinical guidelines (12). The explorer will wear an FFP2 mask, exceptionally a surgical mask, a gown, a hat, nitrile gloves, and a face shield or safety glasses (reusable) and shoe covers. The gel bottle, transducer, and stretcher will be washed prior to each scan with low-level disinfectant Receives: Procedure: Abdominal ultrasound | |
| Telephonic cohort | The patient will be telephonically contacted for a medical visit. Receives: Behavioral: Telephonic medical visit |
What is being measured
The primary outcome is the main question the study is designed to answer.
SARS-CoV-2 infection in patients
Proportion of patients who develop SARS-CoV-2 infection in 3 groups: patients undergoing an abdominal ultrasound examination in a Specialty Center, patients undergoing an endoscopic examination in a third-level hospital with hospitalization facilities COVID-19 and patients who make a non-face-to-face consultation (do not go to the hospital) in the digestive system service
Measured: may-june 2020
Secondary outcomes (1)
SARS-CoV-2 infection in HCW
Number of Health Care Workers (HCW) who develop SARS-CoV-2 infection in endoscopy service in this period
Measured: may-june 2020
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2020
- Study start11 May 2020
- Primary completion30 Jun 2020
- Study completion30 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for SARS-CoV 2Studies 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
- 450 participants (actual)
- Target duration
- 2 Months
Sponsor and investigators
- Lead sponsor
- Hospital del Rio Hortega
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marina de Benito Sanz, Hospital del Rio Hortega
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04401033
- Sponsor's protocol ID
- 003
- Acronym
- DECORE
- Status last verified
- Jul 2020
- First submitted
- 21 May 2020
- Last updated
- 28 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Sociedad Espanola de Patologia Digestiva; Asociacion Espanola de Gastroenterologia. Recommendations by the SEPD and AEG, both in general and on the operation of gastrointestinal endoscopy and gastroenterology units, concerning the current SARS-CoV-2 pandemic (March, 18). Rev Esp Enferm Dig. 2020 Apr;112(4):319-322. doi: 10.17235/reed.2020.7052/2020.
PubMed 32202911Huh S. How to train health personnel to protect themselves from SARS-CoV-2 (novel coronavirus) infection when caring for a patient or suspected case. J Educ Eval Health Prof. 2020 Jan;17:10. doi: 10.3352/jeehp.2020.17.10. Epub 2020 Mar 7. No abstract available.
PubMed 32150796Liu Z, Zhang Y, Wang X, Zhang D, Diao D, Chandramohan K, Booth CM. Recommendations for Surgery During the Novel Coronavirus (COVID-19) Epidemic. Indian J Surg. 2020 Apr;82(2):124-128. doi: 10.1007/s12262-020-02173-3. Epub 2020 Apr 11.
PubMed 32292252The Lancet. COVID-19: protecting health-care workers. Lancet. 2020 Mar 21;395(10228):922. doi: 10.1016/S0140-6736(20)30644-9. No abstract available.
PubMed 32199474Hunter E, Price DA, Murphy E, Schim van der Loeff I, Baker KF, Lendrem D, Lendrem C, Schmid ML, Pareja-Cebrian L, Welch A, Payne BAI, Duncan CJA. First experience of COVID-19 screening of health-care workers in England. Lancet. 2020 May 2;395(10234):e77-e78. doi: 10.1016/S0140-6736(20)30970-3. Epub 2020 Apr 22. No abstract available.
PubMed 32333843Chow EJ, Schwartz NG, Tobolowsky FA, Zacks RLT, Huntington-Frazier M, Reddy SC, Rao AK. Symptom Screening at Illness Onset of Health Care Personnel With SARS-CoV-2 Infection in King County, Washington. JAMA. 2020 May 26;323(20):2087-2089. doi: 10.1001/jama.2020.6637.
PubMed 32301962Mizumoto K, Kagaya K, Zarebski A, Chowell G. Estimating the asymptomatic proportion of coronavirus disease 2019 (COVID-19) cases on board the Diamond Princess cruise ship, Yokohama, Japan, 2020. Euro Surveill. 2020 Mar;25(10):2000180. doi: 10.2807/1560-7917.ES.2020.25.10.2000180.
PubMed 32183930Nishiura H, Kobayashi T, Miyama T, Suzuki A, Jung SM, Hayashi K, Kinoshita R, Yang Y, Yuan B, Akhmetzhanov AR, Linton NM. Estimation of the asymptomatic ratio of novel coronavirus infections (COVID-19). Int J Infect Dis. 2020 May;94:154-155. doi: 10.1016/j.ijid.2020.03.020. Epub 2020 Mar 14. No abstract available.
PubMed 32179137Day M. Covid-19: identifying and isolating asymptomatic people helped eliminate virus in Italian village. BMJ. 2020 Mar 23;368:m1165. doi: 10.1136/bmj.m1165. No abstract available.
PubMed 32205334van Doremalen N, Bushmaker T, Morris DH, Holbrook MG, Gamble A, Williamson BN, Tamin A, Harcourt JL, Thornburg NJ, Gerber SI, Lloyd-Smith JO, de Wit E, Munster VJ. Aerosol and Surface Stability of SARS-CoV-2 as Compared with SARS-CoV-1. N Engl J Med. 2020 Apr 16;382(16):1564-1567. doi: 10.1056/NEJMc2004973. Epub 2020 Mar 17. No abstract available.
PubMed 32182409World Federation for Ultrasound in Medicine and Biology Safety Committee (Jacques S. Abramowicz, Iwaki Akiyama, David Evans, J. Brian Fowlkes, Karel Marsal, Yusef Sayeed and Gail ter Haar); Abramowicz JS, Basseal JM. World Federation for Ultrasound in Medicine and Biology Position Statement: How to Perform a Safe Ultrasound Examination and Clean Equipment in the Context of COVID-19. Ultrasound Med Biol. 2020 Jul;46(7):1821-1826. doi: 10.1016/j.ultrasmedbio.2020.03.033. Epub 2020 Apr 4. No abstract available.
PubMed 32327199Repici A, Aragona G, Cengia G, Cantu P, Spadaccini M, Maselli R, Carrara S, Anderloni A, Fugazza A, Pace F, Rosch T; ITALIAN GI-COVID19 Working Group. Low risk of COVID-19 transmission in GI endoscopy. Gut. 2020 Nov;69(11):1925-1927. doi: 10.1136/gutjnl-2020-321341. Epub 2020 Apr 22. No abstract available.
PubMed 32321857
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Observational Study Evaluating the Increased Risk of SARS-CoronaVirus-2 (SARS-CoV-2) Infection Associated With Endoscopic Procedures (DECORE Study)
- ClinicalTrials.gov ID
- NCT04401033
- Acronym / sponsor ID
- DECORE / 003
- Conditions
- SARS-CoV 2, COVID
- Keywords
- COVID, SARS-CoV 2, Endoscopy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 450 participants (actual)
- Lead sponsor
- Hospital del Rio HortegaUniversity, hospital or other
- Study start
- 11 May 2020 (actual)
- Primary completion
- 30 Jun 2020 (actual)
- Study completion
- 30 Jun 2020 (actual)
- First posted
- 26 May 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.
The aim of our study to compare the proportion of patients who develop SARS-CoV-2 disease in 3 groups: patients undergoing a abdominal ultrasound examination in a Specialty Center, patients undergoing endoscopic procedure in a third level hospital with CoronaVirus Disease (COVID-19) hospitalization plants and patients who make a telephonic visit (do not go to the hospital) in the digestive system service.
Detailed description
Patients will undergo a telephonic interview 48-96h before the procedure where will ask about the presence of symptoms suggestive of SARS-CoV-2 infection. Optionally, they will also be carried out a scan (PCR) to detect infection 48-96h before procedure, withdrawing from the study patients with positive PCR or infection suspected by clinical data according to the questionnaire, after evaluating the responses to the questionnaire by one of the members of the research team.
Endoscopic examinations will be carried out according to the recommendations of the Spanish Society for Digestive Endoscopy (SEED). The patient will perform a hand wash with solution hydroalcoholic before entering the endoscopy room, and you will be placed a surgical mask and gloves. Staff close to the patient will carry FFP2 mask, exceptionally surgical mask, gown (waterproof in high-risk examinations as established in the SEED guidelines), hat, nitrile gloves and face shield or safety glasses (reusable) and shim covers. The examinations will be carried out using sedation guided by endoscopist according to current clinical guidelines.
Ultrasonographic examinations (US) will be carried out according to clinical guideline. The examinator will wear a filtering face pieces 2 (FFP2) mask, exceptionally surgical mask, gown, cap, nitrile gloves and face shield or goggles safety (reusable) and shoe covers. The gel bottle, the transducer and the gurney will be washed before each US with low level disinfectant.
Patients who meet the inclusion criteria and do not have any exclusion criteria will be invited to participate in the study. The patients who agree to participate will complete the informed consent according to the law 41/2002 of patient autonomy without for that reason alter the relationship with your doctor or cause any harm to your treatment. The monitoring period will have a maximum duration of 17 days. It will consist of a telephone control through a pre-established checklist. In case of any positive answer to the questionnaire, it will be completed the study through the consultation of the investigators by means of a polymerase chain reaction (PCR).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Months
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Endoscopic cohort | – | Procedure: Gastrointestinal endoscopyEndoscopic examinations: They will be carried out according to the recommendations of the Spanish society for digestive endoscopy (SEED). In summary, the patient will perform a hand wash with hydroalcoholic solution before entering the endoscopy room, and will put on a surgical mask and gloves. Personnel close to the patient will wear an FFP2 mask, exceptionally a surgical mask, a gown (waterproof in high-risk examinations as established in the SEED guidelines), a cap, nitrile gloves and face shield or safety glasses (reusable) and shoe covers. The examinations will be performed by endoscopist-guided sedation in accordance with current clinical guidelines. |
| Ultrasonography cohort | – | Procedure: Abdominal ultrasoundAbdominal ultrasound: They will be carried out according to international clinical guidelines (12). The explorer will wear an FFP2 mask, exceptionally a surgical mask, a gown, a hat, nitrile gloves, and a face shield or safety glasses (reusable) and shoe covers. The gel bottle, transducer, and stretcher will be washed prior to each scan with low-level disinfectant |
| Telephonic cohort | – | Behavioral: Telephonic medical visitThe patient will be telephonically contacted for a medical visit. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients scheduled for an ambulatory endoscopy, an ambulatory abdominal ultrasound, or a telephonic visit
Key inclusion criteria (1 listed)
- Patients scheduled for an ambulatory endoscopy, an ambulatory abdominal ultrasound, or a telephonic visit Age younger than 18 years.
Key exclusion criteria (2 listed)
- Refusal to sign the informed consent Immunosuppression (steroid treatment with a dose of 20 mg or more of prednisone daily, azathioprine, cyclosporine, mercaptopurine, methotrexate, mycophenolate, tacrolimus, everolimus, chemotherapeutic agents, anti-tumoral necrosis factor (TNF)-α drugs or other biological treatments for inflammatory bowel disease) Immunodeficiency due to a non-pharmacological cause (HIV, hematological dyscrasias, primary immunodeficiencies ...) Previous confirmed diagnosis (by PCR or serology) of SARS-CoV-2 disease. Diagnosis of previous suspicion (documented in the medical history by a physician) of SARS-CoV-2 disease.
- Previous clinical picture compatible with SARS-CoV-2 in the previous 2 months (defined as any positive response to the check-list questionnaire contained in Annex III) Cognitive impairment or hearing impairment preventing the phone visit Habitual residence outside the province of Valladolid Ultrasound interventionism (liver biopsy, ultrasound-guided paracentesis, biliary drainage ...)
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 |
|---|---|---|
| Telephonic medical visitThe patient will receive a telephonic call passing a medical visit | Behavioural | Telephonic cohort |
| Gastrointestinal endoscopyUpper or lower GI endoscopy according to clinical practice and current guidelines | Procedure or surgery | Endoscopic cohort |
| Abdominal ultrasoundDiagnostic abdominal ultrasound according to the current guidelines | Procedure or surgery | Ultrasonography cohort |
Primary outcome
SARS-CoV-2 infection in patients
Time frame: may-june 2020
Proportion of patients who develop SARS-CoV-2 infection in 3 groups: patients undergoing an abdominal ultrasound examination in a Specialty Center, patients undergoing an endoscopic examination in a third-level hospital with hospitalization facilities COVID-19 and patients who make a non-face-to-face consultation (do not go to the hospital) in the digestive system service
1 secondary outcome
SARS-CoV-2 infection in HCW
Time frame: may-june 2020
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2020.
- Background: PubMed 32202911Sociedad Espanola de Patologia Digestiva; Asociacion Espanola de Gastroenterologia. Recommendations by the SEPD and AEG, both in general and on the operation of gastrointestinal endoscopy and gastroenterology units, concerning the current SARS-CoV-2 pandemic (March, 18). Rev Esp Enferm Dig. 2020 Apr;112(4):319-322. doi: 10.17235/reed.2020.7052/2020.
- Background: PubMed 32150796Huh S. How to train health personnel to protect themselves from SARS-CoV-2 (novel coronavirus) infection when caring for a patient or suspected case. J Educ Eval Health Prof. 2020 Jan;17:10. doi: 10.3352/jeehp.2020.17.10. Epub 2020 Mar 7. No abstract available.
- Background: PubMed 32292252Liu Z, Zhang Y, Wang X, Zhang D, Diao D, Chandramohan K, Booth CM. Recommendations for Surgery During the Novel Coronavirus (COVID-19) Epidemic. Indian J Surg. 2020 Apr;82(2):124-128. doi: 10.1007/s12262-020-02173-3. Epub 2020 Apr 11.
- Background: PubMed 32199474The Lancet. COVID-19: protecting health-care workers. Lancet. 2020 Mar 21;395(10228):922. doi: 10.1016/S0140-6736(20)30644-9. No abstract available.
- Background: PubMed 32333843Hunter E, Price DA, Murphy E, Schim van der Loeff I, Baker KF, Lendrem D, Lendrem C, Schmid ML, Pareja-Cebrian L, Welch A, Payne BAI, Duncan CJA. First experience of COVID-19 screening of health-care workers in England. Lancet. 2020 May 2;395(10234):e77-e78. doi: 10.1016/S0140-6736(20)30970-3. Epub 2020 Apr 22. No abstract available.
- Background: PubMed 32301962Chow EJ, Schwartz NG, Tobolowsky FA, Zacks RLT, Huntington-Frazier M, Reddy SC, Rao AK. Symptom Screening at Illness Onset of Health Care Personnel With SARS-CoV-2 Infection in King County, Washington. JAMA. 2020 May 26;323(20):2087-2089. doi: 10.1001/jama.2020.6637.
- Background: PubMed 32183930Mizumoto K, Kagaya K, Zarebski A, Chowell G. Estimating the asymptomatic proportion of coronavirus disease 2019 (COVID-19) cases on board the Diamond Princess cruise ship, Yokohama, Japan, 2020. Euro Surveill. 2020 Mar;25(10):2000180. doi: 10.2807/1560-7917.ES.2020.25.10.2000180.
- Background: PubMed 32179137Nishiura H, Kobayashi T, Miyama T, Suzuki A, Jung SM, Hayashi K, Kinoshita R, Yang Y, Yuan B, Akhmetzhanov AR, Linton NM. Estimation of the asymptomatic ratio of novel coronavirus infections (COVID-19). Int J Infect Dis. 2020 May;94:154-155. doi: 10.1016/j.ijid.2020.03.020. Epub 2020 Mar 14. No abstract available.
- Background: PubMed 32205334Day M. Covid-19: identifying and isolating asymptomatic people helped eliminate virus in Italian village. BMJ. 2020 Mar 23;368:m1165. doi: 10.1136/bmj.m1165. No abstract available.
- Background: PubMed 32182409van Doremalen N, Bushmaker T, Morris DH, Holbrook MG, Gamble A, Williamson BN, Tamin A, Harcourt JL, Thornburg NJ, Gerber SI, Lloyd-Smith JO, de Wit E, Munster VJ. Aerosol and Surface Stability of SARS-CoV-2 as Compared with SARS-CoV-1. N Engl J Med. 2020 Apr 16;382(16):1564-1567. doi: 10.1056/NEJMc2004973. Epub 2020 Mar 17. No abstract available.
- Background: PubMed 32327199World Federation for Ultrasound in Medicine and Biology Safety Committee (Jacques S. Abramowicz, Iwaki Akiyama, David Evans, J. Brian Fowlkes, Karel Marsal, Yusef Sayeed and Gail ter Haar); Abramowicz JS, Basseal JM. World Federation for Ultrasound in Medicine and Biology Position Statement: How to Perform a Safe Ultrasound Examination and Clean Equipment in the Context of COVID-19. Ultrasound Med Biol. 2020 Jul;46(7):1821-1826. doi: 10.1016/j.ultrasmedbio.2020.03.033. Epub 2020 Apr 4. No abstract available.
- Background: PubMed 32321857Repici A, Aragona G, Cengia G, Cantu P, Spadaccini M, Maselli R, Carrara S, Anderloni A, Fugazza A, Pace F, Rosch T; ITALIAN GI-COVID19 Working Group. Low risk of COVID-19 transmission in GI endoscopy. Gut. 2020 Nov;69(11):1925-1927. doi: 10.1136/gutjnl-2020-321341. Epub 2020 Apr 22. No abstract available.
- Individual participant dataSharing planned: Undecided
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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 SARS-CoV 2 and COVID, run by Hospital del Rio Hortega 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 2 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: finished, as of the sponsor's last update on 28 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
SARS-CoV-2 infection in patients (time frame: may-june 2020). 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 NCT04401033, which also lists 12 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 28 Jul 2020.