COVID-19NCT04387890
Serologic Surveillance for SARS-CoV-2 (COVID-19) in a Prospective Cohort of Health Care Workers
An observational study of COVID-19 and SARS-CoV 2, run by Hospital Italiano de Buenos Aires.
Trial summary
The investigators will follow a single prospective cohort of 50 Health Care Workers in the Hospital Italiano de Buenos Aires (Argentina) from May 15th to August 31st 2020 using antibody testing for SARS-CoV-2 IgM and IgG at baseline and every 2 weeks in order to assess the incidence of COVID-19, the prevalence of… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- COVID-19, SARS-CoV 2, Health Personnel
- What is being tested?
- Serologic SARS-CoV-2 screening
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2020to 31 Aug 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Physicians directed involved with the healthcare of COVID-19 patients
Who may be able to join
- Healthcare staff (Physicians) AND
- Directly involved in care of patients with confirmed or suspected COVID-19 AND
- Working in any of the two hospital venues (Hospital Italiano Central and Hospital Italiano San Justo Agustín Rocca).
Who cannot join
- Refusal to sign the Informed Consent Form OR
- Experienced symptoms compatible with COVID-19 in the last 14 days prior to eligibility screening
Trial locations and contacts
No sites are listed yet.
Cristina Elizondo, MD contact
About this study
Official title: Serologic Surveillance for SARS-CoV-2 (COVID-19) in a Prospective Cohort of Health Care
The investigators will follow a single prospective cohort of 50 Health Care Workers in the Hospital Italiano de Buenos Aires (Argentina) from May 15th to August 31st 2020 using antibody testing for SARS-CoV-2 IgM and IgG at baseline and every 2 weeks in order to assess the incidence of COVID-19, the prevalence of anti-SARS-CoV-2 antibodies (IgM and IgG) and incidence of reinfection or reactivations of previous COVID-19 using viral gene sequencing in this cohort.
Read the detailed description
SARS-CoV-2 infection in healthcare workers (HCW) is nowadays a frequent problem for patient care and organization of care teams. SARS-CoV-2 antibody assessment provides a tool to evaluate antibody prevalence in hospital staff identifying previously exposed individuals. Serologic testing could identify new cases of COVID-19 in an early fashion and could help to investigate cases of reactivation or reinfection in hospital workers. The study purpose is to conduct a study using serological screening for health care workers in a University Hospital in Buenos Aires in order to assess the risk of COVID-19 on those who have not developed an immune response against the virus, or to detect it in an early fashion (either pre-symptomatic or asymptomatic). If a study participant is suspected to have potential reinfection or reactivation of COVID-19, the investigators will conduct genome sequencing in order to be able to differentiate each case. The investigators will include 50 participants chosen at random among health care workers from the hospital Emergency Department (ED), Internal Medicine wards, or Critical Care Units who are exposed to COVID-19. Participants who agree to join the study and sign the informed consent form will be screened at baseline for SARS-CoV-2 IgM and IgG antibodies, along with a physical exam and basic laboratory determinations. They will be re-screened with antibodies every 2 weeks for a total of 3 months. If they contract COVID-19, antibody determinations and nasopharyngeal swabs will be carried out in order to identify those who are in favorable conditions to return to work. The main objective is to prospectively determine the incidence of COVID-19, Anti SARS-CoV-2 antibody prevalence, and incidence of SARS-CoV-2 reinfection or reactivation of COVID-19 in a health care workers cohort.
- Conditions
- COVID-19, SARS-CoV 2, Health Personnel
- Being tested
- Serologic SARS-CoV-2 screening
- Keywords
- SARS Virus, SARS-CoV-2, COVID-19, Health Personnel
- Medical subject headings
- COVID-19, Severe Acute Respiratory Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Serologic SARS-CoV-2 screeningDiagnostic test
Quantitative Indirect Chemiluminescence Immunoassay (CLIA) to access SARS-CoV-2 specific IgM and IgG serum antibody level every 2 weeks during follow up
| Study group | Role | What they receive |
|---|---|---|
| Serologic Screening | Participants will be screened for IgM and IgG SARS-CoV-2 antibodies at baseline and every 2 weeks. Participants showing symptoms compatible with COVID-19 will undergo nasopharyngeal swab for PCR testing for diagnosis. Participants recovered from COVID-19 will have to have 2 negative and consecutive nasopharyngeal swab PCR tests in order to return to work. Receives: Diagnostic Test: Serologic SARS-CoV-2 screening |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of anti SARS-CoV-2 antibodies (IgM and IgG) in health personnel
Patients that has a positive result for IgM or IgG at baseline first test
Measured: Baseline at study inclussion
COVID-19 incidence through serology-based screening and/or compatible symptoms in health personnel previously known to be unexposed to the virus
Patients that has a positive result for IgM or IgG or PCR during follow up
Measured: During 3 months follow up
Incidence of reactivation/reinfection for COVID-19 in health personnel with a positive serology for SARS-CoV-2
Patients with confirmed previous SARS Cov 2 antibodies that reactivate symptomons or new increase in antibodies title during follow up
Measured: During 3 months follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2020
- Study start1 Jun 2020 (estimated)
- Primary completion31 Aug 2020 (estimated)
- Study completion31 Aug 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)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
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Italiano de Buenos Aires
- Sponsor type
- University, hospital or other
- Collaborators
- Roche Pharma AG
- Responsible party
- Principal investigator, Diego Hernan Giunta, PhD, MPH, MD, Hospital Italiano de Buenos Aires
- Investigators
- Leticia Peroni, MD, Principal investigator, HIBAVanina Stanek, MD, Principal investigator, HIBADiego Sanchez Thomas, MD, Principal investigator, HIBA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04387890
- Sponsor's protocol ID
- 5566
- Status last verified
- May 2020
- First submitted
- 13 May 2020
- Last updated
- 28 May 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
The 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 32199474Remuzzi A, Remuzzi G. COVID-19 and Italy: what next? Lancet. 2020 Apr 11;395(10231):1225-1228. doi: 10.1016/S0140-6736(20)30627-9. Epub 2020 Mar 13.
PubMed 32178769Kimball A, Hatfield KM, Arons M, James A, Taylor J, Spicer K, Bardossy AC, Oakley LP, Tanwar S, Chisty Z, Bell JM, Methner M, Harney J, Jacobs JR, Carlson CM, McLaughlin HP, Stone N, Clark S, Brostrom-Smith C, Page LC, Kay M, Lewis J, Russell D, Hiatt B, Gant J, Duchin JS, Clark TA, Honein MA, Reddy SC, Jernigan JA; Public Health - Seattle & King County; CDC COVID-19 Investigation Team. Asymptomatic and Presymptomatic SARS-CoV-2 Infections in Residents of a Long-Term Care Skilled Nursing Facility - King County, Washington, March 2020. MMWR Morb Mortal Wkly Rep. 2020 Apr 3;69(13):377-381. doi: 10.15585/mmwr.mm6913e1.
PubMed 32240128Chu DKW, Pan Y, Cheng SMS, Hui KPY, Krishnan P, Liu Y, Ng DYM, Wan CKC, Yang P, Wang Q, Peiris M, Poon LLM. Molecular Diagnosis of a Novel Coronavirus (2019-nCoV) Causing an Outbreak of Pneumonia. Clin Chem. 2020 Apr 1;66(4):549-555. doi: 10.1093/clinchem/hvaa029.
PubMed 32031583Yu F, Yan L, Wang N, Yang S, Wang L, Tang Y, Gao G, Wang S, Ma C, Xie R, Wang F, Tan C, Zhu L, Guo Y, Zhang F. Quantitative Detection and Viral Load Analysis of SARS-CoV-2 in Infected Patients. Clin Infect Dis. 2020 Jul 28;71(15):793-798. doi: 10.1093/cid/ciaa345.
PubMed 32221523Yuan J, Kou S, Liang Y, Zeng J, Pan Y, Liu L. Polymerase Chain Reaction Assays Reverted to Positive in 25 Discharged Patients With COVID-19. Clin Infect Dis. 2020 Nov 19;71(16):2230-2232. doi: 10.1093/cid/ciaa398.
PubMed 32266381Li Y, Yao L, Li J, Chen L, Song Y, Cai Z, Yang C. Stability issues of RT-PCR testing of SARS-CoV-2 for hospitalized patients clinically diagnosed with COVID-19. J Med Virol. 2020 Jul;92(7):903-908. doi: 10.1002/jmv.25786. Epub 2020 Apr 5.
PubMed 32219885Mizumoto 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 32183930Zhao J, Yuan Q, Wang H, Liu W, Liao X, Su Y, Wang X, Yuan J, Li T, Li J, Qian S, Hong C, Wang F, Liu Y, Wang Z, He Q, Li Z, He B, Zhang T, Fu Y, Ge S, Liu L, Zhang J, Xia N, Zhang Z. Antibody Responses to SARS-CoV-2 in Patients With Novel Coronavirus Disease 2019. Clin Infect Dis. 2020 Nov 19;71(16):2027-2034. doi: 10.1093/cid/ciaa344.
PubMed 32221519Elbe S, Buckland-Merrett G. Data, disease and diplomacy: GISAID's innovative contribution to global health. Glob Chall. 2017 Jan 10;1(1):33-46. doi: 10.1002/gch2.1018. eCollection 2017 Jan.
PubMed 31565258Li Q, Guan X, Wu P, Wang X, Zhou L, Tong Y, Ren R, Leung KSM, Lau EHY, Wong JY, Xing X, Xiang N, Wu Y, Li C, Chen Q, Li D, Liu T, Zhao J, Liu M, Tu W, Chen C, Jin L, Yang R, Wang Q, Zhou S, Wang R, Liu H, Luo Y, Liu Y, Shao G, Li H, Tao Z, Yang Y, Deng Z, Liu B, Ma Z, Zhang Y, Shi G, Lam TTY, Wu JT, Gao GF, Cowling BJ, Yang B, Leung GM, Feng Z. Early Transmission Dynamics in Wuhan, China, of Novel Coronavirus-Infected Pneumonia. N Engl J Med. 2020 Mar 26;382(13):1199-1207. doi: 10.1056/NEJMoa2001316. Epub 2020 Jan 29.
PubMed 31995857Hu Z, Song C, Xu C, Jin G, Chen Y, Xu X, Ma H, Chen W, Lin Y, Zheng Y, Wang J, Hu Z, Yi Y, Shen H. Clinical characteristics of 24 asymptomatic infections with COVID-19 screened among close contacts in Nanjing, China. Sci China Life Sci. 2020 May;63(5):706-711. doi: 10.1007/s11427-020-1661-4. Epub 2020 Mar 4.
PubMed 32146694Bai Y, Yao L, Wei T, Tian F, Jin DY, Chen L, Wang M. Presumed Asymptomatic Carrier Transmission of COVID-19. JAMA. 2020 Apr 14;323(14):1406-1407. doi: 10.1001/jama.2020.2565.
PubMed 32083643Guo L, Ren L, Yang S, Xiao M, Chang D, Yang F, Dela Cruz CS, Wang Y, Wu C, Xiao Y, Zhang L, Han L, Dang S, Xu Y, Yang QW, Xu SY, Zhu HD, Xu YC, Jin Q, Sharma L, Wang L, Wang J. Profiling Early Humoral Response to Diagnose Novel Coronavirus Disease (COVID-19). Clin Infect Dis. 2020 Jul 28;71(15):778-785. doi: 10.1093/cid/ciaa310.
PubMed 32198501
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Serologic Surveillance for SARS-CoV-2 (COVID-19) in a Prospective Cohort of Health Care
- ClinicalTrials.gov ID
- NCT04387890
- Acronym / sponsor ID
- 5566
- Conditions
- COVID-19, SARS-CoV 2, Health Personnel
- Keywords
- SARS Virus, SARS-CoV-2, COVID-19, Health Personnel
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Hospital Italiano de Buenos AiresUniversity, hospital or other
- Collaborators
- Roche Pharma AG
- Study start
- 1 Jun 2020 (estimated)
- Primary completion
- 31 Aug 2020 (estimated)
- Study completion
- 31 Aug 2020 (estimated)
- First posted
- 14 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 investigators will follow a single prospective cohort of 50 Health Care Workers in the Hospital Italiano de Buenos Aires (Argentina) from May 15th to August 31st 2020 using antibody testing for SARS-CoV-2 IgM and IgG at baseline and every 2 weeks in order to assess the incidence of COVID-19, the prevalence of anti-SARS-CoV-2 antibodies (IgM and IgG) and incidence of reinfection or reactivations of previous COVID-19 using viral gene sequencing in this cohort.
Detailed description
SARS-CoV-2 infection in healthcare workers (HCW) is nowadays a frequent problem for patient care and organization of care teams. SARS-CoV-2 antibody assessment provides a tool to evaluate antibody prevalence in hospital staff identifying previously exposed individuals. Serologic testing could identify new cases of COVID-19 in an early fashion and could help to investigate cases of reactivation or reinfection in hospital workers. The study purpose is to conduct a study using serological screening for health care workers in a University Hospital in Buenos Aires in order to assess the risk of COVID-19 on those who have not developed an immune response against the virus, or to detect it in an early fashion (either pre-symptomatic or asymptomatic). If a study participant is suspected to have potential reinfection or reactivation of COVID-19, the investigators will conduct genome sequencing in order to be able to differentiate each case. The investigators will include 50 participants chosen at random among health care workers from the hospital Emergency Department (ED), Internal Medicine wards, or Critical Care Units who are exposed to COVID-19. Participants who agree to join the study and sign the informed consent form will be screened at baseline for SARS-CoV-2 IgM and IgG antibodies, along with a physical exam and basic laboratory determinations. They will be re-screened with antibodies every 2 weeks for a total of 3 months. If they contract COVID-19, antibody determinations and nasopharyngeal swabs will be carried out in order to identify those who are in favorable conditions to return to work. The main objective is to prospectively determine the incidence of COVID-19, Anti SARS-CoV-2 antibody prevalence, and incidence of SARS-CoV-2 reinfection or reactivation of COVID-19 in a health care workers cohort.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Serologic Screening | – | Diagnostic Test: Serologic SARS-CoV-2 screeningParticipants will be screened for IgM and IgG SARS-CoV-2 antibodies at baseline and every 2 weeks. Participants showing symptoms compatible with COVID-19 will undergo nasopharyngeal swab for PCR testing for diagnosis. Participants recovered from COVID-19 will have to have 2 negative and consecutive nasopharyngeal swab PCR tests in order to return to work. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Physicians directed involved with the healthcare of COVID-19 patients
Key inclusion criteria (3 listed)
- Healthcare staff (Physicians) AND
- Directly involved in care of patients with confirmed or suspected COVID-19 AND
- Working in any of the two hospital venues (Hospital Italiano Central and Hospital Italiano San Justo Agustín Rocca).
Key exclusion criteria (2 listed)
- Refusal to sign the Informed Consent Form OR
- Experienced symptoms compatible with COVID-19 in the last 14 days prior to eligibility screening
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 |
|---|---|---|
| Serologic SARS-CoV-2 screeningQuantitative Indirect Chemiluminescence Immunoassay (CLIA) to access SARS-CoV-2 specific IgM and IgG serum antibody level every 2 weeks during follow up | Diagnostic test | Serologic Screening |
Primary outcome
Prevalence of anti SARS-CoV-2 antibodies (IgM and IgG) in health personnel
Time frame: Baseline at study inclussion
Patients that has a positive result for IgM or IgG at baseline first test
COVID-19 incidence through serology-based screening and/or compatible symptoms in health personnel previously known to be unexposed to the virus
Time frame: During 3 months follow up
Patients that has a positive result for IgM or IgG or PCR during follow up
Incidence of reactivation/reinfection for COVID-19 in health personnel with a positive serology for SARS-CoV-2
Time frame: During 3 months follow up
Patients with confirmed previous SARS Cov 2 antibodies that reactivate symptomons or new increase in antibodies title during follow up
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2020.
- Results publication: 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.
- Results publication: PubMed 32178769Remuzzi A, Remuzzi G. COVID-19 and Italy: what next? Lancet. 2020 Apr 11;395(10231):1225-1228. doi: 10.1016/S0140-6736(20)30627-9. Epub 2020 Mar 13.
- Results publication: PubMed 32240128Kimball A, Hatfield KM, Arons M, James A, Taylor J, Spicer K, Bardossy AC, Oakley LP, Tanwar S, Chisty Z, Bell JM, Methner M, Harney J, Jacobs JR, Carlson CM, McLaughlin HP, Stone N, Clark S, Brostrom-Smith C, Page LC, Kay M, Lewis J, Russell D, Hiatt B, Gant J, Duchin JS, Clark TA, Honein MA, Reddy SC, Jernigan JA; Public Health - Seattle & King County; CDC COVID-19 Investigation Team. Asymptomatic and Presymptomatic SARS-CoV-2 Infections in Residents of a Long-Term Care Skilled Nursing Facility - King County, Washington, March 2020. MMWR Morb Mortal Wkly Rep. 2020 Apr 3;69(13):377-381. doi: 10.15585/mmwr.mm6913e1.
- Results publication: PubMed 32031583Chu DKW, Pan Y, Cheng SMS, Hui KPY, Krishnan P, Liu Y, Ng DYM, Wan CKC, Yang P, Wang Q, Peiris M, Poon LLM. Molecular Diagnosis of a Novel Coronavirus (2019-nCoV) Causing an Outbreak of Pneumonia. Clin Chem. 2020 Apr 1;66(4):549-555. doi: 10.1093/clinchem/hvaa029.
- Results publication: PubMed 32221523Yu F, Yan L, Wang N, Yang S, Wang L, Tang Y, Gao G, Wang S, Ma C, Xie R, Wang F, Tan C, Zhu L, Guo Y, Zhang F. Quantitative Detection and Viral Load Analysis of SARS-CoV-2 in Infected Patients. Clin Infect Dis. 2020 Jul 28;71(15):793-798. doi: 10.1093/cid/ciaa345.
- Results publication: PubMed 32266381Yuan J, Kou S, Liang Y, Zeng J, Pan Y, Liu L. Polymerase Chain Reaction Assays Reverted to Positive in 25 Discharged Patients With COVID-19. Clin Infect Dis. 2020 Nov 19;71(16):2230-2232. doi: 10.1093/cid/ciaa398.
- Results publication: PubMed 32219885Li Y, Yao L, Li J, Chen L, Song Y, Cai Z, Yang C. Stability issues of RT-PCR testing of SARS-CoV-2 for hospitalized patients clinically diagnosed with COVID-19. J Med Virol. 2020 Jul;92(7):903-908. doi: 10.1002/jmv.25786. Epub 2020 Apr 5.
- Results publication: 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.
- Results publication: PubMed 32221519Zhao J, Yuan Q, Wang H, Liu W, Liao X, Su Y, Wang X, Yuan J, Li T, Li J, Qian S, Hong C, Wang F, Liu Y, Wang Z, He Q, Li Z, He B, Zhang T, Fu Y, Ge S, Liu L, Zhang J, Xia N, Zhang Z. Antibody Responses to SARS-CoV-2 in Patients With Novel Coronavirus Disease 2019. Clin Infect Dis. 2020 Nov 19;71(16):2027-2034. doi: 10.1093/cid/ciaa344.
- Results publication: PubMed 31565258Elbe S, Buckland-Merrett G. Data, disease and diplomacy: GISAID's innovative contribution to global health. Glob Chall. 2017 Jan 10;1(1):33-46. doi: 10.1002/gch2.1018. eCollection 2017 Jan.
- Results publication: PubMed 31995857Li Q, Guan X, Wu P, Wang X, Zhou L, Tong Y, Ren R, Leung KSM, Lau EHY, Wong JY, Xing X, Xiang N, Wu Y, Li C, Chen Q, Li D, Liu T, Zhao J, Liu M, Tu W, Chen C, Jin L, Yang R, Wang Q, Zhou S, Wang R, Liu H, Luo Y, Liu Y, Shao G, Li H, Tao Z, Yang Y, Deng Z, Liu B, Ma Z, Zhang Y, Shi G, Lam TTY, Wu JT, Gao GF, Cowling BJ, Yang B, Leung GM, Feng Z. Early Transmission Dynamics in Wuhan, China, of Novel Coronavirus-Infected Pneumonia. N Engl J Med. 2020 Mar 26;382(13):1199-1207. doi: 10.1056/NEJMoa2001316. Epub 2020 Jan 29.
- Results publication: PubMed 32146694Hu Z, Song C, Xu C, Jin G, Chen Y, Xu X, Ma H, Chen W, Lin Y, Zheng Y, Wang J, Hu Z, Yi Y, Shen H. Clinical characteristics of 24 asymptomatic infections with COVID-19 screened among close contacts in Nanjing, China. Sci China Life Sci. 2020 May;63(5):706-711. doi: 10.1007/s11427-020-1661-4. Epub 2020 Mar 4.
- Novel Coronavirus (2019-nCoV) situation reportsLink provided by the sponsor.
- World Health Organization. Coronavirus disease 2019 (COVID-19) Situation ReportLink provided by the sponsor.
- Coronavirus Disease 2019 (COVID-19). In: Centers for Disease Control and PreventionLink provided by the sponsor.
- Guidance for discharge and ending isolation in the context of widespread community transmission of COVID-19 - first update. In: European Centre for Disease Prevention and ControlLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Cristina Elizondo, MD contact
Leticia Peroni, MD principal investigator
HIBA
Vanina Stanek, MD principal investigator
HIBA
Diego Sanchez Thomas, MD principal investigator
HIBA
Questions about this trial
What is this clinical trial studying?
An observational study of COVID-19 and SARS-CoV 2, run by Hospital Italiano de Buenos Aires.
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 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: status not confirmed, as of the sponsor's last update on 28 May 2020. Status can change between updates, so confirm with the study contact before making plans.
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?
Contact Ines Staneloni, MD (+54 011 4959 0200, maria.staneloni@hospitalitaliano.org.ar), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of anti SARS-CoV-2 antibodies (IgM and IgG) in health personnel (time frame: Baseline at study inclussion). 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 NCT04387890, which also lists 14 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 May 2020.