NCT04387890

Brief 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 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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jun 2020

Shorter than P25 for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 13, 2020

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 14, 2020

Completed
18 days until next milestone

Study Start

First participant enrolled

June 1, 2020

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2020

Completed
Last Updated

May 28, 2020

Status Verified

May 1, 2020

Enrollment Period

3 months

First QC Date

May 13, 2020

Last Update Submit

May 27, 2020

Conditions

COVID-19SARS-CoV 2Health Personnel

Keywords

SARS VirusSARS-CoV-2COVID-19Health Personnel

Outcome Measures

Primary Outcomes (3)

  • 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

    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

    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

    During 3 months follow up

Study Arms (1)

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.

Diagnostic Test: Serologic SARS-CoV-2 screening

Interventions

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

Serologic Screening

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Physicians directed involved with the healthcare of COVID-19 patients

You may qualify if:

  • 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).

You may not qualify if:

  • Refusal to sign the Informed Consent Form OR
  • Experienced symptoms compatible with COVID-19 in the last 14 days prior to eligibility screening

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (14)

  • 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.

    PMID: 32199474RESULT

  • Remuzzi 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.

    PMID: 32178769RESULT

  • Kimball 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.

    PMID: 32240128RESULT

  • Chu 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.

    PMID: 32031583RESULT

  • Yu 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.

    PMID: 32221523RESULT

  • Yuan 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.

    PMID: 32266381RESULT

  • Li 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.

    PMID: 32219885RESULT

  • Mizumoto 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.

    PMID: 32183930RESULT

  • Zhao 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.

    PMID: 32221519RESULT

  • Elbe 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.

    PMID: 31565258RESULT

  • Li 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.

    PMID: 31995857RESULT

  • Hu 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.

    PMID: 32146694RESULT

  • Bai 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.

    PMID: 32083643RESULT

  • Guo 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.

    PMID: 32198501RESULT

Related Links

MeSH Terms

Conditions

COVID-19Severe Acute Respiratory Syndrome

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Leticia Peroni, MD

    HIBA

    PRINCIPAL INVESTIGATOR

  • Vanina Stanek, MD

    HIBA

    PRINCIPAL INVESTIGATOR

  • Diego Sanchez Thomas, MD

    HIBA

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ines Staneloni, MD

CONTACT

+54 011 4959 0200maria.staneloni@hospitalitaliano.org.ar

Cristina Elizondo, MD

CONTACT

cristina.elizondo@hospitalitaliano.org.ar

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, MPH, University SoTL, PhD

Study Record Dates

First Submitted

May 13, 2020

First Posted

May 14, 2020

Study Start

June 1, 2020

Primary Completion

August 31, 2020

Study Completion

August 31, 2020

Last Updated

May 28, 2020

Record last verified: 2020-05

Data Sharing

IPD Sharing
Will not share