NCT04530461

Brief Summary

An observational study aiming to assess the serological profile of SARS-Cov2 patients with systemic diseases such as systemic lupus erythematosus, Sjogren syndrome, sarcoidosis, inflammatory myopathies, Behçet's disease, Rheumatoid arthritis and Spondyloarthritis

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

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

Study Start

First participant enrolled

June 1, 2020

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

August 26, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 28, 2020

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2020

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2021

Completed
Last Updated

September 22, 2020

Status Verified

September 1, 2020

Enrollment Period

6 months

First QC Date

August 26, 2020

Last Update Submit

September 19, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • Serological Profile

    Number of patients with positive serological test of SARS Cov2

    Inclusion

Interventions

Serological testDIAGNOSTIC_TEST

Positive serological test of SARS Cov2

Eligibility Criteria

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

Patients with one of the following conditions: systemic lupus, Sjögren's syndrome, rheumatoid arthritis, inflammatory myopathies, spondyloarthritis, sarcoidosis and Behçet's disease.

You may qualify if:

  • Age over 18 years old
  • One of the following conditions: systemic lupus, Sjögren's syndrome, rheumatoid arthritis, inflammatory myopathies, spondyloarthritis, sarcoidosis and Behçet's disease.
  • Informed consent obtained and signed

You may not qualify if:

  • Refusal to repeat blood sampling if the first one was badly performed
  • Informed consent not obained

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Military Hospital of Tunis

Tunis, Tunisia

RECRUITING

MeSH Terms

Conditions

Severe Acute Respiratory SyndromeLupus Erythematosus, SystemicSjogren's SyndromeSarcoidosisMyositisBehcet SyndromeArthritis, RheumatoidSpondylarthritis

Interventions

Serologic Tests

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsVirus DiseasesRespiratory Tract DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System DiseasesArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesXerostomiaSalivary Gland DiseasesMouth DiseasesStomatognathic DiseasesDry Eye SyndromesLacrimal Apparatus DiseasesEye DiseasesLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesHypersensitivity, DelayedHypersensitivityMuscular DiseasesNeuromuscular DiseasesNervous System DiseasesUveitis, AnteriorPanuveitisUveitisUveal DiseasesVasculitisVascular DiseasesCardiovascular DiseasesHereditary Autoinflammatory DiseasesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesSkin Diseases, GeneticSkin DiseasesSkin Diseases, VascularSpondylitisSpinal DiseasesBone Diseases

Intervention Hierarchy (Ancestors)

Immunologic TestsClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisInvestigative TechniquesImmunologic Techniques

Study Officials

  • Faida Ajili, MD

    Military Hospital of Tunis

    STUDY CHAIR

Central Study Contacts

Faida Ajili, MD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Director of Autoimmune Diseases Research Unit (UR17DN02) and Professor in internal medicine departement. Sponsor and Principal Investigator

Study Record Dates

First Submitted

August 26, 2020

First Posted

August 28, 2020

Study Start

June 1, 2020

Primary Completion

November 30, 2020

Study Completion

January 31, 2021

Last Updated

September 22, 2020

Record last verified: 2020-09

Data Sharing

IPD Sharing
Will not share

Locations