Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04429620
Other study ID # SARS-CoV-2-IIF-002
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date May 30, 2020
Est. completion date December 31, 2020

Study information

Verified date June 2020
Source Szeged University
Contact Katalin Burián, MD
Phone +36 62 544 000
Email burian.katalin@med.u-szeged.hu
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Prospective assay for SARS-CoV-2 antibody detection indirectly by immunofluorescence: SARS-CoV2 IIF method


Description:

Sample preparation, serum separation by centrifugation

- 100 µl of serum for standard SARS-CoV2 ELISA is used according to the instructions for use.

- 100 µl of serum indirect immunofluorescent (IIF) method is used, the samples thus prepared analysis is performed under an automated microscope


Recruitment information / eligibility

Status Recruiting
Enrollment 100
Est. completion date December 31, 2020
Est. primary completion date December 31, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Person over 18 years of age

- Signing a package leaflet and a informal consent

- In the case of a positive group, confirmed by SARS-CoV2 qPCR Patient with COVID-19 or recovered individual.

- In case of negative group by SARS-CoV2 qPCR test 2 negative in COVID-19 suffering individual

Exclusion Criteria:

- Refuses to sign the consent form

Study Design


Related Conditions & MeSH terms


Intervention

Diagnostic Test:
Immunfluorescence
Serum indirect immunofluorescent (IIF) method is used, analysis is performed under an automated microscope.

Locations

Country Name City State
Hungary University of Szeged, Albert Szent-Györgyi Health Center Szeged

Sponsors (2)

Lead Sponsor Collaborator
Szeged University Bilogical Research Centre, Szeged

Country where clinical trial is conducted

Hungary, 

Outcome

Type Measure Description Time frame Safety issue
Primary Sensitivity of the method by SARS-CoV2 ELISA compared Sensitivity of the method by SARS-CoV2 ELISA compared 8 months
Secondary Detectability of the antibodies IgA type against SARS-CoV2 virus Detectability of the antibodies IgA type against SARS-CoV2 virus in the early stages of the disease. 8 months
See also
  Status Clinical Trial Phase
Not yet recruiting NCT04446065 - Previfenon® as Chemoprophylaxis of COVID-19 in Health Workers Phase 2/Phase 3
Completed NCT04419025 - Efficacy of N-Acetylcysteine (NAC) in Preventing COVID-19 From Progressing to Severe Disease Phase 2
Not yet recruiting NCT04400019 - Prevention of COVID19 Infection in Nursing Homes by Chemoprophylaxis With Hydroxychloroquine (PREVICHARM) Phase 2/Phase 3
Completed NCT04463004 - Mavrilimumab to Reduce Progression of Acute Respiratory Failure in COVID-19 Pneumonia and Systemic Hyper-inflammation Phase 2
Completed NCT04446429 - Anti-Androgen Treatment for COVID-19 N/A
Completed NCT04402957 - LSALT Peptide vs. Placebo to Prevent ARDS and Acute Kidney Injury in Patients Infected With SARS-CoV-2 (COVID-19) Phase 2
Recruiting NCT04581148 - SARS-CoV2 Antibodies in Pediatric Patients (COVID-19)
Recruiting NCT04441372 - Prognostication of Oxygen Requirement in Non-severe SARS-CoV-2 Infection
Terminated NCT04371978 - Efficacy and Safety of Dipeptidyl Peptidase-4 Inhibitors in Diabetic Patients With Established COVID-19 Phase 3
Completed NCT04530604 - Defibrotide Therapy for SARS-CoV2 (COVID-19) Acute Respiratory Distress Syndrome (ARDS) Phase 1
Active, not recruiting NCT04635605 - Methylene Blue Treatment of COVID-19 Phase 2
Recruiting NCT04395599 - Risk of Air Contamination During Visceral Surgery in COVID19 Patients N/A
Recruiting NCT04472585 - Efficacy of Subcutaneous Ivermectin With or Without Zinc in COVID-19 Patients Phase 1/Phase 2
Active, not recruiting NCT04411433 - Efficacy and Safety of Hydroxychloroquine and Favipiravir in the Treatment of Mild to Moderate COVID-19 Phase 3
Completed NCT04359706 - Bacterial and Fungal Microbiota of Patients With Severe Viral Pneumonia With COVID-19
Recruiting NCT04395794 - SARS-CoV-2 Disguise Study
Completed NCT04386551 - Detection of COVID-19 in Saliva Collection
Recruiting NCT04403269 - NORMAL HUMAN IMMUNOGLOBULINS (IVIG) IN PATIENTS AGED 75 YEARS AND OVER, COVID-19 WITH SEVERE ACUTE RESPIRATORY FAILURE Phase 2
Withdrawn NCT04379492 - A Study of Hydroxycholoroquine Compared to Placebo as Treatment for People With COVID-19 Phase 2
Completed NCT04407182 - Safety and Efficacy of Viusid and Asbrip in Hospitalized Patients Infected by SARS-Cov-2 With COVID-19 Phase 2