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Clinical and Immunological Responses After SARS-CoV-2 Infection Causing COVID-19

NCT05038475 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 100

Last updated 2023-04-14

No results posted yet for this study

Summary

There are very few long-term studies that analyze the immune responses in patients recovered from COVID-19 caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2).

The main aim of this study is to analyze the clinical profile and immune responses of recovered COVID-19 patients in a representative cohort of people in the Umbria region of Italy. The participants had a history of testing positive for SARS-CoV-2 in March 2020 by Reverse Transcriptase- Quantitative Polymerase Chain Reaction (RT-qPCR). The participants were invited for voluntary participation in a seroprevalence study. This study analyzes longitudinally the presence of antibodies against SARS-CoV-2 by sequential serological tests at different time points using two FDA-approved Immunoassays. At the first serum sample collection, the participants were asked to provide information about their COVID-19 clinical history including clinical profile, co-morbidities, and treatment undertaken using a standardized questionnaire. Successive sequential serological assessments were conducted to understand the immune responses in these recovered patients.

Moreover, stage two of the study involves, analysis of antibody titers in recovered vaccinated individuals and their follow-up.

Conditions

  • Covid19
  • SARS-CoV2 Infection
  • Olfactory Disorder
  • COVID-19
  • Smell Loss
  • Smell Disorder

Interventions

DIAGNOSTIC_TEST

COVID-19 antibody test

FDA-approved Immunoassays were used in the study. At the beginning of the study, up to 3 months, ELISA and CLIA immunoassays were adopted to analyze the antibody titers. Thereafter, CLIA was used for longitudinal analysis of antibody titers for consecutive months. Anti

Sponsors & Collaborators

  • Association "Naso Sano" Onlus

    lead OTHER

Principal Investigators

  • Puya Dehgani-Mobaraki, MD · Associazione Naso sano, Italy

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-05-01
Primary Completion
2023-11-30
Completion
2024-05-31

Countries

  • Italy

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05038475 on ClinicalTrials.gov