Seroconversion in COVID-19 Recovered Population

Seroconversion in COVID-19 Recovered Population: an Observational Study

This study investigate the kinetics of IgG responses to both N and S proteins in the subjects who suffered from COVID 19 and then had recovered.

Study Overview

• Status: Completed
• Conditions: Covid19
• Intervention / Treatment: Diagnostic test: IgG SARS CoV2

Detailed Description

Coronaviruses (CoVs) are enveloped, single positive-strand RNA viruses belonging to the large subfamily Coronavirinae, which can infect mammals and several other animals.The continued spread of coronavirus disease 2019 (COVID-19) has prompted widespread concern around the world, and the World Health Organization (WHO), on 11 March 2020, declared COVID-19 a pandemic. Studies on severe acute respiratory syndrome (SARS) and Middle East respiratory syndrome (MERS) showed that virus-specific antibodies were detectable in 80-100% of patients at 2 weeks after symptom onset. Currently, the antibody responses against SARS-CoV-2 remain poorly understood and the clinical utility of serological testing is unclear Little is known about the kinetics, tissue distribution, cross-reactivity and neutralization antibody response in COVID-19 patients .

The seropositivity rate of both IgM and IgG responses after onset and recovery of disease, and in the context of both N protein and S protein has not been clarified. The kinetics of antibody responses in critical cases or ICU patients has not been reported, and no studies have suggested whether antibody response is associated with disease prognosis

• Study Type: Observational
• Enrollment (Actual): 275

Contacts and Locations

Study Locations

• Pakistan
  • Punjab
    • Lahore, Punjab, Pakistan, 54500
      • Lahore General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

population who have suffered from COVID 19, whose disease was either confirmed by PCR or clinically and then recovered

Description

Inclusion Criteria:

Subjects recovered from COVID 19 confirmed on PCR or clinically

Exclusion Criteria:

subjects who have not been confirmed suffering from COVID 19 by PCR or clinically

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
IgG SARS CoV2	Presence or absence of SARV CoV2 IgG antibodies	5 months

Collaborators and Investigators

• Sponsor: Lahore General Hospital
• Investigators: Principal Investigator: Amina Asif, MPhilMicro, LahoreGeneralHospital.Lahore

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2020
• Primary Completion (Actual): March 31, 2021
• Study Completion (Actual): March 31, 2021

Study Registration Dates

• First Submitted: September 20, 2020
• First Submitted That Met QC Criteria: September 20, 2020
• First Posted (Actual): September 22, 2020

Study Record Updates

• Last Update Posted (Actual): April 1, 2021
• Last Update Submitted That Met QC Criteria: March 30, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: LGH006

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No