NCT04568850

Brief Summary

This study will define the kinetics of IgG responses to both N and S proteins in the subjects who suffered from COVID 19 and then had recovered and those who were previously undiagnosed but were seropositive. These subjects will be followed for four months to evaluate the levels of antibodies in these people.

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
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jul 2020

Geographic Reach
1 country

2 active sites

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

July 1, 2020

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

September 21, 2020

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 29, 2020

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2022

Completed
Last Updated

February 15, 2022

Status Verified

February 1, 2022

Enrollment Period

1.7 years

First QC Date

September 21, 2020

Last Update Submit

February 12, 2022

Conditions

Covid19

Outcome Measures

Primary Outcomes (1)

  • Serum IgG for SARS CoV 2 will be monitored

    Subjects testing reactive for SARS CoV 2 IgG antibodies will be followed for five months to see the levels of IgG SARS CoV 2

    5 months

Interventions

Plasma IgG levelsDIAGNOSTIC_TEST

Plasma IgG levels of subjects who tested reactive for IgG SARS CoV-2 antibodies will be monitored every month for 4 months for IgG levels

Eligibility Criteria

Sexall
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

subjects who suffered from COVID 19 and then had recovered and those who were previously undiagnosed but were seropositive.

You may qualify if:

  • Subjects testing reactive for SARS CoV 2 IgG antibodies

You may not qualify if:

  • Subjects testing nonreactive for SARS CoV-2 IgG antibodies

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Lahore General Hospital

Lahore, Punjab Province, 57000, Pakistan

RECRUITING

Lahore General Hospital

Lahore, Punjab Province, 5700, Pakistan

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Plasma of the subjects will be saved,

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

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

Study Officials

  • Amina Asif, MPhilMicro

    Lahore General Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Amina Asif, MPhilMicro

CONTACT

+92 300 5009929aminasif79@gmail.com

M.Irfan Malik, FCPS

CONTACT

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

September 21, 2020

First Posted

September 29, 2020

Study Start

July 1, 2020

Primary Completion

February 28, 2022

Study Completion

February 28, 2022

Last Updated

February 15, 2022

Record last verified: 2022-02

Locations

PA(2)