Brief Summary

The COVID-19 was declared a global pandemic by WHO more than a year ago, and the world is still experiencing a state of global emergency. This disease is caused by a novel RNA coronavirus suspected to originate in animals like bats and pangolin. Coronaviruses found in humans can be divided into seven classes, and out of them, three, i.e., MERS-CoV, SARS-CoV, and SARS-CoV-2, lead to global outbreaks. SARS-CoV-2 has claimed more than 120 million confirmed global cases of the COVID-19, where more than 26 million fatalities have also been recorded by the mid of March 2021. Many drugs have been repurposed and employed, but no specific antiviral medicine has been approved by the FDA to treat this disease. Although three vaccines have been approved by the FDA, mutations in the SARS-CoV-2 may cause problems in antibody neutralization against the virus. COVID-19 patients have been found either symptomatic or asymptomatic. In most people, the disease was found with mild symptoms with no need for hospitalization, or sometimes patients don't show any symptom. Elderly people and people with compromised health are mainly affected by the disease. Serologic assays involving IgM and IgG antibodies to detect antibodies against SARS-CoV-2 are of great interest as these antibodies can be detected from the second week of the start of COVID-19 symptom's where IgM can be detected after the fourth day of infection and IgG has been found after the eighth day of disease onset. Serologic assays provide quick diagnostic by avoiding PCR false positive/false negative result as well as these provide antibody pattern for estimation of strength and duration of humoral immunity. Here, serologic assays will be used to estimate IgM and IgG antibodies in symptomatic or asymptomatic COVID subjects recovered from the disease.

Trial Health

On Track

Trial Health Score

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

Enrollment

373

participants targeted

Target at P75+ for all trials

Timeline

Completed

Started Jun 2021

Shorter than P25 for all trials

Geographic Reach

1 country

2 active sites

Status

completed

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

11 months study duration

First Submitted

Initial submission to the registry

March 19, 2021

Completed

3 days until next milestone

First Posted

Study publicly available on registry

March 22, 2021

Completed

3 months until next milestone

Study Start

First participant enrolled

June 15, 2021

Completed

6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2021

Completed

5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2022

Completed

Last Updated

July 21, 2022

Status Verified

July 1, 2022

Enrollment Period

6 months

First QC Date

March 19, 2021

Last Update Submit

July 18, 2022

Conditions

COVID-19 Infections

Keywords

COVID-19SARS-CoV-2Humoral response

Outcome Measures

Primary Outcomes (1)

IgG positive
COVID patients
from date of consent to date of test completion, up to 40 days