Monitoring the IgG/IgM Antibodies in COVID-19 Patients

Completed

• Conditions: COVID-19 Infections
• Interventions: Diagnostic Test: Serodiagnosis of IgG and IgM

• Registration Number: NCT04810117
• Lead Sponsor: University of Sargodha

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.

Detailed Description

SARS-CoV-2 (Severe Acute Respiratory Syndrome Coronavirus 2) pandemic has affected millions of people around the globe. Despite many efforts to find some effective medicines against SARS CoV-2, still no established therapeutics available. A year ago, SARS-CoV-2 emerged as a novel virus with no available treatment option and caused a serious disaster across the world. The disease caused by this virus, "COVID-19", announced a global pandemic on March 11, 2020. Without any proper treatment and vaccine for COVID-19, people around the world are currently experiencing a worldwide emergency affecting all societies, and it has sent billions of people into lockdown. Around the world, desperate efforts are underway to curtail this pandemic while it has resulted in the collapsing of health systems and has triggered lasting geopolitical and economic changes. To date, no approved medical treatment is available, which makes social distancing the only best possible solution to stop the spread of the virus. It is thought that future outbreaks of CoVs are unavoidable because of changes in the climate and ecology and increased interaction of humans with animals. Therefore, there is a need to develop effective therapeutics and vaccines against CoVs.

Poor diagnosis of COVID-19 has also contributed to disease severity due to stress (in case of false positive) and disease spread (in case of a false negative). A lack of RT-PCR test sampling of lower tract respiratory specimens was the main reason for the misclassification of symptomatic patients as either having COVID-19 or not. A prompt diagnosis with serological testing shows SARS-CoV-2 IgG/IgM patterns in a better and understandable way of seroconversion.

The IgG/IgM assays to detect the length and origin of humoral responses against SARS-CoV-2 is very important, and these antibodies can be detected from a few days after the onset of diseases and may remain in the body even after years of infection. In the case of COVID-19, IgM and IgG response can be observed from the second week of the disease.

In Coronaviruses, IgM and IgG levels are found to disappear over time in humans. IgG antibodies against SARS-CoV-1 were found to wane approximately two years after infection, and the person may become vulnerable to reinfection after the complete reduction of the immune response. In MERS- CoV, IgG levels were found gradually reduced after a year of infection onset. The length of the protective immunity is very important to avoid reinfection and also helps in the prediction of vaccine response in the body. The humoral immune response varies among young and elderly people, men and women, healthy and health compromised people. Studies on dynamics and the mechanisms of the humoral immune response may help in COVID-19 vaccine development and laws implementation, and other public health responses. This study is particularly designed to access the IgM and IgG antibodies in various COVID-19 subjects in Sargodha, Punjab, Pakistan, where no specific study of this kind has been performed. This will help predict the reinfection probabilities among the local population and predict the length and efficacy of the vaccine and the requirement of vaccine boosters.

Study Timeline

• Study First Submitted: 2021-03-19
• Study First Submitted QC: 2021-03-19
• Study First Posted: 2021-03-22
• Study Start: 2021-06-15
• Primary Completion: 2021-11-30
• Study Completion: 2022-04-30
• Status Verified: 2022-07
• Last Update Submitted: 2022-07-18
• Last Update Posted: 2022-07-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 373

Inclusion Criteria

• Suspected/PCR positive COVID-19 patients
• Patients aged >18 years and < 60 year
• Able to fill/understand/answer the questionnaire and provide consent to use of personal health information.

Read More

Exclusion Criteria

• Impaired/disable patients who can not understand or provide questionnaire answers
• Patients aged <18 years and > 60 year

Read More

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
COVID-19 patients with obvious symptoms who are not yet vaccinated	Serodiagnosis of IgG and IgM	COVID-19 patients with obvious symptoms but PCR test was not conducted for them
Healthy Individuals who are vaccinated	Serodiagnosis of IgG and IgM	Control group
COVID-19 suspected patients with no symptoms who are not yet vaccinated	Serodiagnosis of IgG and IgM	COVID-19 suspected patients with no symptoms but came in obvious contact with infected environmental/biological samples
COVID-19 PCR positive patients who are vaccinated	Serodiagnosis of IgG and IgM	COVID-19 suspected patients who have got either one or two doses of vaccine
COVID-19 PCR positive patients who are not yet vaccinated	Serodiagnosis of IgG and IgM	Patients test positive with PCR and recovered from COVID-19
Healthy Individuals who are not vaccinated	Serodiagnosis of IgG and IgM	Control group

Primary Outcome Measures

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

Trial Locations

Locations (2)

University of Sargodha, Sub campus Bhakkar; 🇵🇰 Bhakkar, Punjab, Pakistan

University of Sargodha; 🇵🇰 Sargodha, Punjab, Pakistan