Monitoring the IgG/IgM Antibodies in COVID-19 Patients
Condition: COVID-19 Infections
MeSH terms: COVID-19
Study type: Observational

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.
    

Intervention name(s): Serodiagnosis of IgG and IgM
Intervention type(s): Diagnostic Test
Intervention description(s): IgG and IgM antibodies will be detected in COVID-19 patients
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Local people living in the Sargodha District
      
Biospecimen description: 
      Blood Samples
    
Keywords: COVID-19; SARS-CoV-2; Humoral response