COVID-19 InfectionsNCT04810117
Monitoring the IgG/IgM Antibodies in COVID-19 Patients
An observational study of COVID-19 Infections, run by University of Sargodha at 2 sites in Pakistan.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- COVID-19 Infections
- What is being tested?
- Serodiagnosis of IgG and IgM
- Type of treatment
- Vaccines
- How many people
- 373 participants
- Where
- 2 sitesPakistan
- Study dates
- 15 Jun 2021to 30 Apr 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Study population: Local people living in the Sargodha District
Who may be able to join
- 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.
Who cannot join
- Impaired/disable patients who can not understand or provide questionnaire answers
- Patients aged <18 years and > 60 year
Trial locations and contacts
2 sites in 1 country.
Pakistan2 sites
University of Sargodha, Sub campus Bhakkar
Bhakkar, Punjab Province, 30000
University of Sargodha
Sargodha, Punjab Province, 40100
About this study
Official title: Monitoring the Patterns of IgG/IgM Antibodies in Asymptomatic/Symptomatic COVID-19 Patients
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.
Read the 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.
- Conditions
- COVID-19 Infections
- Being tested
- Serodiagnosis of IgG and IgM
- Keywords
- COVID-19, SARS-CoV-2, Humoral response
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Serodiagnosis of IgG and IgMDiagnostic test
IgG and IgM antibodies will be detected in COVID-19 patients
| Study group | Role | What they receive |
|---|---|---|
| COVID-19 PCR positive patients who are not yet vaccinated | Patients test positive with PCR and recovered from COVID-19 Receives: Diagnostic Test: Serodiagnosis of IgG and IgM | |
| COVID-19 patients with obvious symptoms who are not yet vaccinated | COVID-19 patients with obvious symptoms but PCR test was not conducted for them Receives: Diagnostic Test: Serodiagnosis of IgG and IgM | |
| COVID-19 suspected patients with no symptoms who are not yet vaccinated | COVID-19 suspected patients with no symptoms but came in obvious contact with infected environmental/biological samples Receives: Diagnostic Test: Serodiagnosis of IgG and IgM | |
| COVID-19 PCR positive patients who are vaccinated | COVID-19 suspected patients who have got either one or two doses of vaccine Receives: Diagnostic Test: Serodiagnosis of IgG and IgM | |
| Healthy Individuals who are vaccinated | Control group Receives: Diagnostic Test: Serodiagnosis of IgG and IgM | |
| Healthy Individuals who are not vaccinated | Control group Receives: Diagnostic Test: Serodiagnosis of IgG and IgM |
What is being measured
The primary outcome is the main question the study is designed to answer.
IgG positive
COVID patients
Measured: from date of consent to date of test completion, up to 40 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2021
- Study start15 Jun 2021
- Primary completion30 Nov 2021
- Study completion30 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for COVID-19 InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 373 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sargodha
- Sponsor type
- University, hospital or other
- Collaborators
- Shanghai Jiao Tong University School of Biomedical engineering
- Responsible party
- Principal investigator, Muhammad Fayyaz ur Rehman, University of Sargodha
- Investigators
- Muhammad Fayyaz U Rehman, PhD, Principal investigator, University of Sargodha
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04810117
- Sponsor's protocol ID
- 15032021-1
- Status last verified
- Jul 2022
- First submitted
- 19 Mar 2021
- Last updated
- 21 Jul 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated device
- Yes
Publications
Rehman MFU, Fariha C, Anwar A, Shahzad N, Ahmad M, Mukhtar S, Farhan Ul Haque M. Novel coronavirus disease (COVID-19) pandemic: A recent mini review. Comput Struct Biotechnol J. 2021;19:612-623. doi: 10.1016/j.csbj.2020.12.033. Epub 2020 Dec 31.
PubMed 33398233Lee YL, Liao CH, Liu PY, Cheng CY, Chung MY, Liu CE, Chang SY, Hsueh PR. Dynamics of anti-SARS-Cov-2 IgM and IgG antibodies among COVID-19 patients. J Infect. 2020 Aug;81(2):e55-e58. doi: 10.1016/j.jinf.2020.04.019. Epub 2020 Apr 23. No abstract available.
PubMed 32335168
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Monitoring the Patterns of IgG/IgM Antibodies in Asymptomatic/Symptomatic COVID-19 Patients
- ClinicalTrials.gov ID
- NCT04810117
- Acronym / sponsor ID
- 15032021-1
- Conditions
- COVID-19 Infections
- Keywords
- COVID-19, SARS-CoV-2, Humoral response
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 373 participants (actual)
- Lead sponsor
- University of SargodhaUniversity, hospital or other
- Collaborators
- Shanghai Jiao Tong University School of Biomedical engineering
- Study start
- 15 Jun 2021 (actual)
- Primary completion
- 30 Nov 2021 (actual)
- Study completion
- 30 Apr 2022 (actual)
- First posted
- 22 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| COVID-19 PCR positive patients who are not yet vaccinated | – | Diagnostic Test: Serodiagnosis of IgG and IgMPatients test positive with PCR and recovered from COVID-19 |
| COVID-19 patients with obvious symptoms who are not yet vaccinated | – | Diagnostic Test: Serodiagnosis of IgG and IgMCOVID-19 patients with obvious symptoms but PCR test was not conducted for them |
| COVID-19 suspected patients with no symptoms who are not yet vaccinated | – | Diagnostic Test: Serodiagnosis of IgG and IgMCOVID-19 suspected patients with no symptoms but came in obvious contact with infected environmental/biological samples |
| COVID-19 PCR positive patients who are vaccinated | – | Diagnostic Test: Serodiagnosis of IgG and IgMCOVID-19 suspected patients who have got either one or two doses of vaccine |
| Healthy Individuals who are vaccinated | – | Diagnostic Test: Serodiagnosis of IgG and IgMControl group |
| Healthy Individuals who are not vaccinated | – | Diagnostic Test: Serodiagnosis of IgG and IgMControl group |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Local people living in the Sargodha District
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (2 listed)
- Impaired/disable patients who can not understand or provide questionnaire answers
- Patients aged <18 years and > 60 year
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Serodiagnosis of IgG and IgMIgG and IgM antibodies will be detected in COVID-19 patients | Diagnostic test | COVID-19 PCR positive patients who are not yet vaccinated, COVID-19 PCR positive patients who are vaccinated, COVID-19 patients with obvious symptoms who are not yet vaccinated, COVID-19 suspected patients with no symptoms who are not yet vaccinated, Healthy Individuals who are not vaccinated, Healthy Individuals who are vaccinated |
Primary outcome
IgG positive
Time frame: from date of consent to date of test completion, up to 40 days
COVID patients
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2022.
- Background: PubMed 33398233Rehman MFU, Fariha C, Anwar A, Shahzad N, Ahmad M, Mukhtar S, Farhan Ul Haque M. Novel coronavirus disease (COVID-19) pandemic: A recent mini review. Comput Struct Biotechnol J. 2021;19:612-623. doi: 10.1016/j.csbj.2020.12.033. Epub 2020 Dec 31.
- Background: PubMed 32335168Lee YL, Liao CH, Liu PY, Cheng CY, Chung MY, Liu CE, Chang SY, Hsueh PR. Dynamics of anti-SARS-Cov-2 IgM and IgG antibodies among COVID-19 patients. J Infect. 2020 Aug;81(2):e55-e58. doi: 10.1016/j.jinf.2020.04.019. Epub 2020 Apr 23. No abstract available.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Muhammad Fayyaz U Rehman, PhD principal investigator
University of Sargodha
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COVID-19 Infections, run by University of Sargodha at 2 sites in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
IgG positive (time frame: from date of consent to date of test completion, up to 40 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04810117, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jul 2022.