- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04810117
Monitoring the IgG/IgM Antibodies in COVID-19 Patients
Monitoring the Patterns of IgG/IgM Antibodies in Asymptomatic/Symptomatic COVID-19 Patients
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Punjab
-
Bhakkar, Punjab, Pakistan, 30000
- University of Sargodha, Sub campus Bhakkar
-
Sargodha, Punjab, Pakistan, 40100
- University of Sargodha
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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.
Exclusion Criteria:
- Impaired/disable patients who can not understand or provide questionnaire answers
- Patients aged <18 years and > 60 year
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
COVID-19 PCR positive patients who are not yet vaccinated
Patients test positive with PCR and recovered from COVID-19
|
IgG and IgM antibodies will be detected in COVID-19 patients
|
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
|
IgG and IgM antibodies will be detected in COVID-19 patients
|
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
|
IgG and IgM antibodies will be detected in COVID-19 patients
|
COVID-19 PCR positive patients who are vaccinated
COVID-19 suspected patients who have got either one or two doses of vaccine
|
IgG and IgM antibodies will be detected in COVID-19 patients
|
Healthy Individuals who are vaccinated
Control group
|
IgG and IgM antibodies will be detected in COVID-19 patients
|
Healthy Individuals who are not vaccinated
Control group
|
IgG and IgM antibodies will be detected in COVID-19 patients
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
IgG positive
Time Frame: from date of consent to date of test completion, up to 40 days
|
COVID patients
|
from date of consent to date of test completion, up to 40 days
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Muhammad Fayyaz U Rehman, PhD, University of Sargodha
Publications and helpful links
General 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.
- Lee 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 15032021-1
Drug and device information, study documents
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on COVID-19 Infections
-
Dr. Soetomo General HospitalIndonesia-MoH; Universitas Airlangga; Biotis Pharmaceuticals, IndonesiaRecruitingCOVID-19 Pandemic | COVID-19 Vaccines | COVID-19 Virus DiseaseIndonesia
-
Indonesia UniversityRecruitingPost-COVID-19 Syndrome | Long COVID | Post COVID-19 Condition | Post-COVID Syndrome | Long COVID-19Indonesia
-
University of Roma La SapienzaQueen Mary University of London; Università degli studi di Roma Foro Italico; Bios Prevention SrlCompletedPost Acute Sequelae of COVID-19 | Post COVID-19 Condition | Long-COVID | Chronic COVID-19 SyndromeItaly
-
Massachusetts General HospitalRecruitingPost Acute COVID-19 Syndrome | Long COVID | Post Acute Sequelae of COVID-19 | Long COVID-19United States
-
First Affiliated Hospital Xi'an Jiaotong UniversityShangluo Central Hospital; Ankang Central Hospital; Hanzhong Central Hospital; Yulin... and other collaboratorsRecruitingCOVID-19 | Post-COVID-19 Syndrome | Post-Acute COVID-19 | Acute COVID-19China
-
Yang I. PachankisActive, not recruitingCOVID-19 Respiratory Infection | COVID-19 Stress Syndrome | COVID-19 Vaccine Adverse Reaction | COVID-19-Associated Thromboembolism | COVID-19 Post-Intensive Care Syndrome | COVID-19-Associated StrokeChina
-
University of Witten/HerdeckeInstitut für Rehabilitationsforschung NorderneyCompletedPost-COVID-19 Syndrome | Long-COVID-19 SyndromeGermany
-
Erasmus Medical CenterDa Vinci Clinic; HGC RijswijkNot yet recruitingPost-COVID-19 Syndrome | Long COVID | Long Covid19 | Post COVID-19 Condition | Post-COVID Syndrome | Post COVID-19 Condition, Unspecified | Post-COVID ConditionNetherlands
-
Medisch Spectrum TwenteZiekenhuisgroep Twente; University of TwenteActive, not recruiting
Clinical Trials on Serodiagnosis of IgG and IgM
-
Sohag UniversityNot yet recruiting
-
Texas Cardiac Arrhythmia Research FoundationUnknown
-
University of ChicagoActive, not recruitingToxoplasma InfectionsUnited States
-
Kenya Medical Research InstituteFoundation for Innovative New Diagnostics (FIND)Unknown
-
IRCCS Sacro Cuore Don Calabria di NegrarRecruitingTick-Borne DiseasesItaly
-
Centre Hospitalier Universitaire de NiceNot yet recruitingToxoplasmosis | Toxoplasmosis, Congenital | Toxoplasma Infections | Toxoplasmosis RecurrentFrance
-
Centre Hospitalier Intercommunal CreteilAssociation Clinique Thérapeutique Infantile du val de MarneCompleted
-
European Institute of OncologyFondazione I.R.C.C.S. Istituto Neurologico Carlo Besta; Azienda Ospedaliera... and other collaboratorsCompleted
-
University of North Carolina, Chapel HillNorth Carolina Translational and Clinical Sciences InstituteCompleted
-
University Hospital, GenevaUniversity of Khartoum; Institute of Tropical Medicine, Belgium; Institut National... and other collaboratorsCompletedHIV | Tuberculosis | Malaria | Visceral Leishmaniasis | Brucellosis | Relapsing Fever | Leptospirosis | Melioidosis | Human African Trypanosomiasis | Enteric Fever | Rickettsial Diseases | Amoebic Liver AbscessCongo, The Democratic Republic of the, Cambodia, Nepal, Sudan