COVID-19 IgG Antibodies in the Serum of Recovered Patients

NCT04470414 | Unknown

• 1 other identifier: Cov-PH2020
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

Coronavirus disease 2019 (COVID-19) is an infectious disease caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), which first appeared in China, in December 2019 and is now spreading worldwide and poses a great threat to public health. In 12th July 2020, the total number of cases worldwide was about 13 million cases with case fatality rate of 4.4% and in Egypt the total cases was 81158 and case fatality rate was 4.6%. (1,2). In recent years, novel coronaviruses emerge periodically in different areas around the world. Severe acute respiratory syndrome coronavirus (SARS-CoV) occurred in 2002, which reportedly infected 8422 people with about 10% case fatality rate (3). Middle East respiratory syndrome coronavirus (MERS-CoV) was first identified in 2012 in Saudi Arabia, bringing a total of 1401 MERS-CoV infections, and about 35% case fatality rate (1). All the infection cases and recent epidemics show that coronaviruses impose a continuous threat to human beings and the economy as they emerge unexpectedly, spread easily, and lead to catastrophic consequences. As the number of recovered patients with COVID-19 continues to be increasing, the strength and duration of immunity after infection is an important point to be studied. Moreover, understanding this issue is a critical point for controlling this epidemic as they are the key for herd immunity and for informing decisions on how and when to ease physical distancing restrictions and to be ready for other waves of the infection. There is currently no evidence if the people who have recovered from COVID-19 have antibodies and protected from a second attack of infection or future wave of this pandemic or not. Therefore, we will carry out a longitudinal study of immunity in recovered patients to assess SARS-Cov2 patients' risk for future reinfection.

Conditions

Covid19

Outcome Measures

Primary Outcomes (1)

• Levels of IgG in the serum of recovered COVID-19 patients

  Levels of IgG in the serum of recovered COVID-19 patients at different points during the first year of infection.

  3rd, 6th and 12th months post infection

Secondary Outcomes (1)

• Factors related to IgG level

  1 year

Study Arms (1)

Recovered COVID-19 patients

Patients recovered from COVID-19 infection within three months before the start of the study.

Diagnostic Test: IgG antibodies immunoassay

Interventions

IgG antibodies immunoassay DIAGNOSTIC_TEST

Assessment of IgG level will be done by quantitative assessment of IgG in the serum of recovered persons by Chemiluminescence Immunoassay (CLIA).

Recovered COVID-19 patients

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients recovered from COVID-19 infection within three months before the start of the study.

You may qualify if:

• Adults aged ≥ 20 years.
• Prior COVID-19 infection confirmed by PCR detection of SARS-CoV-2 RNA or antigen in nasopharyngeal swab.
• Recovery from infection either confirmed by two consecutive negative PCR (collected ≥24 hours apart) or passing of 14 days since onset of COVID-19 symptoms and at least 3 days since resolution of fever without the use of antipyretics and improvement of respiratory symptoms

You may not qualify if:

• Presence of any chronic illness interfere with immunity (autoimmune diseases).
• Pregnancy.
• Recovery from three months or more.

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Faculty of medicine- Assiut university

Asyut, Egypt

Location

Related Publications (3)

• Li G, Fan Y, Lai Y, Han T, Li Z, Zhou P, Pan P, Wang W, Hu D, Liu X, Zhang Q, Wu J. Coronavirus infections and immune responses. J Med Virol. 2020 Apr;92(4):424-432. doi: 10.1002/jmv.25685. Epub 2020 Feb 7.

  PMID: 31981224 BACKGROUND

• Singhal T. A Review of Coronavirus Disease-2019 (COVID-19). Indian J Pediatr. 2020 Apr;87(4):281-286. doi: 10.1007/s12098-020-03263-6. Epub 2020 Mar 13.

  PMID: 32166607 BACKGROUND

• Long QX, Tang XJ, Shi QL, Li Q, Deng HJ, Yuan J, Hu JL, Xu W, Zhang Y, Lv FJ, Su K, Zhang F, Gong J, Wu B, Liu XM, Li JJ, Qiu JF, Chen J, Huang AL. Clinical and immunological assessment of asymptomatic SARS-CoV-2 infections. Nat Med. 2020 Aug;26(8):1200-1204. doi: 10.1038/s41591-020-0965-6. Epub 2020 Jun 18.

  PMID: 32555424 BACKGROUND

Related Links

• Coronavirus: Events as they happen
• Coronavirus Update (Live): Cases and Deaths from COVID-19 Virus Pandemic

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood samples

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Mahmoud A. Abd El Aty, Prof.

  Assiut University- Faculty of Medicine

  STUDY DIRECTOR

• Mariam T. Amin

  Assiut University- Faculty of Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mariam T. Amin

CONTACT

00201064554080; mariam.amin015@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Lecturer

Study Record Dates

• First Submitted: July 12, 2020
• First Posted: July 14, 2020
• Study Start: August 1, 2020
• Primary Completion: July 1, 2021
• Study Completion: September 1, 2021
• Last Updated: July 16, 2020

Record last verified: 2020-07

Locations

EG (1)