COVID-19 IgG Antibodies in the Serum of Recovered Patients

Covid19 Clinical Trial

Official title:

COVID-19 IgG Antibodies in the Serum of Recovered Patients: a Longitudinal Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04470414
• Other study ID #: Cov-PH2020
• Status: Not yet recruiting
• Start date: August 1, 2020
• Est. completion date: September 1, 2021

Study information

• Verified date: July 2020
• Source: Assiut University
• Contact: Mariam T. Amin
• Phone: 00201064554080
• Email: mariam.amin015[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: September 1, 2021
• Est. primary completion date: July 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• Presence of any chronic illness interfere with immunity (autoimmune diseases).

• Pregnancy.

• Recovery from three months or more.

Related Conditions & MeSH terms

• Covid19

Intervention

Diagnostic Test:
• IgG antibodies immunoassay
Assessment of IgG level will be done by quantitative assessment of IgG in the serum of recovered persons by Chemiluminescence Immunoassay (CLIA).

Locations

Country	Name	City	State
Egypt	Faculty of medicine- Assiut university	Assiut

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

References & 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. Review. — View Citation

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 Jun 18. doi: 10.1038/s41591-020-0965-6. [Epub ahead of print] — View Citation

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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Factors related to IgG level	The relationship between the IgG levels and severity of the disease, age of recovered patients and duration of symptoms and viral clearance.	1 year

External Links

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