Covid19NCT04470414
COVID-19 IgG Antibodies in the Serum of Recovered Patients
An observational study of Covid19, run by Assiut University at 1 site in Egypt.
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. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Covid19
- What is being tested?
- IgG antibodies immunoassay
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Aug 2020to 1 Sep 2021
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients recovered from COVID-19 infection within three months before the start of the study.
Who may be able to join
- 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
Who cannot join
- Presence of any chronic illness interfere with immunity (autoimmune diseases).
- Pregnancy.
- Recovery from three months or more.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: COVID-19 IgG Antibodies in the Serum of Recovered Patients: a Longitudinal Study
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
- Being tested
- IgG antibodies immunoassay
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IgG antibodies immunoassayDiagnostic test
Assessment of IgG level will be done by quantitative assessment of IgG in the serum of recovered persons by Chemiluminescence Immunoassay (CLIA).
| Study group | Role | What they receive |
|---|---|---|
| Recovered COVID-19 patients | Patients recovered from COVID-19 infection within three months before the start of the study. Receives: Diagnostic Test: IgG antibodies immunoassay |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3rd, 6th and 12th months post infection
Secondary outcomes (1)
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.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2020
- Study start1 Aug 2020 (estimated)
- Primary completion1 Jul 2021 (estimated)
- Study completion1 Sep 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Covid19Studies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- 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
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mariam T. Amin, Assiut University
- Investigators
- Mahmoud A. Abd El Aty, Prof., Study director, Assiut University- Faculty of MedicineMariam T. Amin, Principal investigator, Assiut University- Faculty of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04470414
- Sponsor's protocol ID
- Cov-PH2020
- Status last verified
- Jul 2020
- First submitted
- 12 Jul 2020
- Last updated
- 16 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 31981224Singhal 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.
PubMed 32166607Long 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.
PubMed 32555424
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- COVID-19 IgG Antibodies in the Serum of Recovered Patients: a Longitudinal Study
- ClinicalTrials.gov ID
- NCT04470414
- Acronym / sponsor ID
- Cov-PH2020
- Conditions
- Covid19
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Aug 2020 (estimated)
- Primary completion
- 1 Jul 2021 (estimated)
- Study completion
- 1 Sep 2021 (estimated)
- First posted
- 14 Jul 2020 (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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Recovered COVID-19 patients | – | Diagnostic Test: IgG antibodies immunoassayPatients recovered from COVID-19 infection within three months before the start of the study. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients recovered from COVID-19 infection within three months before the start of the study.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- Presence of any chronic illness interfere with immunity (autoimmune diseases).
- Pregnancy.
- Recovery from three months or more.
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 |
|---|---|---|
| IgG antibodies immunoassayAssessment of IgG level will be done by quantitative assessment of IgG in the serum of recovered persons by Chemiluminescence Immunoassay (CLIA). | Diagnostic test | Recovered COVID-19 patients |
Primary outcome
Levels of IgG in the serum of recovered COVID-19 patients
Time frame: 3rd, 6th and 12th months post infection
Levels of IgG in the serum of recovered COVID-19 patients at different points during the first year of infection.
1 secondary outcome
Factors related to IgG level
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2020.
- Background: PubMed 31981224Li 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.
- Background: PubMed 32166607Singhal 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.
- Background: PubMed 32555424Long 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.
- Coronavirus: Events as they happenLink provided by the sponsor.
- Coronavirus Update (Live): Cases and Deaths from COVID-19 Virus PandemicLink provided by the sponsor.
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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.
Mahmoud A. Abd El Aty, Prof. study director
Assiut University- Faculty of Medicine
Mariam T. Amin principal investigator
Assiut University- Faculty of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Covid19, run by Assiut University at 1 site in Egypt.
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 3 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: status not confirmed, as of the sponsor's last update on 16 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mariam T. Amin (00201064554080, mariam.amin015@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Levels of IgG in the serum of recovered COVID-19 patients (time frame: 3rd, 6th and 12th months post infection). 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 NCT04470414, which also lists 3 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 16 Jul 2020.