Covid19NCT05038475
Clinical and Immunological Responses After SARS-CoV-2 Infection Causing COVID-19
An observational study of Covid19 and SARS-CoV2 Infection, run by Association "Naso Sano" Onlus at 1 site in Italy.
Trial summary
There are very few long-term studies that analyze the immune responses in patients recovered from COVID-19 caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Covid19, SARS-CoV2 Infection, Olfactory Disorder
- What is being tested?
- COVID-19 antibody test
- How many people
- 100 participants
- Where
- 1 siteItaly
- Study dates
- 1 May 2020to May 2024
- 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 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Individuals who tested positive for SARS-CoV-2 in March 2020 and are not vaccinated till date, within the age range of 18-80 years, with no active respiratory infection / active COVID-19 infection and willing to give informed consent were invited to take part in the study.
Who may be able to join
- Individuals who tested positive for SARS-CoV-2 in March 2020. These patients will be divided into two groups and followed up over time. The first group will include patients who have recovered and have not received the vaccine. The second group will include patients who have recovered and have received the vaccine.
- No acute respiratory infection or active SARS-CoV-2 infection.
- Informed consent of the adult participant.
Who cannot join
- Individuals <18 years or >80 years.
- No informed consent by the adult participant.
- Suspicion of acute COVID-19 infection
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Longitudinal Observation of Clinical and Immunological Profiles After SARS-Cov-2 Infection
There are very few long-term studies that analyze the immune responses in patients recovered from COVID-19 caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2).
The main aim of this study is to analyze the clinical profile and immune responses of recovered COVID-19 patients in a representative cohort of people in the Umbria region of Italy. The participants had a history of testing positive for SARS-CoV-2 in March 2020 by Reverse Transcriptase- Quantitative Polymerase Chain Reaction (RT-qPCR). The participants were invited for voluntary participation in a seroprevalence study. This study analyzes longitudinally the presence of antibodies against SARS-CoV-2 by sequential serological tests at different time points using two FDA-approved Immunoassays. At the first serum sample collection, the participants were asked to provide information about their COVID-19 clinical history including clinical profile, co-morbidities, and treatment undertaken using a standardized questionnaire. Successive sequential serological assessments were conducted to understand the immune responses in these recovered patients.
Moreover, stage two of the study involves, analysis of antibody titers in recovered vaccinated individuals and their follow-up.
Read the detailed description
Study design: A monocentric pilot longitudinal observational study
Study subjects: patients recovered from SARS-CoV-2 infection in March 2020 (detected by RT-PCR)
Study method: The study was conducted after written informed consent for voluntary participation. The antibody titers were longitudinally analyzed by sequential serological tests at different time points (TPs) using two FDA-approved Immunoassays. At the first serum sample collection, the participants were asked to provide information about their COVID-19 clinical history including clinical profile, co-morbidities, and the treatment undertaken using a standardized questionnaire.
From May 2020 to January 2021:
Anti-Nucleocapsid (NCP) antibodies were analyzed using FDA-approved CLIA immunoassay through sequential serum samples.
Time was treated as a factor and six different time points (TPs) were defined (T0-T5). The first blood sample was collected in the month of May 2020, 2 months after the month of infection (March), and was defined as T0. Consecutive serological samples were analyzed at different TPs; three months (T1), five months (T2), seven months (T3), eight months (T4), and ten months (T5) post-infection in June, August, October, November of 2020 and January 2021 respectively.
At this point, a more specific immunoassay was adopted to detect neutralizing antibodies against the Spike-Receptor binding domain for future assessments.
From late February 2021:
an additional n=12 patients (8 female and 4 male), who met the eligibility criteria for participation, were enrolled in the study and added to the original cohort (n=30). These patients (n=12), similar to the original cohort, had a history of testing positive for SARS-CoV-2 by RT-qPCR in March 2020, updating the sample size to n=42.
Since the legal provisions adopted by the Italian Ministry of Health advised mandatory vaccination for all Healthcare Workers, irrespective of previous disease status, n=10 patients (4 female and 6 male) were gradually vaccinated from mid-March 2021 and hence excluded from the original cohort, making the revised final sample size as n=32.
The presence of antibodies was analyzed The study continues to actively enroll patients for future analysis.
with vaccination in progress, the antibody titers of the recovered and then vaccinated patients will also be analysed separately.
- Conditions
- Covid19, SARS-CoV2 Infection, Olfactory Disorder, COVID-19, Smell Loss, Smell Disorder
- Being tested
- COVID-19 antibody test
- Keywords
- Antibody responses, olfaction, smell, sars-cov-2, covid-19, IgG, IgM, serology, immune response, humoral response
- Medical subject headings
- COVID-19, Anosmia, Olfaction Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
COVID-19 antibody testDiagnostic test
FDA-approved Immunoassays were used in the study. At the beginning of the study, up to 3 months, ELISA and CLIA immunoassays were adopted to analyze the antibody titers. Thereafter, CLIA was used for longitudinal analysis of antibody titers for consecutive months. Anti
| Study group | Role | What they receive |
|---|---|---|
| Mild group | As per the WHO guidelines, the patients were divided into two groups based on disease severity: Mild and Moderately severe.
This was based on the self-reported symptoms experienced by the patients during the infection period (March 2020).
Intervention:
COVID-19 Antibody testing at different time points Receives: Diagnostic Test: COVID-19 antibody test | |
| Moderately-severe group | As per the WHO guidelines, the patients were divided into two groups based on disease severity: Mild and Moderately severe.
This was based on the self-reported symptoms experienced by the patients during the infection period (March 2020).
Intervention:
COVID-19 Antibody testing at different time points Receives: Diagnostic Test: COVID-19 antibody test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Analysis of demographic profile (Age) of recovered COVID-19 patients [at inclusion]
Demographic profile included Age at presentation (in years)
Measured: At inclusion
Analysis of demographic profile (Gender) of recovered COVID-19 patients [at inclusion]
Demographic profile included Sex (gender) at presentation (male/female/other)
Measured: At inclusion
Analysis of demographic profile (occupation) of recovered COVID-19 patients [at inclusion]
Demographic profile included occupation at presentation (healthcare-worker/non-healthcare)
Measured: At inclusion
Analysis of clinical profile of recovered COVID-19 patients [at inclusion]
Clinical profile included clinical symptoms experienced at the time of presentation. The participant completed a questionnaire with "Yes" or "no" for each symptom. The symptoms were namely: Fever, Rhinorrhea, Dry cough, Sore throat, Shortness of breath, fatigue, Headche, Muscle ache, skin eruptions, diarrhoea, conjunctivitis, loss of smell, loss of taste, chest pain or any other symptom (please specify).
Measured: At inclusion
Analysis of associated co-morbidities in recovered COVID-19 patients [at inclusion]
Participants completed a questionnaire with "Yes" or "no" for history of comorbidities namely: Asthma/seasonal allergies, Diabetes Mellitus, Hypertension, cardiovascular disease or any other co-morbidity (please specify).
Measured: At inclusion
Analysis of immunological profile recovered COVID-19 patients [at inclusion]
The participants were questioned about their respective blood groups.
Measured: At inclusion
Seroprevalence of IgM and IgG against Nucleocapsid of SARS-CoV-2 (in AU/ml) [from T0 to T5]
From May 2020 to January 2021, anti-nucleocapsid (NCP) antibodies developed against SARS-CoV-2 were analysed using n-CoV IgM/IgG CLIA assay through sequential serological tests in n=30 patients. Time was treated as a factor and six time points were defined. The first blood sample was collected in May 2020 (2 months after infection) and was defined as T0. Consecutive samples were analysed at 3 months (T1), five months (T2) , seven months (T3) and eight months (T4) and ten months (T5) post infection in June, August, October, November of 2020 and January 2021 respectively.
Measured: 8 months
Seroprevalence of IgM and IgG against spike-receptor binding domain of SARS-CoV-2 (in AU/ml) [from T6 to T8]
A more specific immunoassay (CLIA) against SARS-CoV-2 S-RBD was adopted for future assessments. From late February 2021, an additional n = 12 patients (8 female and 4 male), who met the eligibility criteria for participation, were enrolled in the study and added to the original cohort (n = 30). These patients (n=12), similar to the original cohort, had a history of testing positive for SARS-CoV-2 by RT-qPCR in March 2020, updating the sample size to n = 42. Since the legal provisions adopted by the Italian Ministry of Health advised mandatory vaccination for all Healthcare Workers, irrespective of previous disease status,n=10 patients (4 female, 6 male) were gradually vaccinated from mid-March 2021 and excluded from the original cohort, making the revised final sample size,n = 32.
Measured: through study completion, an average of 2 years
Seroprevalence of IgM and IgG against spike-receptor binding domain of SARS-CoV-2 (in AU/ml) for vaccinated individuals
The vaccinated recovered individuals continued to report for follow-up for antibody analysis
Measured: through study completion, an average of 2 years
Secondary outcomes (7)
Co-relation of demographic profile with antibody titers against NCP of SARS-CoV-2 with respect to disease severity [ Time Frame: at inclusion and within observational period ]
Demographic profile such as Age, Sex, occupation were analysed to look for any association with disease severity and antibody titers against NCP at different time points from (T0-T5)
Measured: 8 months
Co-relation of demographic profile with antibody titers against spike- RBD of SARS-CoV-2 with respect to disease severity [ Time Frame: at inclusion and within observational period ]
Demographic profile such as Age, Sex, occupation were analysed to look for any association with disease severity and antibody titers against spike-RBD at different time points from (T6-T8)
Measured: 4 months
Co-relation of symptoms and antibody titer levels against Nucleocapsid of SARS-CoV-2 with respect to disease severity [ Time Frame: at inclusion and within observational period ]
Presence of symptoms (in March 2020) suggestive of a common cold, influenza and similar upper respiratory tract infections with help of questionnaire.
Symptoms recorded : Fever , Rhinorrea, Dry cough, sore throat, Shortness of breath, Headache, skin eruptions, muscle ache, diarrhoea, conjunctivitis, loss of smell, loss of taste, chest pain and its association with disease severity and antibody titers against NCP at different time points (T0-T5).
Measured: at inclusion and within the observational period (8 months)
Co-relation of self reported symptoms and antibody titer levels against spike-RBD with respect to disease severity [ Time Frame: at inclusion and within observational period ]
Presence of symptoms (in March 2020) suggestive of a common cold, influenza and similar upper respiratory tract infections with help of questionnaire.
Symptoms recorded : Fever , Rhinorrea, Dry cough, sore throat, Shortness of breath, Headache, skin eruptions, muscle ache, diarrhoea, conjunctivitis, loss of smell, loss of taste, chest pain and its association with antibody titers against spike receptor binding domain with respect to disease severity at different time points (T6-T8).
Measured: at inclusion and within the observational period (4 months)
Co-relation of co-morbidities and antibody titer levels with respect to disease severity [ at inclusion]
history of asthma/ allergies/diabetes/hypertension/cardiovascular diseases and its association with disease severity and anti-NCP antibody titers (quantitative) at different time points (T0-T5)
Measured: at inclusion and within the observational period (8 months)
Co-relation of co-morbidities and antibody titer levels with respect to disease severity [ at inclusion]
history of asthma/ allergies/diabetes/hypertension/cardiovascular diseases and its association with disease severity and anti-S-RBD antibody titers (quantitative) at different time points (T6-T8)
Measured: at inclusion and within the observational period (through study completion, an average of 2 years)
Co-relation of antibody titer levels and smell and taste dysfuntion with respect to disease severity [ at inclusion]
history of asthma/ allergies/diabetes/hypertension/cardiovascular diseases and its association with disease severity and anti-S-RBD antibody titers (quantitative) at different time points (T6-T8)
Measured: at inclusion and within the observational period (through study completion, an average of 2 years)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2021
- Study start1 May 2020
- Primary completionNov 2023 (estimated)
- Study completionMay 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Covid19Studies 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
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Association "Naso Sano" Onlus
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Puya Dehgani Mobaraki, Association "Naso Sano" Onlus
- Investigators
- Puya Dehgani-Mobaraki, MD, Principal investigator, Associazione Naso sano, Italy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05038475
- Sponsor's protocol ID
- ANS-2020/001
- Status last verified
- Apr 2023
- First submitted
- 10 Jun 2021
- Last updated
- 14 Apr 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Sensitive clinical data from the patients will be collected. Therefore, it is not yet decided, if it will be possible to share IPD while preserving participant anonymity and privacy.
Publications
Abu-Raddad LJ, Chemaitelly H, Coyle P, Malek JA, Ahmed AA, Mohamoud YA, Younuskunju S, Ayoub HH, Al Kanaani Z, Al Kuwari E, Butt AA, Jeremijenko A, Kaleeckal AH, Latif AN, Shaik RM, Abdul Rahim HF, Nasrallah GK, Yassine HM, Al Kuwari MG, Al Romaihi HE, Al-Thani MH, Al Khal A, Bertollini R. SARS-CoV-2 antibody-positivity protects against reinfection for at least seven months with 95% efficacy. EClinicalMedicine. 2021 May;35:100861. doi: 10.1016/j.eclinm.2021.100861. Epub 2021 Apr 28.
PubMed 33937733Piccoli L, Park YJ, Tortorici MA, Czudnochowski N, Walls AC, Beltramello M, Silacci-Fregni C, Pinto D, Rosen LE, Bowen JE, Acton OJ, Jaconi S, Guarino B, Minola A, Zatta F, Sprugasci N, Bassi J, Peter A, De Marco A, Nix JC, Mele F, Jovic S, Rodriguez BF, Gupta SV, Jin F, Piumatti G, Lo Presti G, Pellanda AF, Biggiogero M, Tarkowski M, Pizzuto MS, Cameroni E, Havenar-Daughton C, Smithey M, Hong D, Lepori V, Albanese E, Ceschi A, Bernasconi E, Elzi L, Ferrari P, Garzoni C, Riva A, Snell G, Sallusto F, Fink K, Virgin HW, Lanzavecchia A, Corti D, Veesler D. Mapping Neutralizing and Immunodominant Sites on the SARS-CoV-2 Spike Receptor-Binding Domain by Structure-Guided High-Resolution Serology. Cell. 2020 Nov 12;183(4):1024-1042.e21. doi: 10.1016/j.cell.2020.09.037. Epub 2020 Sep 16.
PubMed 32991844Suthar MS, Zimmerman MG, Kauffman RC, Mantus G, Linderman SL, Hudson WH, Vanderheiden A, Nyhoff L, Davis CW, Adekunle O, Affer M, Sherman M, Reynolds S, Verkerke HP, Alter DN, Guarner J, Bryksin J, Horwath MC, Arthur CM, Saakadze N, Smith GH, Edupuganti S, Scherer EM, Hellmeister K, Cheng A, Morales JA, Neish AS, Stowell SR, Frank F, Ortlund E, Anderson EJ, Menachery VD, Rouphael N, Mehta AK, Stephens DS, Ahmed R, Roback JD, Wrammert J. Rapid Generation of Neutralizing Antibody Responses in COVID-19 Patients. Cell Rep Med. 2020 Jun 23;1(3):100040. doi: 10.1016/j.xcrm.2020.100040. Epub 2020 Jun 8.
PubMed 32835303Sette A, Crotty S. Adaptive immunity to SARS-CoV-2 and COVID-19. Cell. 2021 Feb 18;184(4):861-880. doi: 10.1016/j.cell.2021.01.007. Epub 2021 Jan 12.
PubMed 33497610
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Longitudinal Observation of Clinical and Immunological Profiles After SARS-Cov-2 Infection
- ClinicalTrials.gov ID
- NCT05038475
- Acronym / sponsor ID
- ANS-2020/001
- Conditions
- Covid19, SARS-CoV2 Infection, Olfactory Disorder, COVID-19, Smell Loss, Smell Disorder
- Keywords
- Antibody responses, olfaction, smell, sars-cov-2, covid-19, IgG, IgM, serology
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Association "Naso Sano" OnlusUniversity, hospital or other
- Study start
- 1 May 2020 (actual)
- Primary completion
- Nov 2023 (estimated)
- Study completion
- May 2024 (estimated)
- First posted
- 9 Sep 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.
There are very few long-term studies that analyze the immune responses in patients recovered from COVID-19 caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2).
The main aim of this study is to analyze the clinical profile and immune responses of recovered COVID-19 patients in a representative cohort of people in the Umbria region of Italy. The participants had a history of testing positive for SARS-CoV-2 in March 2020 by Reverse Transcriptase- Quantitative Polymerase Chain Reaction (RT-qPCR). The participants were invited for voluntary participation in a seroprevalence study. This study analyzes longitudinally the presence of antibodies against SARS-CoV-2 by sequential serological tests at different time points using two FDA-approved Immunoassays. At the first serum sample collection, the participants were asked to provide information about their COVID-19 clinical history including clinical profile, co-morbidities, and treatment undertaken using a standardized questionnaire. Successive sequential serological assessments were conducted to understand the immune responses in these recovered patients.
Moreover, stage two of the study involves, analysis of antibody titers in recovered vaccinated individuals and their follow-up.
Detailed description
Study design: A monocentric pilot longitudinal observational study
Study subjects: patients recovered from SARS-CoV-2 infection in March 2020 (detected by RT-PCR)
Study method: The study was conducted after written informed consent for voluntary participation. The antibody titers were longitudinally analyzed by sequential serological tests at different time points (TPs) using two FDA-approved Immunoassays. At the first serum sample collection, the participants were asked to provide information about their COVID-19 clinical history including clinical profile, co-morbidities, and the treatment undertaken using a standardized questionnaire.
From May 2020 to January 2021:
Anti-Nucleocapsid (NCP) antibodies were analyzed using FDA-approved CLIA immunoassay through sequential serum samples.
Time was treated as a factor and six different time points (TPs) were defined (T0-T5). The first blood sample was collected in the month of May 2020, 2 months after the month of infection (March), and was defined as T0. Consecutive serological samples were analyzed at different TPs; three months (T1), five months (T2), seven months (T3), eight months (T4), and ten months (T5) post-infection in June, August, October, November of 2020 and January 2021 respectively.
At this point, a more specific immunoassay was adopted to detect neutralizing antibodies against the Spike-Receptor binding domain for future assessments.
From late February 2021:
an additional n=12 patients (8 female and 4 male), who met the eligibility criteria for participation, were enrolled in the study and added to the original cohort (n=30). These patients (n=12), similar to the original cohort, had a history of testing positive for SARS-CoV-2 by RT-qPCR in March 2020, updating the sample size to n=42.
Since the legal provisions adopted by the Italian Ministry of Health advised mandatory vaccination for all Healthcare Workers, irrespective of previous disease status, n=10 patients (4 female and 6 male) were gradually vaccinated from mid-March 2021 and hence excluded from the original cohort, making the revised final sample size as n=32.
The presence of antibodies was analyzed The study continues to actively enroll patients for future analysis.
with vaccination in progress, the antibody titers of the recovered and then vaccinated patients will also be analysed separately.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mild group | – | Diagnostic Test: COVID-19 antibody testAs per the WHO guidelines, the patients were divided into two groups based on disease severity: Mild and Moderately severe. This was based on the self-reported symptoms experienced by the patients during the infection period (March 2020). Intervention: COVID-19 Antibody testing at different time points |
| Moderately-severe group | – | Diagnostic Test: COVID-19 antibody testAs per the WHO guidelines, the patients were divided into two groups based on disease severity: Mild and Moderately severe. This was based on the self-reported symptoms experienced by the patients during the infection period (March 2020). Intervention: COVID-19 Antibody testing at different time points |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Individuals who tested positive for SARS-CoV-2 in March 2020 and are not vaccinated till date, within the age range of 18-80 years, with no active respiratory infection / active COVID-19 infection and willing to give informed consent were invited to take part in the study.
Key inclusion criteria (3 listed)
- Individuals who tested positive for SARS-CoV-2 in March 2020. These patients will be divided into two groups and followed up over time. The first group will include patients who have recovered and have not received the vaccine. The second group will include patients who have recovered and have received the vaccine.
- No acute respiratory infection or active SARS-CoV-2 infection.
- Informed consent of the adult participant.
Key exclusion criteria (3 listed)
- Individuals <18 years or >80 years.
- No informed consent by the adult participant.
- Suspicion of acute COVID-19 infection
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 |
|---|---|---|
| COVID-19 antibody testFDA-approved Immunoassays were used in the study. At the beginning of the study, up to 3 months, ELISA and CLIA immunoassays were adopted to analyze the antibody titers. Thereafter, CLIA was used for longitudinal analysis of antibody titers for consecutive months. Anti | Diagnostic test | Mild group, Moderately-severe group |
Primary outcome
Analysis of demographic profile (Age) of recovered COVID-19 patients [at inclusion]
Time frame: At inclusion
Demographic profile included Age at presentation (in years)
Analysis of demographic profile (Gender) of recovered COVID-19 patients [at inclusion]
Time frame: At inclusion
Demographic profile included Sex (gender) at presentation (male/female/other)
Analysis of demographic profile (occupation) of recovered COVID-19 patients [at inclusion]
Time frame: At inclusion
Demographic profile included occupation at presentation (healthcare-worker/non-healthcare)
Analysis of clinical profile of recovered COVID-19 patients [at inclusion]
Time frame: At inclusion
Clinical profile included clinical symptoms experienced at the time of presentation. The participant completed a questionnaire with "Yes" or "no" for each symptom. The symptoms were namely: Fever, Rhinorrhea, Dry cough, Sore throat, Shortness of breath, fatigue, Headche, Muscle ache, skin eruptions, diarrhoea, conjunctivitis, loss of smell, loss of taste, chest pain or any other symptom (please specify).
Analysis of associated co-morbidities in recovered COVID-19 patients [at inclusion]
Time frame: At inclusion
Participants completed a questionnaire with "Yes" or "no" for history of comorbidities namely: Asthma/seasonal allergies, Diabetes Mellitus, Hypertension, cardiovascular disease or any other co-morbidity (please specify).
Analysis of immunological profile recovered COVID-19 patients [at inclusion]
Time frame: At inclusion
The participants were questioned about their respective blood groups.
Seroprevalence of IgM and IgG against Nucleocapsid of SARS-CoV-2 (in AU/ml) [from T0 to T5]
Time frame: 8 months
From May 2020 to January 2021, anti-nucleocapsid (NCP) antibodies developed against SARS-CoV-2 were analysed using n-CoV IgM/IgG CLIA assay through sequential serological tests in n=30 patients. Time was treated as a factor and six time points were defined. The first blood sample was collected in May 2020 (2 months after infection) and was defined as T0. Consecutive samples were analysed at 3 months (T1), five months (T2) , seven months (T3) and eight months (T4) and ten months (T5) post infection in June, August, October, November of 2020 and January 2021 respectively.
Seroprevalence of IgM and IgG against spike-receptor binding domain of SARS-CoV-2 (in AU/ml) [from T6 to T8]
Time frame: through study completion, an average of 2 years
A more specific immunoassay (CLIA) against SARS-CoV-2 S-RBD was adopted for future assessments. From late February 2021, an additional n = 12 patients (8 female and 4 male), who met the eligibility criteria for participation, were enrolled in the study and added to the original cohort (n = 30). These patients (n=12), similar to the original cohort, had a history of testing positive for SARS-CoV-2 by RT-qPCR in March 2020, updating the sample size to n = 42. Since the legal provisions adopted by the Italian Ministry of Health advised mandatory vaccination for all Healthcare Workers, irrespective of previous disease status,n=10 patients (4 female, 6 male) were gradually vaccinated from mid-March 2021 and excluded from the original cohort, making the revised final sample size,n = 32.
Seroprevalence of IgM and IgG against spike-receptor binding domain of SARS-CoV-2 (in AU/ml) for vaccinated individuals
Time frame: through study completion, an average of 2 years
The vaccinated recovered individuals continued to report for follow-up for antibody analysis
7 secondary outcomes
Co-relation of demographic profile with antibody titers against NCP of SARS-CoV-2 with respect to disease severity [ Time Frame: at inclusion and within observational period ]
Time frame: 8 months
Co-relation of demographic profile with antibody titers against spike- RBD of SARS-CoV-2 with respect to disease severity [ Time Frame: at inclusion and within observational period ]
Time frame: 4 months
Co-relation of symptoms and antibody titer levels against Nucleocapsid of SARS-CoV-2 with respect to disease severity [ Time Frame: at inclusion and within observational period ]
Time frame: at inclusion and within the observational period (8 months)
Co-relation of self reported symptoms and antibody titer levels against spike-RBD with respect to disease severity [ Time Frame: at inclusion and within observational period ]
Time frame: at inclusion and within the observational period (4 months)
Co-relation of co-morbidities and antibody titer levels with respect to disease severity [ at inclusion]
Time frame: at inclusion and within the observational period (8 months)
Co-relation of co-morbidities and antibody titer levels with respect to disease severity [ at inclusion]
Time frame: at inclusion and within the observational period (through study completion, an average of 2 years)
Co-relation of antibody titer levels and smell and taste dysfuntion with respect to disease severity [ at inclusion]
Time frame: at inclusion and within the observational period (through study completion, an average of 2 years)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2023.
- Results publication: PubMed 33937733Abu-Raddad LJ, Chemaitelly H, Coyle P, Malek JA, Ahmed AA, Mohamoud YA, Younuskunju S, Ayoub HH, Al Kanaani Z, Al Kuwari E, Butt AA, Jeremijenko A, Kaleeckal AH, Latif AN, Shaik RM, Abdul Rahim HF, Nasrallah GK, Yassine HM, Al Kuwari MG, Al Romaihi HE, Al-Thani MH, Al Khal A, Bertollini R. SARS-CoV-2 antibody-positivity protects against reinfection for at least seven months with 95% efficacy. EClinicalMedicine. 2021 May;35:100861. doi: 10.1016/j.eclinm.2021.100861. Epub 2021 Apr 28.
- Results publication: PubMed 32991844Piccoli L, Park YJ, Tortorici MA, Czudnochowski N, Walls AC, Beltramello M, Silacci-Fregni C, Pinto D, Rosen LE, Bowen JE, Acton OJ, Jaconi S, Guarino B, Minola A, Zatta F, Sprugasci N, Bassi J, Peter A, De Marco A, Nix JC, Mele F, Jovic S, Rodriguez BF, Gupta SV, Jin F, Piumatti G, Lo Presti G, Pellanda AF, Biggiogero M, Tarkowski M, Pizzuto MS, Cameroni E, Havenar-Daughton C, Smithey M, Hong D, Lepori V, Albanese E, Ceschi A, Bernasconi E, Elzi L, Ferrari P, Garzoni C, Riva A, Snell G, Sallusto F, Fink K, Virgin HW, Lanzavecchia A, Corti D, Veesler D. Mapping Neutralizing and Immunodominant Sites on the SARS-CoV-2 Spike Receptor-Binding Domain by Structure-Guided High-Resolution Serology. Cell. 2020 Nov 12;183(4):1024-1042.e21. doi: 10.1016/j.cell.2020.09.037. Epub 2020 Sep 16.
- Results publication: PubMed 32835303Suthar MS, Zimmerman MG, Kauffman RC, Mantus G, Linderman SL, Hudson WH, Vanderheiden A, Nyhoff L, Davis CW, Adekunle O, Affer M, Sherman M, Reynolds S, Verkerke HP, Alter DN, Guarner J, Bryksin J, Horwath MC, Arthur CM, Saakadze N, Smith GH, Edupuganti S, Scherer EM, Hellmeister K, Cheng A, Morales JA, Neish AS, Stowell SR, Frank F, Ortlund E, Anderson EJ, Menachery VD, Rouphael N, Mehta AK, Stephens DS, Ahmed R, Roback JD, Wrammert J. Rapid Generation of Neutralizing Antibody Responses in COVID-19 Patients. Cell Rep Med. 2020 Jun 23;1(3):100040. doi: 10.1016/j.xcrm.2020.100040. Epub 2020 Jun 8.
- Results publication: PubMed 33497610Sette A, Crotty S. Adaptive immunity to SARS-CoV-2 and COVID-19. Cell. 2021 Feb 18;184(4):861-880. doi: 10.1016/j.cell.2021.01.007. Epub 2021 Jan 12.
- Individual participant dataSharing planned: Undecided. Sensitive clinical data from the patients will be collected. Therefore, it is not yet decided, if it will be possible to share IPD while preserving participant anonymity and privacy.
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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.
Puya Dehgani-Mobaraki, MD principal investigator
Associazione Naso sano, Italy
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 and SARS-CoV2 Infection, run by Association "Naso Sano" Onlus at 1 site in Italy.
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 14 Apr 2023. 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 Italy. 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?
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?
Analysis of demographic profile (Age) of recovered COVID-19 patients [at inclusion] (time frame: At inclusion). The study lists 9 primary outcomes in all. 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 NCT05038475, which also lists 4 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 14 Apr 2023.