Hospitalized Patients Clinical Trial
— No-SARSOfficial title:
Antibodies Responses to SARS-CoV 2 Infection (COVID-19) in Hospitalized Patients. A Prospective Observational Study
1.5. Why this clinical study?
The prevalence of seropositivity following SARS-CoV 2 infection might have its own potential
benefits in terms of predicting the end of pandemic and the validity of herd immunity. It is
not clear if SARS-CoV 2 infection would have a long-lasting antibody-mediated immunity, and
if the antibodies' persistence is dependent on disease severity.depends on the severity of
illness. If evidence is provided about the persistence of antibodies that is reflective of
the protective immune response, serodiagnosis will be an important tool to identify
individuals with various risk for infection, and those who are in need of receiving the
forthcoming vaccines.
The here proposed prospective clinical study will test the prevalence of seropositivity
following SARS-CoV 2 infection in critically ill patients compared to those who do not
require intensive care unit (ICU) admission or invasive ventilation with respect to the IgM
and IgG levels.
Status | Not yet recruiting |
Enrollment | 158 |
Est. completion date | February 2021 |
Est. primary completion date | December 2020 |
Accepts healthy volunteers | |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Symptomatic infection with at least 2 weeks' time interval since the symptom's onset. - Laboratory-confirmed COVID-19 with positive SARS-CoV-2 real-time polymerase chain reaction (RT-PCR) testing of nasopharyngeal or oropharyngeal swabs. - Inpatients in either isolated wards or ICU. - Agreement for blood sampling during the course of the study. Exclusion Criteria: - Decline consent to participate. - Pregnancy. - Asymptomatic patients, who are PCR positive during routine screening upon admission - Administration of immunoglobulins within the 3 proceeding months including Covid-19 convalescent plasma. - Patients with Don't resuscitate orders - Patients with terminal illnesses regardless of the severity of SARS-CoV 2 infection. |
Country | Name | City | State |
---|---|---|---|
Saudi Arabia | Imam Abdulrahman Bin Faisal University | Dammam | Eastern |
Lead Sponsor | Collaborator |
---|---|
Dammam University | Dammam Medical Complex, Institute for Research and medical consultations (IRMC) |
Saudi Arabia,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Changes in the levels of S specific antibodies in severely ill patients compared to mild cases. | The measurements are dependent on epitope recognitions for synthetic, adsorbed S proteins | Changes from baseline (4 to 6 weeks) at 16 weeks after the onset of symptoms of SARS-Cov2 infection | |
Primary | Changes in the levels of N specific antibodies in severely ill patients compared to mild cases. | The measurements are dependent on epitope recognitions for synthetic, adsorbed N proteins | Changes from baseline (4 to 6 weeks) at 16 weeks after the onset of symptoms of SARS-Cov2 infection | |
Secondary | S specific binding antibodies of SARS-CoV-2 | Titers of the S specific binding antibodies of SARS-CoV-2 would be assayed as described in the interventions | 4 to 6 weeks and 16 weeks after the onset of symptoms of SARS-Cov2 infection | |
Secondary | N specific binding antibodies of SARS-CoV-2 | Titers of the N specific binding antibodies of SARS-CoV-2 would be assayed as described in the interventions | 4 to 6 weeks and 16 weeks after the onset of symptoms of SARS-Cov2 infection | |
Secondary | Neutralizing antibodies directed against S protein of SARS-CoV-2 | Titers of the neutralizing antibodies directed against S protein of SARS-CoV-2 would be assayed as described in the interventions | 4 to 6 weeks and 16 weeks after the onset of symptoms of SARS-Cov2 infection | |
Secondary | The severity category of critically ill | The severity category of critically ill patients would be estimated using an APACHI II score. Minimum score = 0; maximum score = 71. | Day 0, 4 to 6 weeks and 16 weeks after the onset of symptoms of SARS-Cov2 infection | |
Secondary | Length of ICU | Length of ICU stay from the admission day to the ICU | For 16 weeks after the onset of symptoms of SARS-Cov2 infection | |
Secondary | Length of hospital stays | Length of hospital stay from the hospital admission day | For 16 weeks after the onset of symptoms of SARS-Cov2 infection | |
Secondary | Alive status at 28-days | If the patients alive or dead through a telephone interview. | For 28 days after the onset of symptoms of SARS-Cov2 infection | |
Secondary | Alive status at 90-day | If the patients alive or dead through a telephone interview. | For 90 days after the onset of symptoms of SARS-Cov2 infection | |
Secondary | Correlation between the levels of S neutralizing antibodies and disease severity | To correlate the levels of S neutralizing antibodies in severely ill patients compared to mild cases. | For 16 weeks after the onset of symptoms of SARS-Cov2 infection | |
Secondary | Correlation between the levels of N neutralizing antibodies and disease severity | To correlate the levels of N neutralizing antibodies in severely ill patients compared to mild cases. | For 16 weeks after the onset of symptoms of SARS-Cov2 infection |
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