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Evaluation of specific-IgA level against novel coronavirus pneumonia (COVID-19) among convalescents and vaccinated participants by COVID-19 inactivated vaccine

Evaluation of specific-IgA level against novel coronavirus pneumonia (COVID-19) among convalescents and vaccinated participants by COVID-19 inactivated vaccine

Status
Recruiting
Phases
Early Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2100042832
Enrollment
Unknown
Registered
2021-01-30
Start date
2021-01-20
Completion date
Unknown
Last updated
2021-05-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

COVID-19

Interventions

COVID-19 convalescents:Nil
vaccinated healthy individuals by COVID-19 vaccine:Nil

Sponsors

Chongqing Medical University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Object 1: 285 SARS-CoV-2 convalescents Inclusion criteria: (1) Positive result of RT-qPCR test; (2) Genomic sequencing of virus is Highly homologous with the sequence of the currently known SARS-CoV-2 specimens; (3) Positive result of IgM and IgG test; (4) In the judgement of investigator, participants who are eligible to vaccination and capable of giving personal signed informed consent. Object2: 500 vaccinated individuals by COVID-19 vaccine Inclusion criteria: (1)Axillary temperature <= 37.0 degrees C; (2)Positive reslut of RT-qPCR test previouly and Negative result currently; (3)Negative result for HIV test; (4)In the judgement of investigator, participants who are eligible to vaccination and capable of giving personal signed informed consent.

Exclusion criteria

Exclusion criteria: Object 1: 285 SARS-CoV-2 convalescents Exclusion criteria: (1)Individual whose samples are not enough for relataed tests; (2)Sample information or clinical investigation is not explicit enough; (3) Individuals are not capable of giving personal signed informed consent; (4)Individuals hava contraindications to venipuncture. Object 2: 500 vaccinated individuals by COVID-19 vaccine Exclusion criteria: (1) Individuals have fever recently; (2) With history of severe adverse reaction associated with a vaccine and/or severe allergic reaction to any component of the study intervention(s); (3) Individuals with Acute diseases, severe chronic diseases or on acute onset of chronic diseases; (4) Women who are pregnant(HCG+), have family planning within 3 months or breastfeeding; (5) Individuals with uncontrolled epilepsy or other progressive neurological disorders, or a history of Guillain-Barre syndrome; (6) Immunocompromised individuals with known or suspected immunodeficiency, as determined; by history and/or laboratory/physical examination; (7) People who are known or suspected to be suffering from severe respiratory diseases, severe cardiovascular diseases, liver or kidney diseases; (8) Current use of antitumor drug or immunosuppressor; (9) Individuals with thrombocytopenia or hemorrhagic disease; (10) In the judgement of investigator, paiticipants who are not eligible to vaccination; (11) Individuals are participating other clinical trials; (12) COVID-19 convalescents with severe sequelae, eg: lung damage et al.

Design outcomes

Primary

MeasureTime frame
Levels of SARS-CoV-2-specific antibody;Neutralizing antibody of IgG/IgM/IgAtiter (NT50) to SARS-CoV-2 infection;

Countries

China

Contacts

Public ContactAi-long Huang

Chongqing Medical University

ahuang@cqmu.edu.cn+86 023-68486780

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026