NL-OMON50131已完成不适用
In vitro characterization of the immune response of recovered COVID-19 patients and healthy controls to SARS-CoV-2. - Recovered Covid-19 patients blood sampling
ISA Pharmaceuticals B.V.0 个研究点目标入组 14 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 14
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •Inclusion criteria for both recovered COVID-19 patients and healthy participants
- •1. Participant must sign the study informed consent form prior to any
- •study-mandated procedure indicating that he or she understands the purpose,
- •procedures and potential risks, and is willing to participate in the study;
- •2. Participant is male or female and between 18 and 65 years of age, inclusive,
- •at the time of enrollment;
- •3. Participant is willing and able to complete the study procedures;
- •4. Participant has a primary care physician at the time of enrollment;
- •5. Participant is not taking any immunosuppressive medication or other
- •immunomodulating agents (including investigational drugs) for at least 3 weeks
- •prior to study blood sampling.
- •Inclusion criteria for recovered COVID-19 patients only
- •1. Participant reports a previous positive diagnostic test result for
- •SARS-CoV-2 infection (serological testing or viral RNA detection by PCR
- •2. Participant had clinical symptoms of COVID-19 (including, but not limited
- •to: cough, fever, shortness of breath, sudden onset of anosmia, ageusia or
- •dysgeusia). The diagnosis of COVID-19 must be the most plausible cause of the
- •reported symptoms, as deemed by the study physician;
- •3. Participant has recovered from COVID-19 for at least three weeks prior to
- •study blood sampling (residual symptoms such as, but not limited to, fatigue
- •and reduced exercise tolerance - that would not jeopardize study endpoints -
- •are allowed at the investigator*s discretion).
- •Inclusion criteria for healthy participants only
- •1. Participant is generally healthy in the investigator*s clinical judgment, as
- •determined by medical history evaluation, including no clinically significant
- •disorder, condition, infection or disease that would interfere with the study
- •evaluation, procedures or completion.
排除标准
- •Exclusion criteria for both recovered COVID-19 patients and healthy participants
- •1. Participant with a whole blood donation or loss of >500 ml within 21 days
- •before study blood sampling;
- •2. Any known factor, condition, or disease that might interfere with
- •compliance, study conduct or interpretation of the results, as deemed by the
- •investigator.
- •Exclusion criteria for healthy participants only
- •1. Participant reports a previous positive diagnostic test result for
- •SARS-CoV-2 infection (serological testing or viral RNA detection by PCR
- •2. Participant developed clinically overt symptoms of COVID-19 following close
- •contact with a proven SARS-CoV-2 positive patient, but was not tested (e.g. due
- •to limited test capacity and regulations at that time);
- •3. Participant who is currently working, or has worked in an occupation with a
- •high risk of exposure to SARS-CoV-2 (e.g. health care worker).
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