A Prospective observational study to establish the duration of persistence of replication-competent SARS-CoV-2 in oncology patients with COVID-19 on chemotherapy
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Determine the duration of persistence of replication-competent/infectious virus in oncology patients.
研究概览
简要总结
From the observations coming from the previous studies, it has been seen that the samples from patients who recovered from an initial COVID-19 illness and later developed new symptoms and retested positive by RT-PCR (Reverse transcription polymerase chain reaction) were not capable of detecting the virus. Some previous studies have shown that the SARS-Cov-2 virus can replicate inside the body and is released into the environment from the people having low immune system at that point, making these individuals contagious. However, when infected with SARS-Cov-2 virus, the chances of person recovered from the infection, capable of spreading the virus through upper respiratory tract after the beginning of the initial symptoms of the disease, are very low.
Currently, there is only one published study which provides the elements of the persistence of SARS-CoV-2 in individuals who have low ability to fight against infections. The data from other studies of Tata Memorial Hospital show that the patients on active chemotherapy might be at increased risk of worsening their basic cancer treatment due to the positive nasopharyngeal (NP) swab which delays the administration of chemotherapy. In some previous studies, positive nasopharyngeal swabs were shown to detect virus but failed to detect replication and growth capacity of the virus.
Therefore, it becomes important to collect data of such patients to ensure the clearance of replication capable virus in association with certain surrogate markers of viral resolution that can be identified understand the severity of the illness for planning the chemotherapy accordingly. The study aims to observe 50 oncology patients of age 1 to 80 years over a period of 6 months from the point of their first testing positive for SARS-Cov-2 virus, till they are tested for two consecutive tests. This will help the doctor to optimize the course of chemotherapy for cancer patients affected by COVID-19.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 1.00 Year(s) 至 80.00 Year(s)（—）
- 性别
- All
入选标准
- •Oncology patients admitted with RT-PCR confirmed COVID-19 illness
- •Age 1 to 80 years
- •Patients willing to consent for additional blood and nasopharyngeal swabs.
排除标准
- •ICU patients unable to give nasopharyngeal swab or blood sample for study proposes
- •Patients with other inter-current bacterial viral respiratory infections.
- •Patients in palliative therapy.
结局指标
主要结局
Determine the duration of persistence of replication-competent/infectious virus in oncology patients.
时间窗: At the baseline and at the time repeat nasopharyngeal swab if required as per standard reassessment
次要结局
- To identify presence of replication-competent virus in oncology patients who demonstrate a positive RT-PCR after two consecutive negative results(Re-infection)(At the baseline and at the time repeat nasopharyngeal swab if required as per standard reassessment)
- 1. To establish correlation between RT-PCR (Ct value) and persistence of replication competent SARS-CoV-2(At the baseline and at the time repeat nasopharyngeal swab if required as per standard reassessment)
- 2. To identify cancer specific and chemotherapy regimen related risk factors for persistence of replication-competent virus(At the baseline and at the time repeat nasopharyngeal swab if required as per standard reassessment)
- To identify biomarkers (blood parameters like lymphocyte count neutrophil to lymphocyte ratio, inflammatory markers, viral serology) to predict clearance of replication-competent virus in oncology patients on chemotherapy(At the baseline and at the time repeat nasopharyngeal swab if required as per standard reassessment)
- To evaluate whether specific cancer diagnoses or regimens of chemotherapy influence the occurrence of mutation in immune dominant regions in SARS-CoV-2 isolates from oncology patients(At the baseline and at the time repeat nasopharyngeal swab if required as per standard reassessment and during the chemotherapy as per the standards)