Evaluation of Direct Antiviral Treatments Against SARS-CoV-2 in Immunocompromised Patients With Covid-19. A G2i Study, National Multicenter Observational and Retrospective From June 2023 to April 2024
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 300
- 试验地点
- 16
- 主要终点
- Clinical evolution of immunocompromised patients receiving remdesivir and/or nirmatrelvir/ritonavir as curative treatment for COVID-19
研究概览
简要总结
Due to the lower virulence of circulating Omicron variants and the high seroprevalence of anti-SARS-CoV-2 antibodies, the incidence of cases and deaths related to the SARS-CoV-2 virus has significantly decreased in recent months worldwide. However, these infections remain a major public health problem in severely immunocompromised patients, who have decreased vaccine efficacy and are at higher risk of persistent SARS-CoV-2 viral shedding, relapses, secondary invasive fungal infection, intensive care unit hospitalization, and death than non-immunocompromised patients.
The research concerns adult patients at very high risk of severe SARS-CoV-2 disease, suffering from SARS-CoV-2 having resulted in hospitalization in a center participating in the study in France between June 1, 2023 and April 1, 2024 and having received mono- or dual therapy with nirmatrelvir/ritonavir or remdesivir in order to carry out an evaluation of direct antiviral treatments against SARS-CoV-2 in these immunocompromised patients suffering from Covid-19.
The study consists of collecting patient care data from the medical record. Patients will be identified by practitioners at each participating French center.
详细描述
Due to the lower virulence of circulating Omicron variants and the high seroprevalence of anti-SARS-CoV-2 antibodies, the incidence of cases and deaths related to the SARS-CoV-2 virus has significantly decreased in recent months worldwide. However, these infections remain a major public health problem in severely immunocompromised patients, who have decreased vaccine efficacy and are at higher risk of persistent SARS-CoV-2 viral shedding, relapses, secondary invasive fungal infection, intensive care unit hospitalization, and death than non-immunocompromised patients.
The research concerns adult patients at very high risk of severe SARS-CoV-2 disease, suffering from SARS-CoV-2 having resulted in hospitalization in a center participating in the study in France between June 1, 2023 and April 1, 2024 and having received mono- or dual therapy with nirmatrelvir/ritonavir or remdesivir in order to carry out an evaluation of direct antiviral treatments against SARS-CoV-2 in these immunocompromised patients suffering from Covid-19.
Identifying an effective anti-SARS-CoV-2 therapeutic strategy is a real challenge in severely immunocompromised patients because clinicians are faced with chronic carriage and serious complications in these patients, as well as drug interactions with immunosuppressive treatments, the emergence of resistance and the absence of recommendations.
The data currently available in the literature remain heterogeneous and sometimes without sufficient level of evidence. However, some teams have reported in this population the efficacy of repeated or prolonged treatment with nirmatrelvir/ritonavir or even multitherapies combining several antiviral treatments and/or combinations of monoclonal antibodies on persistent carriage of the virus. Thus, some centers recommend prolonged antiviral treatments combining 5 to 10 days of remdesivir with 10 days of nirmatrelvir/ritonavir.
Nirmatrelvir/ritonavir and remdesivir are the currently available antiviral therapies that are still effective against circulating Omicron virus subvariants. It therefore seems important to have more data on their efficacy in monotherapy, dual therapy, or in the case of prolonged treatment.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients with SARS-CoV-2 in France, treated in a center participating in the study
- •Symptomatic patients for Covid-19 who have received mono- or dual therapy with nirmatrelvir/ritonavir or remdesivir
- •SARS-CoV-2 positive by PCR on nasopharyngeal swab, ECBC or bronchoalveolar fluid
- •Hospitalization in a ward or day hospital for SARS-CoV-2 infection
- •Patients at very high risk of severe form of SARS-CoV-2
- •Aggressive lymphomas (all types)
- •Acute lymphocytic leukemia
- •Acute myeloid leukemia
- •Acute promyelocytic leukemia
- •T-cell prolymphocytic leukemia
- •Primary lymphoma of the central nervous system
- •Stem cell transplant
- •Light chain amyloidosis
- •Chronic lymphocytic leukemia
- •Multiple myeloma
- •Hematopoietic stem cell transplant
- •Solid organ transplant
- •Being on the waiting list for an organ transplant
- •Primary immunodeficiency;
- •HIV patients with CD4 <200/mm3 or with a detectable viral load
- •Lymphopenia <200/mm3
- •Neutropenia <1000/mm3 for > 1 week
- •Patients receiving long-term immunosuppressive treatment (period of at least 3 months during treatment during infection) with:
- •anti-CD20 antibodies
- •BTK inhibitors
- •azathioprine
- •cyclophosphamide
- •methotrexate
- •mycophenolate mofetil
- •CAR-T cell gene therapy
- •bi-phenotypic therapeutic antibodies
- •tacrolimus
- •sirolimus
- •long-term corticosteroids (prednisone equivalent dose >5mg for 3 months)
排除标准
- •Opposition formulated (following receipt of the study information note)
- •Patients who received convalescent plasma as first-line treatment for SARS-CoV-2 infection
结局指标
主要结局
Clinical evolution of immunocompromised patients receiving remdesivir and/or nirmatrelvir/ritonavir as curative treatment for COVID-19
时间窗: 37 days
Evolution of the patient's modified (suitable for immunocompromised patients) Ordinal Scale for Clinical Improvement (OSCI) of the World Health Organization (WHO) (score from 0 - non infected patient to 8 - deceased patient) from the initiation of treatment to 30 days (+7 days) following the first line of therapy.
次要结局
- Mortality at 30 days of diagnosis(30 days)
- Tolerance of antiviral treatments against SARS-CoV-2(6 months)
- Evaluate virological evolution(60 days)
- Evaluate radiological evolution(90 days)
- Clinical relapse at discharge from hospital, at D30 and D60(90 days)
- Identified factors associated with favorable evolution(90 days)
- Infectious complications and secondary non-infectious complications(90 days)