NCT04356508Unknown2 期
COVID-19: A Pilot Study of Adaptive Immunity and Anti-PD1
Dr Gerry Gin Wai Kwok0 个研究点目标入组 15 人开始时间: 2020年4月14日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 15
- 主要终点
- Viral clearance kinetics
研究概览
简要总结
This is an open-label, controlled, single-centre pilot study of nivolumab in adult patients with COVID-19. This clinical study aims to evaluate efficacy of anti-PD1 antibody in relation to viral clearance and its safety.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
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
- •Diagnosis of COVID-19 by RT-PCR for SARS-CoV-2
- •Clinically stable with disease severity defined as mild or moderate (mild disease is defined as symptoms with or without lung infiltrates on chest X-Ray or CT imaging; moderate disease is defined as lung infiltrates with evidence of type 1 respiratory failure)
- •Asymptomatic patients may be enrolled if patients have obvious radiographic changes on chest or CT radiography deemed to be related to COVID-19
排除标准
- •Active cancer, rheumatological and autoimmune conditions
- •Transplant recipients, or patients on active immunosuppressants
- •Chronic organ impairment, or documented or suspected concomitant infections (including chronic viral hepatitis B and hepatitis C) other than SARS-CoV-2
- •Lactating mothers and women who are pregnant or intending to become pregnant
- •Acute respiratory distress syndrome, evidence of myocardial injury, disseminated intravascular coagulopathy, organ failure, hemophagocytosis, shock, respiratory distress, or need for mechanical ventilation, AICU admission, or high flow oxygen therapy
研究组 & 干预措施
Intervention (n=10)
Experimental
Nivolumab + best supportive care
干预措施: Nivolumab (Drug)
结局指标
主要结局
Viral clearance kinetics
时间窗: From diagnosis to recovery, assessed up to 6 months
Viral load changes in NPS based on SARS-CoV-2 RT-PCR
次要结局
- Lymphocyte kinetics(On days 1, 4, 6, 8, 10 and 28 from study enrollment)
- Cytokine kinetics(On days 1, 4, 6, 8 and 10 from study enrollment)
- Length of inpatient stay due to COVID-19(From hospital admission to discharge, assessed up to 6 months)
- Treatment-related adverse events of nivolumab (Intervention arm only)(Up to 1 year after nivolumab dosing)
研究者
Dr Gerry Gin Wai Kwok
Doctor
Queen Mary Hospital, Hong Kong
相似试验
撤回
不适用
Recombinant Human Angiotensin-converting Enzyme 2 (rhACE2) as a Treatment for Patients With COVID-19COVID-19NCT04287686The First Affiliated Hospital of Guangzhou Medical University
已完成
2 期
Phase II / III Study of COVID-19 DNA Vaccine (AG0302-COVID19)COVID-19NCT04655625AnGes, Inc.500
Unknown
1 期
Study of the Safety of Therapeutic Treatment With an Immunomodulatory Agent (N-803) in Adults With COVID-19COVID-19NCT04385849ImmunityBio, Inc.1
进行中（未招募）
1 期
Covid-19: A randomized, open-label, adaptive, proof-of- concept clinical trial of new antiviral drug candidates against SARS-CoV-2.EUCTR2020-001243-15-BEZLeuven200
进行中（未招募）
1 期
Covid-19: A randomized, open-label, adaptive, proof-of- concept clinical trial of new antiviral drug candidates against SARS-CoV-2.COVID-19MedDRA version: 20.0Level: LLTClassification code 10038700Term: Respiratory infectionSystem Organ Class: 100000004862EUCTR2020-001614-38-BEZLeuven282