A Randomized Phase 2 Trial of Peginterferon Lambda-1a (Lambda) for the Treatment of Hospitalized Patients Infected With SARS-CoV-2 With Non-critical Illness
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 主要终点
- Number of participants with resolution of hypoxia
研究概览
简要总结
The main purpose of this research study is to test the safety and effectiveness of an investigational drug peginterferon lambda-1a in treating COVID-19.
详细描述
Primary Objective: Determine efficacy of pegylated interferon lambda as measured by clinical improvement. This will be defined as improvement in supplemental oxygen requirement.
Secondary Objectives:
- Determine safety and tolerability of pegylated interferon lambda
- Days with fever
- Time to resolution of fever
- Rate of progression to requiring critical care
- Overall survival
- Time to discharge
Exploratory Objectives: Determining the effect systemically on inflammatory markers in the blood, as well as viral load.
Diagnosis and Main Inclusion Criteria: Patients must have a confirmed diagnosis of infection with SARS-CoV-2 and be receiving supplemental oxygen. Many patients may be receiving hydroxychloroquine with or without other antimicrobials.
研究设计
- 研究类型
- Interventional
- 分配方式
- 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
- •Confirmed diagnosis of SARS-CoV-2
- •Hospitalization due to diagnosis with SARS-CoV-2
- •Sp02 < 93% on ambient air or PaO2/FiO2 < 300 mmHg and requires supplemental oxygen
排除标准
- •Patients must not be pregnant or nursing
- •Patients cannot be admitted to intensive care unit at time of admission or require positive pressure ventilation
- •Patients cannot be requiring continuous supplemental oxygen normally (pre-SARS-CoV-2)
- •Patient is receiving steroids >1mg/kg
- •Has diagnosis of primary immunodeficiency
- •Has active autoimmune disease that has required systemic treatment in the past year
- •Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial
- •Patients with ferritin >2000ng/mL and/or C-reactive protein >100mg/L
- •History of allogeneic hematopoietic cell transplantation or solid organ transplantation
- •Childs-Pugh class B or C cirrhosis or class A if portal hypertension is present
- •Documented allergic or hypersensitivity response to protein therapeutics
- •No serious disease requiring mechanical ventilation at time of enrollment
研究组 & 干预措施
Peginterferon lambda-1a
Peginterferon lambda-1a (Lambda) 180mcg subcutaneous injection once
干预措施: Peginterferon Lambda-1A (Drug)
结局指标
主要结局
Number of participants with resolution of hypoxia
时间窗: 7 days
The clinical improvement as defined as resolution of hypoxia requiring supplemental oxygen to maintain SpO2\>92% at 7 days.
次要结局
- Rate of progression to requiring critical care(during hospitalization, average of 5 days)
- Overall survival(until 90 days after receipt of treatment)
- Time to resolution of fever(during hospitalization, average of 7 days)
- Time to discharge(average of 7 days)
- Days with fever(during hospitalization, average of 7 days)
- Number of adverse events.(until 90 days after receipt of treatment)
研究者
Thomas Marron
Assistant Professor
Icahn School of Medicine at Mount Sinai