NCT04331899已完成2 期
A Phase 2 Randomized, Single-Blind Study of a Single Dose of Peginterferon Lambda-1a (Lambda) Compared With Placebo in Outpatients With Mild COVID-19
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Duration Until Viral Shedding Cessation
研究概览
简要总结
To evaluate the efficacy of a single dose of subcutaneous injections of 180 ug of Peginterferon Lambda-1a, compared with placebo in reducing the duration of viral shedding of SARS-CoV-2 virus in patients with uncomplicated COVID-19 disease.
详细描述
Patients will attend up to 9 study visits over a period of up to 28 days.
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
- Single (Participant)
盲法说明
Single-blind study in which only patients are blinded.
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years and ≤ 75 years at the time of the assessment
- •Able and willing to understand the study, adhere to all study procedures, and provide written informed consent
- •Diagnosis of COVID-19 disease:
- •If symptomatic, the presence of mild to moderate symptoms without signs of respiratory distress, with FDA-cleared molecular diagnostic assay positive for SARS-CoV-2 within 72 hours from swab to the time of commencing informed consent:
- •If asymptomatic, initial diagnosis of SARS-CoV-2 infection with positive FDA-cleared molecular diagnostic assay obtained no more than 72 hours from initial swab to the time of commencing informed consent
排除标准
- •Patients who are hospitalized for inpatient treatment or currently being evaluated for potential hospitalization at the time of initiation of informed consent
- •Patients with a known allergy to Peginterferon Lambda-1a or any component thereof
- •Display symptoms of respiratory distress (Respiratory rate >20, room air oxygen saturation of <94%.)
- •Participation in a clinical trial with or use of any investigational agent within 30 days before screening
- •Treatment with interferons (IFN) within 12 months before screening
- •Previous use of Peginterferon Lambda-1a
- •History or evidence of any intolerance or hypersensitivity to IFNs or other substances contained in the study medication.
- •Female patients who are pregnant or breastfeeding. Male patients must confirm that their female sexual partners are not pregnant.
- •Current or previous history of decompensated liver disease (Child-Pugh Class B or C) or hepatocellular carcinoma
- •Co-infected with human immunodeficiency virus (HIV)
- •Significant abnormal laboratory test results at screening.
- •Other significant medical condition that may require intervention during the study
- •Concurrent use of any of the following medications:
- •Therapy with an immunomodulatory agent
- •Current use of heparin or Coumadin
- •Received blood products within 30 days before study randomization
- •Use of hematologic growth factors within 30 days before study randomization
- •Systemic antibiotics, antifungals, or antivirals for treatment of active infection within 24 hours before study randomization
- •Any prescription or herbal product that is not approved by the investigator
- •Long-term treatment (> 2 weeks) with agents that have a high risk for nephrotoxicity or hepatotoxicity unless it is approved by the medical monitor
- •Receipt of systemic immunosuppressive therapy within 3 months before screening
研究组 & 干预措施
Placebo injection
Placebo Comparator
Study participants will receive a placebo along with the standard of care treatment.
干预措施: Placebo (Other)
Study drug Peginterferon Lambda-1a
Experimental
Study participants assigned to study drug will receive a single subcutaneous dose of Peginterferon Lambda-1a in addition to standard of care treatment.
干预措施: Peginterferon Lambda-1a (Drug)
结局指标
主要结局
Duration Until Viral Shedding Cessation
时间窗: Assessed for up to 28 days
Time to first of two consecutive negative respiratory secretions obtained by oropharyngeal and/or anterior nare swabs for SARS-CoV-2 by qRT-PCR.
次要结局
- Count of Participants Requiring Emergency Department Visits or Hospitalizations Within 28 Days of Initiation of Treatment(28 days)
- Duration Until Resolution of Symptoms(Up to 28 days)
- Change in Sars-CoV-2 Viral Load(baseline, day 14)
- Area Under the Curve of SARS-COV-2 Viral Load(baseline through day 14)
研究者
研究点 (1)
Loading locations...
相似试验
终止
2 期
Peginterferon Lambda-1a for the Prevention and Treatment of SARS-CoV-2 (COVID-19) InfectionSars-CoV-2 InfectionNCT04344600Johns Hopkins University6
已完成
2 期
Study to Evaluate Analgesic Effect of Intravenous Administration of Kappa Agonist CR845 After Hysterectomy SurgeryAcute PainNCT00877799Cara Therapeutics, Inc.114
已完成
2 期
Safety and Immune Response of One Dose of OVX836 at Two Dose Levels, in Comparison to Influvac TetraTM, After Intramuscular Administration in Healthy Subjects Aged 18-65 YearsInfluenzaNCT04192500Osivax300
已完成
1 期
Safety of Interleukin-7 in HIV Infected People Currently Taking Anti-HIV DrugsHIV InfectionsNCT00099671National Institute of Allergy and Infectious Diseases (NIAID)25
已完成
1 期
Study in Blood Stage Malaria Infection After DVI of Cryopreserved P. Falciparum (NF54 Strain) SporozoitesMalaria,FalciparumParasitemiaParasitic DiseaseProtozoan InfectionsNCT04310085Medicines for Malaria Venture16