A Phase II, Multicenter, Open-label, Randomized, Comparator Controlled Study to Evaluate the Efficacy and Safety of Pegylated Interferon - α2b in the Treatment of Adult Patients Diagnosed With SARS-CoV2 (COVID-19)
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 7
- 试验地点
- 2
- 主要终点
- Change in Clinical status of subject on a 7-point ordinal scale
研究概览
简要总结
This is a phase II, multicenter, open-label, randomized, comparator-controlled study to evaluate the efficacy and safety of Pegylated Interferon -α2b in the treatment of adult patients diagnosed with SARS-CoV2 (COVID-19).Initial 1 mcg/kg of Pegylated Interferon-α2b will be administered on day 1. After safety evaluation of first dose, next dose (second dose) 1 mcg/kg on day 8 will be administered with recommended standard care during the trial.
详细描述
This is a phase II, multicenter, open-label, randomized, comparator-controlled study to evaluate the efficacy and safety of Pegylated Interferon -α2b in the treatment of adult patients diagnosed with SARS-CoV2 (COVID-19).Moderate COVID-19 subjects will be randomly assigned to receive test arm or reference arm in a 1:1 ratio.
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
- •Ability to comprehend and willingness to sign a written ICF for the study.
- •Male or non-pregnant females, ≥18 years of age at the time of enrolment.
- •Understands and agrees to comply with planned study procedures.
- •Agrees to the collection of pharyngeal swabs and blood sample as per protocol.
- •Has laboratory-confirmed SARS-CoV-2 infection as determined by PCR, or other commercial or public health assay in any specimen within one week
- •Patients with SpO2 > 93% and respiratory rate <30 breaths/min.
- •Illness of any duration, and at least one of the following:
- •Radiographic infiltrates by imaging (chest x-ray)
- •Clinical assessment (evidence of rales/crackles or other clinical symptoms on exam).
- •Women of childbearing potential must agree to use at least one primary form of contraception
排除标准
- •ALT/AST >5 times the upper limit of normal.
- •Patients with respiratory rate <20 breaths/min and normal SpO2 with confirmed SARS-CoV-2 infection as determined by PCR (Mild COVID-19 subjects).
- •Patients with respiratory rate ≥30 breaths/min and SpO2 at rest ≤93% (Severe COVID-19 subjects).
- •Stage ≥4 severe chronic kidney disease or requiring dialysis (i.e. eGFR <30 mL/min/1.73 m2).
- •Pregnant or breast feeding.
- •Allergy to any study medication or usage of test drug during last 14 days prior to screening
- •Severe co-morbidity (e.g. uncontrolled hypertension and uncontrolled DM, systemic disease which affect the vital organs severity, immunocompromised patients etc.) as per investigator's assessment.
- •Comorbid condition like myocardial infarction or heart failure within 90 days of recruitment.
- •Prolong QT interval (>450 ms).
研究组 & 干预措施
Pegylated Interferon-α2b + Standard of care
Test :- Pegylated Interferon-α2b + Standard of care (SOC)
Pegylated Interferon-α2b-Initial 1 mcg/kg will be administered on day 1. After safety evaluation of first dose, next dose (second dose) 1 mcg/kg on day 8 will be administered along with the recommended standard of care at the time of conduct of trial.
干预措施: Pegylated Interferon-α2b (Drug)
Pegylated Interferon-α2b + Standard of care
Test :- Pegylated Interferon-α2b + Standard of care (SOC)
Pegylated Interferon-α2b-Initial 1 mcg/kg will be administered on day 1. After safety evaluation of first dose, next dose (second dose) 1 mcg/kg on day 8 will be administered along with the recommended standard of care at the time of conduct of trial.
干预措施: Standard of Care (Other)
Standard of Care
Control: Standard of care
Standard of care treatment will be provided as per regulatory recommendation and approval.
干预措施: Standard of Care (Other)
结局指标
主要结局
Change in Clinical status of subject on a 7-point ordinal scale
时间窗: Week 2
1. Not hospitalized, no limitations on activities. 2. Not hospitalized, limitation on activities. 3. Hospitalized, not requiring supplemental oxygen. 4. Hospitalized, requiring supplemental oxygen. 5. Hospitalized, on non-invasive ventilation or high flow oxygen devices. 6. Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO). 7. Death.
次要结局
- Ferritin(Week 2 and Week 4)
- TNF alpha(Week 2 and Week 4)
- Interleukin 1-β(Week 2 and Week 4)
- Incidence of Treatment-Emergent Adverse Events(Week 2 and Week 4)
- Mechanical Ventilation(Week 2 and Week 4)
- PCR test(Week 2 and Week 4)
- Supplemental Oxygen(Week 2 and Week 4)
- C-reactive protein (CRP)(Week 2 and Week 4)
- Interleukin 6 (IL-6)(Week 2 and Week 4)
- D-dimer(Week 2 and Week 4)
- Interferon gamma(Week 2 and Week 4)