A Phase I/II Randomized, Double-blind, Placebo-controlled Study of Inhaled Interferon α2b for the Treatment of Coronavirus Disease 19 (COVID-19)
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 173
- 试验地点
- 1
- 主要终点
- Treatment-emergent adverse events in healthy subjects
研究概览
简要总结
The IN2COVID Study is a 2-staged phase I/II double-blind, randomized, placebo-controlled trial to evaluate the efficacy and safety of AP-003 (Interferon α2b) when administered via inhalation twice daily for 10 days. Participants will have a final visit at Day 11.
A lead-in phase 1 substudy will be performed with at least 18 healthy adult male subjects to assess safety and tolerability of inhaled AP-003 compared to placebo for 10 days. Two cohorts of 9 subjects will be randomly assigned to receive two doses of inhaled AP-003 or placebo with an allocation ratio of 2:1. The first cohort will assess a dose of 2.5 MIU of inhaled AP-003. If no adverse events are observed, the second cohort will be conducted using a dose of 5 MIU of inhaled AP-003. Maximum tolerated dose will be determined in this phase 1 substudy.
After the completion of phase 1, the study will continue with a phase 2 treatment RCT in patients with COVID-19. In this phase, 150 adults with mild or moderate COVID-19 demonstrated by SARS-CoV-2 positive polymerase chain reaction (PCR) ≤ 5 days at enrollment will be randomized 1:1 (75 in each arm) to receive nebulized AP-003 or identical placebo twice daily during 10 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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Part 1a: Interferon alpha 2b 2.5 MIU
Nebulized interferon alpha 2b 2.5 MIU every 12 hours during 10 days (20 doses total)
干预措施: Interferon-Alpha2B (Drug)
Part 1b: Interferon alpha 2b 5 MIU
Nebulized interferon alpha 2b 5 MIU every 12 hours during 10 days (20 doses total)
干预措施: Interferon-Alpha2B (Drug)
Part 1: Placebo
Nebulized placebo every 12 hours during 10 days (20 doses total)
干预措施: Placebo (Drug)
Part 2: Interferon alpha 2b 5 MIU (or maximum tolerated dose from part 1)
Nebulized interferon alpha 2b 5 MIU (or maximum tolerated dose from part 1) every 12 hours during 10 days (20 doses total)
干预措施: Interferon-Alpha2B (Drug)
Part 2: Placebo
Nebulized placebo every 12 hours during 10 days (20 doses total)
干预措施: Placebo (Drug)
结局指标
主要结局
Treatment-emergent adverse events in healthy subjects
时间窗: At the end of Phase 1 (Phase 1 is 11 days)
Safety and tolerability of AP-003 as measured by subject incidence of treatment-emergent adverse events.
Change in perception of health status measured by EQ VAS in COVID-19 patients
时间窗: At Day 5 of Phase 2 (Phase 2 is 28 days)
Changes from baseline evaluation in COVID-19(+) participants' perception of health status at Day 5 as measured by EQ VAS in AP-003 treated patients compared to placebo.
次要结局
- Serum levels of interferon alpha 2b(Up to Day 11 of Phase 1 (Phase 1 is 11 days))
- Expression of interferon-induced genes in blood sputum samples(Up to Day 11 of Phase 1 (Phase 1 is 11 days))
- Change in EuroQoL Quality of Life instrument (EQ-5D-5L)(Up to day 28 of Phase 2 (Phase 2 is 28 days))
- Change in Ordinal Scale for Clinical Improvement(Up to day 28 of Phase 2 (Phase 2 is 28 days))
- Change in SARS CoV-2 viral load(Up to day 28 of Phase 2 (Phase 2 is 28 days))
- Emergency department visits(Up to day 28 of Phase 2 (Phase 2 is 28 days))
- Change in inflammatory parameters(Up to day 28 of Phase 2 (Phase 2 is 28 days))
- Change in perception of health status measured by EQ VAS(Day 28 of Phase 2 (Phase 2 is 28 days))
- Time from consent to clinical deterioration(Up to day 28 of Phase 2 (Phase 2 is 28 days))
- Improvement in clinical symptoms(Up to day 28 of Phase 2 (Phase 2 is 28 days))
- Hospitalizations(Up to day 28 of Phase 2 (Phase 2 is 28 days))
- Duration of hospitalization(Up to day 28 of Phase 2 (Phase 2 is 28 days))
- Organ failure rate(Up to day 28 of Phase 2 (Phase 2 is 28 days))
- Death rate(Up to day 28 of Phase 2 (Phase 2 is 28 days))