Inhaled Interferon α2b for the Treatment of Coronavirus Disease 19 (COVID-19)
- Conditions
- Coronavirus Disease 2019
- Interventions
- Drug: Placebo
- Registration Number
- NCT04988217
- Lead Sponsor
- Pontificia Universidad Catolica de Chile
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 173
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Part 2: Interferon alpha 2b 5 MIU (or maximum tolerated dose from part 1) Interferon-Alpha2B Nebulized interferon alpha 2b 5 MIU (or maximum tolerated dose from part 1) every 12 hours during 10 days (20 doses total) Part 1a: Interferon alpha 2b 2.5 MIU Interferon-Alpha2B Nebulized interferon alpha 2b 2.5 MIU every 12 hours during 10 days (20 doses total) Part 2: Placebo Placebo Nebulized placebo every 12 hours during 10 days (20 doses total) Part 1b: Interferon alpha 2b 5 MIU Interferon-Alpha2B Nebulized interferon alpha 2b 5 MIU every 12 hours during 10 days (20 doses total) Part 1: Placebo Placebo Nebulized placebo every 12 hours during 10 days (20 doses total)
- Primary Outcome Measures
Name Time Method Treatment-emergent adverse events in healthy subjects 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 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.
- Secondary Outcome Measures
Name Time Method Serum levels of interferon alpha 2b Up to Day 11 of Phase 1 (Phase 1 is 11 days) Pharmacokinetics of nebulized AP-003 in healthy adults assessed by serial serum quantification of interferon alpha 2b
Expression of interferon-induced genes in blood sputum samples Up to Day 11 of Phase 1 (Phase 1 is 11 days) Evaluation of interferon-induced biomarkers after treatment with AP-003 in blood and sputum of healthy adults to assess biological effect of Interferon
Change in EuroQoL Quality of Life instrument (EQ-5D-5L) Up to day 28 of Phase 2 (Phase 2 is 28 days) Changes in participants' perception of health status from baseline to Day 5, from baseline to Day 10, and from baseline to Day 28 as measured by EuroQoL Quality of Life instrument (EQ-5D-5L).
Change in Ordinal Scale for Clinical Improvement Up to day 28 of Phase 2 (Phase 2 is 28 days) Changes in participants' overall health from baseline to Day 5, from baseline to Day 10, and from baseline to Day 28 as measured by Ordinal Scale for Clinical Improvement in AP-003 treated patients compared to placebo.
Change in SARS CoV-2 viral load Up to day 28 of Phase 2 (Phase 2 is 28 days) SARS CoV-2 viral load by quantitative PCR from baseline to Day 5, from baseline to Day 10, and from baseline to Day 28 in AP-003 treated patients compared to placebo.
Emergency department visits Up to day 28 of Phase 2 (Phase 2 is 28 days) The proportion of participants attending an emergency department for COVID-19 by Day 28 in AP-003 treated patients compared to placebo.
Change in inflammatory parameters Up to day 28 of Phase 2 (Phase 2 is 28 days) Changes in D dimer, CRP, Ferritin, Troponin, creatine phosphokinase (CPK), LDH, IL-6 from baseline through Day 28 in AP-003 treated patients compared to placebo.
Change in perception of health status measured by EQ VAS Day 28 of Phase 2 (Phase 2 is 28 days) Changes in participants' perception of health status from baseline to Day 28 as measured by EQ VAS in AP-003 treated patients compared to placebo.
Time from consent to clinical deterioration Up to day 28 of Phase 2 (Phase 2 is 28 days) Time from consent to clinical deterioration defined as requiring or recommended for ventilatory support (continuous positive airway pressure \[CPAP\] or ventilator), shock requiring vasopressor support, and/or heart failure (defined as left ventricular ejection fraction \[LVEF\] \< 30%) in AP-003 treated patients compared to placebo.
Improvement in clinical symptoms Up to day 28 of Phase 2 (Phase 2 is 28 days) Changes in participant's improvement in clinical symptoms from baseline to Day 5, from baseline to Day 10, and from baseline to Day 28 as measured by a daily symptom diary in AP-003 treated patients compared to placebo.
Hospitalizations Up to day 28 of Phase 2 (Phase 2 is 28 days) The proportion of participants hospitalized for COVID-19 by Day 28 in AP-003 treated patients compared to placebo.
Duration of hospitalization Up to day 28 of Phase 2 (Phase 2 is 28 days) For hospitalized participants, duration of hospitalization in AP-003 treated patients compared to placebo.
Organ failure rate Up to day 28 of Phase 2 (Phase 2 is 28 days) Organ failure, any organ, from consent through Day 28 in AP-003 treated patients compared to placebo.
Death rate Up to day 28 of Phase 2 (Phase 2 is 28 days) Death, any cause, from consent through Day 28 in AP-003 treated patients compared to placebo.
Trial Locations
- Locations (1)
Red de Salud UC Christus
🇨🇱Santiago, RM, Chile