A Phase 1/2 interventional study of Interferon-Alpha2B and Placebo in Coronavirus Disease 2019, sponsored by Pontificia Universidad Catolica de Chile. Completed at 1 site in Chile. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-08-05.
Sponsored by Pontificia Universidad Catolica de Chile · Phase 1/2, Interventional, and Treatment
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.
7,640 studies on the registry are indexed under COVID-19; 488 are open to participants now.
This study's enrollment of 173 is above the median of 100 across 4,099 interventional studies indexed under COVID-19.
Browse COVID-19 studies →Pontificia Universidad Catolica de Chile is the lead sponsor of 215 studies on the registry; 56 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Phase 1 stage:
Inclusion criteria:
Exclusion Criteria
Phase 2 stage:
Inclusion criteria:
Exclusion Criteria
Nebulized interferon alpha 2b 2.5 MIU every 12 hours during 10 days (20 doses total)
Drug: Interferon-Alpha2B
Nebulized interferon alpha 2b 5 MIU every 12 hours during 10 days (20 doses total)
Drug: Interferon-Alpha2B
Nebulized placebo every 12 hours during 10 days (20 doses total)
Drug: Placebo
Nebulized interferon alpha 2b 5 MIU (or maximum tolerated dose from part 1) every 12 hours during 10 days (20 doses total)
Drug: Interferon-Alpha2B
Nebulized placebo every 12 hours during 10 days (20 doses total)
Drug: Placebo
Nebulized interferon alpha 2B
Also known as: AP-003
Nebulized placebo
Treatment-emergent adverse events in healthy subjects
Safety and tolerability of AP-003 as measured by subject incidence of treatment-emergent adverse events.
Time frame: At the end of Phase 1 (Phase 1 is 11 days)
Change in perception of health status measured by EQ VAS in COVID-19 patients
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.
Time frame: At Day 5 of Phase 2 (Phase 2 is 28 days)
Serum levels of interferon alpha 2b
Pharmacokinetics of nebulized AP-003 in healthy adults assessed by serial serum quantification of interferon alpha 2b
Time frame: Up to Day 11 of Phase 1 (Phase 1 is 11 days)
Expression of interferon-induced genes in blood sputum samples
Evaluation of interferon-induced biomarkers after treatment with AP-003 in blood and sputum of healthy adults to assess biological effect of Interferon
Time frame: Up to Day 11 of Phase 1 (Phase 1 is 11 days)
Change in perception of health status measured by EQ VAS
Changes in participants' perception of health status from baseline to Day 10 as measured by EQ VAS in AP-003 treated patients compared to placebo.
Time frame: Day 10 of Phase 2 (Phase 2 is 28 days)
Change in perception of health status measured by EQ VAS
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 frame: Day 28 of Phase 2 (Phase 2 is 28 days)
Change in EuroQoL Quality of Life instrument (EQ-5D-5L)
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).
Time frame: Up to day 28 of Phase 2 (Phase 2 is 28 days)
Change in Ordinal Scale for Clinical Improvement
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.
Time frame: Up to day 28 of Phase 2 (Phase 2 is 28 days)
Improvement in clinical symptoms
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.
Time frame: Up to day 28 of Phase 2 (Phase 2 is 28 days)
Emergency department visits
The proportion of participants attending an emergency department for COVID-19 by Day 28 in AP-003 treated patients compared to placebo.
Time frame: Up to day 28 of Phase 2 (Phase 2 is 28 days)
Hospitalizations
The proportion of participants hospitalized for COVID-19 by Day 28 in AP-003 treated patients compared to placebo.
Time frame: Up to day 28 of Phase 2 (Phase 2 is 28 days)
Duration of hospitalization
For hospitalized participants, duration of hospitalization in AP-003 treated patients compared to placebo.
Time frame: Up to day 28 of Phase 2 (Phase 2 is 28 days)
Time from consent to clinical deterioration
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.
Time frame: Up to day 28 of Phase 2 (Phase 2 is 28 days)
Change in SARS CoV-2 viral load
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.
Time frame: Up to day 28 of Phase 2 (Phase 2 is 28 days)
Change in inflammatory parameters
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.
Time frame: Up to day 28 of Phase 2 (Phase 2 is 28 days)
Organ failure rate
Organ failure, any organ, from consent through Day 28 in AP-003 treated patients compared to placebo.
Time frame: Up to day 28 of Phase 2 (Phase 2 is 28 days)
Death rate
Death, any cause, from consent through Day 28 in AP-003 treated patients compared to placebo.
Time frame: Up to day 28 of Phase 2 (Phase 2 is 28 days)
Plan to share: Yes — Available upon reasonable request.
Supporting information: Study protocol, Sap, Icf, Csr
No publications or documents are linked to this record.
This study is completed, as verified in Apr 2022. You cannot join it, but the record below documents what was studied.
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Pontificia Universidad Catolica de Chile