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Inhaled Interferon α2b for the Treatment of Coronavirus Disease 19 (COVID-19) (IN2COVID)

Primary Purpose

Coronavirus Disease 2019

Status

Completed

Phase

Phase 1

Locations

Chile

Study Type

Interventional

Intervention

Interferon-Alpha2B

Placebo

About this trial

This is an interventional treatment trial for Coronavirus Disease 2019 focused on measuring Interferon alpha 2b, COVID-19

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Phase 1 stage:

Inclusion criteria:

Male subjects aged 18-50 years;
In good state of health, determined by medical history, physical exam, and normal laboratory tests at screening;
Are able to provide informed consent for participation;
Are able and willing to comply with the study schedule and procedures.

Exclusion Criteria

Active SARS-CoV-2 infection demonstrated by positive polymerase chain reaction (PCR) at enrollment;
Requiring CPAP for sleep apnea;
Pre-existing pulmonary disease;
Have any serious acute concomitant illness that, in the opinion of the investigator, would interfere with evaluation of safety of AP-003, or put the participant at risk of harm from study participation;
Are currently receiving an investigational agent, have participated in another study of an investigational agent within 30 days of enrollment, or were previously enrolled in the current study;
Are legally incompetent and unable to understand the study's purpose, significance, and consequences, and to make decisions accordingly;
Have known hypersensitivity to interferon alpha or any component of the study drug or placebo control.

Phase 2 stage:

Inclusion criteria:

Active SARS-CoV-2 infection demonstrated by positive polymerase chain reaction (PCR) ≤ 5 days at enrollment;
Symptomatic of mild or moderate COVID-19 for ≤ 5 days at enrollment. Symptoms can include fever, cough, sore throat, malaise, headache, muscle pain, gastrointestinal symptoms, chest pain, with or without shortness of breath on exertion/dyspnea;
Age ≥ 18 years;
Are able to provide informed consent for participation;
Are able and willing to comply with the study schedule and procedures.

Exclusion Criteria

Patients requiring CPAP for sleep apnea.
Patients with pre-existing pulmonary disease requiring chronic O2 supplementation.
Patients with known infection with Influenza A or B;
In the opinion of the Investigator, should undergo ventilatory (CPAP, mechanical ventilation, etc.) or circulatory support within 24 hours of study enrollment;
Have any serious acute concomitant illness that, in the opinion of the Investigator, would interfere with evaluation of safety or efficacy, or put the participant at risk of harm from study participation;
Are currently receiving an investigational agent, have participated in another study of an investigational agent within 30 days of enrollment, or were previously enrolled in the current study;
Are legally incompetent and unable to understand the study's purpose, significance, and consequences, and to make decisions accordingly;
Women who are pregnant or breast-feeding, or planning to conceive in the next 30 days;
Have known hypersensitivity to interferon alpha or any component of the study drug or placebo control.

Sites / Locations

Red de Salud UC Christus

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Placebo Comparator

Experimental

Placebo Comparator

Arm Label

Part 1a: Interferon alpha 2b 2.5 MIU

Part 1b: Interferon alpha 2b 5 MIU

Part 1: Placebo

Part 2: Interferon alpha 2b 5 MIU (or maximum tolerated dose from part 1)

Part 2: Placebo

Arm Description

Nebulized interferon alpha 2b 2.5 MIU every 12 hours during 10 days (20 doses total)

Nebulized interferon alpha 2b 5 MIU every 12 hours during 10 days (20 doses total)

Nebulized placebo every 12 hours during 10 days (20 doses total)

Nebulized interferon alpha 2b 5 MIU (or maximum tolerated dose from part 1) every 12 hours during 10 days (20 doses total)

Nebulized placebo every 12 hours during 10 days (20 doses total)

Outcomes

Primary Outcome Measures

Treatment-emergent adverse events in healthy subjects

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

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

Serum levels of interferon alpha 2b

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

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 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.

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.

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).

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.

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.

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.

Hospitalizations

The proportion of participants hospitalized for COVID-19 by Day 28 in AP-003 treated patients compared to placebo.

Duration of hospitalization

For hospitalized participants, duration of hospitalization in AP-003 treated patients compared to placebo.

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.

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.

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.

Organ failure rate

Organ failure, any organ, from consent through Day 28 in AP-003 treated patients compared to placebo.

Death rate

Death, any cause, from consent through Day 28 in AP-003 treated patients compared to placebo.

Full Information

NCT ID

NCT04988217

First Posted

July 22, 2021

Last Updated

August 3, 2022

Sponsor

Pontificia Universidad Catolica de Chile

Collaborators

Altum Pharmaceuticals INC

1. Study Identification

Unique Protocol Identification Number

NCT04988217

Brief Title

Inhaled Interferon α2b for the Treatment of Coronavirus Disease 19 (COVID-19)

Acronym

IN2COVID

Official Title

A Phase I/II Randomized, Double-blind, Placebo-controlled Study of Inhaled Interferon α2b for the Treatment of Coronavirus Disease 19 (COVID-19)

Study Type

Interventional

2. Study Status

Record Verification Date

April 2022

Overall Recruitment Status

Completed

Study Start Date

September 15, 2021 (Actual)

Primary Completion Date

April 15, 2022 (Actual)

Study Completion Date

July 28, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Pontificia Universidad Catolica de Chile

Collaborators

Altum Pharmaceuticals INC

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Coronavirus Disease 2019

Keywords

Interferon alpha 2b, COVID-19

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

173 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Part 1a: Interferon alpha 2b 2.5 MIU

Arm Type

Experimental

Arm Description

Nebulized interferon alpha 2b 2.5 MIU every 12 hours during 10 days (20 doses total)

Arm Title

Part 1b: Interferon alpha 2b 5 MIU

Arm Type

Experimental

Arm Description

Nebulized interferon alpha 2b 5 MIU every 12 hours during 10 days (20 doses total)

Arm Title

Part 1: Placebo

Arm Type

Placebo Comparator

Arm Description

Nebulized placebo every 12 hours during 10 days (20 doses total)

Arm Title

Part 2: Interferon alpha 2b 5 MIU (or maximum tolerated dose from part 1)

Arm Type

Experimental

Arm Description

Nebulized interferon alpha 2b 5 MIU (or maximum tolerated dose from part 1) every 12 hours during 10 days (20 doses total)

Arm Title

Part 2: Placebo

Arm Type

Placebo Comparator

Arm Description

Nebulized placebo every 12 hours during 10 days (20 doses total)

Intervention Type

Drug

Intervention Name(s)

Interferon-Alpha2B

Other Intervention Name(s)

AP-003

Intervention Description

Nebulized interferon alpha 2B

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Nebulized placebo

Primary Outcome Measure Information:

Title

Treatment-emergent adverse events in healthy subjects

Description

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)

Title

Change in perception of health status measured by EQ VAS in COVID-19 patients

Description

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)

Secondary Outcome Measure Information:

Title

Serum levels of interferon alpha 2b

Description

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)

Title

Expression of interferon-induced genes in blood sputum samples

Description

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)

Title

Change in perception of health status measured by EQ VAS

Description

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)

Title

Change in perception of health status measured by EQ VAS

Description

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)

Title

Change in EuroQoL Quality of Life instrument (EQ-5D-5L)

Description

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