Coronavirus Disease 2019Phase 1/2IN2COVIDNCT04988217
Inhaled Interferon α2b for the Treatment of Coronavirus Disease 19 (COVID-19)
A Phase 1/2 study testing Interferon-Alpha2B in people with Coronavirus Disease 2019, run by Pontificia Universidad Catolica de Chile at 1 site in Chile.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Coronavirus Disease 2019
- What is being tested?
- Interferon-Alpha2B
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 173 participants
- Where
- 1 siteChile
- Study dates
- 15 Sep 2021to 28 Jul 2022
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
- 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;
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- Age ≥ 18 years;
- Are able to provide informed consent for participation;
- Are able and willing to comply with the study schedule and procedures.
Who cannot join
- 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;
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- Have known hypersensitivity to interferon alpha or any component of the study drug or placebo control.
- Phase 2 stage:
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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)
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.
- Conditions
- Coronavirus Disease 2019
- Being tested
- Interferon-Alpha2B, Placebo
- Keywords
- Interferon alpha 2b, COVID-19
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Interferon-Alpha2BDrug
Also called AP-003
Nebulized interferon alpha 2B
PlaceboDrug
Nebulized placebo
| Study group | Role | What they receive |
|---|---|---|
| Part 1a: Interferon alpha 2b 2.5 MIU | Experimental | Nebulized interferon alpha 2b 2.5 MIU every 12 hours during 10 days (20 doses total) Receives: Drug: Interferon-Alpha2B |
| Part 1b: Interferon alpha 2b 5 MIU | Experimental | Nebulized interferon alpha 2b 5 MIU every 12 hours during 10 days (20 doses total) Receives: Drug: Interferon-Alpha2B |
| Part 1: Placebo | Placebo comparator | Nebulized placebo every 12 hours during 10 days (20 doses total) Receives: Drug: Placebo |
| Part 2: Interferon alpha 2b 5 MIU (or maximum tolerated dose from part 1) | Experimental | Nebulized interferon alpha 2b 5 MIU (or maximum tolerated dose from part 1) every 12 hours during 10 days (20 doses total) Receives: Drug: Interferon-Alpha2B |
| Part 2: Placebo | Placebo comparator | Nebulized placebo every 12 hours during 10 days (20 doses total) Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment-emergent adverse events in healthy subjects
Safety and tolerability of AP-003 as measured by subject incidence of treatment-emergent adverse events.
Measured: 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.
Measured: At Day 5 of Phase 2 (Phase 2 is 28 days)
Secondary outcomes (15)
Serum levels of interferon alpha 2b
Pharmacokinetics of nebulized AP-003 in healthy adults assessed by serial serum quantification of interferon alpha 2b
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Up to day 28 of Phase 2 (Phase 2 is 28 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2021
- Study start15 Sep 2021
- Primary completion15 Apr 2022
- Study completion28 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Coronavirus Disease 2019Studies of the same condition, open and under way.
- More trials run by Pontificia Universidad Catolica de ChileThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 173 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pontificia Universidad Catolica de Chile
- Sponsor type
- University, hospital or other
- Collaborators
- Altum Pharmaceuticals INC
- Responsible party
- Sponsor
- Investigators
- Arturo Borzutzky, M.D., Study director, Pontificia Universidad Catolica de ChileDiego García-Huidobro, M.D., Ph.D., Principal investigator, Pontificia Universidad Catolica de ChileCarolina Iturriaga, R.N., Principal investigator, Pontificia Universidad Catolica de ChileJose A Castro-Rodríguez, M.D., Ph.D., Principal investigator, Pontificia Universidad Catolica de ChileEleanor Fish, Ph.D., Principal investigator, University Health Network, Toronto, Canada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04988217
- Sponsor's protocol ID
- 210224003
- Acronym
- IN2COVID
- Status last verified
- Apr 2022
- First submitted
- 22 Jul 2021
- Last updated
- 5 Aug 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Available upon reasonable request.
Publications
Garcia-Huidobro D, Iturriaga C, Perez-Mateluna G, Fajuri P, Severino N, Urzua M, Fraga JP, de la Cruz J, Poli C, Castro-Rodriguez JA, Fish E, Borzutzky A; IN(2)COVID Research Team. Safety, Tolerability, Bioavailability, and Biological Activity of Inhaled Interferon-alpha2b in Healthy Adults: The IN2COVID Phase I Randomized Trial. Clin Drug Investig. 2023 Jun;43(6):447-461. doi: 10.1007/s40261-023-01278-3. Epub 2023 Jun 22.
PubMed 37347370
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT04988217
- Acronym / sponsor ID
- IN2COVID / 210224003
- Conditions
- Coronavirus Disease 2019
- Keywords
- Interferon alpha 2b, COVID-19
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 173 participants (actual)
- Lead sponsor
- Pontificia Universidad Catolica de ChileUniversity, hospital or other
- Collaborators
- Altum Pharmaceuticals INC
- Study start
- 15 Sep 2021 (actual)
- Primary completion
- 15 Apr 2022 (actual)
- Study completion
- 28 Jul 2022 (actual)
- First posted
- 3 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Part 1a: Interferon alpha 2b 2.5 MIU | Experimental | Drug: Interferon-Alpha2BNebulized interferon alpha 2b 2.5 MIU every 12 hours during 10 days (20 doses total) |
| Part 1b: Interferon alpha 2b 5 MIU | Experimental | Drug: Interferon-Alpha2BNebulized interferon alpha 2b 5 MIU every 12 hours during 10 days (20 doses total) |
| Part 1: Placebo | Placebo comparator | Drug: PlaceboNebulized placebo every 12 hours during 10 days (20 doses total) |
| Part 2: Interferon alpha 2b 5 MIU (or maximum tolerated dose from part 1) | Experimental | Drug: Interferon-Alpha2BNebulized interferon alpha 2b 5 MIU (or maximum tolerated dose from part 1) every 12 hours during 10 days (20 doses total) |
| Part 2: Placebo | Placebo comparator | Drug: PlaceboNebulized placebo every 12 hours during 10 days (20 doses total) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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.
- Active SARS-CoV-2 infection demonstrated by positive polymerase chain reaction (PCR) ≤ 5 days at enrollment;
Key exclusion criteria (17 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Interferon-Alpha2BAlso: AP-003Nebulized interferon alpha 2B | Drug | Part 1a: Interferon alpha 2b 2.5 MIU, Part 1b: Interferon alpha 2b 5 MIU, Part 2: Interferon alpha 2b 5 MIU (or maximum tolerated dose from part 1) |
| PlaceboNebulized placebo | Drug | Part 1: Placebo, Part 2: Placebo |
Primary outcome
Treatment-emergent adverse events in healthy subjects
Time frame: 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
Time frame: 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.
15 secondary outcomes
Serum levels 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
Time frame: Up to Day 11 of Phase 1 (Phase 1 is 11 days)
Change in perception of health status measured by EQ VAS
Time frame: Day 10 of Phase 2 (Phase 2 is 28 days)
Change in perception of health status measured by EQ VAS
Time frame: Day 28 of Phase 2 (Phase 2 is 28 days)
Change in 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
Time frame: Up to day 28 of Phase 2 (Phase 2 is 28 days)
Improvement in clinical symptoms
Time frame: Up to day 28 of Phase 2 (Phase 2 is 28 days)
Emergency department visits
Time frame: Up to day 28 of Phase 2 (Phase 2 is 28 days)
Hospitalizations
Time frame: Up to day 28 of Phase 2 (Phase 2 is 28 days)
Duration of hospitalization
Time frame: Up to day 28 of Phase 2 (Phase 2 is 28 days)
Time from consent to clinical deterioration
Time frame: Up to day 28 of Phase 2 (Phase 2 is 28 days)
Change in SARS CoV-2 viral load
Time frame: Up to day 28 of Phase 2 (Phase 2 is 28 days)
Change in inflammatory parameters
Time frame: Up to day 28 of Phase 2 (Phase 2 is 28 days)
Organ failure rate
Time frame: Up to day 28 of Phase 2 (Phase 2 is 28 days)
Death rate
Time frame: Up to day 28 of Phase 2 (Phase 2 is 28 days)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2022.
- Derived from this study: PubMed 37347370Garcia-Huidobro D, Iturriaga C, Perez-Mateluna G, Fajuri P, Severino N, Urzua M, Fraga JP, de la Cruz J, Poli C, Castro-Rodriguez JA, Fish E, Borzutzky A; IN(2)COVID Research Team. Safety, Tolerability, Bioavailability, and Biological Activity of Inhaled Interferon-alpha2b in Healthy Adults: The IN2COVID Phase I Randomized Trial. Clin Drug Investig. 2023 Jun;43(6):447-461. doi: 10.1007/s40261-023-01278-3. Epub 2023 Jun 22.
- Individual participant dataSharing planned: Yes. Available upon reasonable request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Arturo Borzutzky, M.D. study director
Pontificia Universidad Catolica de Chile
Diego García-Huidobro, M.D., Ph.D. principal investigator
Pontificia Universidad Catolica de Chile
Carolina Iturriaga, R.N. principal investigator
Pontificia Universidad Catolica de Chile
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Interferon-Alpha2B in people with Coronavirus Disease 2019, run by Pontificia Universidad Catolica de Chile at 1 site in Chile.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Chile. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment-emergent adverse events in healthy subjects (time frame: At the end of Phase 1 (Phase 1 is 11 days)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04988217, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Aug 2022.