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

NCT04988217 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 173

Last updated 2022-08-05

No results posted yet for this study

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.

Conditions

  • Coronavirus Disease 2019

Interventions

DRUG

Interferon-Alpha2B

Nebulized interferon alpha 2B

DRUG

Placebo

Nebulized placebo

Sponsors & Collaborators

  • Altum Pharmaceuticals INC

    collaborator INDUSTRY

  • Pontificia Universidad Catolica de Chile

    lead OTHER

Principal Investigators

  • Arturo Borzutzky, M.D. · Pontificia Universidad Catolica de Chile

  • Diego García-Huidobro, M.D., Ph.D. · Pontificia Universidad Catolica de Chile

  • Carolina Iturriaga, R.N. · Pontificia Universidad Catolica de Chile

  • Jose A Castro-Rodríguez, M.D., Ph.D. · Pontificia Universidad Catolica de Chile

  • Eleanor Fish, Ph.D. · University Health Network, Toronto, Canada

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-09-15
Primary Completion
2022-04-15
Completion
2022-07-28

Countries

  • Chile

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04988217 on ClinicalTrials.gov