Inhaled Interferon α2b for the Treatment of Coronavirus Disease 19 (COVID-19)
Status:
Recruiting
Trial end date:
2022-06-01
Target enrollment:
Participant gender:
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.