Phase 1&2 Study to Evaluate the Safety & Efficacy of Inhaled IBIO123 in Severe COVID-19 Illness

COVID-19 Clinical Trial

Official title: A Randomized, Double-blind, Placebo-Controlled, Escalating Single Dose, Phase 1 & Phase 2 Study to Evaluate the Safety and Efficacy of Inhaled IBIO123 in Participants With Severe COVID-19 Illness

Status Completed

Clinical Trial Summary

This is a Phase 1 and phase 2, adaptive, placebo-controlled, double-blind, randomized single-dose study in participants with Severe COVID-19 illness.

Clinical Trial Description

In Phase 1, in hospital in a continuous observation setting the first cohort will recruit a total of 8 participants who will receive a single inhaled administration of the study treatment. This cohort will consist of 6 participants on active treatment at a dose of 5mg (0.5cc) of IBIO123 and 2 participants on placebo (0.5cc). Participants will be followed for a total duration of 7 days which is greater than 5 expected half-lives of the study drug in lungs. Therefore, after 7 days, negligible amount of the study drug should remain in the lungs of participants. Safety data will be collected and reviewed by a Data Monitoring Committee (DMC). If no stopping rules have been met, the DMC will recommend the dosing of the second cohort at the expected therapeutic dose of 10mg. If stopping rules have been met the DMC will recommend the termination of the study.

The second cohort will be recruited in hospital in continuous observation setting and recruit a total of 8 participants who will receive a single inhaled administration of the study treatment. This cohort will consist of 6 participants on active treatment at a dose of 10mg of IBIO123 (1 cc) and 2 participants on placebo (1 cc).

Participants will be followed for a total duration of 7 days which is greater than 5 expected half-lives of the study drug in lungs. Therefore, after 7 days, negligible amount of the study drug should remain in the lungs of participants. Safety data will be collected and reviewed by a Data Monitoring Committee (DMC). If no stopping rules have been met the DMC will recommend the phase 2 dose of 10mg. If stopping rules have been met the DMC will recommend a phase 2 dose of 5 mg.

In Phase 2, in the lead-in portion of the phase 2, the DMC will meet 7 days after the first 9 subjects (3 Placebo and 6 Active) have completed their day 7 visit to review safety information of these subjects that have been dosed with 10mg of IBIO123 on Days 1 and 3. If this dose regimen is deemed safe by the DMC, the phase 2 study enrolment will pursue and be completed at 10mg on Day 1 and 10 mg on Day 3. If stopping rules were obtained during the Safety review, the study enrolment will be pursued with a single dose of 10mg of IBIO 123 on Day 1. ;

Related Conditions & MeSH terms

• COVID-19

• NCT number: NCT05303376
• Study type: Interventional
• Source: Immune Biosolutions Inc
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: February 22, 2022
• Completion date: June 27, 2023