Safety and Efficacy Study of Acthar in Subjects With ARDS

What Was Tested

This registered phase 2 trial tested ACTH (Corticotropin).

Approximately 210 subjects will be randomized to 1 of 6 possible treatment groups in a 3:2:3:2:3:2 ratio.

Study medication (SM) will be administered via subcutaneous (SC) injection for 4 weeks using a blinded gradually tapering regimen, and subjects will be followed for 60 days post-randomization.

It had six arms (groups): Group 1 (experimental), Group 2 (placebo comparator), Group 3 (experimental), Group 4 (placebo comparator) and Group 5 (experimental).

The registry classes the interventions as drug.

Who Took Part

It was open to people of any sex aged from 18 years with no upper age limit.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Patients ≥ 18 years. ARDS as defined by:. PaO2 /FiO2 ≤ 200 mmHg with PEEP ≥ 5cm H2O. Bilateral opacities on chest radiography not explained by atelectasis, effusions, nodules, or preexisting disease. Requirement for positive pressure ventilation via an endotracheal tube.

The full record lists 8 inclusion and 12 exclusion criteria; among the exclusions: subject unwilling to receive or intolerant of sc injections; major surgery within 48 hours before randomization, or evidence of currently active bleeding postoperatively, or plan for any major surgery during the study period.

How the Study Was Run

Design: randomized, parallel-group and quadruple-blind.

Random assignment meant chance, not the researchers, decided who got ACTH (Corticotropin) and who got the comparison, which limits bias.

Groups ran in parallel: each of the participants stayed in one arm throughout.

Neither the participants nor the staff measuring them knew who was on ACTH (Corticotropin), so expectations could not easily colour the readings.

Those kept unaware of assignments: participant, care provider, investigator and outcomes assessor.

It started in 2014-08 with completion listed for 2016-08.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Number of ventilator-free days (subjects alive and breathing without assistance for ≥ 48 hr) by Day 28 after randomization (time frame: 60 days (28 days of treatment with a 32 day follow-up period)).

It also tracked 8 secondary outcomes, for example Mortality at Day 28 and Day 60, Number of ICU-free and hospital free days for all subjects who survive to ICU and hospital discharge, respectively, Number of extra-pulmonary organ failure-free days, Change in PaO2/FiO2 ratio and oxygenation index (OI) from baseline for subjects on mechanical ventilation, Change in Systemic Organ Failure Assessment Score (SOFA) score from baseline and Number of treatment-emergent serious adverse events.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of ACTH (Corticotropin) in people.

It was withdrawn before enrolling anyone; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the ACTH (Corticotropin) compound page, all human trials.