PMID- 34775578 OWN - NLM STAT- PubMed-not-MEDLINE LR - 20220216 IS - 2193-8229 (Print) IS - 2193-6382 (Electronic) IS - 2193-6382 (Linking) VI - 11 IP - 1 DP - 2022 Feb TI - A Randomized Controlled Trial to Evaluate the Safety and Efficacy of a Novel Inhaled Biologic Therapeutic in Adults with Respiratory Distress Secondary to COVID-19 Infection. PG - 595-605 LID - 10.1007/s40121-021-00562-z [doi] AB - INTRODUCTION: Inhaled therapeutics may act to directly target and attenuate lung inflammation due to COVID-19. An inhalation form of a novel biologic drug, AMP5A, is being developed as an immunomodulatory agent to treat dysregulated immune responses and is being studied in hospitalized patients to treat respiratory complications due to COVID-19. METHODS: A randomized, controlled, phase I trial was conducted to evaluate hospitalized adults with respiratory distress secondary to COVID-19. Patients received the standard care (SOC) for COVID-19, including respiratory therapy, corticosteroids, and antiviral therapies such as remdesivir. Patients were randomized 1:1 to inhalation treatment with AMP5A as an adjunct to SOC or to SOC alone (control). AMP5A was administered via inhalation daily for 5 days via hand-held nebulizer, non-invasive ventilator, or mechanical ventilation. Safety and clinical efficacy endpoints were evaluated. RESULTS: Forty subjects were enrolled and randomized (n = 19 AMP5A, n = 21 control). Remdesivir was used in fewer AMP5A subjects (26%) than control (52%), and dexamethasone was administered for most subjects (84% AMP5A, 71% control). The study met its primary endpoint with no AMP5A treatment-related adverse events (AEs), and the incidence and severity of AEs were comparable between groups: 18 AEs for control (8 mild, 1 moderate, 9 severe) and 19 AEs for AMP5A (7 mild, 7 moderate, 5 severe). Notably, subjects treated with AMP5A had fewer deaths (5% vs. 24%), shorter hospital stay (8 days vs. 12 days), fewer ICU admissions (21% vs. 33%), and a greater proportion with improved clinical outcomes than control. CONCLUSION: The phase I clinical results indicate inhaled AMP5A is safe, is well tolerated, and could lead to fewer patients experiencing deterioration or death. Based on the treatment effect (i.e., reduced mortality), a phase II trial has been initiated. TRIAL REGISTRATION: Clinicaltrials.gov identifier: NCT04606784. CI - (c) 2021. The Author(s). FAU - Roshon, Michael AU - Roshon M AD - Physician Residencies and Research Operations, Centura Hospital, Colorado Springs, CO, USA. FAU - Lemos-Filho, Luciano AU - Lemos-Filho L AD - National Jewish Division of Pulmonary at Swedish Medical Center, Englewood, CO, USA. FAU - Cherevka, Holli AU - Cherevka H AD - Ampio Pharmaceuticals, Inc., Englewood, CO, USA. FAU - Goldberg, Laura AU - Goldberg L AD - Ampio Pharmaceuticals, Inc., Englewood, CO, USA. FAU - Salottolo, Kristin AU - Salottolo K AD - Trauma Research Department, Penrose Hospital, Colorado Springs, CO, USA. AD - Trauma Research Department, Swedish Medical Center, Englewood, CO, USA. FAU - Bar-Or, David AU - Bar-Or D AUID- ORCID: 0000-0002-3685-314X AD - Ampio Pharmaceuticals, Inc., Englewood, CO, USA. davidbme49@gmail.com. AD - Trauma Research Department, Penrose Hospital, Colorado Springs, CO, USA. davidbme49@gmail.com. AD - Trauma Research Department, Swedish Medical Center, Englewood, CO, USA. davidbme49@gmail.com. LA - eng SI - ClinicalTrials.gov/NCT04606784 PT - Journal Article DEP - 20211114 PL - New Zealand TA - Infect Dis Ther JT - Infectious diseases and therapy JID - 101634499 PMC - PMC8590808 OTO - NOTNLM OT - COVID-19 OT - Efficacy OT - Inhalation treatment OT - Safety EDAT- 2021/11/15 06:00 MHDA- 2021/11/15 06:01 PMCR- 2021/11/14 CRDT- 2021/11/14 21:16 PHST- 2021/10/06 00:00 [received] PHST- 2021/10/29 00:00 [accepted] PHST- 2021/11/15 06:00 [pubmed] PHST- 2021/11/15 06:01 [medline] PHST- 2021/11/14 21:16 [entrez] PHST- 2021/11/14 00:00 [pmc-release] AID - 10.1007/s40121-021-00562-z [pii] AID - 562 [pii] AID - 10.1007/s40121-021-00562-z [doi] PST - ppublish SO - Infect Dis Ther. 2022 Feb;11(1):595-605. doi: 10.1007/s40121-021-00562-z. Epub 2021 Nov 14.