NCT04387786

Dornase Alfa Administered to Patients With COVID-19 (DACOVID)

Nebulized In-line Endotracheal Dornase Alfa and Albuterol Administered to Mechanically Ventilated COVID-19 Patients: A Case Series

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 5 (actual)
• Sponsor: Feinstein Institute for Medical Research · Academic / Other
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

Mechanically ventilated patients with coronavirus disease 2019 (COVID-19) have a mortality of 24-53%, in part due to distal mucopurulent secretions interfering with ventilation. Dornase alfa is recombinant human DNase 1 and digests DNA in mucoid sputum. Nebulized dornase alfa is FDA-approved for cystic fibrosis treatment. DNA from neutrophil extracellular traps (NETs) contributes to the viscosity of mucopurulent secretions. NETs are found in the serum of patients with severe COVID-19, and targeting NETs reduces mortality in animal models of acute respiratory distress syndrome (ARDS). Thus, dornase alfa may be beneficial to patients with severe COVID-19-acting as a mucolytic and targeting NETs.

Detailed description

Demographic, clinical data, and outcomes were collected from the electronic medical records of five mechanically ventilated patients with COVID-19-including three requiring veno-venous extracorporeal membrane oxygenation (VV-ECMO)-treated with nebulized in-line endotracheal dornase alfa co-administered with albuterol (used to increase delivery to the alveoli), between March 31 and April 24, 2020. Data on tolerability and responses, including longitudinal values capturing respiratory function and inflammatory status, were analyzed.

Conditions

• COVID-19
• Mechanical Ventilation

Interventions

Type	Name	Description
DRUG	Dornase Alfa	nebulized in-line endotracheal dornase alfa co-administered with albuterol

Timeline

• Start date: 2020-03-31
• Primary completion: 2020-04-24
• Completion: 2020-09-04
• First posted: 2020-05-14
• Last updated: 2020-11-13

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study