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

Completed

• Conditions: COVID-19; Mechanical Ventilation

• Registration Number: NCT04387786
• Lead Sponsor: Feinstein Institute for Medical Research

Brief 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.

Study Timeline

• Study Start: 2020-03-31
• Primary Completion: 2020-04-24
• Study First Submitted: 2020-05-11
• Study First Submitted QC: 2020-05-12
• Study First Posted: 2020-05-14
• Study Completion: 2020-09-04
• Status Verified: 2020-11
• Last Update Submitted: 2020-11-12
• Last Update Posted: 2020-11-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 5

Inclusion Criteria

• mechanically ventilated patients with COVID-19

Exclusion Criteria

• healthy, non-ventilated

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Number of participants discharged from the intensive care unit (ICU)	2 months	discharge from ICU will be determined from the enterprise health record reporting database
Number of participants who survived COVID-19	2-4 months	survival will be determined from the enterprise health record reporting database

Secondary Outcome Measures

Name	Time	Method
Mean change in FiO2	2 months	fraction of inspired oxygen requirements will be measured

Trial Locations

Locations (1)

Feinstein Insitute for Medical Research at Northwell Health; 🇺🇸 Manhasset, New York, United States