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

COVID-19 Clinical Trial

— DACOVID  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04387786
• Other study ID #: 216
• Status: Completed
• Start date: March 31, 2020
• Est. completion date: September 4, 2020

Study information

• Verified date: November 2020
• Source: Northwell Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 5
• Est. completion date: September 4, 2020
• Est. primary completion date: April 24, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

Inclusion Criteria:

• mechanically ventilated patients with COVID-19

Exclusion Criteria:

• healthy, non-ventilated

Related Conditions & MeSH terms

• COVID-19
• Mechanical Ventilation

Intervention

Drug:
• Dornase Alfa
nebulized in-line endotracheal dornase alfa co-administered with albuterol

Locations

Country	Name	City	State
United States	Feinstein Insitute for Medical Research at Northwell Health	Manhasset	New York

Sponsors (2)

Lead Sponsor	Collaborator
Feinstein Institute for Medical Research	Cold Spring Harbor Laboratory

Country where clinical trial is conducted

United States, 

References & Publications (1)

Barnes BJ, Adrover JM, Baxter-Stoltzfus A, Borczuk A, Cools-Lartigue J, Crawford JM, Daßler-Plenker J, Guerci P, Huynh C, Knight JS, Loda M, Looney MR, McAllister F, Rayes R, Renaud S, Rousseau S, Salvatore S, Schwartz RE, Spicer JD, Yost CC, Weber A, Zuo Y, Egeblad M. Targeting potential drivers of COVID-19: Neutrophil extracellular traps. J Exp Med. 2020 Jun 1;217(6). pii: e20200652. doi: 10.1084/jem.20200652. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants discharged from the intensive care unit (ICU)	discharge from ICU will be determined from the enterprise health record reporting database	2 months
Primary	Number of participants who survived COVID-19	survival will be determined from the enterprise health record reporting database	2-4 months
Secondary	Mean change in FiO2	fraction of inspired oxygen requirements will be measured	2 months