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

NCT04387786 | Completed DMC FDA Drug

• 1 other identifier: 216
• Study Type: observational
• Target: 5
• Locations: 1 country
• Sites: 1

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.

Conditions

COVID-19; Mechanical Ventilation

Outcome Measures

Primary Outcomes (2)

• 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

• Number of participants who survived COVID-19

  survival will be determined from the enterprise health record reporting database

  2-4 months

Secondary Outcomes (1)

• Mean change in FiO2

  2 months

Interventions

Dornase Alfa DRUG

nebulized in-line endotracheal dornase alfa co-administered with albuterol

Also known as: albuterol

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

mechanically ventilated patients with COVID-19

You may qualify if:

• mechanically ventilated patients with COVID-19

You may not qualify if:

• healthy, non-ventilated

Sponsors & Collaborators

• Feinstein Institute for Medical Research: lead
• Cold Spring Harbor Laboratory: collaborator

Study Sites (1)

Feinstein Insitute for Medical Research at Northwell Health

Manhasset, New York, 11030, United States

Location

Related 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):e20200652. doi: 10.1084/jem.20200652.

  PMID: 32302401 BACKGROUND

MeSH Terms

Conditions

COVID-19

Interventions

dornase alfa; Albuterol

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Phenethylamines; Ethylamines

Study Officials

• Betsy J Barnes

  Feinstein Institute for Medical Research

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Investigator/Professor

Study Record Dates

• First Submitted: May 11, 2020
• First Posted: May 14, 2020
• Study Start: March 31, 2020
• Primary Completion: April 24, 2020
• Study Completion: September 4, 2020
• Last Updated: November 13, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: CSR
• Time Frame: 3-6 months
• Access Criteria: de-identified data

Locations

US (1)