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Completed

NCT Number: NCT04387786

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

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.

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Key information

Conditions

COVID-19 Coronaviridae Infections Coronavirus Infections Infections Lung Diseases Mechanical Ventilation Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Feinstein Insitute for Medical Research at Northwell Health

Manhasset, New York, 11030, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • mechanically ventilated patients with COVID-19

Exclusion criteria

  • healthy, non-ventilated

Treatment and study plan

Dornase Alfa

Drug

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

Other names: albuterol

Primary outcomes

  1. Number of participants discharged from the intensive care unit (ICU)

    Time frame: 2 months

    discharge from ICU will be determined from the enterprise health record reporting database

  2. Number of participants who survived COVID-19

    Time frame: 2-4 months

    survival will be determined from the enterprise health record reporting database

Secondary outcomes

  1. Mean change in FiO2

    Time frame: 2 months

    fraction of inspired oxygen requirements will be measured

Sponsors and collaborators

Lead sponsor

Feinstein Institute for Medical Research

Other

Collaborators

  • Cold Spring Harbor Laboratory

Registry information

Official study title

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

Acronym: DACOVID

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
May 14, 2020
Registry last updated
Nov 13, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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