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

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ClinicalTrials.gov Identifier: NCT04387786
Recruitment Status : Completed
First Posted : May 14, 2020
Last Update Posted : November 13, 2020
Cold Spring Harbor Laboratory
Information provided by (Responsible Party):
Betsy J Barnes, 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.

Condition or disease Intervention/treatment
COVID-19 Mechanical Ventilation Drug: Dornase Alfa

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.

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Study Type : Observational
Actual Enrollment : 5 participants
Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: Nebulized In-line Endotracheal Dornase Alfa and Albuterol Administered to Mechanically Ventilated COVID-19 Patients: A Case Series
Actual Study Start Date : March 31, 2020
Actual Primary Completion Date : April 24, 2020
Actual Study Completion Date : September 4, 2020

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

Primary Outcome Measures :
  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 Outcome Measures :
  1. Mean change in FiO2 [ Time Frame: 2 months ]
    fraction of inspired oxygen requirements will be measured

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
mechanically ventilated patients with COVID-19

Inclusion Criteria:

  • mechanically ventilated patients with COVID-19

Exclusion Criteria:

  • healthy, non-ventilated

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04387786

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United States, New York
Feinstein Insitute for Medical Research at Northwell Health
Manhasset, New York, United States, 11030
Sponsors and Collaborators
Feinstein Institute for Medical Research
Cold Spring Harbor Laboratory
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Principal Investigator: Betsy J Barnes Feinstein Institute for Medical Research
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Responsible Party: Betsy J Barnes, Investigator/Professor, Feinstein Institute for Medical Research
ClinicalTrials.gov Identifier: NCT04387786    
Other Study ID Numbers: 216
First Posted: May 14, 2020    Key Record Dates
Last Update Posted: November 13, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: study will be published and data will be made available
Supporting Materials: Clinical Study Report (CSR)
Time Frame: 3-6 months
Access Criteria: de-identified data

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Respiratory Tract Infections
Pneumonia, Viral
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Tocolytic Agents
Reproductive Control Agents
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action