Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04387786
Recruitment Status : Active, not recruiting
First Posted : May 14, 2020
Last Update Posted : May 14, 2020
Sponsor:
Collaborator:
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.

Layout table for study information
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
Estimated Study Completion Date : July 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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
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
Criteria

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


Locations
Layout table for location information
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
Investigators
Layout table for investigator information
Principal Investigator: Betsy J Barnes Feinstein Institute for Medical Research
Publications:
Layout table for additonal information
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: May 14, 2020
Last Verified: May 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

Layout table for additional information
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:
Layout table for MeSH terms
Albuterol
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