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

NCT ID: NCT04387786

Last Updated: 2020-11-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

5 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-03-31

Study Completion Date

2020-09-04

Brief Summary

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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.

Detailed Description

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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.

Conditions

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COVID-19 Mechanical Ventilation

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

RETROSPECTIVE

Interventions

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Dornase Alfa

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

Intervention Type DRUG

Other Intervention Names

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albuterol

Eligibility Criteria

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Inclusion Criteria

* mechanically ventilated patients with COVID-19

Exclusion Criteria

* healthy, non-ventilated
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Cold Spring Harbor Laboratory

OTHER

Sponsor Role collaborator

Feinstein Institute for Medical Research

OTHER

Sponsor Role lead

Responsible Party

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Betsy J Barnes

Investigator/Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Betsy J Barnes

Role: PRINCIPAL_INVESTIGATOR

Feinstein Institute for Medical Research

Locations

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Feinstein Insitute for Medical Research at Northwell Health

Manhasset, New York, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 32302401 (View on PubMed)

Other Identifiers

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216

Identifier Type: -

Identifier Source: org_study_id