NCT04402944

Pulmozyme to Improve COVID-19 ARDS Outcomes

Status unknown Phase 2 Last updated 17 December 2021

What this trial tests

Phase 2 trial testing Pulmozyme in COVID in 60 participants. Status unknown.

Timeline

5 July 2020

Primary endpoint
31 December 2021

31 December 2021

Quick facts

Lead sponsor	Boston Children's Hospital
Phase	Phase 2
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	60
Start date	5 July 2020
Primary completion	31 December 2021
Estimated completion	31 December 2021
Sites	3 locations across United States

Drugs / interventions tested

• Pulmozyme (DORNASE ALFA) — full drug profile →
• Placebo

Conditions studied

• COVID — all drugs for COVID →

Sponsor

Boston Children's Hospital

Who can join

3 and older, any sex, with COVID. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This is a randomized double-blind placebo-controlled Phase II trial of recombinant human deoxyribonuclease I (rhDNase I) - Pulmozyme - in mechanically ventilated patients with COVID-19 pneumonia.

Patients admitted to the ICU with severe COVID-19 pneumonia who require mechanical ventilation will be invited to participate in this study. Potential subjects will be identified from medical record review or from direct contact with physicians. Investigators will check medical history and confirm eligibility. Informed consent will be obtained from either the patient or designated healthcare proxy.

60 subjects will be enrolled. After obtaining informed consent, patients will be randomized 2:1 to Pulmozyme 2.5 mg BID for up to 28 days or until they are no longer receiving mechanical ventilation, whichever is sooner plus standard of care vs. placebo normal saline 2.5 ml plus standard of care.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Endothelial dysfunction and immunothrombosis as key pathogenic mechanisms in COVID-19.
   Bonaventura A, Vecchié A, Dagna L, Martinod K, et al · · 2021 · cited 738× · PMID 33824483 · DOI 10.1038/s41577-021-00536-9
2. Neutrophil phenotypes and functions in cancer: A consensus statement.
   Quail DF, Amulic B, Aziz M, Barnes BJ, et al · · 2022 · cited 261× · PMID 35522219 · DOI 10.1084/jem.20220011
3. Host-directed immunotherapy of viral and bacterial infections: past, present and future.
   Wallis RS, O'Garra A, Sher A, Wack A. · · 2023 · cited 169× · PMID 35672482 · DOI 10.1038/s41577-022-00734-z
4. Circulating Markers of Neutrophil Extracellular Traps Are of Prognostic Value in Patients With COVID-19.
   Ng H, Havervall S, Rosell A, Aguilera K, et al · · 2021 · cited 158× · PMID 33267662 · DOI 10.1161/atvbaha.120.315267
5. COVID-19 and Neutrophils: The Relationship between Hyperinflammation and Neutrophil Extracellular Traps.
   Borges L, Pithon-Curi TC, Curi R, Hatanaka E. · · 2020 · cited 151× · PMID 33343232 · DOI 10.1155/2020/8829674
6. Insights Into Immunothrombosis: The Interplay Among Neutrophil Extracellular Trap, von Willebrand Factor, and ADAMTS13.
   Yang J, Wu Z, Long Q, Huang J, et al · · 2020 · cited 82× · PMID 33343584 · DOI 10.3389/fimmu.2020.610696
7. Neutrophils in COVID-19: Not Innocent Bystanders.
   McKenna E, Wubben R, Isaza-Correa JM, Melo AM, et al · · 2022 · cited 76× · PMID 35720378 · DOI 10.3389/fimmu.2022.864387
8. Defective NET clearance contributes to sustained FXII activation in COVID-19-associated pulmonary thrombo-inflammation.
   Englert H, Rangaswamy C, Deppermann C, Sperhake JP, et al · · 2021 · cited 76× · PMID 34000623 · DOI 10.1016/j.ebiom.2021.103382