COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT04402944

Robert Fowler

robert.fowler@childrens.harvard.edu

2020-05-27

Recruiting

RCT

Randomized

Parallel

Blind label

multi-center

Treatment

inclusion criteria: - icu admission for pneumonia complicated by respiratory failure. - rt-pcr (or equivalent) confirmed covid-19 infection. - intubated and on mechanical ventilation within 120 hours of initiation of mechanical ventilation. - age ≥ 3 years of age.

- allergy or known intolerance to pulmozyme or chinese hamster ovary cell products - history of moderate to severe asthma, cystic fibrosis, or severe copd (baseline fev1 ≤ 40% predicted) - active malignancy other than basal cell melanoma or in situ breast cancer - unstable angina - chronic liver disease as judged by the investigator that would pose significant risk to participation - chronic renal disease as judged by the investigator that would pose significant risk to participation - inability to obtain informed consent from patient or legally authorized representative (lar) - pregnant or breastfeeding use of extracorporeal membrane oxygenation (ecmo) - prisoner status - concurrent treatment with other inhaled investigational agent for covid-19** - patient, surrogate, or physician not committed to full support (exception: a patient will not be excluded if he/she would receive all supportive care except for attempts at resuscitation from cardiac arrest) - moribund patient not expected to survive 24 hours - active hemoptysis

2

Boston Children's Hospital

3

100

United States

Critical disease at enrollment

8: Critical disease at enrollment

60

Ventilator-free days at 28 days

None

Phase 2

[{"arm_notes": "", "treatment_id": 416, "treatment_name": "Dornase alfa", "treatment_type": "Respiratory agents", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]