Pulmozyme to Improve COVID-19 ARDS Outcomes

Fowler et al., NCT04402944, NCT04402944, Dec 2021

Estimated 60 patient dornase alfa late treatment RCT with results not reported over 3 years after estimated completion.

4 dornase alfa RCTs have results missing long after expected1-4
The trials report a total of 297 patients, with 2 trials having actual enrollment of 177, and the remainder estimated.

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1. Fowler et al., Pulmozyme to Improve COVID-19 ARDS Outcomes, NCT04402944, clinicaltrials.gov/study/NCT04402944clinicaltrials.gov.

2. Grégoire et al., Efficacy and Safety of Dornase Alfa Aerosol in ARDS Secondary to SARS-CoV-2 Coronavirus Respiratory Infection - COVID-19, NCT04355364, clinicaltrials.gov/study/NCT04355364clinicaltrials.gov.

3. Ovalı et al., Determination of Dornase Alpha Effectiveness in COVID-19 Treatment, NCT04432987, clinicaltrials.gov/study/NCT04432987clinicaltrials.gov.

4. Markova et al., A Prospective Open-label Study of the Tigerase® Efficacy and Safety as Part of Complex Therapy in Patients With COVID-19, NCT04459325, clinicaltrials.gov/study/NCT04459325clinicaltrials.gov.

Fowler et al., 31 Dec 2021, Double Blind Randomized Controlled Trial, placebo-controlled, USA, trial NCT04402944 (history). Contact: robert.fowler@childrens.harvard.edu, mailto:kzambranovera@bwh.harvard.edu, ssmith3@southshorehealth.org.

Late treatment
is less effective