Phase 2 Trial Using rhDNase to Reduce Mortality in COVID-19 Patients With Respiratory Failure (DAMPENCOVID)

Jon Simmons

Status and phase: Enrolling; Phase 2

Conditions: Covid19

Treatments: Drug: Pulmozyme/ Recombinant human deoxyribonuclease (rh-DNase); Drug: 0.9%sodium chloride

Study type: Interventional

Funder types: Other

Identifiers

NCT04445285

USAH 1002 000

Details and patient eligibility

About

This Phase 2 Randomized Placebo Controlled Trial will determine if administering nebulized Dornase Alpha (rhDNase) to COVID-19 patients with respiratory failure is safe and will reduce 28-day mortality.

Enrollment: 44 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Male or Female age 18 or older
2. On high flow oxygen =/> 6 liters nasal cannula (or)
3. On mechanical ventilation
4. Clinical diagnosis of COVID-19 & positive PCR test (or)
5. Clinical diagnosis of COVID-19 & negative PCR test with clinical symptoms of COVID-19 and pathognomonic lesions on a chest CT scan

Exclusion criteria

1. Known allergy to Pulmozyme
2. Less than 18 years of age
3. Grave condition with anticipated death within 48 hours; at the discretion of treating physician.
4. Enrollment in another clinical trial receiving investigatory drugs

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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44 participants in 2 patient groups, including a placebo group

Treatment Arm

Experimental group

Description:

Patient will receive 2.5mg Pulmozyme/ Recombinant human deoxyribonuclease (rh-DNase) aerosolized treatment once every 24 hours for five (5) consecutive days; a total of five (5) doses.

Treatment:

Drug: Pulmozyme/ Recombinant human deoxyribonuclease (rh-DNase)

Placebo Arm 0.9% sodium chloride

Placebo Comparator group

Description:

Patient will receive 2.5ml of Sodium Chloride 0.9% aerosolized treatment once every 24 hours for five (5) consecutive days; a total of five (5) doses.

Treatment:

Drug: 0.9%sodium chloride