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Phase III DAS181 Lower Tract PIV Infection in Immunocompromised Subjects (Substudy: DAS181 for COVID-19): RCT Study
This study will seek to enroll immunocompromised patients with Lower Tract parainfluenza infection. It also contains a sub-study to enroll patients with severe COVID-19.
Study details:
Eligible subjects (i. e. , those meeting the Inclusion / Exclusion criteria) will be enrolled in one of four cohorts based on the following criteria:.
Cohort 1:. All eligible subjects in the PoI who are ≥18 year old subjects with a PIV infection and meet all of the following criteria:. 1.
1 Meet criteria for being severely immunocompromised 1. 2 Prior to the onset of PIV infection, had no ongoing need for oxygen therapy due to a chronic respiratory condition (e. g.
, COPD, sleep apnea) and are assessed as acutely hypoxemic due to their PIV infection 1. 3 At the time of randomization are not on mechanical, bi-level or continuous positive airway pressure (Bi-PAP or CPAP) ventilation 1. 4 Have no known concurrent respiratory viral coinfection(s).
Cohort 2:. All eligible subjects in the PoI who are ≥18 year old with a PIV infection (including those with PIV and another SAD-RV) who do not meet one or more of the listed criteria for Cohort 1. Cohort 3:.
All eligible subjects in the PoI who are \<18 year old subjects with a PIV infection (including those with PIV and another concurrent SAD-RV). There is no lower age limit for this cohort. Cohort 4:.
All eligible subjects in the PoI with a respiratory infection due to any SAD-RV infection except PIV. Eligible subjects with both PIV and an additional concurrent SAD-RV, will be enrolled for either Cohorts 2 or 3 depending on their age. There is no lower age limit for this cohort.
Sub-Study:. Patients with Severe COVID-19.
Eligibility criteria
Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.
Inclusion criteria
Exclusion criteria
Eligibility
Age eligible for study : 0 and older
Healthy volunteers accepted : No
Gender eligible for study: All
Things to know
Study dates
Study start: 2019-05-23
Primary completion: 2024-12-31
Study completion finish: 2024-12-31
Study type
TREATMENT
Phase
PHASE3
Trial ID
NCT03808922
Intervention or treatment
DRUG: DAS181
DRUG: Placebo
DRUG: DAS181 COVID-19
DRUG: DAS181 OL
Conditions
- • COVID-19
- • Lower Respiratory Tract Infection
- • Parainfluenza
- • Immunocompromised
Find a site
Closest Location:
Westmead Hospital
Research sites nearby
Select from list below to view details:
Westmead Hospital
Sydney, New South Wales, Australia
The Wesley Hospital
Auchenflower, Queensland, Australia
Royal Melbourne Hospital
Melbourne, Victoria, Australia
Peter MacCallum Cancer Centre
Melbourne, Victoria, Australia
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Participant Group/Arm | Intervention/Treatment |
---|---|
EXPERIMENTAL: Cohort 1 and Cohort 2 Treatment
| DRUG: DAS181
|
PLACEBO_COMPARATOR: Cohort 1 and Cohort 2 Placebo
| DRUG: Placebo
|
EXPERIMENTAL: Cohort 3
| DRUG: DAS181 OL
|
EXPERIMENTAL: Cohort 4
| DRUG: DAS181 OL
|
EXPERIMENTAL: DAS181 COVID-19 Treatment
| DRUG: DAS181 COVID-19
|
PLACEBO_COMPARATOR: DAS181 COVID-19 Placebo
| DRUG: Placebo
|
What is the study measuring?
Primary outcome
Primary Outcome Measure | Primary Outcome Description | Primary Outcome Time Frame |
---|---|---|
Percent of subjects who Return to Room Air (RTRA) (main study) | Removal of all oxygen support (with stable SpO2) | by Day 28 |
Percent of subjects with improved COVID-19 Clinical Status Scale (sub-study) | Not Specified | Day 14 |
Secondary outcome
Secondary Outcome Measure | Secondary Outcome Description | Secondary Outcome Time Frame |
---|---|---|
All-cause mortality rate (main study) | Not Specified | at Day 28 |
Percent of subjects who Return to Room Air (RTRA) (main study) | Not Specified | by Day 21 |
Time (in days) to RTRA (main study) | Not Specified | Days 10, 14, 21, 28 |
Percent of subjects who achieve clinical stability (main study) | Not Specified | by Day 28 |
Percent of subjects discharged (without mortality and hospice) (main study) | Not Specified | by Days 14, 21, 28 and 35 |
Time (in days) to first hospital discharge (without hospice) (main study) | Not Specified | through Day 35 |
Total number of inpatient days (main study) | Not Specified | up to Day 35 |
Baseline SAD-RV infection-related mortality rate (main study) | Not Specified | at Day 28 |
Baseline SAD-RV infection-related mortality rate (main study) | Not Specified | at Day 35 |
All-cause mortality rate (main study) | Not Specified | at Day 35 |
Change in pulmonary function (FEV1% predicted) (main study) | Not Specified | Day 1, Day 7, Day 14, Day 28 |
Time to improved COVID19 clinical status (Sub-study) | Not Specified | Day 5, Day 10, Day 21, Day 28 |
Time to RTRA | Not Specified | Day 10, Day 14, Day 21, Day 28 |
Time to Clinical stability | Not Specified | Day 14, Day 21, Day 28 |
Time to SARS-CoV-2 RNA in the respiratory specimens being undetectable | Not Specified | Day 5, Day 10, Day 14, Day 21, Day 28 |
Time to Clinical deterioration | Not Specified | Day 5, Day 10, Day 14, Day 21, Day 28 |
Time to Discharge from hospital (without readmission before Day 28). | Not Specified | Day 14, Day 21, Day 28 |
Time to Death (all causes) | Not Specified | Day 14, Day 21, Day 28 |
Frequently Asked Questions
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