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Phase III DAS181 Lower Tract PIV Infection in Immunocompromised Subjects (Substudy: DAS181 for COVID-19): RCT Study

ConditionsLower Respiratory Tract InfectionParainfluenzaImmunocompromisedCOVID-19
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
AgeNot listed
SponsorAnsun Biopharma, Inc.

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

At the time of randomization, requires supplemental oxygen ≥2 LPM due to hypoxemia.

Received an autologous or allogeneic hematopoietic stem cell transplantation (HSCT) at any time in the past

Received a solid organ transplant at any time in the past

Has been or is currently being treated with chemotherapy for hematologic malignancies (e.g., leukemia, myeloma, lymphoma) and/or solid tumor malignancies (e.g., lung, breast, brain cancer) at any time in the past

Disqualifiers

Subjects may not be on hospice care or, in the opinion of the investigator, have a low chance of survival during the first 10 days of treatment

Subjects with Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), or Alkaline Phosphatase (ALP) ≥3x ULN and Total Bilirubin (TBILI) ≥2x ULN Note: Subjects with ALT/AST/ALP ≥ 3x ULN AND TB ≥2x ULN that have been chronically stable (for >1 year on more than one assessments) due to known liver pathology including malignancy (primary or metastasis), chronic medications, transplantation, or chronic infection will not be excluded

Female subjects breastfeeding or planning to breastfeed at any time through 30 days after the last dose of study drug

Subjects taking any other investigational drug used to treat pulmonary infection.

Trial design

Design model

Parallel

Treatments tested in this trial

  • DAS181

    Drug

    DAS181 4.5mg nebulized qd x 7 OR 10 days

  • Placebo

    Drug

    Placebo nebulized qd x 7 OR 10 days

  • DAS181 COVID-19

    Drug

    DAS181 4.5mg nebulized q12h/day x 7 OR 10 days

  • DAS181 OL

    Drug

    DAS181 4.5mg nebulized qd x 7 OR 10 days ≥ 40kg DAS181 2.5mg nebulized qd x 7 OR 10 days \< 40kg

Treatment groups

274 Participants
are divided into 6 treatment groups

6

Treatment groups

See each treatment group below.

Group A: Cohort 1 and Cohort 2 TreatmentExperimental treatment 1 intervention
Group B: Cohort 1 and Cohort 2 PlaceboPlacebo comparator 1 intervention
Group C: Cohort 3Experimental treatment 1 intervention
Group D: Cohort 4Experimental treatment 1 intervention
Group E: DAS181 COVID-19 TreatmentExperimental treatment 1 intervention
Group F: DAS181 COVID-19 PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Percent of subjects who Return to Room Air (RTRA) (main study)

Removal of all oxygen support (with stable SpO2)

Time frame
by Day 28
2

Percent of subjects with improved COVID-19 Clinical Status Scale (sub-study)

Time frame
Day 14

Secondary outcomes

1

All-cause mortality rate (main study)

Time frame
at Day 28
2

Percent of subjects who Return to Room Air (RTRA) (main study)

Time frame
by Day 21
3

Time (in days) to RTRA (main study)

Time frame
Days 10, 14, 21, 28
4

Percent of subjects who achieve clinical stability (main study)

Time frame
by Day 28

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Ansun Biopharma, Inc.

Lead sponsor

Source ClinicalTrials.gov
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