DAS181 for Respiratory Infections

Recruiting in Palo Alto (17 mi)

+27 other locations

Age: Any Age

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Recruiting

Sponsor: Ansun Biopharma, Inc.

Must not be taking: Investigational drugs, Immunomodulating biologics

Disqualifiers: Hospice care, Severe sepsis, HIV-positive, others

Pivotal Trial (Near Approval)

Prior Safety Data

Trial Summary

What is the purpose of 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.

Do I need to stop my current medications to join the trial?

The trial does not specify if you need to stop taking your current medications, but you cannot be on any other investigational drug for pulmonary infection or certain immunomodulating biologics. It's best to discuss your specific medications with the trial team.

How is the drug DAS181 unique for treating respiratory infections like COVID-19?

DAS181 is unique because it is a nebulized drug with sialidase activity, which means it works by targeting the host cells rather than the virus itself, potentially reducing the virus's ability to attach and enter cells. This host-directed approach is different from many other treatments that directly target the virus. ^{1 2 3 4 5}

Research Team

Lisa Li

Principal Investigator

Ansun Biopharma, Inc.

Eligibility Criteria

This trial is for immunocompromised patients, including those who've had stem cell transplants or chemotherapy. It's open to adults and children with certain immune deficiencies and severe COVID-19 needing oxygen but not intensive ventilation. Participants must agree to contraception if applicable.

Inclusion Criteria

I am a man who has not had a vasectomy and will use birth control.

I have a weakened immune system due to a transplant, chemotherapy, a genetic condition, or a recent serious lung infection.

I understand and can follow the study's procedures.

Exclusion Criteria

I am currently taking a trial drug for lung infection.

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

You have certain abnormal liver function test results.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive DAS181 or placebo for 7 or 10 days depending on cohort and weight

1-2 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment, with primary outcome measured by Day 28

4 weeks

Treatment Details

Interventions

• DAS181 (Virus Therapy)
• DAS181 COVID-19 (Virus Therapy)
• DAS181 OL (Virus Therapy)
• Placebo (Other)

Trial Overview The study tests DAS181, a drug for lower respiratory infections in the immunocompromised, against a placebo. A sub-study focuses on severe COVID-19 cases. The goal is to see if DAS181 can help these patients by comparing outcomes between the drug and placebo groups.

Participant Groups

Group I: DAS181 COVID-19 Treatment Experimental Treatment 1 Intervention

DAS181 4.5mg q12h x 7 OR 10 days

Group II: Cohort 4 Experimental Treatment 1 Intervention

DAS181 4.5mg qd x 7 OR 10 days

Group III: Cohort 3 Experimental Treatment 1 Intervention

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

Group IV: Cohort 1 and Cohort 2 Treatment Experimental Treatment 1 Intervention

DAS181 4.5mg qd x 7 OR 10 days

Group V: Cohort 1 and Cohort 2 Placebo Placebo Group 1 Intervention

Placebo qd x 7 OR 10 days

Group VI: DAS181 COVID-19 Placebo Placebo Group 1 Intervention

Placebo q12h x 7 OR 10 days

DAS181 is already approved in China for the following indications:

Approved in China as DAS181 for:

• Severe hospitalized influenza infections

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Froedtert Medical College Pulmonary Clinic Milwaukee, WI

University of Kansas Medical Center Fairway, KS

Brigham and Women's Hospital Boston, MA

Duke University Durham, NC

More Trial Locations

Who Is Running the Clinical Trial?

Ansun Biopharma, Inc.

Lead Sponsor

Trials

11

Patients Recruited

1,500+

Findings from Research

In a study involving three male patients with severe COVID-19 pneumonia, nebulized DAS181 treatment for 10 days led to all patients returning to room air by day 14, indicating a significant improvement in respiratory function.

DAS181 was well tolerated with no reported adverse events, and it showed potential benefits in reducing the need for supplemental oxygen and improving clinical severity and inflammatory markers in hypoxic COVID-19 patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Resolution of Coronavirus Disease 2019 Infection and Pulmonary Pathology With Nebulized DAS181: A Pilot Study. Ho, JH., Zhao, Y., Liu, Z., et al.[2022]

A 10-month-old girl with respiratory distress due to COVID-19 was successfully treated with the investigational drug DAS181, which was well tolerated with minimal side effects.

The patient's respiratory distress and positive COVID-19 viral test quickly improved after starting DAS181 therapy, indicating its potential efficacy in treating severe respiratory symptoms associated with the virus.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Novel Treatment of Infant With COVID-19 With the Sialidase Fusion Protein, DAS181. Danziger-Isakov, L., Khalil, N., Divanovic, A., et al.[2023]

References

1. United States pubmed.ncbi.nlm.nih.gov

Resolution of Coronavirus Disease 2019 Infection and Pulmonary Pathology With Nebulized DAS181: A Pilot Study. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

A Prospective, Randomized, Open-Label Trial of Early versus Late Favipiravir Therapy in Hospitalized Patients with COVID-19. [2022]

3. Malaysia pubmed.ncbi.nlm.nih.gov

Clinical and radiological outcomes of SARS-CoV-2 related organising pneumonia in COVID-19 survivors. [2023]

4. Germany pubmed.ncbi.nlm.nih.gov

Which severe COVID-19 patients could benefit from high dose dexamethasone? A Bayesian post-hoc reanalysis of the COVIDICUS randomized clinical trial. [2023]

5. United States pubmed.ncbi.nlm.nih.gov

Novel Treatment of Infant With COVID-19 With the Sialidase Fusion Protein, DAS181. [2023]