DAS181 for Respiratory Infections

Recruiting at 27 trial locations

Overseen By Lana Ordonez

Age: Any Age

Sex: Any

Trial Phase: Phase 3

Sponsor: Ansun Biopharma, Inc.

Must not be taking: Investigational drugs, Immunomodulating biologics

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

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 1-2 weeks

274 Participants Needed

Trial Summary

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}

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.

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.

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
• DAS181 COVID-19
• DAS181 OL
• Placebo

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 United States, European Union, China for the following indications:

Approved in United States as DAS181 for:

• Lower respiratory tract parainfluenza virus infections in immunocompromised patients
• Severe COVID-19

Approved in European Union as DAS181 for:

• Lower respiratory tract parainfluenza virus infections in immunocompromised patients
• Severe COVID-19

Approved in China as DAS181 for:

• Severe hospitalized influenza infections

Who Is Running the Clinical Trial?

Ansun Biopharma, Inc.

Lead Sponsor

Trials

11

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]

In a study involving 89 patients with mild COVID-19, favipiravir did not significantly improve viral clearance by day 6, but it was associated with a faster reduction in fever duration, suggesting potential benefits in symptom management.

The treatment was generally safe, with no disease progression or deaths reported during the 28-day study period, although 84.1% of patients experienced transient hyperuricemia as a side effect.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Prospective, Randomized, Open-Label Trial of Early versus Late Favipiravir Therapy in Hospitalized Patients with COVID-19. Doi, Y., Hibino, M., Hase, R., et al.[2022]

In a study of 131 post-COVID-19 patients, about one-third continued to experience symptoms like cough and fatigue three months after discharge, indicating ongoing health issues related to COVID-19-related organizing pneumonia.

Despite persistent symptoms, most patients showed significant improvement in their lung imaging, with 94.8% of those who had follow-up CT scans demonstrating improvement, although those who had been in intensive care or on mechanical ventilation had poorer outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical and radiological outcomes of SARS-CoV-2 related organising pneumonia in COVID-19 survivors. Kho, SS., Lim, KC., Muhammad, NA., et al.[2023]

In a post hoc analysis of 473 patients from the COVIDICUS trial, high-dose dexamethasone (DXM20) may provide a significant benefit for patients under 70 years old with acute respiratory failure if treatment is initiated within 7 days of symptom onset.

The analysis also indicated that patients receiving remdesivir had a higher probability of benefiting from high-dose dexamethasone, suggesting that certain patient characteristics can influence treatment efficacy.

NCBI (Pubmed)

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. Chevret, S., Bouadma, L., Dupuis, C., et al.[2023]

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]