NCT04298060

Brief Summary

This is a Phase IIb study consisting of two cohorts to evaluate efficacy, safety and pharmacokinetics of DAS181 in IFV infection. An approximate total of 280 subjects will be enrolled into this study.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
280

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Jul 2020

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 28, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 6, 2020

Completed
4 months until next milestone

Study Start

First participant enrolled

July 1, 2020

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2021

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2022

Completed
Last Updated

July 9, 2020

Status Verified

July 1, 2020

Enrollment Period

8 months

First QC Date

February 28, 2020

Last Update Submit

July 8, 2020

Conditions

Influenza InfectionSAD-RV Infection and COVID-19

Keywords

Severe hospitalized influenzaLower Respiratory Tract DiseaseAcute HypoxemiaDAS181Ansuninfection

Outcome Measures

Primary Outcomes (2)

  • Percent of subjects who have returned to room air

    Percent of subjects who have returned to room air

    7 days

  • Percent change of subjects return to baseline oxygen requirement

    Percent change of subjects return to baseline oxygen requirement by Day 7 compared to Day 1

    7 days

Study Arms (6)

DAS181 SD group Cohort 1, Stage 1

EXPERIMENTAL

DAS181 SD group 4.5mg/day for 7 or 10 days

Drug: DAS181

DAS181 HD group Cohort 1, Stage 1

EXPERIMENTAL

DAS181 HD group 9mg/day for 7 or 10 days.

Drug: DAS181

Placebo, Cohort 1, Stage 1

PLACEBO COMPARATOR

Placebo 0mg/day for 7 or 10 days

Drug: Placebo

DAS181 group, Cohort 1, Stage 2

EXPERIMENTAL

DAS181 4.5mg/day or 9mg/day. Dosage will be determined after completion of stage 1.

Drug: DAS181

Placebo, Cohort 1, Stage 2

PLACEBO COMPARATOR

Placebo 0mg/day for 7 or 10 days

Drug: Placebo

DAS181 group, Cohort 2, Stage1 and 2

EXPERIMENTAL

DAS181 4.5mg/day or 9mg/day for 7 or 10 days

Drug: DAS181

Interventions

DAS181DRUG

SD (4.5mg/day), HD (9mg/day)

DAS181 HD group Cohort 1, Stage 1DAS181 SD group Cohort 1, Stage 1DAS181 group, Cohort 1, Stage 2DAS181 group, Cohort 2, Stage1 and 2
PlaceboDRUG

Placebo 0mg/day

Placebo, Cohort 1, Stage 1Placebo, Cohort 1, Stage 2

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Cohort 1:
  • Males and Females ≥18 years old
  • Diagnosed as influenza (IFV) infection within 3 days before randomization
  • Requires, at the time of randomization, supplemental oxygen ≥2 LPM due to hypoxemia
  • Subjects are severely ill
  • In the opinion of investigator, subjects will be hospitalized at least 1 week.
  • If female, subject must not be pregnant or nursing
  • Cohort 2:
  • Males and Females ≥18 years old
  • Hypoxemia
  • Subjects fulfill one of the following conditions:
  • Subjects confirmed with non-IFV SAD viral infection.

You may not qualify if:

  • Cohort 1 and 2:
  • Subjects requiring mechanical, Bi-PAP or CPAP ventilation at randomization.
  • Life expectancy less than 30 days.
  • Subjects with conscious disturbance (slow response, drowsy, restlessness, anxiety, confusion, twitching or convulsion)
  • Subjects with unstable hemodynamics such as systolic blood pressure \< 90 mmHg or septic shock
  • Subjects with BUN≧7.14 mmol/L
  • Subjects treated with inhaled anti-viral therapy and washout period ≦ 48 hours.
  • If Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) or Alkaline Phosphatase (ALP) are ≥3x ULN and Total Bilirubin (TB) is ≥2x ULN.
  • Female subjects with positive pregnancy test result, 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 for another respiratory infection.
  • Psychiatric or cognitive illness or recreational drug/alcohol use that, in the opinion of the principal investigator, would affect subject safety and/or compliance.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

Shanghai, China

Location

MeSH Terms

Conditions

COVID-19Infections

Interventions

oplunofusp

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Jennifer Ho, MD, PhD

    Ansun Biopharma, Inc.

    STUDY DIRECTOR

Central Study Contacts

Ivy Fan

CONTACT

+86 186 2190 9313ifan@ansunbiopharma.com

Sylvie Lu-Hinh

CONTACT

858-452-2631slu-hinh@ansunbiopharma.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Masking Details
Stage 2, Ansun will know the dosage.
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 28, 2020

First Posted

March 6, 2020

Study Start

July 1, 2020

Primary Completion

March 1, 2021

Study Completion

September 1, 2022

Last Updated

July 9, 2020

Record last verified: 2020-07

Locations

CN(1)