DAS181 for Patients With Severe Hospitalized Flu and SAD-RVs (COVID-19) (STOP-Flu)

A Phase IIb Randomized Placebo-Controlled Study to Examine the Efficacy and Safety of DAS181 for the Treatment of Severe Influenza Infection

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.

Study Overview

• Status: Unknown
• Conditions: Influenza Infection; SAD-RV Infection and COVID-19
• Intervention / Treatment: Drug: DAS181; Drug: Placebo

Detailed Description

Cohort 1: It is designed as a two stage, multi-center, randomized, double-blind, two parallel doses, placebo-controlled study that will investigate the efficacy of DAS181 for the treatment of serious IFV in hospitalized patients who suffered from acute hypoxemia requiring supplemental oxygen therapy.

Cohort 2: It is designed as an open-label study that will investigate the efficacy of DAS181 for the treatment of patients with sever IFV but not eligible for Cohort 1 and non-IFV SAD viral infection, e.g. parainfluenza virus, human metapneumovirus, enterovirus and all strains of β-coronaviruses (including but not limited to SARS-CoV-2), with hypoxemia requiring supplemental oxygen therapy.

• Study Type: Interventional
• Enrollment (Anticipated): 280
• Phase: Phase 2

Contacts and Locations

Study Locations

• China
  • Shanghai, China
    • Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion criteria of Cohort 1 #4 is adapted from the Flu guideline in China (2018) and community acquired pneumonia (CAP) guideline in China (2016)

Cohort 1:

Subjects must meet all of the following inclusion criteria at the time of randomization to be eligible for participation in this study:

1. Males and Females ≥18 years old
2. Diagnosed as influenza (IFV) infection within 3 days before randomization
3. Requires, at the time of randomization, supplemental oxygen ≥2 LPM due to hypoxemia
4. Subjects are severely ill
5. In the opinion of investigator, subjects will be hospitalized at least 1 week.
6. If female, subject must not be pregnant or nursing

Cohort 2:

Subjects must meet all of the following inclusion criteria at the time of randomization to be eligible for participation in this study:

1. Males and Females ≥18 years old
2. Hypoxemia

3. Subjects fulfill one of the following conditions:

   1. IFV subjects who are eligible for all inclusion criteria of Cohort 1 except for acute hypoxemia at enrollment.
   2. Subjects confirmed with non-IFV SAD viral infection.
4. Same in inclusion criteria #5 to #8 in Cohort 1.

Exclusion Criteria

Cohort 1 and 2:

Subjects who meet any of the following exclusion criteria are not to be enrolled in this study:

1. Subjects requiring mechanical, Bi-PAP or CPAP ventilation at randomization.
2. Life expectancy less than 30 days.
3. Subjects with conscious disturbance (slow response, drowsy, restlessness, anxiety, confusion, twitching or convulsion)
4. Subjects with unstable hemodynamics such as systolic blood pressure < 90 mmHg or septic shock
5. Subjects with BUN≧7.14 mmol/L
6. Subjects treated with inhaled anti-viral therapy and washout period ≦ 48 hours.
7. If Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) or Alkaline Phosphatase (ALP) are ≥3x ULN and Total Bilirubin (TB) is ≥2x ULN.
8. 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.
9. Subjects taking any other investigational drug used to treat for another respiratory infection.
10. Psychiatric or cognitive illness or recreational drug/alcohol use that, in the opinion of the principal investigator, would affect subject safety and/or compliance.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: DAS181 SD group Cohort 1, Stage 1; DAS181 SD group 4.5mg/day for 7 or 10 days	Drug: DAS181; SD (4.5mg/day), HD (9mg/day)
Experimental: DAS181 HD group Cohort 1, Stage 1; DAS181 HD group 9mg/day for 7 or 10 days.	Drug: DAS181; SD (4.5mg/day), HD (9mg/day)
Placebo Comparator: Placebo, Cohort 1, Stage 1; Placebo 0mg/day for 7 or 10 days	Drug: Placebo; Placebo 0mg/day
Experimental: DAS181 group, Cohort 1, Stage 2; DAS181 4.5mg/day or 9mg/day. Dosage will be determined after completion of stage 1.	Drug: DAS181; SD (4.5mg/day), HD (9mg/day)
Placebo Comparator: Placebo, Cohort 1, Stage 2; Placebo 0mg/day for 7 or 10 days	Drug: Placebo; Placebo 0mg/day
Experimental: DAS181 group, Cohort 2, Stage1 and 2; DAS181 4.5mg/day or 9mg/day for 7 or 10 days	Drug: DAS181; SD (4.5mg/day), HD (9mg/day)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Ansun Biopharma, Inc.
• Investigators: Study Director: Jennifer Ho, MD, PhD, Ansun Biopharma, Inc.

Study record dates

Study Major Dates

• Study Start (Anticipated): July 1, 2020
• Primary Completion (Anticipated): March 1, 2021
• Study Completion (Anticipated): September 1, 2022

Study Registration Dates

• First Submitted: February 28, 2020
• First Submitted That Met QC Criteria: March 4, 2020
• First Posted (Actual): March 6, 2020

Study Record Updates

• Last Update Posted (Actual): July 9, 2020
• Last Update Submitted That Met QC Criteria: July 8, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Keywords: infection; Ansun; Lower Respiratory Tract Disease; DAS181; Severe hospitalized influenza; Acute Hypoxemia
• Additional Relevant MeSH Terms: Pathologic Processes; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; Disease Attributes; Orthomyxoviridae Infections; COVID-19; Infections; Communicable Diseases; Influenza, Human
• Other Study ID Numbers: DAS181-2-07

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No