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

Sponsor

Ansun Biopharma, Inc. (Industry)

Overall Status

Not yet recruiting

CT.gov ID

NCT04298060

Collaborator

(none)

280

Enrollment

Location

Arms

Anticipated Duration (Months)

10.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Influenza Infection SAD-RV Infection and COVID-19	Drug: DAS181 Drug: Placebo	Phase 2

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 Design

Study Type:

Interventional

Anticipated Enrollment :

280 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Care Provider, Investigator)

Masking Description:

Stage 2, Ansun will know the dosage.

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Jul 1, 2020

Anticipated Primary Completion Date :

Mar 1, 2021

Anticipated Study Completion Date :

Sep 1, 2022

Arms and Interventions

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)

Outcome Measures

Primary Outcome Measures

Percent of subjects who have returned to room air [7 days]
Percent of subjects who have returned to room air
Percent change of subjects return to baseline oxygen requirement [7 days]
Percent change of subjects return to baseline oxygen requirement by Day 7 compared to Day 1

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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:

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:

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

Males and Females ≥18 years old
Hypoxemia
Subjects fulfill one of the following conditions:
IFV subjects who are eligible for all inclusion criteria of Cohort 1 except for acute hypoxemia at enrollment.
Subjects confirmed with non-IFV SAD viral infection.
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:

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.