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

Phase 2

• Conditions: Influenza Infection; SAD-RV Infection and COVID-19
• Interventions: Drug: Placebo; Drug: DAS181

• Registration Number: NCT04298060
• Lead Sponsor: Ansun Biopharma, Inc.

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.

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 Timeline

• Study First Submitted: 2020-02-28
• Study First Submitted QC: 2020-03-04
• Study First Posted: 2020-03-06
• Status Verified: 2020-07
• Study Start: 2020-07
• Last Update Submitted: 2020-07-08
• Last Update Posted: 2020-07-09
• Primary Completion: 2021-03
• Study Completion: 2022-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 280

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo, Cohort 1, Stage 2	Placebo	Placebo 0mg/day for 7 or 10 days
DAS181 group, Cohort 2, Stage1 and 2	DAS181	DAS181 4.5mg/day or 9mg/day for 7 or 10 days
Placebo, Cohort 1, Stage 1	Placebo	Placebo 0mg/day for 7 or 10 days
DAS181 HD group Cohort 1, Stage 1	DAS181	DAS181 HD group 9mg/day for 7 or 10 days.
DAS181 group, Cohort 1, Stage 2	DAS181	DAS181 4.5mg/day or 9mg/day. Dosage will be determined after completion of stage 1.
DAS181 SD group Cohort 1, Stage 1	DAS181	DAS181 SD group 4.5mg/day for 7 or 10 days

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine; 🇨🇳 Shanghai, China