DAS181 for STOP COVID-19

NCT04354389 | Withdrawn Phase 2 FDA Drug

• 2 other identifiers: DAS181-2-082020-003192-17
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 2

Brief Summary

It is a multicenter, randomized, placebo-controlled, double-blind study. The study population is defined as subjects diagnosed with lower respiratory tract COVID-19 who require supplemental oxygen ≥2 LPM at the time of randomization.

Conditions

COVID-19

Keywords

COVID-19; Lower Respiratory Tract Disease; DAS181; SARS-CoV-2; Coronavirus; Hypoxemia; Ansun

Outcome Measures

Primary Outcomes (1)

• Percent of subjects return to room air (RTRA)

  Day 14

Secondary Outcomes (8)

• Percent of subjects who have recovered

  Day 5, 10, 14, 21, 28

• Improved COVID-19 Clinical Classification

  Day 28

• Return To Room Air (RTRA)

  Day 10, 21, 28

• Percent of subjects who achieve clinical stability

  Day 28

• SARS-CoV-2 RNA undetectable

  Day 28

Study Arms (3)

DAS181 b.i.d.+ standard local care for COVID-19

EXPERIMENTAL

4.5 mg DAS181 b.i.d nebulized inhalation for 10 consecutive days + standard local care for COVID-19

Drug: DAS181

Placebo+ standard local care for COVID-19

PLACEBO COMPARATOR

nebulized inhalation for 10 consecutive days + standard local care for COVID-19

Drug: Placebo

DAS181 q.d.+ standard local care for COVID-19

EXPERIMENTAL

4.5 mg placebo q.d. nebulized inhalation for 10 consecutive days + standard local care for COVID-19

Drug: DAS181

Interventions

DAS181 DRUG

4.5 mg b.i.d

DAS181 q.d.+ standard local care for COVID-19

Placebo DRUG

q.d. or b.i.d.

Placebo+ standard local care for COVID-19

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Be ≥18 years of age
• Provide adequate medical history to permit accurate stratification by health status
• Prior to SARS CoV 2 infection, has no chronic or recurring requirement for supplemental oxygen
• Have lower respiratory tract infection (LRTI) confirmed by imaging
• Has laboratory-confirmation of the presence of SARS-CoV-2 in the respiratory tract
• At the time of randomization, requires supplemental oxygen ≥2 LPM for treatment of hypoxia or pulmonary stress as evidenced by at least one of the following:
• Respiratory rate ≥ 30 breaths/min
• SpO2 ≤93% at rest
• PaO2/FiO2≤300 mmHg
• Showing the progression of lung lesions within 24 to 48h by \>50%
• If female, subject must meet one of the following conditions:
• Not be of childbearing potential or
• Be of childbearing potential and have a negative urine/serum pregnancy test and agrees to practice an acceptable method of contraception
• Non-vasectomized males are required to practice effective birth control methods
• Capable of understanding and complying with procedures as outlined in the protocol

You may not qualify if:

• At the time of randomization, classified as critical (life-threatening) disease
• Subjects currently receiving any other investigational drug, as part of a clinical trial or under emergency approval for SARS-CoV-2
• Subjects who are known asthmatic patients or HIV-positive
• Subjects who are currently receiving inhaled biologics or anti-viral agents
• Subjects with severe sepsis due to either their SARS-CoV-2 infection or a concurrent viral, bacterial, or fungal infection with vital organ failure or required vasopressors to maintain blood pressure
• Subjects with Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), or Alkaline Phosphatase (ALP) ≥3x ULN and Total Bilirubin (TBILI) ≥2xULN
• Female subjects breastfeeding or planning to breastfeed at any time through 30 days after the last dose of study drug.
• Psychiatric or cognitive illness or recreational drug/alcohol use that, in the opinion of the principal investigator, would affect subject safety and/or compliance.
• Subjects with known hypersensitivity to DAS181 and/or any of its components.

Sponsors & Collaborators

• Ansun Biopharma, Inc.: lead

Study Sites (2)

Fondazione IRCCS Ca' Granda - Ospedale Maggiore Policlinico

Milan, Italy

Location

A.O.U Policlinico Di Modena

Modena, Italy

Location

MeSH Terms

Conditions

COVID-19; Coronavirus Infections; Hypoxia

Interventions

oplunofusp

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Jennifer Ho, MD, PhD

  Ansun Biopharma, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 15, 2020
• First Posted: April 21, 2020
• Study Start: July 25, 2020
• Primary Completion: September 30, 2020
• Study Completion: November 30, 2020
• Last Updated: August 11, 2020

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will not share

Locations

IT (2)