DAS181 for STOP COVID-19

DAS181 for COVID-19: A Phase II Multicenter, Randomized, Placebo-Controlled, Double-Blind Study

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.

Study Overview

• Status: Withdrawn
• Conditions: COVID-19
• Intervention / Treatment: Drug: DAS181; Drug: DAS181; Drug: Placebo

Detailed Description

The first stage is randomized, double-blind study to confirm the optimal dose of the study. Twenty-two (n=22) subjects with COVID-19 and clinically significant impairment of respiratory function will be enrolled to evaluate the two dosing regimens (4.5mg-q.d or 4.5mg-b.i.d) of DAS181. At the end of Stage 1, the Sponsor will evaluate the dose regimen based on the safety and efficacy assessments of the data. An optimal dose will be selected to proceed to Stage 2.

The second stage is a randomized, placebo-controlled and double-blind study to expand enrollment with an additional eighty-two (n=82) subjects to provide adequate power to potentially demonstrate statistically significant therapeutic efficacy.

• Study Type: Interventional
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• Italy
  • Milano, Italy
    • Fondazione Irccs Ca' Granda - Ospedale Maggiore Policlinico
  • Modena, Italy
    • A.O.U Policlinico di Modena

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:

1. Be ≥18 years of age
2. Provide adequate medical history to permit accurate stratification by health status
3. Prior to SARS CoV 2 infection, has no chronic or recurring requirement for supplemental oxygen
4. Have lower respiratory tract infection (LRTI) confirmed by imaging
5. Has laboratory-confirmation of the presence of SARS-CoV-2 in the respiratory tract

6. 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:

   1. Respiratory rate ≥ 30 breaths/min
   2. SpO2 ≤93% at rest
   3. PaO2/FiO2≤300 mmHg
   4. Showing the progression of lung lesions within 24 to 48h by >50%

7. If female, subject must meet one of the following conditions:

   1. Not be of childbearing potential or
   2. Be of childbearing potential and have a negative urine/serum pregnancy test and agrees to practice an acceptable method of contraception
8. Non-vasectomized males are required to practice effective birth control methods
9. Capable of understanding and complying with procedures as outlined in the protocol
10. Provides signed informed consent prior to the initiation of any screening or study-specific procedures

Exclusion Criteria:

1. At the time of randomization, classified as critical (life-threatening) disease
2. Subjects currently receiving any other investigational drug, as part of a clinical trial or under emergency approval for SARS-CoV-2
3. Subjects who are known asthmatic patients or HIV-positive
4. Subjects who are currently receiving inhaled biologics or anti-viral agents
5. 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
6. Subjects with Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), or Alkaline Phosphatase (ALP) ≥3x ULN and Total Bilirubin (TBILI) ≥2xULN
7. Female subjects breastfeeding or planning to breastfeed at any time through 30 days after the last dose of study drug.
8. Psychiatric or cognitive illness or recreational drug/alcohol use that, in the opinion of the principal investigator, would affect subject safety and/or compliance.
9. Subjects with known hypersensitivity to DAS181 and/or any of its components.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: DAS181 b.i.d.+ standard local care for COVID-19; 4.5 mg DAS181 b.i.d nebulized inhalation for 10 consecutive days + standard local care for COVID-19	Drug: DAS181; 4.5 mg b.i.d; Drug: DAS181; 4.5 mg q.d.
Placebo Comparator: Placebo+ standard local care for COVID-19; nebulized inhalation for 10 consecutive days + standard local care for COVID-19	Drug: Placebo; q.d. or b.i.d.
Experimental: DAS181 q.d.+ standard local care for COVID-19; 4.5 mg placebo q.d. nebulized inhalation for 10 consecutive days + standard local care for COVID-19	Drug: DAS181; 4.5 mg b.i.d; Drug: DAS181; 4.5 mg q.d.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Percent of subjects return to room air (RTRA)	Day 14

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percent of subjects who have recovered	Percent of subjects who reach level 1 of COVID-19 Clinical Classification (discharged or return to normal activity)	Day 5, 10, 14, 21, 28
Improved COVID-19 Clinical Classification	time to Improved COVID-19 Clinical Classification 1 to 6 (where higher score means worse outcome)	Day 28
Return To Room Air (RTRA)	Percent of subjects RTRA	Day 10, 21, 28
Percent of subjects who achieve clinical stability		Day 28
SARS-CoV-2 RNA undetectable	Time to	Day 28
Clinical Deterioration	Time to	Day 28
Percent of subjects discharged	Percent of subjects discharge	Day 14, 21, 28
Death (all cause)	Time to	Day 28

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 25, 2020
• Primary Completion (Anticipated): September 30, 2020
• Study Completion (Anticipated): November 30, 2020

Study Registration Dates

• First Submitted: April 15, 2020
• First Submitted That Met QC Criteria: April 16, 2020
• First Posted (Actual): April 21, 2020

Study Record Updates

• Last Update Posted (Actual): August 11, 2020
• Last Update Submitted That Met QC Criteria: August 7, 2020
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Keywords: SARS-CoV-2; Coronavirus; COVID-19; Hypoxemia; Ansun; Lower Respiratory Tract Disease; DAS181
• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: DAS181-2-08; 2020-003192-17 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes