DAS181 for STOP COVID-19

Phase 2

Withdrawn

• Conditions: COVID-19
• Interventions: Drug: Placebo; Drug: DAS181

• Registration Number: NCT04354389
• Lead Sponsor: Ansun Biopharma, Inc.

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.

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 Timeline

• Study First Submitted: 2020-04-15
• Study First Submitted QC: 2020-04-16
• Study First Posted: 2020-04-21
• Study Start: 2020-07-25
• Status Verified: 2020-08
• Last Update Submitted: 2020-08-07
• Last Update Posted: 2020-08-11
• Primary Completion: 2020-09-30
• Study Completion: 2020-11-30

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Placebo+ standard local care for COVID-19	Placebo	nebulized inhalation for 10 consecutive days + standard local care for COVID-19
DAS181 q.d.+ standard local care for COVID-19	DAS181	4.5 mg placebo q.d. nebulized inhalation for 10 consecutive days + standard local care for COVID-19
DAS181 b.i.d.+ standard local care for COVID-19	DAS181	4.5 mg DAS181 b.i.d nebulized inhalation for 10 consecutive days + standard local care for COVID-19

Primary Outcome Measures

Name	Time	Method
Percent of subjects return to room air (RTRA)	Day 14

Secondary Outcome Measures

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

Trial Locations

Locations (2)

A.O.U Policlinico Di Modena; 🇮🇹 Modena, Italy

Fondazione IRCCS Ca' Granda - Ospedale Maggiore Policlinico; 🇮🇹 Milano, Italy