DAS181 for Severe COVID-19: Compassionate Use

NCT04324489 | Completed

• 1 other identifier: DAS181-SARS-CoV-2
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of the study is to investigate the safety and potential efficacy of DAS181 for the treatment of severe COVID-19.

Conditions

COVID-19

Keywords

COVID-19; SARS-CoV-2; DAS181; Hypoxemia

Outcome Measures

Primary Outcomes (2)

• Improved clinical status

  Percent of subjects with improved clinical status

  Day 14

• Return to room air

  Percent of subjects return to room air

  Day 14

Secondary Outcomes (3)

• SARS-CoV-2 RNA

  28 days

• Discharge

  Days 14, 21, 28

• Death

  Day 14, 21, 28

Study Arms (1)

DAS181 Treatment

EXPERIMENTAL

Nebulized DAS181 9mg/day (4.5 mg bid/day) for 10 days

Drug: DAS181

Interventions

DAS181 DRUG

Patient receives nebulized DAS181 (4.5 mg BID/day, a total 9 mg/day) for 10 days.

DAS181 Treatment

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Positive for RNA of SARS-CoV-2 from respiratory specimens or blood specimens
• Hypoxemic
• Severe COVID-19
• If female, subject must not be pregnant or nursing.
• Non-vasectomized males are required to practice effective birth control methods
• Capable of understanding and complying with procedures as outlined in the protocol as judged by the Investigator and able to sign informed consent form prior to the initiation of any screening or study-specific procedures.

You may not qualify if:

• ALT or AST\> 8 x ULN
• (ALT or AST\> 3 x ULN) and (Total bilirubin\> 2.5 x ULN or INR\> 2.0 x ULN)
• Female subjects who have a positive pregnancy test and are breastfeeding
• Subjects using any other investigational antiviral drugs during the hospitalization before enrollment.
• Subjects participating in other clinical trials
• Subjects may be transferred to a non-participating hospital within 72 hours
• People who cannot cooperate well due to mental illness, have no self-control, and cannot express clearly
• Severe underlying diseases affecting survival
• Critical COVID-19 requiring mechanical ventilator at the time enrolled

Sponsors & Collaborators

• Renmin Hospital of Wuhan University: lead
• Ansun Biopharma, Inc.: collaborator

Study Sites (1)

Renmin Hospital of Wuhan University

Wuhan, Hubei, China

Location

MeSH Terms

Conditions

COVID-19; Hypoxia

Interventions

oplunofusp

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; 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

• Zuojiong Gong, MD

  Renmin Hospital of Wuhan University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Department of Infectious Disease

Study Record Dates

• First Submitted: March 25, 2020
• First Posted: March 27, 2020
• Study Start: March 6, 2020
• Primary Completion: April 16, 2020
• Study Completion: April 30, 2020
• Last Updated: May 5, 2020

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)