DAS181 for Severe COVID-19: Compassionate Use

Not Applicable

Completed

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

• Registration Number: NCT04324489
• Lead Sponsor: Renmin Hospital of Wuhan University

Brief Summary

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

Detailed Description

Each eligible subject is treated with DAS181 for 10 days and observed for 28 days from the first day of administration.

From day 1 to 10, once or twice a day, for 10 consecutive days, a total of 9 mg (7 ml) nebulized DAS181 is given. If DAS181 is given by twice a day, one vial containing 4.5 mg (3.5m1) DAS181 should be delivered with about 12-hour interval.

Study Timeline

• Study Start: 2020-03-06
• Study First Submitted: 2020-03-25
• Study First Submitted QC: 2020-03-25
• Study First Posted: 2020-03-27
• Primary Completion: 2020-04-16
• Study Completion: 2020-04-30
• Status Verified: 2020-05
• Last Update Submitted: 2020-05-01
• Last Update Posted: 2020-05-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 4

Inclusion Criteria

1. Positive for RNA of SARS-CoV-2 from respiratory specimens or blood specimens
2. Hypoxemic
3. Severe COVID-19
4. If female, subject must not be pregnant or nursing.
5. Non-vasectomized males are required to practice effective birth control methods
6. 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.

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
DAS181 Treatment	DAS181	Nebulized DAS181 9mg/day (4.5 mg bid/day) for 10 days

Primary Outcome Measures

Name	Time	Method
Improved clinical status	Day 14	Percent of subjects with improved clinical status
Return to room air	Day 14	Percent of subjects return to room air

Secondary Outcome Measures

Name	Time	Method
Discharge	Days 14, 21, 28	Percent of patients discharge from hospital
Death	Day 14, 21, 28	All-cause mortality rate
SARS-CoV-2 RNA	28 days	time to SARS-CoV-2 RNA in the respiratory specimens being undetectable

Trial Locations

Locations (1)

Renmin Hospital of Wuhan University; 🇨🇳 Wuhan, Hubei, China