COVID-19NCT04324489
DAS181 for Severe COVID-19: Compassionate Use
A study testing DAS181 in people with COVID-19, run by Renmin Hospital of Wuhan University at 1 site in China.
Trial summary
The objective of the study is to investigate the safety and potential efficacy of DAS181 for the treatment of severe COVID-19. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- COVID-19
- What is being tested?
- DAS181
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteChina
- Study dates
- 6 Mar 2020to 30 Apr 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
The objective of the study is to investigate the safety and potential efficacy of DAS181 for the treatment of severe COVID-19.
Read the 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.
- Conditions
- COVID-19
- Being tested
- DAS181
- Keywords
- COVID-19, SARS-CoV-2, DAS181, Hypoxemia
- Medical subject headings
- COVID-19, Hypoxia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DAS181Drug
Patient receives nebulized DAS181 (4.5 mg BID/day, a total 9 mg/day) for 10 days.
| Study group | Role | What they receive |
|---|---|---|
| DAS181 Treatment | Experimental | Nebulized DAS181 9mg/day (4.5 mg bid/day) for 10 days Receives: Drug: DAS181 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improved clinical status
Percent of subjects with improved clinical status
Measured: Day 14
Return to room air
Percent of subjects return to room air
Measured: Day 14
Secondary outcomes (3)
SARS-CoV-2 RNA
time to SARS-CoV-2 RNA in the respiratory specimens being undetectable
Measured: 28 days
Discharge
Percent of patients discharge from hospital
Measured: Days 14, 21, 28
Death
All-cause mortality rate
Measured: Day 14, 21, 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2020
- Study start6 Mar 2020
- Primary completion16 Apr 2020
- Study completion30 Apr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Renmin Hospital of Wuhan University
- Sponsor type
- University, hospital or other
- Collaborators
- Ansun Biopharma, Inc.
- Responsible party
- Principal investigator, Gong Zuojiong, Renmin Hospital of Wuhan University
- Investigators
- Zuojiong Gong, MD, Principal investigator, Renmin Hospital of Wuhan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04324489
- Sponsor's protocol ID
- DAS181-SARS-CoV-2
- Status last verified
- May 2020
- First submitted
- 25 Mar 2020
- Last updated
- 5 May 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- DAS181 for Severe COVID-19: Compassionate Use
- ClinicalTrials.gov ID
- NCT04324489
- Acronym / sponsor ID
- DAS181-SARS-CoV-2
- Conditions
- COVID-19
- Keywords
- COVID-19, SARS-CoV-2, DAS181, Hypoxemia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Renmin Hospital of Wuhan UniversityUniversity, hospital or other
- Collaborators
- Ansun Biopharma, Inc.
- Study start
- 6 Mar 2020 (actual)
- Primary completion
- 16 Apr 2020 (actual)
- Study completion
- 30 Apr 2020 (actual)
- First posted
- 27 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| DAS181 Treatment | Experimental | Drug: DAS181Nebulized DAS181 9mg/day (4.5 mg bid/day) for 10 days |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DAS181Patient receives nebulized DAS181 (4.5 mg BID/day, a total 9 mg/day) for 10 days. | Drug | DAS181 Treatment |
Primary outcome
Improved clinical status
Time frame: Day 14
Percent of subjects with improved clinical status
Return to room air
Time frame: Day 14
Percent of subjects return to room air
3 secondary outcomes
SARS-CoV-2 RNA
Time frame: 28 days
Discharge
Time frame: Days 14, 21, 28
Death
Time frame: Day 14, 21, 28
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zuojiong Gong, MD principal investigator
Renmin Hospital of Wuhan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing DAS181 in people with COVID-19, run by Renmin Hospital of Wuhan University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improved clinical status (time frame: Day 14). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 May 2020.