DAS181 for Severe COVID-19: Compassionate Use
Latest Information Update: 06 May 2020
At a glance
- Drugs Oplunofusp (Primary)
- Indications COVID 2019 infections
- Focus Expanded access; Therapeutic Use
- 01 May 2020 Status changed from recruiting to completed.
- 02 Apr 2020 According to an Ansun Biopharma Media Release, in the first 14 days, the first two patients no longer required supplemental oxygen, and showed stabilized vital signs, increased oxygen saturation, and resolution of infiltrates on chest CT scans. The third patient, who had been a persistent SARS-CoV-2 carrier for more than 33 days, was completely virus-free before the end of the 10-day DAS181 regimen and met all discharge criteria, and the fourth is currently undergoing treatment.
- 02 Apr 2020 According to an Ansun Biopharma Media Release, Dr. Ke Hu is the principal investigator.
Most Recent Events
Trial Overview
Purpose
The objective of the study is to investigate the safety and potential efficacy of DAS181 for the treatment of severe COVID-19.
Primary Endpoints
Improved clinical status
description: Percent of subjects with improved clinical status
time_frame: Day 14
Return to room air
description: Percent of subjects return to room air
time_frame: Day 14
Other Endpoints
SARS-CoV-2 RNA
description: time to SARS-CoV-2 RNA in the respiratory specimens being undetectable
time_frame: 28 days
Discharge
description: Percent of patients discharge from hospital
time_frame: Days 14, 21, 28
Death
description: All-cause mortality rate
time_frame: Day 14, 21, 28 [1]
Diseases Treated
Indication | Qualifiers | Patient Segments |
---|---|---|
COVID 2019 infections | treatment | - |
Subjects
- Subject Type patients
-
Number
Planned: 4
Actual: 4
- Sex male & female
- Age Group 18-70 years; adult; elderly
Patient Inclusion Criteria
Key 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.
Patient 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
Trial Details
Identifiers
Identifier | Owner |
---|---|
NCT04324489 | ClinicalTrials.gov: US National Institutes of Health |
DAS181SARS-CoV2 | - |
Organisations
- Affiliations Ansun Biopharma
Trial Dates
-
Initiation Dates
Actual : 06 Mar 2020
-
Primary Completion Dates
Planned : 25 Apr 2020
Actual : 16 Apr 2020
-
End Dates
Planned : 30 Apr 2020
Actual : 30 Apr 2020
Other Details
- Design open; prospective
- Phase of Trial Clinical Phase Unknown
- Location China
- Focus Expanded access; Therapeutic Use
Interventions
Drugs | Route | Formulation |
---|---|---|
OplunofuspPrimary Drug | Inhalation | Powder |
DAS181 Treatment
Nebulized DAS181 9mg/day (4.5 mg bid/day) for 10 days
Drug: DAS181 (Patient receives nebulized DAS181 (4.5 mg BID/day, a total 9 mg/day) for 10 days.)
Results
Therapeutic efficacy
Preliminary results from an investigator-initiated programme in four evaluable patients showcased that the first two patients precluded the need for supplemental oxygen while displaying stabilised vital signs, enhanced oxygen saturation and infiltrate resolution, as apparent from chest CT scans. The third patient, who was a persistent SARS-CoV-2 carrier for more than 33 days, was completely relieved of the virus, before the end of the 10th day drug regimen, meeting all discharge criteria. The fourth patient was undergoing treatment and exhibiting positive trends [2] .
2020-04-08 11:06:33.517
Publications
-
Ansun Biopharma. Ansun Biopharma Announces Positive Results from Investigator-Initiated Trial of Novel COVID-19 Treatment. Media-Rel 2020;.
Media Release
Trial Centres
Investigators
Investigator | Centre Name | Trial Centre Country |
---|---|---|
Kejx Hu, MD
027-88999120
show details
hukejx@163.com |
-
|
|
Zuojiong Gong, MD
027-88999120
show details
zjgong@163.com |
Renmin Hospital of Wuhan University | China |
Zuojiong Guong, MD | Renmin Hospital of Wuhan University | China |
Centres
Centre Name | Location | Trial Centre Country |
---|---|---|
- |
-
|
-
|
Ansun Biopharma, Inc. |
-
|
-
|
Renmin Hospital of Wuhan University |
-
|
-
|
Renmin Hospital of Wuhan University | Wuhan, Hubei | China |
Trial History
Event Date | Event Type | Comment |
---|---|---|
06 May 2020 | Other trial event | Last checked against ClinicalTrials.gov record. Updated 06 May 2020 |
01 May 2020 | Status change - completed | Status changed from recruiting to completed. Updated 06 May 2020 |
02 Apr 2020 | Other trial event | According to an Ansun Biopharma Media Release, in the first 14 days, the first two patients no longer required supplemental oxygen, and showed stabilized vital signs, increased oxygen saturation, and resolution of infiltrates on chest CT scans. The third patient, who had been a persistent SARS-CoV-2 carrier for more than 33 days, was completely virus-free before the end of the 10-day DAS181 regimen and met all discharge criteria, and the fourth is currently undergoing treatment. Updated 06 Apr 2020 |
02 Apr 2020 | Other trial event | According to an Ansun Biopharma Media Release, Dr. Ke Hu is the principal investigator. Updated 06 Apr 2020 |
02 Apr 2020 | Results | Results published in the Ansun Biopharma Media Release. Updated 06 Apr 2020 |
30 Mar 2020 | New trial record | New trial record Updated 30 Mar 2020 |
Table of Contents
References
-
ClinicalTrials.gov: US National Institutes of Health. Trial-Reg 2023;.
Available from: URL: http://clinicaltrials.gov -
Ansun Biopharma. Ansun Biopharma Announces Positive Results from Investigator-Initiated Trial of Novel COVID-19 Treatment. Media-Rel 2020;.
Media Release
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