v3.0.7
Please consider this website is continuously evolving and still under development
to harmonize automatic data extraction and integrate manual data annotation.
| Column | Value |
|---|---|
| Trial registration number | NCT04398303 |
|
Full text link
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
|
|
First author
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
|
|
Contact
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
regulatory@aspire2cure.com |
|
Registration date
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
2020-05-21 |
|
Recruitment status
Last imported at : May 11, 2022, 6 a.m. Source : ClinicalTrials.gov |
Unknown |
|
Study design
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
RCT |
|
Allocation
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
Randomized |
|
Design
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
Parallel |
|
Masking
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
Blind label |
|
Center
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
unclear |
|
Study aim
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
Treatment |
|
Inclusion criteria
Last imported at : Nov. 16, 2021, 6:30 p.m. Source : ClinicalTrials.gov |
inclusion criteria: male or female patients age 18 to 85, inclusive confirmed positive test for covid-19 by standard reverse transcriptase polymerase chain reaction (rt-pcr) assay or equivalent on mechanical ventilation (n=35), or high-flow o2 support (n=35) and: disease severity level of "moderate" (pao2/fio2 of 100-200) (n=35), or "severe" (pao2/fio2 < 100) (n=35) as established using the berlin criteria for ards (barbas, isola & caser, 2014; baron & levy, 2016). positive end-expiratory airway pressure (peep) ≥ 5 cmh2o oxygen saturation ≤ 93% non-cardiogenic bilateral pulmonary edema on frontal chest radiograph that cannot be explained by effusion, collapsed lung or lung nodule able to understand and provide voluntary informed consent |
|
Exclusion criteria
Last imported at : Nov. 16, 2021, 6:30 p.m. Source : ClinicalTrials.gov |
unable to understand and provide voluntary informed consent current infection with hiv-1, hiv-2, hepatitis b, hepatitis c or htlv history of malignancy, other than non-melanoma skin cancer or non-metastatic prostate cancer currently receiving extracorporeal life support or high-frequency oscillatory ventilation weight > 150 kg current severe chronic respiratory disease, as demonstrated by: paco2 > 50 mm hg, or history of use of home oxygen major trauma within the past 7 days lung transplant recipient who class iii or iv pulmonary hypertension documented deep vein thrombosis or pulmonary embolism within the past 3 months currently pregnant or lactating currently participating in another clinical trial, or participation in another clinical trial within 30 days of enrollment hypersensitivity to dextran-40 or dimethyl sulfoxide (dmso) current pharmacotherapy using hydroxychloroquine or interleukin-6 inhibitors history of cva or mi within 180 days of study enrollment |
|
Number of arms
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
3 |
|
Funding
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
Aspire Health Science |
|
Inclusion age min
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
18 |
|
Inclusion age max
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
85 |
|
Countries
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
None |
|
Type of patients
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
Severe/critical disease at enrollment |
|
Severity scale
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
7: Severe/critical disease at enrollment |
|
Total sample size
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
70 |
|
primary outcome
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
Mortality at day 30 |
|
Notes
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
None |
|
Phase
Last imported at : Feb. 25, 2021, 7:58 p.m. Source : ClinicalTrials.gov |
Phase 1/Phase 2 |
|
Arms
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
[{"arm_notes": "", "treatment_id": 22, "treatment_name": "Act-20-msc", "treatment_type": "Advanced therapy medicinal products (atmp)", "pharmacological_treatment": "Biological treatment"}, {"arm_notes": "", "treatment_id": 21, "treatment_name": "Act-20-cm", "treatment_type": "Advanced therapy medicinal products (atmp)", "pharmacological_treatment": "Biological treatment"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}] |