| Trial registration number
|
NCT05241067 |
Full text link
Last imported at : Feb. 16, 2022, 4:30 p.m.
Source : ClinicalTrials.gov
|
https://clinicaltrials.gov/show/NCT05241067
|
First author
Last imported at : Feb. 16, 2022, 4:30 p.m.
Source : ClinicalTrials.gov
|
Not reported
|
Contact
Last imported at : Feb. 16, 2022, 4:30 p.m.
Source : ClinicalTrials.gov
|
Not reported
|
Registration date
Last imported at : Feb. 16, 2022, 4:30 p.m.
Source : ClinicalTrials.gov
|
2022-02-15
|
Recruitment status
Last imported at : Feb. 16, 2022, 4:30 p.m.
Source : ClinicalTrials.gov
|
Not recruiting
|
Study design
Last imported at : Feb. 16, 2022, 4:30 p.m.
Source : ClinicalTrials.gov
|
RCT
|
Allocation
Last imported at : Feb. 16, 2022, 4:30 p.m.
Source : ClinicalTrials.gov
|
Randomized
|
Design
Last imported at : Feb. 16, 2022, 4:30 p.m.
Source : ClinicalTrials.gov
|
Parallel
|
Masking
Last imported at : Feb. 16, 2022, 4:30 p.m.
Source : ClinicalTrials.gov
|
Blind label
|
Center
Last imported at : Feb. 16, 2022, 4:30 p.m.
Source : ClinicalTrials.gov
|
multi-center
|
Study aim
Last imported at : Feb. 16, 2022, 4:30 p.m.
Source : ClinicalTrials.gov
|
Treatment
|
Inclusion criteria
Last imported at : Feb. 16, 2022, 4:30 p.m.
Source : ClinicalTrials.gov
|
inclusion criteria:
a subject will be eligible for inclusion in the study if he/she fulfils the following criteria:
adult males or females aged 18 years or older
rt-pcr confirmation for sars-cov2 infection from respiratory tract specimens)
currently hospitalized and intubated covid-19 patients
p/f ratio of <100 mmhg with peep ≥ 5 cm h20
systolic blood pressure below 90 mmhg
written informed consent
|
Exclusion criteria
Last imported at : Feb. 16, 2022, 4:30 p.m.
Source : ClinicalTrials.gov
|
a subject will not be eligible for inclusion in this study if he/she meets any of the following
|
Number of arms
Last imported at : Feb. 16, 2022, 4:30 p.m.
Source : ClinicalTrials.gov
|
2
|
Funding
Last imported at : Feb. 16, 2022, 4:30 p.m.
Source : ClinicalTrials.gov
|
Pharmazz, Inc.
|
Inclusion age min
Last imported at : Feb. 16, 2022, 4:30 p.m.
Source : ClinicalTrials.gov
|
18
|
Inclusion age max
Last imported at : Feb. 16, 2022, 4:30 p.m.
Source : ClinicalTrials.gov
|
100
|
Countries
Last imported at : Feb. 16, 2022, 4:30 p.m.
Source : ClinicalTrials.gov
|
None
|
Type of patients
Last imported at : Feb. 16, 2022, 4:30 p.m.
Source : ClinicalTrials.gov
|
Critical disease at enrollment
|
Severity scale
Last imported at : Feb. 16, 2022, 4:30 p.m.
Source : ClinicalTrials.gov
|
8: Critical disease at enrollment
|
Total sample size
Last imported at : Feb. 16, 2022, 4:30 p.m.
Source : ClinicalTrials.gov
|
60
|
primary outcome
Last imported at : Feb. 16, 2022, 4:30 p.m.
Source : ClinicalTrials.gov
|
Clinical improvement of ARDS in critically ill COVID-19 patients
|
Notes
Last imported at : Feb. 16, 2022, 4:30 p.m.
Source : ClinicalTrials.gov
|
None
|
Phase
Last imported at : Feb. 16, 2022, 4:30 p.m.
Source : ClinicalTrials.gov
|
Phase 2
|
Arms
Last imported at : Feb. 16, 2022, 4:30 p.m.
Source : ClinicalTrials.gov
|
[{"arm_notes": "", "treatment_id": 2177, "treatment_name": "Centhaquine", "treatment_type": "Cardiovascular agents", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]
|