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 | NCT04353596 |
|
Full text link
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
|
|
First author
Last imported at : March 4, 2021, 12:31 a.m. Source : ClinicalTrials.gov |
|
|
Contact
Last imported at : March 4, 2021, 12:31 a.m. Source : ClinicalTrials.gov |
None |
|
Registration date
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
2020-04-20 |
|
Recruitment status
Last imported at : March 4, 2021, 12:31 a.m. Source : ClinicalTrials.gov |
Completed |
|
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 : March 15, 2023, 4 a.m. Source : ClinicalTrials.gov |
multi-center |
|
Study aim
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
Treatment |
|
Inclusion criteria
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
inclusion criteria: - female and male patients competent to make a decision - proven and symptomatic sars-cov2 infection ≤ 5 days - patient age ≥ 18 years - provided written informed consent - chronic (≥ 1 month) acei/arb therapy for treatment of arterial hypertension, diabetes mellitus, heart failure or coronary artery disease - stable hemodynamic conditions allowing to stop or continue treatment with acei/arb (systolic blood pressure ≤180mmhg) |
|
Exclusion criteria
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
- women capable of bearing children as well as pregnant and breastfeeding women - participant in another interventional trail - at screening visit, no oral medication intake possible - advanced heart failure nyha stage iii-iv - left ventricular ejection fraction <30% or ntprobnp ≥600pg/ml in case of clinical signs of heart failure - acute coronary syndrome ≤ 3 months - severe arterial hypertension (concomitant use of more than 4 different antihypertensive drug classes) - acute respiratory distress syndrome with need for mechanical ventilation - patients who at not capable of home blood pressure monitoring - patients who cannot be switched to an alternative medication |
|
Number of arms
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
2 |
|
Funding
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
Medical University Innsbruck |
|
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 |
100 |
|
Countries
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
Austria;Germany |
|
Type of patients
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
No restriction on type of patients |
|
Severity scale
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
0: No restriction on type of patients |
|
Total sample size
Last imported at : March 4, 2021, 12:31 a.m. Source : ClinicalTrials.gov |
216 |
|
primary outcome
Last imported at : Sept. 15, 2022, 2 a.m. Source : ClinicalTrials.gov |
Composite of Admission to an Intensive Care Unit (ICU), the Use of Mechanical Ventilation, or All-cause Death;Composite of the Maximum Sequential Organ Failure Assessment (SOFA) Score and Death Within 30 Days |
|
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 4 |
|
Arms
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
[{"arm_notes": "nan", "treatment_id": 1410, "treatment_name": "Ace inhibitor+angiotensin receptor blocker (arb)", "treatment_type": "Cardiovascular agents", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "nan", "treatment_id": 2188, "treatment_name": "Standard of care", "treatment_type": "Standard of care", "pharmacological_treatment": "Standard of care"}] |