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 | NCT04471636 |
|
Full text link
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
|
|
First author
Last imported at : May 20, 2022, 9 a.m. Source : ClinicalTrials.gov |
|
|
Contact
Last imported at : May 20, 2022, 9 a.m. Source : ClinicalTrials.gov |
not reported |
|
Registration date
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
2020-07-15 |
|
Recruitment status
Last imported at : May 20, 2022, 9 a.m. Source : ClinicalTrials.gov |
Not recruiting |
|
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 |
Open label |
|
Center
Last imported at : March 15, 2023, 4 a.m. Source : ClinicalTrials.gov |
single-center |
|
Study aim
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
Treatment |
|
Inclusion criteria
Last imported at : April 16, 2021, 12:31 a.m. Source : ClinicalTrials.gov |
inclusion criteria: - confirmed sars-cov2 infection and clinical covid-19 disease - age ≥18 years - presence of ≥1 relevan cardiovascular condition, defined as (or): - atrial fibrillation - systolic or diastolic heart failure - lv ejection fraction <50% - coronary artery disease with past pci or cabg - past myocardial infarction - diabetes mellitus - arterial hypertension (treated or untreated) - active smoking - chronic obstructive lung disease - obesity (bmi ≥30kg/m2) - availability of smartphone and sufficient internet connectivity at home - ability to use smartwatch - informed consent to study participation and data protection concept |
|
Exclusion criteria
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
- participation in concurrent clinical trial - indication for hospitalization at study entry |
|
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 |
Ludwig-Maximilians - University of Munich |
|
Inclusion age min
Last imported at : April 16, 2021, 12:31 a.m. Source : ClinicalTrials.gov |
18 |
|
Inclusion age max
Last imported at : April 16, 2021, 12:31 a.m. Source : ClinicalTrials.gov |
59 |
|
Countries
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
Germany |
|
Type of patients
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
Mild/moderate disease at enrollment |
|
Severity scale
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
2: Mild/moderate disease at enrollment |
|
Total sample size
Last imported at : May 20, 2022, 9 a.m. Source : ClinicalTrials.gov |
607 |
|
primary outcome
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
Rate of participants with a combination of hospitalization and unplanned use of hospital emergency department or emergency medical service |
|
Notes
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
None |
|
Phase
Last imported at : Nov. 16, 2021, 6:30 p.m. Source : ClinicalTrials.gov |
Not reported |
|
Arms
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
[{"arm_notes": "", "treatment_id": 1388, "treatment_name": "Withings scanwatch", "treatment_type": "Medical device", "pharmacological_treatment": "Non pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2188, "treatment_name": "Standard of care", "treatment_type": "Standard of care", "pharmacological_treatment": "Standard of care"}] |