To investigate the feasibility of measuring the oxygen saturation at home by pulse oximetry as added to usual (primary) care in patients with or at risk of cardiovascular risk who have moderate to severe symptoms of (presumably) COVID-19 as compared…
ID
Source
Brief title
Condition
- Viral infectious disorders
- Respiratory tract infections
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Feasibility defined as successful inclusion of 50 participants within 6 months.
Secondary outcome
- the feeling of safety during the first two weeks of illness as reported by
the patient
- disability-free survival at 45 days (% change in WHODAS-2 between baseline
and day 45)
- number of days alive at home during 45 days after inclusion
- time to discharge from medical follow-up (defined as last contact with healh
care professional according to primary care electronic health record data)
- number of primary care contacts during 45 days after inclusion
- number of emergency care department visits during 45 days after inclusion
- proportion of hospitalised patients within 45 days after inclusion
- characteristics of hospital admissions within 45 days after inclusion
o clinical profile at time of hospitalisation (according to the warning signs
of Dutch College of General Practitioners)
o length of stay (total and stratified into ward and ICU)
o proportion of patients admitted to ICU
o type of treatments
- 45 day mortality
o overall mortality
o out-of-hospital mortality
o in-hospital mortality
In a parallel process evaluation, we will examine:
- how the intervention has been used in practice in terms of:
(i) Fidelity - whether the intervention was carried out as planned;
(ii) Dose - whether the intervention has been used as long and frequently as
planned;
(iii) Adjustments - whether adjustments have been made to the intervention and
why;
(iv) Reach - whether the intended audience has been reached and
- the experiences of patients in the intervention group and their informal
caregivers in terms of disease perception, fear and use of the intervention
- GPs' experiences with the intervention (usability of pulseoximetry as
diagnostic procedure and impact on healthcare utilization)
To determine the expression of Neprilysin/CD10 on neutrophil granulocytes in
the blood of study participants and to explore its predictive value in terms of
clinical deterioration in COVID-19 patients and whether this expression is
associated with prolonged symptoms in COVID-19 patients.
Background summary
Patients with moderate to severe symptoms of (presumably) COVID-19 are
monitored at home by their GP using teleconsultation. This leaves the GP with a
situation in which he/she has to rely on patients' symptom presentation and
subjective assessment of shortness of breath by telephone. It is however known
that patients' condition can deteriorate considerably after 7-14 days of
symptom onset. Such a deterioratation with corresponding low oxygen saturation
levels does often not align with patients' symptoms. In particular patients
with overweight, hypertension, diabetes and other cardiovascular risk factors
and cardiovascular diseases are at increased risk of a more complicated disease
course requiring hospitalisation and sometimes even ICU admission. An important
process underlying a serious course of COVID-19 is pulmonary edema which may be
the result of delayed breakdown of bradykinin. This hypothesis is based on the
fact that the virus porte-d'entree is angiotensin-converting enzyme-2 (ACE2)
and that this enzyme is down-regulated during virus uptake. Like
Neprilysin/CD10 on the neutrophil granulocyte, ACE2 is involved in the
regulated degradation of bradykinin. Low expression of Neprilysin/CD10 on
neutrophil granulocytes might therefore contribute to increased bradykinin
concentration in the lung of COVID-19 patients who also have decreased ACE2
expression.
Several weeks of home monitoring of blood oxygen levels by pulse oximetry might
benefit the patient by early detection of hypoxemia, an important indicator for
hospitalisation. In the proposed pilot trial, we perform an early phase
evaluation of this new intervention in primary care.
Study objective
To investigate the feasibility of measuring the oxygen saturation at home by
pulse oximetry as added to usual (primary) care in patients with or at risk of
cardiovascular risk who have moderate to severe symptoms of (presumably)
COVID-19 as compared to usual (primary) care. The aim of the substudy is to
determine the Neprilysin/CD10 expression on neutrophil granulocytes in the
blood of study participants at baseline and after 3-6 months.
Study design
Individually randomised controlled pilot trial with parallel process evaluation
and two times a venapuncture.
Intervention
Intervention: three times daily (and if needed any additional) measurement of
oxygen saturation and pulse rate with a pulse oximeter as added to usual
(primary) care. Comparator: usual (primary) care.
Study burden and risks
The additional risk of using the pulse oxymeter itself and two times a
venapuncture are negligible. The pulse oximeter that will be used in this study
is validated/approved for medical use and has a CE mark. These will be
registered and checked by the MTKF department of the UMC Utrecht for quality
assurance purposes. Besides, it is unlikely that measuring oxygen saturation at
home together with the (safety) instructions within this study will add any
risk for the patient in terms of disease progression and/or mortality. However,
this study will be conducted in a vulnerable patient population in which
hospital (and ICU) admission and mortality may occur. Therefore, we judged our
trial as a negligible risk study.
Heidelberglaan 100
Utrecht 3508GA
NL
Heidelberglaan 100
Utrecht 3508GA
NL
Listed location countries
Age
Inclusion criteria
1) Age *40 years
2) Cardiovasculair risk profile or cardiovascular disease (overweight,
hypertension, diabetes, smoking, coronary artery disease, previous myocardial
infarction, heart failure)
3) Presumably COVID-19 (both SARS-CoV-2 positive and non-COVID-19 confirmed
patients)
4) Moderate-severe symptoms
5) Mentally competent
Exclusion criteria
1) Severe illness requiring hospital admission
2) Patient does not want future hospitalisation
3) Known anemia
4) Inadequate mastery of the Dutch language
5) Not willing to sign informed consent
6) Not willing to adhere to study procedures
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL73826.041.20 |
| Other | Trial NL8954 |