CovidTHERAPY@HOME. Action research on development of a regionally supported, safe, feasible and scalable intervention to monitor and optimally treat patients with acute respiratory infection (including COVID-19) with or without hypoxemia and/or increased respiratory labor in their home setting

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 90

Inclusion Criteria

Three categories of patients will be included:

Category 0:
Patients with moderate to severe COVID-19 (Utrecht: acute respiratory tract
infections) and co-morbidity, without hypoxemia and/or respiratory distress,
who would normally stay at home without structural monitoring by a regional
monitoring entity.

Category 1:
Patients with COVID-19 (Utrecht: acute respiratory tract infections) and
hypoxemia and/or respiratory distress without signs of clinical instability who
normally would be admitted to a hospital COVID ward for treatment

Category 2:
Patients with (a strong suspicion of) COVID-19 (Utrecht: acute respiratory
tract infections) and hypoxemia and/or respiratory distress for whom
hospitalisation is not considered desirable, but treatment at home is
considered desirable.

Inclusion criteria for category 0:
- Nijmegen Positive SARS-CoV-2 test (PCR or rapid antigen test) with
moderate-severe complaints (>=three days: temperature >=37.5*C; and/or new
complaints of cough, nose cold, sore throat combined with shortness of breath
or combined with fatigue)
- Utrecht: clinical diagnosis of community-acquired acute respiratory tract
infection (CA-ARTI):
-- at least two respiratory symptoms: cough, sore throat, runny nose, nasal
congestion, dyspnea AND
-- at least one systemic symptoms: fever, feverish, chills, fatigue, headache,
myalgia, loss of smell, loss of taste AND
-- clinician judges that symptoms are most likely attributable to CA-ARTI.
- No indication for hospital referral: no hypoximia (measured at rest; SpO2
>94%); no increased respiratory effort (measured at rest; respiratory rate
<24/min); haemodynamically stable (blood pressure > 120/80 mmHg and heart rate
>50/min and <100/min)
- Sufficient proficiency of the Dutch language to provide informed consent (or
translator available to mitigate the language barrier)
- Patient is at risk for complicated disease course (age >70, and/or
immunocompromised, and/or chronic kidney disease, and/or cardiovascular
disease, and/or diabetes mellitus, and/or COPD, and or liver cirrhosis, and/or
obesity (BMI>40)).

Inclusion criteria for category 1:
- Nijmegen Positive SARS-CoV-2 test (PCR or rapid antigen test)
- Utrecht: clinical diagnosis of community-acquired acute respiratory tract
infection (CA-ARTI):
-- at least two respiratory symptoms: cough, sore throat, runny nose, nasal
congestion, dyspnea AND
-- at least one systemic symptoms: fever, feverish, chills, fatigue, headache,
myalgia, loss of smell, loss of taste AND
-- clinician judges that symptoms are most likely attributable to CA-ARTI.
- GP considers referral to hospital because of hypoxemia (SpO2 <94% at rest,
and/or increased respiratory effort with respiratory rate >24/min at rest)
- Haemodynamically stable (blood pressure > 120/80 mmHg and heart rate >50/min
and <100/min)
- Partner/caregiver present at the patient's home for providing supportive care
- Capable of using a pulseoximeter (or caregiver can help)
- Age 18 years or older
- Mentally competent
- Sufficient proficiency of the Dutch language to provide informed consent (or
translator available to mitigate the language barrier)

Inclusion criteria for category 2 :
- Nijmegen Strong suspicion of COVID-19 or positive SARS-CoV-2 test (PCR or
rapid an

Exclusion Criteria

Exclusion criteria for all three patients categories:
- Active smoking (due to associated risks with oxygen therapy)
- Severe dementia or severe psychiatric illness (patient is not able to follow
studyinstructions)
- Inadequate mastery of the Dutch language and absence of care giver who can
translate to mitigate the language barriaer.

Additional exclusion criteria for category 1:
- Severe clinical condition warranting intensive treatment in hospital setting
or ICU admission
- More medical care is necessary than can be organised in the home setting
- Chronic pulmonary disease, heart failure, immunocompromised status, kidney
failure or liver failure of which decompensation risk is deemed too high by
treating physician and necessitates clinical admission
- PE/DVT in past month

Additional exclusion cirteria for category 2:
- severe disease or such critical clinical condition that the physician decides
to abstain all care

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Feasibility defined as reaching a stable, regionally supported intervention to<br /><br>optimally treat patients with (strong suspicion of) COVID-19 (Utrecht:<br /><br>CA-ARTI)and hypoxemia and/or increased respiratory effort in their home setting<br /><br>by evaluation in short cycles assessing the care trajectory of 45 patients<br /><br>within the study</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>- Feeling of safety during the first two weeks of illness as reported by the<br /><br>patient<br /><br>- Disability-free survival after 30 days (% change in WHODAS-2 questionnaire<br /><br>between baseline and day 30)<br /><br>- Number of days living at home during 30 days follow-up<br /><br>- Time to discharge from medical follow-up (defined as last contact with<br /><br>healthcare professional based on EHR)<br /><br>- Number of GP contacts during 30 days follow-up<br /><br>- Number of emergency room visits during 30 days follow-up<br /><br>- Proportion of patients admitted to hospital at 30 days follow-up<br /><br>- Characteristics of hospitalization within 30 days follow-up<br /><br>- Mortality at 30 days follow-up<br /><br>- Cost-benefit analysis</p><br>