Clinical trial NCT04515199: Home Management of Adult Egyptian Mild COVID-19 Cases
Official title: Effectiveness of Telemedicine Use in Home Management of Adult Egyptian Mild COVID-19 Cases
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Covid19
Telemedicine
Quality of Life
Safety Issues
Symptoms
Keywords: COVID19
Telemedicine
Home Isolation
Mild cases
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2020-08-17
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 400 adult mild COVID cases consented to home isolation to follow them by: phone calls, what's app, hot line for emergency, Triage sheet, zoom meetings.

Brief summary: Keeping in mind the rising number of cases in Egypt and the strain they put on hospital infrastructure, the idea of home isolation and follow up for COVID 19 positive cases has been adopted in many countries and was approved by World Health Organization (WHO) and Egyptian Ministry of health (MOH).

Telehealth can help to mitigate this risk by minimizing the amount of face-to-face interactions. The WHO mentioned telemedicine among essential services in "strengthening the Health Systems Response to COVID-19" policy. The aim in this study is to study the effectiveness of telemedicine in managing mild COVID cases regarding isolation measures, symptoms, medications adherence, and reporting of red flags and side effects.

Detailed description: Objectives:

* To assess the effectiveness of follow up of mild COVID-19 cases in home isolation
* To assess the applicability of telemedicine tools in the follow up of those patients and early identification of warning symptoms needing more intensive management measures.
* To assess the clinical characteristics for mild COVID-19 cases and post covid sequelae and the course of symptoms
* To assess the persistence of symptoms during follow up.
* To assess the quality of life during home management period.
* To assess cost-effectivenes of home isolation vs hospital admission in mild COVID-19 cases.

Study population \& Sample size :

The study includes 400 Adult (18-65 years) Egyptian patients with mild COVID 19 diagnosed by PCR consented (oral consent) to home isolation to follow them.

Study Design:

Prospective observational study.

Methods:

• All patients will be subjected to thorough history and clinical examination. 400 adult mild COVID cases consented to home isolation to follow them by: phone calls, what's app, hot line for emergency, Triage sheet, zoom meetings.

Patients will be given brochures about home isolation (by Egyptian MOH), list of medications, plan of follow up.

1. Daily follow up for: fever chart, report any new symptoms or progression of previously present symptom or presence of red flags.
2. Blood samples will be obtained and CT chest will be done according to the usual protocol.
3. Patients will be followed for 3 months to detect post covid sequelae and the course of symptoms (and the persistence of any symptoms).
4. Questionnaire will be done to assess the patients' commitment to the advices and regulations of home isolation as well as forms to assess fatigue and the quality of life (36-Item Short Form Survey; SF-36).

Eligibility criteria: Inclusion Criteria:

1. No co-morbidities that necessitates hospital admission due to high risk for progression of the disease: Pregnancy, uncontrolled Diabetes, Chronic lung disease, Chronic kidney disease, Chronic liver disease, Serious heart diseases (arrythmia, Ischemic heart disease, uncontrolled hypertension), immunocompromised: prolonged use of corticosteroids and other immunosuppressive drugs/ organ transplantation/ HIV/ Immunodeficiency.
2. No fever (oral, below or equal 37.50 C )
3. No shortness of breath (Respiratory rate 12-20/min)
4. Oxygen saturation \>= 96 %
5. CT chest: Normal
6. Labs: D-dimer\<1000ng/ml, CPK\< twice upper limit of normal, CRP\<100, LDH\<245, Ferritin\<500, absolute lymphocytic count \>0.8

Exclusion Criteria:

1. Moderate and severe cases not fulfilling the definition of mild cases.
2. Children and young \< 18 years.
3. Age \>65 years.
4. Presence of any of the previously mentioned comorbidities.

Primary outcomes:
measure: Percent of adherence to isolation measures
timeFrame: 3-6 months
measure: The incidence of symptoms and their duration
timeFrame: 3-6 months
Secondary outcomes:
measure: Change in Short Form 35 (SF-36) Questionnaire
timeFrame: 3-6 months
measure: Cost- effectiveness of Home Isolation vs hospital admission in mild COVID-19 cases
timeFrame: 3-6 months
measure: Identifying the duration of post-COVID-19 symptoms
timeFrame: 3-6 months
measure: long-term respiratory complications
timeFrame: 3-6 months
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Faculty of Medicine Cairo University
Study officials:
affiliation: Internal Medicine Department, Faculty of Medicine, Cairo University
name: Ibrahim El Ebrashy, Professor
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Shi Y, Yu X, Zhao H, Wang H, Zhao R, Sheng J. Host susceptibility to severe COVID-19 and establishment of a host risk score: findings of 487 cases outside Wuhan. Crit Care. 2020 Mar 18;24(1):108. doi: 10.1186/s13054-020-2833-7. No abstract available.
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