Home Management of Adult Egyptian Mild COVID-19 Cases (COVID-19)

Effectiveness of Telemedicine Use in Home Management of Adult Egyptian Mild COVID-19 Cases

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.

Study Overview

• Status: Unknown
• Conditions: Quality of Life; Covid19; Telemedicine; Safety Issues; Symptoms

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).

• Study Type: Observational
• Enrollment (Anticipated): 400

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt
    • Recruiting
    • Faculty of medicine cairo university
    • Contact: Mohamed Tharwat Hegazy, Lecturer; Phone Number: +2 01205408765; Email: dr_moh_tharwat@kasralainy.edu.eg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percent of adherence to isolation measures	A checklist to check the percent of the patients who followed the advices for home isolation and will be validated	3-6 months
The incidence of symptoms and their duration	days	3-6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Short Form 35 (SF-36) Questionnaire	A validated questionnaire assessing function and quality of life for patients with pulmonary function issues	3-6 months
Cost- effectiveness of Home Isolation vs hospital admission in mild COVID-19 cases	We will measure the costs of home isolation vs hospital admission through collectin the expected costs if those mild cases have been admitted in the hospital as in the start of the crisis.	3-6 months
Identifying the duration of post-COVID-19 symptoms	Days	3-6 months
long-term respiratory complications	Interstitial lung disease diagnosed with a thoracic CT-scan	3-6 months

Collaborators and Investigators

• Sponsor: Cairo University
• Investigators: Principal Investigator: Ibrahim El Ebrashy, Professor, Internal Medicine Department, Faculty of Medicine, Cairo University

Publications and helpful links

General Publications

• Wynants L, Van Calster B, Collins GS, Riley RD, Heinze G, Schuit E, Bonten MMJ, Dahly DL, Damen JAA, Debray TPA, de Jong VMT, De Vos M, Dhiman P, Haller MC, Harhay MO, Henckaerts L, Heus P, Kammer M, Kreuzberger N, Lohmann A, Luijken K, Ma J, Martin GP, McLernon DJ, Andaur Navarro CL, Reitsma JB, Sergeant JC, Shi C, Skoetz N, Smits LJM, Snell KIE, Sperrin M, Spijker R, Steyerberg EW, Takada T, Tzoulaki I, van Kuijk SMJ, van Bussel B, van der Horst ICC, van Royen FS, Verbakel JY, Wallisch C, Wilkinson J, Wolff R, Hooft L, Moons KGM, van Smeden M. Prediction models for diagnosis and prognosis of covid-19: systematic review and critical appraisal. BMJ. 2020 Apr 7;369:m1328. doi: 10.1136/bmj.m1328. Erratum In: BMJ. 2020 Jun 3;369:m2204.
• 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.
• Lee C, Chen D, Katz RL. Characteristics of nondepolarizing neuromuscular block: (I) post-junctional block by alpha-bungarotoxin. Can Anaesth Soc J. 1977 Mar;24(2):212-9. doi: 10.1007/BF03006234.

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2020
• Primary Completion (Anticipated): January 1, 2021
• Study Completion (Anticipated): March 1, 2021

Study Registration Dates

• First Submitted: August 7, 2020
• First Submitted That Met QC Criteria: August 13, 2020
• First Posted (Actual): August 17, 2020

Study Record Updates

• Last Update Posted (Actual): August 17, 2020
• Last Update Submitted That Met QC Criteria: August 13, 2020
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Keywords: Telemedicine; COVID19; Home Isolation; Mild cases
• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: Telemedicine in Mild COVID-19

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No