Home Management of Adult Egyptian Mild COVID-19 Cases

NCT ID: NCT04515199

Last Updated: 2020-08-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

400 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-07-01

Study Completion Date

2021-03-31

Brief Summary

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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

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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).

Conditions

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Covid19 Telemedicine Quality of Life Safety Issues Symptoms

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Cairo University

OTHER

Sponsor Role lead

Responsible Party

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Mohamed Tharwat Hegazy

Lecturer of Internal Medicine, Rheumatology and Clinical Immunology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ibrahim El Ebrashy, Professor

Role: PRINCIPAL_INVESTIGATOR

Internal Medicine Department, Faculty of Medicine, Cairo University

Locations

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Faculty of Medicine Cairo University

Cairo, , Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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Mohamed Tharwat Hegazy, Lecturer

Role: CONTACT

01205408765 ext. +2

Maha Hossam Al-Din Ibrahim, Professor

Role: CONTACT

01227770290 ext. +2

Facility Contacts

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Mohamed Tharwat Hegazy, Lecturer

Role: primary

01205408765 ext. +2

References

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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.

Reference Type BACKGROUND
PMID: 32265220 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 32188484 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 139198 (View on PubMed)

Other Identifiers

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Telemedicine in Mild COVID-19

Identifier Type: -

Identifier Source: org_study_id

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