Home Management of Adult Egyptian Mild COVID-19 Cases

NCT04515199 | Unknown DMC

• 1 other identifier: Telemedicine in Mild COVID-19
• Study Type: observational
• Target: 400
• Locations: 1 country
• Sites: 1

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.

Conditions

Covid19; Telemedicine; Quality of Life; Safety Issues; Symptoms

Keywords

COVID19; Telemedicine; Home Isolation; Mild cases

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• Change in Short Form 35 (SF-36) Questionnaire

  3-6 months

• Cost- effectiveness of Home Isolation vs hospital admission in mild COVID-19 cases

  3-6 months

• Identifying the duration of post-COVID-19 symptoms

  3-6 months

• long-term respiratory complications

  3-6 months

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.
• No fever (oral, below or equal 37.50 C )
• No shortness of breath (Respiratory rate 12-20/min)
• Oxygen saturation \>= 96 %
• CT chest: Normal
• Labs: D-dimer\<1000ng/ml, CPK\< twice upper limit of normal, CRP\<100, LDH\<245, Ferritin\<500, absolute lymphocytic count \>0.8

You may not qualify if:

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

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Faculty of Medicine Cairo University

Cairo, Egypt

RECRUITING

Related Publications (3)

• 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.

  PMID: 32265220 BACKGROUND

• 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.

  PMID: 32188484 BACKGROUND

• 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.

  PMID: 139198 BACKGROUND

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Ibrahim El Ebrashy, Professor

  Internal Medicine Department, Faculty of Medicine, Cairo University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mohamed Tharwat Hegazy, Lecturer

CONTACT

01205408765; dr_moh_tharwat@kasralainy.edu.eg

Maha Hossam Al-Din Ibrahim, Professor

CONTACT

01227770290; mahahossam@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of Internal Medicine, Rheumatology and Clinical Immunology

Study Record Dates

• First Submitted: August 7, 2020
• First Posted: August 17, 2020
• Study Start: July 1, 2020
• Primary Completion: January 1, 2021
• Study Completion: March 1, 2021
• Last Updated: August 17, 2020

Record last verified: 2020-08

Locations

EG (1)