AzTrials
AzTrials

Covid19COVID-19NCT04515199

Home Management of Adult Egyptian Mild COVID-19 Cases

An observational study of Covid19 and Telemedicine, run by Cairo University at 1 site in Egypt.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Covid19, Telemedicine, Quality of Life
How many people
400 participants
Where
1 siteEgypt
Study dates
1 Jul 2020to Mar 2021
How long will I take part?
6 Months
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Who may be able to join

  • 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

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Mohamed Tharwat Hegazy, Lecturer contact

01205408765 ext. +2

dr_moh_tharwat@kasralainy.edu.eg

Maha Hossam Al-Din Ibrahim, Professor contact

01227770290 ext. +2

mahahossam@gmail.com

Egypt1 site, 1 recruiting

  • Faculty of Medicine Cairo University

    Cairo

    Mohamed Tharwat Hegazy, Lecturer, 01205408765 ext. +2, dr_moh_tharwat@kasralainy.edu.eg

    Recruiting

Other trials in Egypt

About this study

Official title: 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.

Read the 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).
Keywords
COVID19, Telemedicine, Home Isolation, Mild cases
Medical subject headings
COVID-19

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: 3-6 months

  2. The incidence of symptoms and their duration

    days

    Measured: 3-6 months

Secondary outcomes (4)

  1. Change in Short Form 35 (SF-36) Questionnaire

    A validated questionnaire assessing function and quality of life for patients with pulmonary function issues

    Measured: 3-6 months

  2. 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.

    Measured: 3-6 months

  3. Identifying the duration of post-COVID-19 symptoms

    Days

    Measured: 3-6 months

  4. long-term respiratory complications

    Interstitial lung disease diagnosed with a thoracic CT-scan

    Measured: 3-6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Aug 2020
  2. Study start1 Jul 2020
  3. Primary completionJan 2021 (estimated)
  4. Study completionMar 2021 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
400 participants (estimated)
Target duration
6 Months
IDs, dates and publications
ClinicalTrials.gov ID
NCT04515199
Sponsor's protocol ID
Telemedicine in Mild COVID-19
Acronym
COVID-19
Status last verified
Aug 2020
First submitted
7 Aug 2020
Last updated
17 Aug 2020
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

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.

    PubMed 32265220

  • 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.

    PubMed 32188484

  • 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.

    PubMed 139198

Questions about this trial

What is this clinical trial studying?

An observational study of Covid19 and Telemedicine, run by Cairo University at 1 site in Egypt.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 17 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Mohamed Tharwat Hegazy, Lecturer (01205408765 ext. +2, dr_moh_tharwat@kasralainy.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percent of adherence to isolation measures (time frame: 3-6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04515199, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Aug 2020.

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