COVID-19NCT04479293
Post COVID-19 Functional Status in Egypt
An observational study of COVID-19 and Coronavirus Disease, run by Assiut University at 1 site in Egypt.
Trial summary
Since the outbreak of coronavirus disease - COVID-19 pandemic, most attention has focused on mode of transmission, clinical picture of the disease, treatment and prevention. In the coming weeks and months emphasis will gradually involve the post- acute care of COVID-19 survivors. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- COVID-19, Coronavirus Disease, SARS-CoV-2
- What is being tested?
- Post COVID-19 Functional Satus Scale
- How many people
- 400 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jul 2020to 30 Nov 2020
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: All patients diagnosed as COVID-19 on clinical, laboratory, radiologic or PCR based are included. Patients with different severity mild, moderate, severe , managed at home or in hospitals are included.
Who may be able to join
- All confirmed cases with COVID-19
Who cannot join
- Non COVID-19 cases
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Aliaa Hussein
Asyut, 71515
Aliaa AR Hussein, +201222302352, aliaehussein@aun.edu.eg
About this study
Official title: Assessment of Functional Recovery From COVID-19 Using the Proposed Post- COVID-19 Functional Status Score
Since the outbreak of coronavirus disease - COVID-19 pandemic, most attention has focused on mode of transmission, clinical picture of the disease, treatment and prevention. In the coming weeks and months emphasis will gradually involve the post- acute care of COVID-19 survivors. It is anticipated that COVID-19 may have major impact on physical, cognitive, mental, social health status even in patients with mild disease. Moreover, pulmonary, radiologic, laboratory, sleep issues remain to be addressed
- Conditions
- COVID-19, Coronavirus Disease, SARS-CoV-2
- Being tested
- Post COVID-19 Functional Satus Scale
- Keywords
- Functional score, Radiologic changes, Psychologic changes, Laboratory, Sleep disturbance
- Medical subject headings
- COVID-19, Parasomnias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Post COVID-19 Functional Satus ScaleOther
scale from 0-64 assessing functional limitation
What is being measured
The primary outcome is the main question the study is designed to answer.
number of functional limitations post COVID-19
scale 0-64 points
Measured: 3-6 month
Secondary outcomes (4)
number of psychologic changes
Hamilton scale, points
Measured: 3-6 months
Sleep Disturbance and quality
ESS scale 0-20, points
Measured: 3-6 months
Radiologic changes
Chest HRCT
Measured: 3-6 months
Laboratory changes
Complete blood count, C - reactive protein, serum ferritin
Measured: 3-6 moths
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2020
- Study start1 Jul 2020
- Primary completion30 Oct 2020 (estimated)
- Study completion30 Nov 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aliae AR Mohamed Hussein, Assiut University
- Investigators
- Aliae Mohamed-Hussein, MD, Principal investigator, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04479293
- Sponsor's protocol ID
- AssiutU16
- Status last verified
- Sep 2020
- First submitted
- 19 Jul 2020
- Last updated
- 9 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Functional Recovery From COVID-19 Using the Proposed Post- COVID-19 Functional Status Score
- ClinicalTrials.gov ID
- NCT04479293
- Acronym / sponsor ID
- AssiutU16
- Conditions
- COVID-19, Coronavirus Disease, SARS-CoV-2
- Keywords
- Functional score, Radiologic changes, Psychologic changes, Laboratory, Sleep disturbance
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Jul 2020 (actual)
- Primary completion
- 30 Oct 2020 (estimated)
- Study completion
- 30 Nov 2020 (estimated)
- First posted
- 21 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Since the outbreak of coronavirus disease - COVID-19 pandemic, most attention has focused on mode of transmission, clinical picture of the disease, treatment and prevention. In the coming weeks and months emphasis will gradually involve the post- acute care of COVID-19 survivors. It is anticipated that COVID-19 may have major impact on physical, cognitive, mental, social health status even in patients with mild disease. Moreover, pulmonary, radiologic, laboratory, sleep issues remain to be addressed
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All patients diagnosed as COVID-19 on clinical, laboratory, radiologic or PCR based are included. Patients with different severity mild, moderate, severe , managed at home or in hospitals are included.
Key inclusion criteria (1 listed)
- All confirmed cases with COVID-19
Key exclusion criteria (1 listed)
- Non COVID-19 cases
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Post COVID-19 Functional Satus Scalescale from 0-64 assessing functional limitation | Other | – |
Primary outcome
number of functional limitations post COVID-19
Time frame: 3-6 month
scale 0-64 points
4 secondary outcomes
number of psychologic changes
Time frame: 3-6 months
Sleep Disturbance and quality
Time frame: 3-6 months
Radiologic changes
Time frame: 3-6 months
Laboratory changes
Time frame: 3-6 moths
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2020.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Aliae Mohamed-Hussein, MD principal investigator
Assiut University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COVID-19 and Coronavirus Disease, run by Assiut 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 1 inclusion and 1 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 9 Sep 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 Aliae Mohamed-Hussein (01222302352, aliaehussein@aun.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
number of functional limitations post COVID-19 (time frame: 3-6 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Sep 2020.