Covid19NCT04561141
Post Covid Syndrome: Clinical Pattern and Functional Assessment
An observational study of Covid19, run by Assiut University.
Trial summary
Aim(s) of the Research : 1. Identify post covid symptoms 2. prevalance of post covid syndrome among survivours Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Covid19
- How many people
- 85 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2020to 1 Jan 2022
- 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 80 years
- All sexes
- Adult, Older adult
Study population: will be carried out in Assuit university hospital among health team workers(doctors, nurses, employes), in Emergency room(ER) , clinics , ICU and wards for patients who had covid 19
Who may be able to join
- patients diagnosed as covid 19 with chest ct and/or nasopharyngeal swab for covid 19
- age 18 years old and above
- post covid syndrome after 6 weeks
Who cannot join
- 1-below age of 18 2 -not confirmed cases 3. symptoms less than 6 weeks
Trial locations and contacts
No sites are listed yet.
About this study
Aim(s) of the Research :
- Identify post covid symptoms
- prevalance of post covid syndrome among survivours
Read the detailed description
There is currently very limited information on the nature and prevalence of post-COVID-19 symptoms after hospital discharge. On 11th March 2020, corona virus disease 2019 (COVID-19) was declared a global pandemic by the World Health Organisation (WHO). Egypt has been one of the worst affected countries with over 101,500 confirmed cases and more than 5,696 confirmed deaths at the time of writing (17/9 2020) .1 COVID-19 is caused by the corona virus SARSCoV-2 and presents with a wide spectrum of clinical symptoms. Wu et al reported that 81% of people with COVID-19 in China presented with mild symptoms; 14% presented with symptoms of severe respiratory dysfunction; and 5% developed a critical illness with respiratory failure, septic shock, and multiple organ dysfunction or failure.2 The medium and long-term problems experienced by survivors of COVID-19 after discharge from hospital are currently unknown, but there is some emerging evidence. An Italian study followed-up 143 individuals 7 weeks post-discharge and found 53% reporting fatigue, 43% breathlessness and 27% joint pain.3 Post-discharge symptoms may also be predicted from the previous coronavirus outbreaks of Severe Acute Respiratory Syndrome (SARS) in 2002 and Middle East Respiratory Syndrome (MERS) in 2012. A meta-analysis of 28 follow-up studies found that one quarter of hospitalised survivors of SARS and MERS had reduced lung function and exercise capacity at six months post-discharge.4 At one year, post-traumatic stress disorder (PTSD), depression and anxiety, and reduced quality of life were observed Specific data concerning the rehabilitation needs of this group is therefore urgently required.
- Conditions
- Covid19
- Medical subject headings
- COVID-19
What is being measured
The primary outcome is the main question the study is designed to answer.
Identify post covid symptoms
by interview questionnaire
Measured: after 4 weeks of diagnosis
Secondary outcomes (1)
prevalance of post covid syndrome among survivours
by interview questionnaire
Measured: after 4 weeks of diagnosis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2020
- Study start1 Dec 2020 (estimated)
- Primary completion1 Dec 2021 (estimated)
- Study completion1 Jan 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Covid19Studies 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 85 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mostafa Mahmoud, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04561141
- Sponsor's protocol ID
- postcovid syndrome
- Status last verified
- Sep 2020
- First submitted
- 22 Sep 2020
- Last updated
- 25 Sep 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post Covid Syndrome: Clinical Pattern and Functional Assessment
- ClinicalTrials.gov ID
- NCT04561141
- Acronym / sponsor ID
- postcovid syndrome
- Conditions
- Covid19
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 85 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Dec 2020 (estimated)
- Primary completion
- 1 Dec 2021 (estimated)
- Study completion
- 1 Jan 2022 (estimated)
- First posted
- 23 Sep 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.
Aim(s) of the Research :
- Identify post covid symptoms
- prevalance of post covid syndrome among survivours
Detailed description
There is currently very limited information on the nature and prevalence of post-COVID-19 symptoms after hospital discharge. On 11th March 2020, corona virus disease 2019 (COVID-19) was declared a global pandemic by the World Health Organisation (WHO). Egypt has been one of the worst affected countries with over 101,500 confirmed cases and more than 5,696 confirmed deaths at the time of writing (17/9 2020) .1 COVID-19 is caused by the corona virus SARSCoV-2 and presents with a wide spectrum of clinical symptoms. Wu et al reported that 81% of people with COVID-19 in China presented with mild symptoms; 14% presented with symptoms of severe respiratory dysfunction; and 5% developed a critical illness with respiratory failure, septic shock, and multiple organ dysfunction or failure.2 The medium and long-term problems experienced by survivors of COVID-19 after discharge from hospital are currently unknown, but there is some emerging evidence. An Italian study followed-up 143 individuals 7 weeks post-discharge and found 53% reporting fatigue, 43% breathlessness and 27% joint pain.3 Post-discharge symptoms may also be predicted from the previous coronavirus outbreaks of Severe Acute Respiratory Syndrome (SARS) in 2002 and Middle East Respiratory Syndrome (MERS) in 2012. A meta-analysis of 28 follow-up studies found that one quarter of hospitalised survivors of SARS and MERS had reduced lung function and exercise capacity at six months post-discharge.4 At one year, post-traumatic stress disorder (PTSD), depression and anxiety, and reduced quality of life were observed Specific data concerning the rehabilitation needs of this group is therefore urgently required.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- will be carried out in Assuit university hospital among health team workers(doctors, nurses, employes), in Emergency room(ER) , clinics , ICU and wards for patients who had covid 19
Key inclusion criteria (3 listed)
- patients diagnosed as covid 19 with chest ct and/or nasopharyngeal swab for covid 19
- age 18 years old and above
- post covid syndrome after 6 weeks
Key exclusion criteria (1 listed)
- 1-below age of 18 2 -not confirmed cases 3. symptoms less than 6 weeks
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Identify post covid symptoms
Time frame: after 4 weeks of diagnosis
by interview questionnaire
1 secondary outcome
prevalance of post covid syndrome among survivours
Time frame: after 4 weeks of diagnosis
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2020.
- Related InfoLink provided by the sponsor.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Covid19, run by Assiut University.
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 3 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 25 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
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 Mostafa Mahmoud (0101 212 4598, mostafamahmoud826@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Identify post covid symptoms (time frame: after 4 weeks of diagnosis). 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 25 Sep 2020.