Corona Virus InfectionCOVID-19NCT04764773
Persistence of Symptoms After Improvement of Acute COVID-19
An observational study of Corona Virus Infection, run by Sohag University at 1 site in Egypt.
Trial summary
Coronavirus disease pandemic has been started in late 2019. Survivors of COVID-19 are significantly more likely to develop clinical sequelae three months after discharge from the hospital than those without COVID-19 infection. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Corona Virus Infection
- How many people
- 172 participants
- Where
- 1 siteEgypt
- Study dates
- 1 May 2020to 31 Mar 2021
- 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
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: patients who were test positive for SARS-CoV2 and were improved and discharged from Sohag isolation hospitals and isolation department for COVID19 in Sohag University hospitals
Who may be able to join
- Positive for SARS-CoV2
Who cannot join
- Patients with severe complex illness, pregnant or lactating females and patient who refuse to participate or give complete detailed history
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Persistence of Symptoms After Improvement of Acute COVID19 Infection in Sohag Governorate, Egypt, A Longitudinal Study
Coronavirus disease pandemic has been started in late 2019. Survivors of COVID-19 are significantly more likely to develop clinical sequelae three months after discharge from the hospital than those without COVID-19 infection. This is true not only for general and respiratory symptoms but also for cardiovascular and psychosocial symptoms. This suggests that these symptoms may indeed be the sequelae of recovery for COVID-19 survivors. So, we aimed to detect the prevalence and to evaluate the type of symptoms that could persist after the recovery from COVID19 infection in Sohag governorate, Egypt.
Read the detailed description
About one hundred patients who were test positive for SARS-CoV2 and were improved and discharged from Sohag isolation hospitals and isolation department for COVID19 in Sohag University hospitals during the period from 15th May, 2020 to 25th July, 2020 will be included in our study. Patient improvement and discharge criteria include 10 day from symptoms onset in addition to 3 day free of fever and respiratory symptoms.
Patients with severe complex illness, pregnant or lactating females and patient who refuse to participate or give complete detailed history will be excluded from the study.
The study protocol will be approved by the scientific Research Ethical committee, Faculty of Medicine, Sohag University A control group of healthy volunteer who were age and sex matched to our patient were included
After taken informed consent according to Sohag University Ethical Committee, the baseline data will be collected from Sohag isolation hospital of COVID19, then the researchers will perform interviews with all participants through mobile phone. The interview will include:
- Name (Optional)
- Age
- Sex
- Occupation
- Presence of DM, HTN or any chronic illness
- Asking about Smoking
- The date of catching COVID19 infection
- Asking about symptoms of COVID19 infection and duration of each symptom.
- Asking about any residual symptoms as: Fatigue, Myalgia, Arthralgia, Chest pain, Dyspnea, Dry cough, Productive cough, Sore Throat, Anosmia, Loss of taste sensation, Nausea, Anorexia, Diarrhea, Redness of the eye, Headache, Confusion and Depression
Statistical analysis:
Data will be analyzed using STATA version 14.2 (Statistical Software: Release 14.2 College Station, TX: Stata Corp LP). Quantitative data will be represented as mean, standard deviation, median and range. normally distributed. Qualitative data will be presented as numbers and percentages. Chi square test will be used for comparison of percentages in different groups. P value will be considered significant if it was less than 0.05.
- Conditions
- Corona Virus Infection
- Being tested
- No intervention
- Keywords
- Persistent symptoms, Recovery, COVID-19
- Medical subject headings
- Coronavirus Infections, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
No intervention
| Study group | Role | What they receive |
|---|---|---|
| Case | Patient who had COVID19 infection Receives: Other: No intervention | |
| control | healthy volunteer who were age and sex matched with our patients Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of patient who had persistent symptoms after recovery of acute covid19
Measured: during the period from 15th May,2020 to the end of February, 2021
Type of persistent symptom after acute covid19
Measured: during the period from the start of June 2020 to the end of July 2020
Risk factors for persistent symptoms after recovery of acute covid19
Measured: during the period from 15th May,2020 to the end of February, 2021
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2021
- Study start1 May 2020
- Primary completion28 Feb 2021
- Study completion31 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Corona Virus InfectionStudies of the same condition, open and under way.
- More trials run by Sohag 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 172 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mona Mohammed Abdelrhman, Sohag University
- Investigators
- Noha Abdelrahman, assistant-lecturer, Study chair, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04764773
- Sponsor's protocol ID
- Soh-Med-21-02-46
- Acronym
- COVID-19
- Status last verified
- Nov 2021
- First submitted
- 19 Feb 2021
- Last updated
- 2 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Xiong Q, Xu M, Li J, Liu Y, Zhang J, Xu Y, Dong W. Clinical sequelae of COVID-19 survivors in Wuhan, China: a single-centre longitudinal study. Clin Microbiol Infect. 2021 Jan;27(1):89-95. doi: 10.1016/j.cmi.2020.09.023. Epub 2020 Sep 23.
PubMed 32979574Abdelrahman MM, Abd-Elrahman NM, Bakheet TM. Persistence of symptoms after improvement of acute COVID19 infection, a longitudinal study. J Med Virol. 2021 Oct;93(10):5942-5946. doi: 10.1002/jmv.27156. Epub 2021 Jul 2.
PubMed 34171139
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Persistence of Symptoms After Improvement of Acute COVID19 Infection in Sohag Governorate, Egypt, A Longitudinal Study
- ClinicalTrials.gov ID
- NCT04764773
- Acronym / sponsor ID
- COVID-19 / Soh-Med-21-02-46
- Conditions
- Corona Virus Infection
- Keywords
- Persistent symptoms, Recovery, COVID-19
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 172 participants (actual)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 1 May 2020 (actual)
- Primary completion
- 28 Feb 2021 (actual)
- Study completion
- 31 Mar 2021 (actual)
- First posted
- 21 Feb 2021 (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.
Coronavirus disease pandemic has been started in late 2019. Survivors of COVID-19 are significantly more likely to develop clinical sequelae three months after discharge from the hospital than those without COVID-19 infection. This is true not only for general and respiratory symptoms but also for cardiovascular and psychosocial symptoms. This suggests that these symptoms may indeed be the sequelae of recovery for COVID-19 survivors. So, we aimed to detect the prevalence and to evaluate the type of symptoms that could persist after the recovery from COVID19 infection in Sohag governorate, Egypt.
Detailed description
About one hundred patients who were test positive for SARS-CoV2 and were improved and discharged from Sohag isolation hospitals and isolation department for COVID19 in Sohag University hospitals during the period from 15th May, 2020 to 25th July, 2020 will be included in our study. Patient improvement and discharge criteria include 10 day from symptoms onset in addition to 3 day free of fever and respiratory symptoms.
Patients with severe complex illness, pregnant or lactating females and patient who refuse to participate or give complete detailed history will be excluded from the study.
The study protocol will be approved by the scientific Research Ethical committee, Faculty of Medicine, Sohag University A control group of healthy volunteer who were age and sex matched to our patient were included
After taken informed consent according to Sohag University Ethical Committee, the baseline data will be collected from Sohag isolation hospital of COVID19, then the researchers will perform interviews with all participants through mobile phone. The interview will include:
- Name (Optional)
- Age
- Sex
- Occupation
- Presence of DM, HTN or any chronic illness
- Asking about Smoking
- The date of catching COVID19 infection
- Asking about symptoms of COVID19 infection and duration of each symptom.
- Asking about any residual symptoms as: Fatigue, Myalgia, Arthralgia, Chest pain, Dyspnea, Dry cough, Productive cough, Sore Throat, Anosmia, Loss of taste sensation, Nausea, Anorexia, Diarrhea, Redness of the eye, Headache, Confusion and Depression
Statistical analysis:
Data will be analyzed using STATA version 14.2 (Statistical Software: Release 14.2 College Station, TX: Stata Corp LP). Quantitative data will be represented as mean, standard deviation, median and range. normally distributed. Qualitative data will be presented as numbers and percentages. Chi square test will be used for comparison of percentages in different groups. P value will be considered significant if it was less than 0.05.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Case | – | Other: No interventionPatient who had COVID19 infection |
| control | – | Other: No interventionhealthy volunteer who were age and sex matched with our patients |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- patients who were test positive for SARS-CoV2 and were improved and discharged from Sohag isolation hospitals and isolation department for COVID19 in Sohag University hospitals
Key inclusion criteria (1 listed)
- Positive for SARS-CoV2
Key exclusion criteria (1 listed)
- Patients with severe complex illness, pregnant or lactating females and patient who refuse to participate or give complete detailed history
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 |
|---|---|---|
| No interventionNo intervention | Other | Case, control |
Primary outcome
Percentage of patient who had persistent symptoms after recovery of acute covid19
Time frame: during the period from 15th May,2020 to the end of February, 2021
Type of persistent symptom after acute covid19
Time frame: during the period from the start of June 2020 to the end of July 2020
Risk factors for persistent symptoms after recovery of acute covid19
Time frame: during the period from 15th May,2020 to the end of February, 2021
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2021.
- Background: PubMed 32979574Xiong Q, Xu M, Li J, Liu Y, Zhang J, Xu Y, Dong W. Clinical sequelae of COVID-19 survivors in Wuhan, China: a single-centre longitudinal study. Clin Microbiol Infect. 2021 Jan;27(1):89-95. doi: 10.1016/j.cmi.2020.09.023. Epub 2020 Sep 23.
- Derived from this study: PubMed 34171139Abdelrahman MM, Abd-Elrahman NM, Bakheet TM. Persistence of symptoms after improvement of acute COVID19 infection, a longitudinal study. J Med Virol. 2021 Oct;93(10):5942-5946. doi: 10.1002/jmv.27156. Epub 2021 Jul 2.
- Individual participant dataSharing planned: No
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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.
Noha Abdelrahman, assistant-lecturer study chair
Sohag 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 Corona Virus Infection, run by Sohag 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: finished, as of the sponsor's last update on 2 Nov 2021. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of patient who had persistent symptoms after recovery of acute covid19 (time frame: during the period from 15th May,2020 to the end of February, 2021). The study lists 3 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 NCT04764773, which also lists 2 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 2 Nov 2021.