COVID-19NCT05185700
Symptoms ,Signs and Complications That Appear After Infection With Covid 19 Virus
An observational study of COVID-19, run by Assiut University.
Trial summary
1. Raise awareness for persistent post-COVID syndrome (PPCS). 2. Rising tide of physical and psychological disabilities that have been described in post-COVID patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID-19
- What is being tested?
- post covid 19 symtoms
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 180 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2022to 1 Dec 2023
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: This prospective study will be conducted on 175 patients who were previously diagnosed as covid-19. A written consent will be obtained from the patient or from his first degree-relative.
Who may be able to join
- patient diagnosed as covid-19.
- Presence of post covid-19 symptoms.
Who cannot join
- Patient refusal.
- Patient less than 18 years.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Post Covid 19 Syndrome
- Raise awareness for persistent post-COVID syndrome (PPCS).
- Rising tide of physical and psychological disabilities that have been described in post-COVID patients.
Read the detailed description
Since SARS-CoV-2 infection was recognised in late 2019, the academic and clinical emphasis has been on respiratory manifestations .
Post-COVID syndrome appears to be a multisystem disease, occurring even after a relatively mild acute illness. Increasing evidence exists for direct multiorgan effects, and indirect effects on other organ systems and disease processes, such as cardiovascular diseases and cancers, through changes in healthcare delivery and patient behaviors . So, the long term effects of covid-19 on individuals and health systems are becoming clear, investigation across organ systems is urgently needed. Long covid, or post-covid syndrome, is not one condition, and is defined by the National Institute for Health and Care Excellence (NICE) as "signs and symptoms that develop during or after an infection consistent with covid-19 which continue for more than 12 weeks and are not explained by an alternative diagnosis . NICE guidelines recommend referral to post-covid syndrome assessment clinics if post covid symptoms persist for 6-12 weeks . Pre-existing conditions and risk factors are predictors of acute covid-19 outcomes (such as admission to the intensive care unit and mortality, but the epidemiology of postcovid syndrome has been less well defined . Because of the unclear medium and long term pathophysiology across organ systems. When post-covid syndrome clinics are established, characterization of the epidemiology of the disease will help with appropriate diagnosis, care, public health interventions and policy, and resource planning. So, further research is highly indicated.
- Conditions
- COVID-19
- Being tested
- post covid 19 symtoms
- Keywords
- post covid-19
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
post covid 19 symtomsBehavioural
observation
What is being measured
The primary outcome is the main question the study is designed to answer.
Identifying post covid -19 respiratory manifestations.
detection of respiratory symptoms and signs appears within 6 months after infection with covid 19
Measured: 1 year
Secondary outcomes (1)
identifying other post covid -19 manifestations.
detection of extra respiratory manifestions of covid 19 infection to improve outcome of post covid 19 patients
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2022
- Study start1 Jul 2022 (estimated)
- Primary completion1 Dec 2023 (estimated)
- Study completion1 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- 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
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Kamal Darwish, Assiut University
- Investigators
- Rafaat T El-Sokry, professor, Study director, assuit university hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05185700
- Sponsor's protocol ID
- post covid 19 syndrome
- Status last verified
- Jan 2022
- First submitted
- 9 Jan 2022
- Last updated
- 11 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Puntmann VO, Carerj ML, Wieters I, Fahim M, Arendt C, Hoffmann J, Shchendrygina A, Escher F, Vasa-Nicotera M, Zeiher AM, Vehreschild M, Nagel E. Outcomes of Cardiovascular Magnetic Resonance Imaging in Patients Recently Recovered From Coronavirus Disease 2019 (COVID-19). JAMA Cardiol. 2020 Nov 1;5(11):1265-1273. doi: 10.1001/jamacardio.2020.3557.
PubMed 32730619Tabary M, Khanmohammadi S, Araghi F, Dadkhahfar S, Tavangar SM. Pathologic features of COVID-19: A concise review. Pathol Res Pract. 2020 Sep;216(9):153097. doi: 10.1016/j.prp.2020.153097. Epub 2020 Jul 4.
PubMed 32825963Alqahtani SA, Schattenberg JM. Liver injury in COVID-19: The current evidence. United European Gastroenterol J. 2020 Jun;8(5):509-519. doi: 10.1177/2050640620924157.
PubMed 32450787Somasundaram NP, Ranathunga I, Ratnasamy V, Wijewickrama PSA, Dissanayake HA, Yogendranathan N, Gamage KKK, de Silva NL, Sumanatilleke M, Katulanda P, Grossman AB. The Impact of SARS-Cov-2 Virus Infection on the Endocrine System. J Endocr Soc. 2020 Jul 2;4(8):bvaa082. doi: 10.1210/jendso/bvaa082. eCollection 2020 Aug 1.
PubMed 32728654Farouk SS, Fiaccadori E, Cravedi P, Campbell KN. COVID-19 and the kidney: what we think we know so far and what we don't. J Nephrol. 2020 Dec;33(6):1213-1218. doi: 10.1007/s40620-020-00789-y. Epub 2020 Jul 20.
PubMed 32691342Ball S, Banerjee A, Berry C, Boyle JR, Bray B, Bradlow W, Chaudhry A, Crawley R, Danesh J, Denniston A, Falter F, Figueroa JD, Hall C, Hemingway H, Jefferson E, Johnson T, King G, Lee KK, McKean P, Mason S, Mills NL, Pearson E, Pirmohamed M, Poon MTC, Priedon R, Shah A, Sofat R, Sterne JAC, Strachan FE, Sudlow CLM, Szarka Z, Whiteley W, Wyatt M; CVD-COVID-UK Consortium. Monitoring indirect impact of COVID-19 pandemic on services for cardiovascular diseases in the UK. Heart. 2020 Dec;106(24):1890-1897. doi: 10.1136/heartjnl-2020-317870. Epub 2020 Oct 5.
PubMed 33020224Lai AG, Pasea L, Banerjee A, Hall G, Denaxas S, Chang WH, Katsoulis M, Williams B, Pillay D, Noursadeghi M, Linch D, Hughes D, Forster MD, Turnbull C, Fitzpatrick NK, Boyd K, Foster GR, Enver T, Nafilyan V, Humberstone B, Neal RD, Cooper M, Jones M, Pritchard-Jones K, Sullivan R, Davie C, Lawler M, Hemingway H. Estimated impact of the COVID-19 pandemic on cancer services and excess 1-year mortality in people with cancer and multimorbidity: near real-time data on cancer care, cancer deaths and a population-based cohort study. BMJ Open. 2020 Nov 17;10(11):e043828. doi: 10.1136/bmjopen-2020-043828.
PubMed 33203640Katsoulis M, Gomes M, Lai AG, Henry A, Denaxas S, Lagiou P, Nafilyan V, Humberstone B, Banerjee A, Hemingway H, Lumbers RT. Estimating the Effect of Reduced Attendance at Emergency Departments for Suspected Cardiac Conditions on Cardiac Mortality During the COVID-19 Pandemic. Circ Cardiovasc Qual Outcomes. 2021 Jan;14(1):e007085. doi: 10.1161/CIRCOUTCOMES.120.007085. Epub 2020 Dec 20. No abstract available.
PubMed 33342219Greenhalgh T, Knight M, A'Court C, Buxton M, Husain L. Management of post-acute covid-19 in primary care. BMJ. 2020 Aug 11;370:m3026. doi: 10.1136/bmj.m3026. No abstract available.
PubMed 32784198
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post Covid 19 Syndrome
- ClinicalTrials.gov ID
- NCT05185700
- Acronym / sponsor ID
- post covid 19 syndrome
- Conditions
- COVID-19
- Keywords
- post covid-19
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Jul 2022 (estimated)
- Primary completion
- 1 Dec 2023 (estimated)
- Study completion
- 1 Dec 2023 (estimated)
- First posted
- 11 Jan 2022 (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.
- Raise awareness for persistent post-COVID syndrome (PPCS).
- Rising tide of physical and psychological disabilities that have been described in post-COVID patients.
Detailed description
Since SARS-CoV-2 infection was recognised in late 2019, the academic and clinical emphasis has been on respiratory manifestations .
Post-COVID syndrome appears to be a multisystem disease, occurring even after a relatively mild acute illness. Increasing evidence exists for direct multiorgan effects, and indirect effects on other organ systems and disease processes, such as cardiovascular diseases and cancers, through changes in healthcare delivery and patient behaviors . So, the long term effects of covid-19 on individuals and health systems are becoming clear, investigation across organ systems is urgently needed. Long covid, or post-covid syndrome, is not one condition, and is defined by the National Institute for Health and Care Excellence (NICE) as "signs and symptoms that develop during or after an infection consistent with covid-19 which continue for more than 12 weeks and are not explained by an alternative diagnosis . NICE guidelines recommend referral to post-covid syndrome assessment clinics if post covid symptoms persist for 6-12 weeks . Pre-existing conditions and risk factors are predictors of acute covid-19 outcomes (such as admission to the intensive care unit and mortality, but the epidemiology of postcovid syndrome has been less well defined . Because of the unclear medium and long term pathophysiology across organ systems. When post-covid syndrome clinics are established, characterization of the epidemiology of the disease will help with appropriate diagnosis, care, public health interventions and policy, and resource planning. So, further research is highly indicated.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This prospective study will be conducted on 175 patients who were previously diagnosed as covid-19. A written consent will be obtained from the patient or from his first degree-relative.
Key inclusion criteria (2 listed)
- patient diagnosed as covid-19.
- Presence of post covid-19 symptoms.
Key exclusion criteria (2 listed)
- Patient refusal.
- Patient less than 18 years.
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 symtomsobservation | Behavioural | – |
Primary outcome
Identifying post covid -19 respiratory manifestations.
Time frame: 1 year
detection of respiratory symptoms and signs appears within 6 months after infection with covid 19
1 secondary outcome
identifying other post covid -19 manifestations.
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2022.
- Background: PubMed 32730619Puntmann VO, Carerj ML, Wieters I, Fahim M, Arendt C, Hoffmann J, Shchendrygina A, Escher F, Vasa-Nicotera M, Zeiher AM, Vehreschild M, Nagel E. Outcomes of Cardiovascular Magnetic Resonance Imaging in Patients Recently Recovered From Coronavirus Disease 2019 (COVID-19). JAMA Cardiol. 2020 Nov 1;5(11):1265-1273. doi: 10.1001/jamacardio.2020.3557.
- Background: PubMed 32825963Tabary M, Khanmohammadi S, Araghi F, Dadkhahfar S, Tavangar SM. Pathologic features of COVID-19: A concise review. Pathol Res Pract. 2020 Sep;216(9):153097. doi: 10.1016/j.prp.2020.153097. Epub 2020 Jul 4.
- Background: PubMed 32450787Alqahtani SA, Schattenberg JM. Liver injury in COVID-19: The current evidence. United European Gastroenterol J. 2020 Jun;8(5):509-519. doi: 10.1177/2050640620924157.
- Background: PubMed 32728654Somasundaram NP, Ranathunga I, Ratnasamy V, Wijewickrama PSA, Dissanayake HA, Yogendranathan N, Gamage KKK, de Silva NL, Sumanatilleke M, Katulanda P, Grossman AB. The Impact of SARS-Cov-2 Virus Infection on the Endocrine System. J Endocr Soc. 2020 Jul 2;4(8):bvaa082. doi: 10.1210/jendso/bvaa082. eCollection 2020 Aug 1.
- Background: PubMed 32691342Farouk SS, Fiaccadori E, Cravedi P, Campbell KN. COVID-19 and the kidney: what we think we know so far and what we don't. J Nephrol. 2020 Dec;33(6):1213-1218. doi: 10.1007/s40620-020-00789-y. Epub 2020 Jul 20.
- Background: PubMed 33020224Ball S, Banerjee A, Berry C, Boyle JR, Bray B, Bradlow W, Chaudhry A, Crawley R, Danesh J, Denniston A, Falter F, Figueroa JD, Hall C, Hemingway H, Jefferson E, Johnson T, King G, Lee KK, McKean P, Mason S, Mills NL, Pearson E, Pirmohamed M, Poon MTC, Priedon R, Shah A, Sofat R, Sterne JAC, Strachan FE, Sudlow CLM, Szarka Z, Whiteley W, Wyatt M; CVD-COVID-UK Consortium. Monitoring indirect impact of COVID-19 pandemic on services for cardiovascular diseases in the UK. Heart. 2020 Dec;106(24):1890-1897. doi: 10.1136/heartjnl-2020-317870. Epub 2020 Oct 5.
- Background: PubMed 33203640Lai AG, Pasea L, Banerjee A, Hall G, Denaxas S, Chang WH, Katsoulis M, Williams B, Pillay D, Noursadeghi M, Linch D, Hughes D, Forster MD, Turnbull C, Fitzpatrick NK, Boyd K, Foster GR, Enver T, Nafilyan V, Humberstone B, Neal RD, Cooper M, Jones M, Pritchard-Jones K, Sullivan R, Davie C, Lawler M, Hemingway H. Estimated impact of the COVID-19 pandemic on cancer services and excess 1-year mortality in people with cancer and multimorbidity: near real-time data on cancer care, cancer deaths and a population-based cohort study. BMJ Open. 2020 Nov 17;10(11):e043828. doi: 10.1136/bmjopen-2020-043828.
- Background: PubMed 33342219Katsoulis M, Gomes M, Lai AG, Henry A, Denaxas S, Lagiou P, Nafilyan V, Humberstone B, Banerjee A, Hemingway H, Lumbers RT. Estimating the Effect of Reduced Attendance at Emergency Departments for Suspected Cardiac Conditions on Cardiac Mortality During the COVID-19 Pandemic. Circ Cardiovasc Qual Outcomes. 2021 Jan;14(1):e007085. doi: 10.1161/CIRCOUTCOMES.120.007085. Epub 2020 Dec 20. No abstract available.
- Background: PubMed 32784198Greenhalgh T, Knight M, A'Court C, Buxton M, Husain L. Management of post-acute covid-19 in primary care. BMJ. 2020 Aug 11;370:m3026. doi: 10.1136/bmj.m3026. No abstract available.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- 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.
Rafaat T El-Sokry, professor study director
assuit university hospital
Questions about this trial
What is this clinical trial studying?
An observational study of COVID-19, 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 2 inclusion and 2 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 11 Jan 2022. 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 Mohamed Kl Mohamed, phd (01098989377, mkdarwish90@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Identifying post covid -19 respiratory manifestations. (time frame: 1 year). 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 NCT05185700, which also lists 9 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 11 Jan 2022.