COVID-19NCT04896762
Extrapulmonary Presentations of COVID-19 Patients
An observational study of COVID-19, run by Sohag University at 1 site in Egypt.
Trial summary
An observational study about the extrapulmonary presentations of COVID-19 patients during the second wave of the pandemic. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- COVID-19
- How many people
- 948 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Sep 2020to Dec 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: patients presented at a triage point in a tertiary health care facility with a suspected covid 19 disease.
Who may be able to join
- all patient with confirmed covid 19 disease presented to our health facility during the second wave of the pandemic
Who cannot join
- other diagnosis than covid 19 as a primary cause of presentation of the patient
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Extrapulmonary Presentation of COVID-19 Patients During the Second Wave
An observational study about the extrapulmonary presentations of COVID-19 patients during the second wave of the pandemic.
Read the detailed description
a prospective observational study that aimed at
- provide an overview about the prevalence of extra-pulmonary presentation of COVID-19 during the second wave of the pandemic and
- Detection of the most frequent affected systems with comparison between the pulmonary and extrapulmonary presentation of COVID 19 as regard patient demographics, comorbidity and level of care needed.
- Conditions
- COVID-19
- Keywords
- extrapulmonary presentation, pulmonary
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Extrapulmonary presentation for COVID-19 | patients with confirmed covid 19 disease who primarily presented with extrapulmonary system affection | |
| pulmonary presentation for COVID-19 | patients with confirmed covid 19 disease who primarily presented with pulmonary disease |
What is being measured
The primary outcome is the main question the study is designed to answer.
extrapulmonary presentation in COVID-19
frequency of extrapulmonary presentation inCOVID-19 second wave pandemic
Measured: Baseline presentation of confirmed cases with COVID-19
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2021
- Study start1 Sep 2020
- Primary completion31 Dec 2021
- Study completionDec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)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 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 948 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hend Mohammed Abdelraheem Esmaeel, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04896762
- Sponsor's protocol ID
- Soh-Med-21-04-25
- Status last verified
- Oct 2022
- First submitted
- 15 May 2021
- Last updated
- 25 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Dong E, Du H, Gardner L. An interactive web-based dashboard to track COVID-19 in real time. Lancet Infect Dis. 2020 May;20(5):533-534. doi: 10.1016/S1473-3099(20)30120-1. Epub 2020 Feb 19. No abstract available.
PubMed 32087114Huang C, Wang Y, Li X, Ren L, Zhao J, Hu Y, Zhang L, Fan G, Xu J, Gu X, Cheng Z, Yu T, Xia J, Wei Y, Wu W, Xie X, Yin W, Li H, Liu M, Xiao Y, Gao H, Guo L, Xie J, Wang G, Jiang R, Gao Z, Jin Q, Wang J, Cao B. Clinical features of patients infected with 2019 novel coronavirus in Wuhan, China. Lancet. 2020 Feb 15;395(10223):497-506. doi: 10.1016/S0140-6736(20)30183-5. Epub 2020 Jan 24.
PubMed 31986264Guan WJ, Ni ZY, Hu Y, Liang WH, Ou CQ, He JX, Liu L, Shan H, Lei CL, Hui DSC, Du B, Li LJ, Zeng G, Yuen KY, Chen RC, Tang CL, Wang T, Chen PY, Xiang J, Li SY, Wang JL, Liang ZJ, Peng YX, Wei L, Liu Y, Hu YH, Peng P, Wang JM, Liu JY, Chen Z, Li G, Zheng ZJ, Qiu SQ, Luo J, Ye CJ, Zhu SY, Zhong NS; China Medical Treatment Expert Group for Covid-19. Clinical Characteristics of Coronavirus Disease 2019 in China. N Engl J Med. 2020 Apr 30;382(18):1708-1720. doi: 10.1056/NEJMoa2002032. Epub 2020 Feb 28.
PubMed 32109013
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Extrapulmonary Presentation of COVID-19 Patients During the Second Wave
- ClinicalTrials.gov ID
- NCT04896762
- Acronym / sponsor ID
- Soh-Med-21-04-25
- Conditions
- COVID-19
- Keywords
- extrapulmonary presentation, pulmonary
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 948 participants (actual)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 1 Sep 2020 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- Dec 2022 (estimated)
- First posted
- 21 May 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.
An observational study about the extrapulmonary presentations of COVID-19 patients during the second wave of the pandemic.
Detailed description
a prospective observational study that aimed at
- provide an overview about the prevalence of extra-pulmonary presentation of COVID-19 during the second wave of the pandemic and
- Detection of the most frequent affected systems with comparison between the pulmonary and extrapulmonary presentation of COVID 19 as regard patient demographics, comorbidity and level of care needed.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Extrapulmonary presentation for COVID-19 | – | –patients with confirmed covid 19 disease who primarily presented with extrapulmonary system affection |
| pulmonary presentation for COVID-19 | – | –patients with confirmed covid 19 disease who primarily presented with pulmonary disease |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- patients presented at a triage point in a tertiary health care facility with a suspected covid 19 disease.
Key inclusion criteria (1 listed)
- all patient with confirmed covid 19 disease presented to our health facility during the second wave of the pandemic
Key exclusion criteria (1 listed)
- other diagnosis than covid 19 as a primary cause of presentation of the patient
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
extrapulmonary presentation in COVID-19
Time frame: Baseline presentation of confirmed cases with COVID-19
frequency of extrapulmonary presentation inCOVID-19 second wave pandemic
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Oct 2022.
- Background: PubMed 32087114Dong E, Du H, Gardner L. An interactive web-based dashboard to track COVID-19 in real time. Lancet Infect Dis. 2020 May;20(5):533-534. doi: 10.1016/S1473-3099(20)30120-1. Epub 2020 Feb 19. No abstract available.
- Background: PubMed 31986264Huang C, Wang Y, Li X, Ren L, Zhao J, Hu Y, Zhang L, Fan G, Xu J, Gu X, Cheng Z, Yu T, Xia J, Wei Y, Wu W, Xie X, Yin W, Li H, Liu M, Xiao Y, Gao H, Guo L, Xie J, Wang G, Jiang R, Gao Z, Jin Q, Wang J, Cao B. Clinical features of patients infected with 2019 novel coronavirus in Wuhan, China. Lancet. 2020 Feb 15;395(10223):497-506. doi: 10.1016/S0140-6736(20)30183-5. Epub 2020 Jan 24.
- Background: PubMed 32109013Guan WJ, Ni ZY, Hu Y, Liang WH, Ou CQ, He JX, Liu L, Shan H, Lei CL, Hui DSC, Du B, Li LJ, Zeng G, Yuen KY, Chen RC, Tang CL, Wang T, Chen PY, Xiang J, Li SY, Wang JL, Liang ZJ, Peng YX, Wei L, Liu Y, Hu YH, Peng P, Wang JM, Liu JY, Chen Z, Li G, Zheng ZJ, Qiu SQ, Luo J, Ye CJ, Zhu SY, Zhong NS; China Medical Treatment Expert Group for Covid-19. Clinical Characteristics of Coronavirus Disease 2019 in China. N Engl J Med. 2020 Apr 30;382(18):1708-1720. doi: 10.1056/NEJMoa2002032. Epub 2020 Feb 28.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
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, 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: status not confirmed, as of the sponsor's last update on 25 Oct 2022. 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?
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?
extrapulmonary presentation in COVID-19 (time frame: Baseline presentation of confirmed cases with COVID-19). 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 NCT04896762, 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 25 Oct 2022.