COVID-19NCT04336657
Corona-Like Illness: Did we Got it Before WHO Announcement of the Disease?
An observational study of COVID-19, run by Assiut University at 1 site in Egypt.
Trial summary
A pneumonia of unknown cause detected in Wuhan, China was first reported to the WHO Country Office in China on 31 December 2019. The outbreak was declared a Public Health Emergency of International Concern on 30 January 2020. The spread and severity of the disease is variable from one country to another. Read more about this study
- Who is it for?
- Ages 8 to 80 years
- Conditions the study is for
- COVID-19
- What is being tested?
- Questionnaire and IgG
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- Apr 2020to May 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 8 to 80 years
- All sexes
- Child, Adult, Older adult
Study population: The survey will be distributed online in English and Arabic and all responders well be included
Who may be able to join
- All subject except excluded group
Who cannot join
- subject diagnosed as COVID-19 positive and their contacts
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
AssiutU
Asyut, 71111
Aliae AR Mohamed-Hussein, +201222302352, aliaehussein@gmail.com
About this study
Official title: COVID-19-Like Illness: Did we Have Unusual Severe Respiratory Tract Infections October-December 2019 Before WHO Announcement ?
A pneumonia of unknown cause detected in Wuhan, China was first reported to the WHO Country Office in China on 31 December 2019. The outbreak was declared a Public Health Emergency of International Concern on 30 January 2020. The spread and severity of the disease is variable from one country to another. Our team as well as many reports suggested that in some countries a " Flu like illness but much worse" was described in October, November and early in December before the WHO announcement. Was it COVID-19?
- Conditions
- COVID-19
- Being tested
- Questionnaire, IgG
- Keywords
- COVID-19, Corona-like illness, WHO announcement, Survey, IgG
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnaireOther
Survey to identify number of people who got unusual severe flu- like illness in last October- November
IgGDiagnostic test
Measure the past immunity of the disease (if possible)
What is being measured
The primary outcome is the main question the study is designed to answer.
Measure frequency of people suffered from unusual flu-like symptoms before December 2019
fever, dry cough, dyspnea, malaise, headache
Measured: one month
Secondary outcomes (1)
Measure remote immunity for COVID-19 in subject with past history of severe flu before WHO announcement date- if possible
serum IgG
Measured: 3 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2020
- Study startApr 2020 (estimated)
- Primary completionMay 2020 (estimated)
- Study completionMay 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
- Ecologic or community
- Time perspective
- Prospective
- Enrolment
- 100 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04336657
- Sponsor's protocol ID
- AssiutU11
- Status last verified
- Apr 2020
- First submitted
- 3 Apr 2020
- Last updated
- 7 Apr 2020
- Results posted
- 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 7 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- COVID-19-Like Illness: Did we Have Unusual Severe Respiratory Tract Infections October-December 2019 Before WHO Announcement ?
- ClinicalTrials.gov ID
- NCT04336657
- Acronym / sponsor ID
- AssiutU11
- Conditions
- COVID-19
- Keywords
- COVID-19, Corona-like illness, WHO announcement, Survey, IgG
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Apr 2020 (estimated)
- Primary completion
- May 2020 (estimated)
- Study completion
- May 2020 (estimated)
- First posted
- 7 Apr 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.
A pneumonia of unknown cause detected in Wuhan, China was first reported to the WHO Country Office in China on 31 December 2019. The outbreak was declared a Public Health Emergency of International Concern on 30 January 2020. The spread and severity of the disease is variable from one country to another. Our team as well as many reports suggested that in some countries a " Flu like illness but much worse" was described in October, November and early in December before the WHO announcement. Was it COVID-19?
Study design
- Observational model
- Ecologic or community
- Time perspective
- Prospective
Who may qualify
- Ages
- 8 to 80 years
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- The survey will be distributed online in English and Arabic and all responders well be included
Key inclusion criteria (1 listed)
- All subject except excluded group
Key exclusion criteria (1 listed)
- subject diagnosed as COVID-19 positive and their contacts
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 |
|---|---|---|
| QuestionnaireSurvey to identify number of people who got unusual severe flu- like illness in last October- November | Other | – |
| IgGMeasure the past immunity of the disease (if possible) | Diagnostic test | – |
Primary outcome
Measure frequency of people suffered from unusual flu-like symptoms before December 2019
Time frame: one month
fever, dry cough, dyspnea, malaise, headache
1 secondary outcome
Measure remote immunity for COVID-19 in subject with past history of severe flu before WHO announcement date- if possible
Time frame: 3 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 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.
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 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 7 Apr 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?
Measure frequency of people suffered from unusual flu-like symptoms before December 2019 (time frame: one 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 7 Apr 2020.