COVID-19 PandemicNCT06544369
Prospective Study on COVID -19 Reinfection on Vaccinated and Non-vaccinated Outpatients
An observational study of COVID-19 Pandemic, run by Soad Ali at 1 site in Egypt.
Trial summary
the aim of the study is to compare the severity of symptoms in case of reinfection with COVID-19. the study will compare between two groups; vaccinated and non vaccinated. the side effects from vaccination and symptoms of infection and reinfection will be reprted. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- COVID-19 Pandemic
- What is being tested?
- COVID-19 vaccin
- Type of treatment
- Vaccines, Injection or infusion
- How many people
- 200 participants
- Where
- 1 siteEgypt
- Study dates
- 20 Nov 2021to 18 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: the study group are infected patients with COVID-19
Who may be able to join
- clinically diagnosed with COVID infection
- take any type of vaccines
Who cannot join
- no accept sharing
- not vaccinated with COVID vaccine
Trial locations and contacts
1 site in 1 country.
About this study
the aim of the study is to compare the severity of symptoms in case of reinfection with COVID-19. the study will compare between two groups; vaccinated and non vaccinated. the side effects from vaccination and symptoms of infection and reinfection will be reprted.
- Conditions
- COVID-19 Pandemic
- Being tested
- COVID-19 vaccin
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
COVID-19 vaccinBiological
injection
| Study group | Role | What they receive |
|---|---|---|
| Vaccinated group | all criteria are accepted for study Receives: Biological: COVID-19 vaccin | |
| Non-vaccinated group | all criteria are accepted for study Receives: Biological: COVID-19 vaccin |
What is being measured
The primary outcome is the main question the study is designed to answer.
percent of reinfection with COVID-19 in vaccinated and non vaccinated
Measured: one year
Secondary outcomes (1)
scoring of symptoms in case of reinfection in vaccinated and non vaccinated
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2024
- Study start20 Nov 2021
- Primary completion18 Jan 2022
- Study completion18 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19 PandemicStudies of the same condition, open and under way.
- 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
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Soad Ali
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Soad Ali, Deraya University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06544369
- Sponsor's protocol ID
- Deraya university
- Status last verified
- Aug 2024
- First submitted
- 25 Oct 2021
- Last updated
- 9 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Study on COVID -19 Reinfection on Vaccinated and Non-vaccinated Outpatients
- ClinicalTrials.gov ID
- NCT06544369
- Acronym / sponsor ID
- Deraya university
- Conditions
- COVID-19 Pandemic
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Soad AliUniversity, hospital or other
- Study start
- 20 Nov 2021 (actual)
- Primary completion
- 18 Jan 2022 (actual)
- Study completion
- 18 Jan 2022 (actual)
- First posted
- 9 Aug 2024 (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.
the aim of the study is to compare the severity of symptoms in case of reinfection with COVID-19. the study will compare between two groups; vaccinated and non vaccinated. the side effects from vaccination and symptoms of infection and reinfection will be reprted.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vaccinated group | – | Biological: COVID-19 vaccinall criteria are accepted for study |
| Non-vaccinated group | – | Biological: COVID-19 vaccinall criteria are accepted for study |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- the study group are infected patients with COVID-19
Key inclusion criteria (2 listed)
- clinically diagnosed with COVID infection
- take any type of vaccines
Key exclusion criteria (2 listed)
- no accept sharing
- not vaccinated with COVID vaccine
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 |
|---|---|---|
| COVID-19 vaccininjection | Biological | Non-vaccinated group, Vaccinated group |
Primary outcome
percent of reinfection with COVID-19 in vaccinated and non vaccinated
Time frame: one year
1 secondary outcome
scoring of symptoms in case of reinfection in vaccinated and non vaccinated
Time frame: one year
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 9 Aug 2024.
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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 Pandemic, run by Soad Ali 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 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: finished, as of the sponsor's last update on 9 Aug 2024. 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?
percent of reinfection with COVID-19 in vaccinated and non vaccinated (time frame: one year). 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 9 Aug 2024.