Covid19NCT05033834
Covid-19 Infection in After Vaccination
An observational study of Covid19, run by Assiut University at 3 sites in Egypt.
Trial summary
Coronavirus disease 2019 (COVID-19), caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), was first identified in Wuhan, China. It rapidly spread, resulting a global pandemic in March 2020. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Covid19
- What is being tested?
- covid-19 vaccines registered in Egypt
- Type of treatment
- Vaccines
- How many people
- 100 participants
- Where
- 3 sitesEgypt
- Study dates
- 1 Nov 2021to 31 Dec 2022
- How long will I take part?
- 1 Year
- 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 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Group A: people receive vaccination at the study period will be followed by phone calls or email for any new infection. Group B: patients who will be confirmed to have recent COVID-19 infection who visit outpatient clinic or admit to ward or ICU of Assiut University hospital at study period.
Who may be able to join
- • Patients 18 years old and above of both genders.
- Received at least one dose of COVID-19 registered vaccines.
- Diagnosed COVID-19 positive after vaccination by real time PCR (confirmed case) or combined clinical and radiological diagnosis (possible case).
Who cannot join
- Children less than 18 years.
- Cases non vaccinated with COVID-19 registered vaccine
Trial locations and contacts
3 sites in 1 country.
Egypt3 sites
AssiutU
Asyut, 71111
Pulmonology Departments
Asyut, 71111
Aliae AR Mohamed-Hussein
Asyut, 71515
About this study
Official title: Covid-19 Infection in Partially and Fully Vaccinated Cases: Cohort Study
Coronavirus disease 2019 (COVID-19), caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), was first identified in Wuhan, China. It rapidly spread, resulting a global pandemic in March 2020. Globally, till 27 August 2021, there have been 214,468,601 confirmed cases of COVID-19, including 4,470,969 deaths, reported to WHO.
With the absence of curative treatment for COVID-19 infection the development of safe and effective vaccines is critical to ending the COVID-19 pandemic. The Pfizer/BioNtech Comirnaty vaccine was listed for WHO Emergency Use Listing (EUL) on 31 December 2020. The SII/Covishield and AstraZeneca/AZD1222 vaccines (developed by AstraZeneca/Oxford and manufactured by the State Institute of India and SK Bio respectively) were given EUL on 16 February. The Janssen/Ad26.COV 2.S developed by Johnson \& Johnson, was listed for EUL on 12 March 2021. The Moderna COVID-19 vaccine (mRNA 1273) was listed for EUL on 30 April 2021 and the Sinopharm COVID-19 vaccine was listed for EUL on 7 May 2021. The Sinopharm vaccine is produced by Beijing Bio-Institute of Biological Products Co Ltd, subsidiary of China National Biotec Group (CNBG). The Sinovac-CoronaVac was listed for EUL on 1 June 2021. As of 25 August 2021, a total of 4,953,887,422 vaccine doses have been administered. In large, randomized-controlled trials, vaccines were found to be safe and efficacious in preventing symptomatic, laboratory-confirmed COVID-19.
However, a small percentage of fully vaccinated persons will develop symptomatic or asymptomatic infections with SARS-CoV-2, the virus that causes COVID-19. A vaccine breakthrough infection is defined as the detection of SARS-CoV-2 RNA or antigen in a respiratory specimen collected from a person ≥14 days after receipt of all recommended doses of an FDA-authorized COVID-19 vaccine. A total of 10,262 SARS-CoV-2 vaccine breakthrough infections had been reported from 46 U.S. states and territories as of April 30, 2021. Among these cases, 6,446 (63%) occurred in females, and the median patient age was 58 years (interquartile range = 40-74 years). Based on preliminary data, 2,725 (27%) vaccine breakthrough infections were asymptomatic, 995 (10%) patients were known to be hospitalized, and 160 (2%) patients died.
- Conditions
- Covid19
- Being tested
- covid-19 vaccines registered in Egypt
- Keywords
- COVID-19, COVID-19 vaccination, Post vaccination infection, breakthrough COVID-19, Partially vaccinated, Fully vaccinated
- Medical subject headings
- COVID-19, COVID-19 breakthrough infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
covid-19 vaccines registered in EgyptOther
Astra Zeneka vaccine, Sinopharm vaccine, Sinovac vaccine, Jonson and Jonson vaccine, Spotnic V vaccine
| Study group | Role | What they receive |
|---|---|---|
| Group A | People received any registered COVID-19 vaccination Receives: Other: covid-19 vaccines registered in Egypt | |
| Group B | People developed COVID-19 infection after partial or full vaccination with any registered COVID-19 vaccine Receives: Other: covid-19 vaccines registered in Egypt |
What is being measured
The primary outcome is the main question the study is designed to answer.
assess the prevalence of COVID-19 infection after vaccination
number of cases with covid-19 after vaccination
Measured: one year
Secondary outcomes (2)
evaluate the severity of infection after vaccination
severity of covid-19 infection in partially and fully vaccinated cases
Measured: 2 weeks
Predict possible risk factors of post vaccination infection
adherence to protective measures
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 posted5 Sep 2021
- Study start1 Nov 2021 (estimated)
- Primary completion1 Nov 2022 (estimated)
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Covid19Studies 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
- 100 participants (estimated)
- Target duration
- 1 Year
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
- NCT05033834
- Sponsor's protocol ID
- Assiut-breakthrough covid-19
- Status last verified
- Sep 2021
- First submitted
- 2 Sep 2021
- Last updated
- 13 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: upon reasonable request
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Covid-19 Infection in Partially and Fully Vaccinated Cases: Cohort Study
- ClinicalTrials.gov ID
- NCT05033834
- Acronym / sponsor ID
- Assiut-breakthrough covid-19
- Conditions
- Covid19
- Keywords
- COVID-19, COVID-19 vaccination, Post vaccination infection, breakthrough COVID-19, Partially vaccinated, Fully vaccinated
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Nov 2021 (estimated)
- Primary completion
- 1 Nov 2022 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 5 Sep 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 2019 (COVID-19), caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), was first identified in Wuhan, China. It rapidly spread, resulting a global pandemic in March 2020. Globally, till 27 August 2021, there have been 214,468,601 confirmed cases of COVID-19, including 4,470,969 deaths, reported to WHO.
With the absence of curative treatment for COVID-19 infection the development of safe and effective vaccines is critical to ending the COVID-19 pandemic. The Pfizer/BioNtech Comirnaty vaccine was listed for WHO Emergency Use Listing (EUL) on 31 December 2020. The SII/Covishield and AstraZeneca/AZD1222 vaccines (developed by AstraZeneca/Oxford and manufactured by the State Institute of India and SK Bio respectively) were given EUL on 16 February. The Janssen/Ad26.COV 2.S developed by Johnson \& Johnson, was listed for EUL on 12 March 2021. The Moderna COVID-19 vaccine (mRNA 1273) was listed for EUL on 30 April 2021 and the Sinopharm COVID-19 vaccine was listed for EUL on 7 May 2021. The Sinopharm vaccine is produced by Beijing Bio-Institute of Biological Products Co Ltd, subsidiary of China National Biotec Group (CNBG). The Sinovac-CoronaVac was listed for EUL on 1 June 2021. As of 25 August 2021, a total of 4,953,887,422 vaccine doses have been administered. In large, randomized-controlled trials, vaccines were found to be safe and efficacious in preventing symptomatic, laboratory-confirmed COVID-19.
However, a small percentage of fully vaccinated persons will develop symptomatic or asymptomatic infections with SARS-CoV-2, the virus that causes COVID-19. A vaccine breakthrough infection is defined as the detection of SARS-CoV-2 RNA or antigen in a respiratory specimen collected from a person ≥14 days after receipt of all recommended doses of an FDA-authorized COVID-19 vaccine. A total of 10,262 SARS-CoV-2 vaccine breakthrough infections had been reported from 46 U.S. states and territories as of April 30, 2021. Among these cases, 6,446 (63%) occurred in females, and the median patient age was 58 years (interquartile range = 40-74 years). Based on preliminary data, 2,725 (27%) vaccine breakthrough infections were asymptomatic, 995 (10%) patients were known to be hospitalized, and 160 (2%) patients died.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | – | Other: covid-19 vaccines registered in EgyptPeople received any registered COVID-19 vaccination |
| Group B | – | Other: covid-19 vaccines registered in EgyptPeople developed COVID-19 infection after partial or full vaccination with any registered COVID-19 vaccine |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Group A: people receive vaccination at the study period will be followed by phone calls or email for any new infection. Group B: patients who will be confirmed to have recent COVID-19 infection who visit outpatient clinic or admit to ward or ICU of Assiut University hospital at study period.
Key inclusion criteria (3 listed)
- • Patients 18 years old and above of both genders.
Key exclusion criteria (2 listed)
- Children less than 18 years.
- Cases non vaccinated with COVID-19 registered 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 vaccines registered in EgyptAstra Zeneka vaccine, Sinopharm vaccine, Sinovac vaccine, Jonson and Jonson vaccine, Spotnic V vaccine | Other | Group A, Group B |
Primary outcome
assess the prevalence of COVID-19 infection after vaccination
Time frame: one year
number of cases with covid-19 after vaccination
2 secondary outcomes
evaluate the severity of infection after vaccination
Time frame: 2 weeks
Predict possible risk factors of post vaccination infection
Time frame: one year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2021.
- Individual participant dataSharing planned: Undecided. upon reasonable request
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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.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Covid19, run by Assiut University at 3 sites 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 3 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 13 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
assess the prevalence of COVID-19 infection after vaccination (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 13 Sep 2021.