Clinical trial NCT05033834: Covid-19 Infection in After Vaccination
Official title: Covid-19 Infection in Partially and Fully Vaccinated Cases: Cohort Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Covid19
Keywords: COVID-19
COVID-19 vaccination
Post vaccination infection
breakthrough COVID-19
Partially vaccinated
Fully vaccinated
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2021-09-05
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
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.

Brief 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. 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.


Eligibility criteria: Inclusion Criteria:

* • 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).

Exclusion Criteria:

• Children less than 18 years.

* Cases non vaccinated with COVID-19 registered vaccine

Primary outcomes:
measure: assess the prevalence of COVID-19 infection after vaccination
timeFrame: one year
Secondary outcomes:
measure: evaluate the severity of infection after vaccination
timeFrame: 2 weeks
measure: Predict possible risk factors of post vaccination infection
timeFrame: one year
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: AssiutU
city: Assiut
country: Egypt
facility: Pulmonology Departments
city: Assiut
country: Egypt
facility: Aliae AR Mohamed-Hussein
Study officials:
References: