Covid-19 Infection in After Vaccination

Last updated: September 4, 2021
Sponsor: Assiut University
Overall Status: Active - Not Recruiting

Phase

N/A

Condition

N/A

Treatment

N/A

Clinical Study ID

NCT05033834
Assiut-breakthrough covid-19
  • Ages 18-80
  • All Genders
  • Accepts Healthy Volunteers

Study 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

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

Exclusion Criteria:

• Children less than 18 years.

  • Cases non vaccinated with COVID-19 registered vaccine

Study Design

Total Participants: 100
Study Start date:
November 01, 2021
Estimated Completion Date:
December 31, 2022

Connect with a study center

  • Aliae AR Mohamed-Hussein

    Assiut, 71515
    Egypt

    Site Not Available

  • AssiutU

    Assiut, 71111
    Egypt

    Site Not Available

  • Pulmonology Departments

    Assiut, 71111
    Egypt

    Site Not Available

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