Covid-19 Infection in After Vaccination

Covid19 Clinical Trial

Official title:

Covid-19 Infection in Partially and Fully Vaccinated Cases: Cohort Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05033834
• Other study ID #: Assiut-breakthrough covid-19
• Status: Not yet recruiting
• Start date: November 1, 2021
• Est. completion date: December 31, 2022

Study information

• Verified date: September 2021
• Source: Assiut University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical 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. 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: December 31, 2022
• Est. primary completion date: November 1, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Covid19
• Infection

Intervention

Other:
• covid-19 vaccines registered in Egypt
Astra Zeneka vaccine, Sinopharm vaccine, Sinovac vaccine, Jonson and Jonson vaccine, Spotnic V vaccine

Locations

Country	Name	City	State
Egypt	Aliae AR Mohamed-Hussein	Assiut
Egypt	AssiutU	Assiut
Egypt	Pulmonology Departments	Assiut

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	assess the prevalence of COVID-19 infection after vaccination	number of cases with covid-19 after vaccination	one year
Secondary	evaluate the severity of infection after vaccination	severity of covid-19 infection in partially and fully vaccinated cases	2 weeks
Secondary	Predict possible risk factors of post vaccination infection	adherence to protective measures	one year