UnknownNot Applicable

Effects of COVID 19 Vaccine on Egyptian Population

800 participantsStarted 2021-03

Plain-language summary

The aim of this study is to identify adverse events following vaccination by the COVID-19 vaccine by evaluating adverse side effects, hematological values; immunogenicity in the Egyptian candidates in response to COVID-19 vaccine, summarizing the which may occur following administration of COVID-19 vaccine.

Who can participate

Age range

18 Years – 80 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. People aged 18-80 years.
. Negative for serum-specific IgM/IgG antibodies against SARS-CoV-2, as measured by a commercial kit (Innovita, China) at the time of screening.

Exclusion criteria

. A history of infection with SARS-CoV 3 months before the vaccine.
. Fever, cough, runny nose, sore throat, diarrhoea, dyspnoea, or tachypnoea in the 14 days before vaccination.
. Pregnancy.
. A history of seizures or mental illness.
. Being on immunosuppressive agents.
. Being on anticoagulation therapy.
. Being unable to comply with the study schedule.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

serological antibodies against SARS-CoV-2 e

Timeframe: change from baseline at one month after first dose

serological antibodies against SARS-CoV-2 e

Timeframe: one month after second dose

Complete blood count (CBC)

Timeframe: change from baseline at one month after first dose

Complete blood count (CBC)

Timeframe: one month after second dose

Complete blood count (CBC)

Timeframe: change from baseline at one month after first dose

Complete blood count (CBC)

Timeframe: one month after second dose

Complete blood count (CBC)

Timeframe: change from baseline at one month after first dose

Trial details

NCT IDNCT04809948

SponsorAssiut University

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2021-09-01

Contact for this trial

Mariam Elkhayat, lecturer

01003708261 mariam.elkhayat@aun.edu.eg

View on ClinicalTrials.gov More COVID 19 Vaccine trials

Plain-language summary

Who can participate

Age range

18 Years – 80 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. People aged 18-80 years.
. Negative for serum-specific IgM/IgG antibodies against SARS-CoV-2, as measured by a commercial kit (Innovita, China) at the time of screening.

Exclusion criteria

. A history of infection with SARS-CoV 3 months before the vaccine.
. Fever, cough, runny nose, sore throat, diarrhoea, dyspnoea, or tachypnoea in the 14 days before vaccination.
. Pregnancy.
. A history of seizures or mental illness.
. Being on immunosuppressive agents.
. Being on anticoagulation therapy.
. Being unable to comply with the study schedule.

What they're measuring

serological antibodies against SARS-CoV-2 e

Timeframe: change from baseline at one month after first dose

serological antibodies against SARS-CoV-2 e

Timeframe: one month after second dose

Complete blood count (CBC)

Timeframe: change from baseline at one month after first dose

Complete blood count (CBC)

Timeframe: one month after second dose

Complete blood count (CBC)

Timeframe: change from baseline at one month after first dose

Complete blood count (CBC)

Timeframe: one month after second dose

Complete blood count (CBC)

Timeframe: change from baseline at one month after first dose