Helminths InfectionNCT05185778
Parasitism & COVID19 Vaccines: New Challenge.
An observational study of Helminths Infection and Protozoan Infections, run by Assiut University.
Trial summary
Parasitic infection is a serious public health problem throughout the world particularly in developing countries including Egypt. The individuals infected with helminths are responding to the parasite infections by a specific Th2 type innate and adaptive immune responses. Read more about this study
- Who is it for?
- Ages 15 years and older
- Conditions the study is for
- Helminths Infection, Protozoan Infections
- What is being tested?
- stool examination, blood sample collected
- Type of treatment
- Vaccines
- How many people
- 128 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2022to 30 Oct 2025
- 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 15 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Vaccinated and non-vaccinated individuals with COVID-19 vaccines who are known to have different parasitic infections (helminths and protozoan) and admitted to Assiut city hospitals.
Who may be able to join
- Vaccinated and non-vaccinated individuals with COVID-19 vaccines who are known to have different parasitic infections (helminths and protozoan) and admitted to Assiut city hospitals.
Who cannot join
- Bleeding disorders that may alter CBC results.
About this study
Official title: Evaluation of Blood Elements Changes and Different Cytokines in Helminthic and Protozoan Infected Patients in Relation to COVID19 Vaccines.
- Parasitic infection is a serious public health problem throughout the world particularly in developing countries including Egypt. The individuals infected with helminths are responding to the parasite infections by a specific Th2 type innate and adaptive immune responses. The Coronavirus Disease 2019 pandemic has affected over 169 million people and caused the death of millions worldwide. COVID vaccines with up to 95% of efficacy and effectiveness have been developed and approved by the Food and Drug Administration (FDA), USA. Moreover, it's reported that vaccination against COVID may lead to Cytokine Storm Syndrome in some vaccinated people with release of large amounts of cytokines as (IFNγ, IL-12, TNFα).
Read the detailed description
- Parasitic infection is a serious public health problem throughout the world particularly in developing countries including Egypt.
- Stool examination and CBC(complete blood count) are considered as the most easily, affordable and accessible diagnostic tool to suspect the presence of parasitic infection.
- One of the most important laboratory findings in many helminthic and protozoan infections is the high rate of peripheral blood eosinophilia. Giardia lamblia cause increased number of lymphocytes.
- The individuals infected with helminths are responding to the parasite infections by a specific Th2 type innate and adaptive immune responses. The Th2 pattern cytokines predominate in long-term helminth infected individuals.
- During chronic helminths infection, there is increased production of interleukin-4 (IL-4) and interleukin-10 (IL-10) as anti-inflammatory cytokines, as well as increased activation and expansion of eosinophils, mast cells and basophils.
- In addition, IFNγ have an important inflammatory role in many protozoan parasites as Cryptosporidium, Microsporidia, Entamoeba histolytica.
- The Coronavirus Disease 2019 pandemic has affected over 169 million people and caused the death of millions worldwide. COVID vaccines with up to 95% of efficacy and effectiveness have been developed and approved by the Food and Drug Administration (FDA), USA.
- Moreover, it's reported that vaccination against COVID may lead to Cytokine Storm Syndrome in some vaccinated people with release of large amounts of cytokines as (IFNγ, IL-12, TNFα).
- Conditions
- Helminths Infection, Protozoan Infections
- Being tested
- stool examination, blood sample collected
- Medical subject headings
- Protozoan Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
stool examination, blood sample collectedBiological
Stool examination macroscopically for consistency, color, and presence of blood and/or mucus and microscopically using the following methods:
- Saline and iodine wet mount.
- Formalin-ethyl acetate sedimentation method.
- Modified Ziehl-Nielsen staining : It was done to all cases with manifestations suggestive of protozoa.
- Collection of peripheral blood samples for Automated CBC and blood indices evaluation.
- Molecular detection of inflammatory cytokines level (IFNγ, TNFα) and antiinflammatory cytokines (IL4, IL10) by Real-time PCR(polymerase chain reaction).
| Study group | Role | What they receive |
|---|---|---|
| parasitic infected individuals received COVID-19 vaccine | parasitic infected individuals with helminthic or protozoan who received COVID-19 vaccines of any type Receives: Biological: stool examination, blood sample collected | |
| parasitic infected individuals not received COVID-19 vaccine | parasitic infected individuals with helminthic or protozoan who don't receive COVID-19 vaccines of any type Receives: Biological: stool examination, blood sample collected |
What is being measured
The primary outcome is the main question the study is designed to answer.
-Evaluation of CBC changes associated with some helminths and protozoan infected patients.
Measured: 3 years
- Estimation of cytokines level in some helminths and protozoan infected patients.
Measured: 3 years
- Correlation of CBC changes and cytokines level with COVID-19 vaccine administration.
Measured: 3 years
Secondary outcomes (1)
- study parasitic prevalence in community after COVID changes.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2022
- Study start1 Apr 2022 (estimated)
- Primary completion30 Oct 2024 (estimated)
- Study completion30 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Helminths InfectionStudies 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
- Cross-sectional
- Enrolment
- 128 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Reham Hany Mohammed, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05185778
- Sponsor's protocol ID
- parasitism & COVID19 vaccines
- Status last verified
- Mar 2022
- First submitted
- 9 Jan 2022
- Last updated
- 1 Apr 2022
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Blood Elements Changes and Different Cytokines in Helminthic and Protozoan Infected Patients in Relation to COVID19 Vaccines.
- ClinicalTrials.gov ID
- NCT05185778
- Acronym / sponsor ID
- parasitism & COVID19 vaccines
- Conditions
- Helminths Infection, Protozoan Infections
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 128 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Apr 2022 (estimated)
- Primary completion
- 30 Oct 2024 (estimated)
- Study completion
- 30 Oct 2025 (estimated)
- First posted
- 11 Jan 2022 (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.
- Parasitic infection is a serious public health problem throughout the world particularly in developing countries including Egypt. The individuals infected with helminths are responding to the parasite infections by a specific Th2 type innate and adaptive immune responses. The Coronavirus Disease 2019 pandemic has affected over 169 million people and caused the death of millions worldwide. COVID vaccines with up to 95% of efficacy and effectiveness have been developed and approved by the Food and Drug Administration (FDA), USA. Moreover, it's reported that vaccination against COVID may lead to Cytokine Storm Syndrome in some vaccinated people with release of large amounts of cytokines as (IFNγ, IL-12, TNFα).
Detailed description
- Parasitic infection is a serious public health problem throughout the world particularly in developing countries including Egypt.
- Stool examination and CBC(complete blood count) are considered as the most easily, affordable and accessible diagnostic tool to suspect the presence of parasitic infection.
- One of the most important laboratory findings in many helminthic and protozoan infections is the high rate of peripheral blood eosinophilia. Giardia lamblia cause increased number of lymphocytes.
- The individuals infected with helminths are responding to the parasite infections by a specific Th2 type innate and adaptive immune responses. The Th2 pattern cytokines predominate in long-term helminth infected individuals.
- During chronic helminths infection, there is increased production of interleukin-4 (IL-4) and interleukin-10 (IL-10) as anti-inflammatory cytokines, as well as increased activation and expansion of eosinophils, mast cells and basophils.
- In addition, IFNγ have an important inflammatory role in many protozoan parasites as Cryptosporidium, Microsporidia, Entamoeba histolytica.
- The Coronavirus Disease 2019 pandemic has affected over 169 million people and caused the death of millions worldwide. COVID vaccines with up to 95% of efficacy and effectiveness have been developed and approved by the Food and Drug Administration (FDA), USA.
- Moreover, it's reported that vaccination against COVID may lead to Cytokine Storm Syndrome in some vaccinated people with release of large amounts of cytokines as (IFNγ, IL-12, TNFα).
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| parasitic infected individuals received COVID-19 vaccine | – | Biological: stool examination, blood sample collectedparasitic infected individuals with helminthic or protozoan who received COVID-19 vaccines of any type |
| parasitic infected individuals not received COVID-19 vaccine | – | Biological: stool examination, blood sample collectedparasitic infected individuals with helminthic or protozoan who don't receive COVID-19 vaccines of any type |
Who may qualify
- Ages
- 15 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Vaccinated and non-vaccinated individuals with COVID-19 vaccines who are known to have different parasitic infections (helminths and protozoan) and admitted to Assiut city hospitals.
Key inclusion criteria (1 listed)
- Vaccinated and non-vaccinated individuals with COVID-19 vaccines who are known to have different parasitic infections (helminths and protozoan) and admitted to Assiut city hospitals.
Key exclusion criteria (1 listed)
- Bleeding disorders that may alter CBC results.
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 |
|---|---|---|
| stool examination, blood sample collectedStool examination macroscopically for consistency, color, and presence of blood and/or mucus and microscopically using the following methods: * Saline and iodine wet mount. * Formalin-ethyl acetate sedimentation method. * Modified Ziehl-Nielsen staining : It was done to all cases with manifestations suggestive of protozoa. * Collection of peripheral blood samples for Automated CBC and blood indices evaluation. * Molecular detection of inflammatory cytokines level (IFNγ, TNFα) and antiinflammatory cytokines (IL4, IL10) by Real-time PCR(polymerase chain reaction). | Biological | parasitic infected individuals not received COVID-19 vaccine, parasitic infected individuals received COVID-19 vaccine |
Primary outcome
-Evaluation of CBC changes associated with some helminths and protozoan infected patients.
Time frame: 3 years
- Estimation of cytokines level in some helminths and protozoan infected patients.
Time frame: 3 years
- Correlation of CBC changes and cytokines level with COVID-19 vaccine administration.
Time frame: 3 years
1 secondary outcome
- study parasitic prevalence in community after COVID changes.
Time frame: 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2022.
- Individual participant dataSharing planned: Yes
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Helminths Infection and Protozoan Infections, run by Assiut University.
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 1 inclusion and 1 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 1 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
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?
-Evaluation of CBC changes associated with some helminths and protozoan infected patients. (time frame: 3 years). The study lists 3 primary outcomes in all. 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 1 Apr 2022; AzTrials last refreshed its copy on 6 Nov 2026.