Genetic Basis of COVID-19 InfectionNCT04384250
Genetic and Immunologic Basis of COVID-19 Infection
An observational study of Genetic Basis of COVID-19 Infection, run by Mansoura University at 1 site in Egypt.
Trial summary
We will study genetic factors causing severe disease due to infection with SARS-COV-2 which may help to find targeted therapy Read more about this study
- Who is it for?
- Ages 1 day to 50 years
- Conditions the study is for
- Genetic Basis of COVID-19 Infection
- What is being tested?
- Whole Exome Sequencing
- How many people
- 500 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jun 2020to 30 Dec 2024
- 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 1 day to 50 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: COVID-19 positive patients
Who may be able to join
- severe COVID-19 infection
Who cannot join
- Comorbidity ((DM, hypertension, Chronic liver or Kidney diseases, HIV, morbid obesity, Malignancy, Immunosuppressive therapy)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Genetic Factors Influencing the Response to Infection with SARS-COV-2
We will study genetic factors causing severe disease due to infection with SARS-COV-2 which may help to find targeted therapy
- Conditions
- Genetic Basis of COVID-19 Infection
- Being tested
- Whole Exome Sequencing
- Keywords
- SARS-COV-2, Genetics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Whole Exome SequencingDiagnostic test
Genetic study of patients
What is being measured
The primary outcome is the main question the study is designed to answer.
Mutations leading to increase susceptibility to SARS-COV-2 infection
Genetic susceptibility to COVID-19
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2020
- Study start1 Jun 2020
- Primary completion30 Dec 2023
- Study completion30 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Genetic Basis of COVID-19 InfectionStudies of the same condition, open and under way.
- More trials run by Mansoura 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 500 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ali Sobh, Mansoura University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04384250
- Sponsor's protocol ID
- RP:20.05.70
- Status last verified
- Mar 2025
- First submitted
- 10 May 2020
- Last updated
- 11 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Genetic Factors Influencing the Response to Infection with SARS-COV-2
- ClinicalTrials.gov ID
- NCT04384250
- Acronym / sponsor ID
- RP:20.05.70
- Conditions
- Genetic Basis of COVID-19 Infection
- Keywords
- SARS-COV-2, Genetics
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 500 participants (actual)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 1 Jun 2020 (actual)
- Primary completion
- 30 Dec 2023 (actual)
- Study completion
- 30 Dec 2024 (actual)
- First posted
- 12 May 2020 (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.
We will study genetic factors causing severe disease due to infection with SARS-COV-2 which may help to find targeted therapy
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 1 day to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- COVID-19 positive patients
Key inclusion criteria (1 listed)
- severe COVID-19 infection
Key exclusion criteria (1 listed)
- Comorbidity ((DM, hypertension, Chronic liver or Kidney diseases, HIV, morbid obesity, Malignancy, Immunosuppressive therapy)
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 |
|---|---|---|
| Whole Exome SequencingGenetic study of patients | Diagnostic test | – |
Primary outcome
Mutations leading to increase susceptibility to SARS-COV-2 infection
Time frame: 12 months
Genetic susceptibility to COVID-19
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2025.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Genetic Basis of COVID-19 Infection, run by Mansoura University at 1 site in Egypt.
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: finished, as of the sponsor's last update on 11 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Mutations leading to increase susceptibility to SARS-COV-2 infection (time frame: 12 months). 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 11 Mar 2025.