LymphopeniaNCT04404608
Etiology of Lymphopenia in Covid19 Infection
An observational study of Lymphopenia, run by Dr Medhat Khafagy at 1 site in Egypt.
Trial summary
Study of the cause of lymphopenia in Covid19 viral infection will be done in 3 cohorts. First cohort will be patients asymptomatic or with mild symptoms. Second cohort will be patients with severe illness and admitted to ICU. Third cohort will be patients critically ill and on artificial ventilation. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Lymphopenia
- What is being tested?
- Complete blood picture, bone marrow aspiration cytology
- How many people
- 172 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jun 2020to 1 Dec 2021
- 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 Any age
- All sexes
- Child, Adult, Older adult
Study population: All patients admitted with the diagnosis off Covid19 viral infection of all ages and all ethnic backgrounds and agree about the study
Who may be able to join
- Any patient admitted with the diagnosis of Covid19 viral infection
Who cannot join
- Any patient who died within one day of admission
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Study of the Etiology of Lymphopenia in Covid19 Viral Infection
Study of the cause of lymphopenia in Covid19 viral infection will be done in 3 cohorts. First cohort will be patients asymptomatic or with mild symptoms. Second cohort will be patients with severe illness and admitted to ICU. Third cohort will be patients critically ill and on artificial ventilation.
Read the detailed description
Each cohort will include 30 patients. Complete blood count in all patients will be done daily in all patients. Bone marrow aspiration cytology will be done in some selected patients especially those with lymphopenia less than 1000 per cubic mm.
Correlation of the degree of lymphopenia with the status of the patients will be done. Also correlation will be done about the relation of recovery of lymphopenia and status of the patients.
- Conditions
- Lymphopenia
- Being tested
- Complete blood picture, bone marrow aspiration cytology
- Medical subject headings
- Lymphopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Complete blood picture, bone marrow aspiration cytologyDiagnostic test
none except the regular routine investigations in such cases
| Study group | Role | What they receive |
|---|---|---|
| Asymptomatic or mild symptoms patients patients | Patients with no or mild symptoms and need no respiratory support. Receives: Diagnostic Test: Complete blood picture, bone marrow aspiration cytology | |
| Severe symptoms patients | Patients who need admission to ICU because he needs oxygen by nasal canula and needs drugs whether azthromycin or remdesivir according to treatment protocol. Receives: Diagnostic Test: Complete blood picture, bone marrow aspiration cytology | |
| Critically ill patients | Patients who need artificial ventilation because of many causes and may need plasma from convalescent patients Receives: Diagnostic Test: Complete blood picture, bone marrow aspiration cytology |
What is being measured
The primary outcome is the main question the study is designed to answer.
Death or recovery
Follow up
Measured: Up to 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2020
- Study start1 Jun 2020
- Primary completion1 Jun 2021
- Study completion1 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LymphopeniaStudies of the same condition, open and under way.
- 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
- Prospective
- Enrolment
- 172 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dr Medhat Khafagy
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Dr Medhat Khafagy, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04404608
- Sponsor's protocol ID
- 201920008.2
- Status last verified
- Jul 2022
- First submitted
- 23 May 2020
- Last updated
- 20 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Etiology of Lymphopenia in Covid19 Viral Infection
- ClinicalTrials.gov ID
- NCT04404608
- Acronym / sponsor ID
- 201920008.2
- Conditions
- Lymphopenia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 172 participants (actual)
- Lead sponsor
- Dr Medhat KhafagyUniversity, hospital or other
- Study start
- 1 Jun 2020 (actual)
- Primary completion
- 1 Jun 2021 (actual)
- Study completion
- 1 Dec 2021 (actual)
- First posted
- 27 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.
Study of the cause of lymphopenia in Covid19 viral infection will be done in 3 cohorts. First cohort will be patients asymptomatic or with mild symptoms. Second cohort will be patients with severe illness and admitted to ICU. Third cohort will be patients critically ill and on artificial ventilation.
Detailed description
Each cohort will include 30 patients. Complete blood count in all patients will be done daily in all patients. Bone marrow aspiration cytology will be done in some selected patients especially those with lymphopenia less than 1000 per cubic mm.
Correlation of the degree of lymphopenia with the status of the patients will be done. Also correlation will be done about the relation of recovery of lymphopenia and status of the patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Asymptomatic or mild symptoms patients patients | – | Diagnostic Test: Complete blood picture, bone marrow aspiration cytologyPatients with no or mild symptoms and need no respiratory support. |
| Severe symptoms patients | – | Diagnostic Test: Complete blood picture, bone marrow aspiration cytologyPatients who need admission to ICU because he needs oxygen by nasal canula and needs drugs whether azthromycin or remdesivir according to treatment protocol. |
| Critically ill patients | – | Diagnostic Test: Complete blood picture, bone marrow aspiration cytologyPatients who need artificial ventilation because of many causes and may need plasma from convalescent patients |
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- All patients admitted with the diagnosis off Covid19 viral infection of all ages and all ethnic backgrounds and agree about the study
Key inclusion criteria (1 listed)
- Any patient admitted with the diagnosis of Covid19 viral infection
Key exclusion criteria (1 listed)
- Any patient who died within one day of admission
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 |
|---|---|---|
| Complete blood picture, bone marrow aspiration cytologynone except the regular routine investigations in such cases | Diagnostic test | Asymptomatic or mild symptoms patients patients, Critically ill patients, Severe symptoms patients |
Primary outcome
Death or recovery
Time frame: Up to 24 weeks
Follow up
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 20 Jul 2022.
- Individual participant dataSharing planned: No
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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 Lymphopenia, run by Dr Medhat Khafagy 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 20 Jul 2022. 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?
Death or recovery (time frame: Up to 24 weeks). 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 20 Jul 2022.