NCT04404608

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
172

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 23, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 27, 2020

Completed
5 days until next milestone

Study Start

First participant enrolled

June 1, 2020

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2021

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2021

Completed
Last Updated

July 20, 2022

Status Verified

July 1, 2022

Enrollment Period

1 year

First QC Date

May 23, 2020

Last Update Submit

July 19, 2022

Conditions

Lymphopenia

Outcome Measures

Primary Outcomes (1)

  • Death or recovery

    Follow up

    Up to 24 weeks

Study Arms (3)

Asymptomatic or mild symptoms patients patients

Patients with no or mild symptoms and need no respiratory support.

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.

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

Diagnostic Test: Complete blood picture, bone marrow aspiration cytology

Interventions

Complete blood picture, bone marrow aspiration cytologyDIAGNOSTIC_TEST

none except the regular routine investigations in such cases

Asymptomatic or mild symptoms patients patientsCritically ill patientsSevere symptoms patients

Eligibility Criteria

Sexall
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

All patients admitted with the diagnosis off Covid19 viral infection of all ages and all ethnic backgrounds and agree about the study

You may qualify if:

  • Any patient admitted with the diagnosis of Covid19 viral infection

You may not qualify if:

  • Any patient who died within one day of admission

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Cancer Institute Cairo University

Cairo, Egypt

Location

MeSH Terms

Conditions

Lymphopenia

Condition Hierarchy (Ancestors)

LeukopeniaCytopeniaHematologic DiseasesHemic and Lymphatic DiseasesLeukocyte DisordersImmunologic Deficiency SyndromesImmune System Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
professor of surgical oncology

Study Record Dates

First Submitted

May 23, 2020

First Posted

May 27, 2020

Study Start

June 1, 2020

Primary Completion

June 1, 2021

Study Completion

December 1, 2021

Last Updated

July 20, 2022

Record last verified: 2022-07

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)