NCT04746066

Brief Summary

The COVID-19 pandemic is causing many deaths around the world, putting a strain on health services. Patients with pre-existing chronic conditions are most affected by the SARS-COV2 infection. Infectious complications are a common cause of mortality and one of the main causes of morbidity in all these diseases. The main objective of this project is the assessment of patients with thalassemia, drepanocytosis, other haemoglobinopathies and rares inherited anemias suffering from SARS-COV-2 to:

  1. 1.Obtain clinical and epidemiological data that can provide information on a possible increased vulnerability of these patients to SARS-COV-2 infection;
  2. 2.Sharing therapeutic approaches considering the lack of information about the treatment.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
10,000

participants targeted

Target at P75+ for all trials

Timeline
56mo left

Started Mar 2020

Longer than P75 for all trials

Geographic Reach
1 country

2 active sites

Status
recruiting

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

Study Progress57%
Mar 2020Dec 2030

Study Start

First participant enrolled

March 31, 2020

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

February 2, 2021

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 9, 2021

Completed
9.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2030

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2030

Last Updated

May 5, 2022

Status Verified

May 1, 2022

Enrollment Period

10.7 years

First QC Date

February 2, 2021

Last Update Submit

May 4, 2022

Conditions

Haemoglobinopathies

Outcome Measures

Primary Outcomes (1)

  • Number of Patients with Covid 19 infection

    Incidence of Covid 19 infections in patient with Hemoglobinopathies and Rare Anemia inherit

    through study completion, an average of 1 year

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with an established diagnosis of thalassemia, sickle cell disease, other haemoglobinopathies and Rare Anemia inherit

You may qualify if:

  • Patients with an established diagnosis of thalassemia, sickle cell disease, other haemoglobinopathies and Rare Anemia inherit with a virological diagnosis of SARS-COV-2 infection.

You may not qualify if:

  • nobody

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

E.O. Ospedali Galliera

Genova, 16128, Italy

RECRUITING

Ospedali Galliera - S.S.D. Microcitemia, anemie congenite e dismetabolismo del ferro

Genova, 16128, Italy

RECRUITING

MeSH Terms

Conditions

Hemoglobinopathies

Condition Hierarchy (Ancestors)

Hematologic DiseasesHemic and Lymphatic DiseasesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

  • Gian Luca Forni

    Ospedali Galliera - SSD Microcitemia, anemie congenite e dismetabolismo del ferro

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Gian Luca Forni

CONTACT

0105634gianluca.forni@galliera.it

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 2, 2021

First Posted

February 9, 2021

Study Start

March 31, 2020

Primary Completion (Estimated)

December 1, 2030

Study Completion (Estimated)

December 1, 2030

Last Updated

May 5, 2022

Record last verified: 2022-05

Locations

IT(2)