Clinical Trial Details
— Status: Active, not recruiting
Administrative data
| NCT number |
NCT04746092 |
| Other study ID # |
1068-20 |
| Secondary ID |
|
| Status |
Active, not recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
January 6, 2021 |
| Est. completion date |
May 24, 2022 |
Study information
| Verified date |
February 2021 |
| Source |
Tel-Aviv Sourasky Medical Center |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
The corona pandemic is a continuing global challenge due to Corona Virus 2019 (COVID-19).
The purpose of the study is to evaluate the capability of Haemato-oncology patients to
generate antibodies against COVID-19 after infection and vaccination.
Description:
In December 2019, a backlog of patients with respiratory disease was identified in Hubei
Province, China. The number of infections increased rapidly, and more patients were
identified in other provinces in China, and in various countries in the Far East, Europe and
the United States. With few exceptions, patients became infected while staying in China. The
cause of the disease has been identified as a virus from the corona family - SARS-CoV-2 and
the new name given to the disease. (COVID-19) Coronavirus disease The virus belongs to a
family of respiratory viruses that often cause mild respiratory illness, however, viruses
from this family have also caused epidemics of severe respiratory infections. On March 11,
2020, the World Health Organization declared the corona virus a global pandemic. The average
incubation period (from exposure to the onset of clinical symptoms) is 6 days, with a range
of 2 to 11 days. Common symptoms of coronary heart disease include: fever, cough, shortness
of breath, muscle aches.Some patients develop complications, including pneumonia, respiratory
failure, myocarditis and death. Similar to other respiratory viruses, 2019-nCov is
transmitted by respiratory droplets. Diagnosis is made by PCR examination from a sample of
the upper respiratory tract (pharynx and nose).
In the literature accumulated in recent months suggests that haemato-oncology patients are at
increased risk for severe corona disease and mortality. In haemato-oncology patients the
recovery process from corona may be prolonged, including a prolonged secretion of the virus
compared to a healthy population.
The study population: CLL, Multiple Myeloma or Lymphoma patients as well control group of
healthy patients who are vaccinated with COVID-19 in a commercial preparation, regardless of
the study.
Serology test between two and three weeks after the second dose of the vaccine to test the
effectiveness of the vaccine will be performed as part of the study .During the follow-up
period in patients who have developed antibodies to the virus, patients will be offered to
repeat the serological test after six months, irrespectively of whether they received a third
vaccine within the Israeli standard of care.
All data collected in the study will be typed into Excel and analyzed using SPSS version
21.0. Continuous data will be described using averages and standard deviations, and
categorical data will be described using prevalence and percentages.
