The Capability of Haemato-oncology Patients to Generate Antibodies Against COVID-19

NCT ID: NCT04746092

Last Updated: 2021-08-16

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 630 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-01-06
• Study Completion Date: 2022-05-24

Brief 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.

Detailed 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.

Conditions

CLL; Multiple Myeloma; Lymphoma

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

Inclusion Criteria

• Age ≥ 18 years old
• Patient sex - male and female
• CLL, Lymphoma or Multiple Myeloma patients, in follow up or during an active treatment period, who have recovered from COVID19 (COVID19 recovery defined as the presence of two negative PCR tests), who have been vaccinated against the virus or patients who plan to be vaccinated against COVID19
• Healthy participants who have been vaccinated against the virus as a control group.

Exclusion Criteria

• Irrelevant

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Tel-Aviv Sourasky Medical Center

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Yair Herishanu, Prof.

Role: PRINCIPAL_INVESTIGATOR

Tel-Aviv Sourasky Medical Center

Locations

Tel-Aviv Sourasky Medical Center

Tel Aviv, , Israel

Countries

Israel

References

Perry C, Luttwak E, Balaban R, Shefer G, Morales MM, Aharon A, Tabib Y, Cohen YC, Benyamini N, Beyar-Katz O, Neaman M, Vitkon R, Keren-Khadmy N, Levin M, Herishanu Y, Avivi I. Efficacy of the BNT162b2 mRNA COVID-19 vaccine in patients with B-cell non-Hodgkin lymphoma. Blood Adv. 2021 Aug 24;5(16):3053-3061. doi: 10.1182/bloodadvances.2021005094.

Reference Type: DERIVED

PMID: 34387648 (View on PubMed)

Herishanu Y, Avivi I, Aharon A, Shefer G, Levi S, Bronstein Y, Morales M, Ziv T, Shorer Arbel Y, Scarfo L, Joffe E, Perry C, Ghia P. Efficacy of the BNT162b2 mRNA COVID-19 vaccine in patients with chronic lymphocytic leukemia. Blood. 2021 Jun 10;137(23):3165-3173. doi: 10.1182/blood.2021011568.

Reference Type: DERIVED

PMID: 33861303 (View on PubMed)

Other Identifiers

1068-20

Identifier Type: -

Identifier Source: org_study_id