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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04746092
Recruitment Status : Active, not recruiting
First Posted : February 9, 2021
Last Update Posted : August 16, 2021
Sponsor:
Information provided by (Responsible Party):
Tel-Aviv Sourasky Medical Center

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.


Condition or disease
CLL Multiple Myeloma Lymphoma

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.

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Study Type : Observational
Actual Enrollment : 630 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: The Capability of Haemato-oncology Patients to Generate Antibodies Against COVID-19 After Infection and Vaccination
Actual Study Start Date : January 6, 2021
Estimated Primary Completion Date : May 24, 2022
Estimated Study Completion Date : May 24, 2022





Primary Outcome Measures :
  1. Capability of Haemato-oncology patients to generate antibodies against COVID-19 after infection and vaccination. [ Time Frame: 14 to 21 days counting since second vaccination is initiated. ]
    Evaluate the capability of Haemato-oncology patients to generate antibodies against COVID-19 after infection and vaccination by using serology tests.


Secondary Outcome Measures :
  1. Assess COVID19 morbidity rates [ Time Frame: 12-month follow-up as part of routine clinic visits. ]
    Assess COVID19 morbidity rates in hematologic patients receiving vaccine. patients informs the attending physician in case of diagnosis / infection by COVID 19.

  2. Documentation of the vaccine side effects [ Time Frame: 14 to 21 days counting since second vaccination is initiated. ]
    Documentation of the vaccine side effects among haemato-oncology patients by questioning patients while taking the blood sample.

  3. Comparison of antibody formation to COVID19 between haemato-oncology patients and healthy participants [ Time Frame: During the results processing phase about a year and a half from the beginning of the study ]
    Comparison of antibody formation to COVID19 between haemato-oncology patients and healthy participants by comparing their serology tests.


Biospecimen Retention:   Samples Without DNA
Blood sample


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
CLL, Lymphoma or Multiple Myeloma patients and and their caregivers - healthy participants.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04746092


Locations
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Israel
Tel-Aviv Sourasky Medical Center
Tel Aviv, Israel, 6423906
Sponsors and Collaborators
Tel-Aviv Sourasky Medical Center
Investigators
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Principal Investigator: Yair Herishanu, Prof. Tel-Aviv Sourasky Medical Center
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Tel-Aviv Sourasky Medical Center
ClinicalTrials.gov Identifier: NCT04746092    
Other Study ID Numbers: 1068-20
First Posted: February 9, 2021    Key Record Dates
Last Update Posted: August 16, 2021
Last Verified: February 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases