CLLNCT04746092
The Capability of Haemato-oncology Patients to Generate Antibodies Against COVID-19
An observational study of CLL and Multiple Myeloma, run by Tel-Aviv Sourasky Medical Center at 1 site in Israel.
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. Read more about this study
- Who is it for?
- Ages 18 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- CLL, Multiple Myeloma, Lymphoma
- How many people
- 630 participants
- Where
- 1 siteIsrael
- Study dates
- 6 Jan 2021to 24 May 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: CLL, Lymphoma or Multiple Myeloma patients and and their caregivers - healthy participants.
Who may be able to join
- 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.
Who cannot join
- Irrelevant
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Capability of Haemato-oncology Patients to Generate Antibodies Against COVID-19 After Infection and Vaccination
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.
Read the 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
- Medical subject headings
- Multiple Myeloma, Lymphoma
What is being measured
The primary outcome is the main question the study is designed to answer.
Capability of Haemato-oncology patients to generate antibodies against COVID-19 after infection and vaccination.
Evaluate the capability of Haemato-oncology patients to generate antibodies against COVID-19 after infection and vaccination by using serology tests.
Measured: 14 to 21 days counting since second vaccination is initiated.
Secondary outcomes (3)
Assess COVID19 morbidity rates
Assess COVID19 morbidity rates in hematologic patients receiving vaccine. patients informs the attending physician in case of diagnosis / infection by COVID 19.
Measured: 12-month follow-up as part of routine clinic visits.
Documentation of the vaccine side effects
Documentation of the vaccine side effects among haemato-oncology patients by questioning patients while taking the blood sample.
Measured: 14 to 21 days counting since second vaccination is initiated.
Comparison of antibody formation to COVID19 between haemato-oncology patients and healthy participants
Comparison of antibody formation to COVID19 between haemato-oncology patients and healthy participants by comparing their serology tests.
Measured: During the results processing phase about a year and a half from the beginning of the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2021
- Study start6 Jan 2021
- Primary completion24 May 2022 (estimated)
- Study completion24 May 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for CLLStudies of the same condition, open and under way.
- More trials run by Tel-Aviv Sourasky Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 630 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tel-Aviv Sourasky Medical Center
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Yair Herishanu, Prof., Principal investigator, Tel-Aviv Sourasky Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04746092
- Sponsor's protocol ID
- 1068-20
- Status last verified
- Feb 2021
- First submitted
- 2 Feb 2021
- Last updated
- 16 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 34387648Herishanu 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.
PubMed 33861303
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Capability of Haemato-oncology Patients to Generate Antibodies Against COVID-19 After Infection and Vaccination
- ClinicalTrials.gov ID
- NCT04746092
- Acronym / sponsor ID
- 1068-20
- Conditions
- CLL, Multiple Myeloma, Lymphoma
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 630 participants (actual)
- Lead sponsor
- Tel-Aviv Sourasky Medical CenterOther government
- Study start
- 6 Jan 2021 (actual)
- Primary completion
- 24 May 2022 (estimated)
- Study completion
- 24 May 2022 (estimated)
- First posted
- 9 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- CLL, Lymphoma or Multiple Myeloma patients and and their caregivers - healthy participants.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (1 listed)
- Irrelevant
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
3 secondary outcomes
Assess COVID19 morbidity rates
Time frame: 12-month follow-up as part of routine clinic visits.
Documentation of the vaccine side effects
Time frame: 14 to 21 days counting since second vaccination is initiated.
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Aug 2021.
- Derived from this study: PubMed 34387648Perry 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.
- Derived from this study: PubMed 33861303Herishanu 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yair Herishanu, Prof. principal investigator
Tel-Aviv Sourasky Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of CLL and Multiple Myeloma, run by Tel-Aviv Sourasky Medical Center at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04746092, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Aug 2021.