SARS-CoV InfectionPhase 4TXCoronavacNCT04801667
Evaluate the Impact, Safety, Tolerability and Immunogenicity of the Coronavac Vaccine in Kidney Transplant Recipients
A Phase 4 study testing Coronavac in people with SARS-CoV Infection and Coronavirus Infection, run by Hospital do Rim e Hipertensão at 1 site in Brazil.
Trial summary
Since the beginning of the SARS-CoV-2 pandemic, 1031 (8.7%) of the 11875 kidney transplant recipients being followed up at Hospital do Rim have been infected. The overall lethality rate was 24%, reaching 53% among those over 70 years old. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- SARS-CoV Infection, Coronavirus Infection, Vaccine Adverse Reaction
- What is being tested?
- Coronavac
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3,371 participants
- Where
- 1 siteBrazil
- Study dates
- 20 Mar 2021to 1 Mar 2023
- Phase
- Phase 4
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults over 18 years old;
- Time after transplantation greater than 3 months;
- Time after treatment with anti-thymocyte globulin longer than 4 weeks;
- Able and willing (in the investigator's opinion) to comply with all study requirements;
- Provide written informed consent
Who cannot join
- Planned receipt of any vaccine (authorized or experimental), within 30 days before and after vaccination;
- Prior receipt of an experimental or authorized vaccine with the possibility of impacting the interpretation of the study data (for example, vectorized vaccines by Adenovirus, any vaccines against coronavirus);
- Administration of immunoglobulins and / or any blood products in the three months prior to the planned administration of the candidate vaccine;
- Any history of angioedema or anaphylaxis;
- Pregnancy, lactation or willingness / intention to become pregnant during the study;
- Diagnosis or current treatment for cancer (except basal cell carcinoma of the skin and cervical carcinoma in situ);
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- History of severe psychiatric illness that possibly affects your participation in the study;
- Hemorrhagic disorder (eg, factor deficiency, coagulopathy or platelet disorder) or a previous history of significant bleeding or hematoma after IM injections or venipuncture;
- Continued use of anticoagulants, such as coumarins and related anticoagulants (for example, warfarin) or new oral anticoagulants (for example, apixaban, rivaroxaban, dabigatran and edoxaban);
- Current suspected or known addiction to alcohol or drugs.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective Study in a Single Center to Evaluate the Impact, Safety, Tolerability and Immunogenicity of the Coronavac Vaccine in Kidney Transplant Recipients
Since the beginning of the SARS-CoV-2 pandemic, 1031 (8.7%) of the 11875 kidney transplant recipients being followed up at Hospital do Rim have been infected. The overall lethality rate was 24%, reaching 53% among those over 70 years old. Among the survivors, there is also a high incidence of renal dysfunction with loss of the renal graft and definitive return to dialysis. Patients receiving pharmacological immunosuppression, including transplant recipients, have not been included in the studies carried out to date. In addition, kidney transplant recipients may have reduced vaccine responses compared to the general population. The severity, the high incidence of renal dysfunction and loss of renal graft, and the high lethality associated with COVD-19 justify the investigation of the epidemiological impact and immunogenicity of the vaccine against SARS-CoV-2 infection.
- Being tested
- Coronavac
- Medical subject headings
- Severe Acute Respiratory Syndrome, Coronavirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CoronavacBiological
The CoronaVac is manufactured by Sinovac Life Sciences Co., Ltd. This vaccine contains the inactivated SARS-CoV-2 virus antigen and is administered intramuscularly.
| Study group | Role | What they receive |
|---|---|---|
| Coronavac vaccine | Experimental | Kidney transplant recipients receiving the coronavac vaccine Receives: Biological: Coronavac |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the incidence of hospitalization or death in 28 days associated with COVID-19 (symptomatic cases confirmed virologically by COVID -19 with positive CRP) 14 ± 2 days after the second dose of the vaccine.
Measured: 45 days
Secondary outcomes (6)
Evaluate the impact of the vaccine on the incidence of COVID-19 according to the severity criterion of the World Health Organization.
Measured: 6 months
Evaluate the impact of the vaccine on the incidence of COVID-19 and hospitalization for COVID-19 disease, confirmed by PCR, for a period of 6 months after the final vaccination.
Measured: 6 months
Evaluate the vaccine's safety, tolerability, and reactogenicity profile: occurrence of signs and symptoms of local and systemic reactogenicity requested seven days after vaccination.
Measured: 7 days
Evaluate the incidence of serious adverse events for a period of 6 months after the final vaccination.
Measured: 6 months
Evaluate immunogenicity by detecting antibodies against SARS-CoV-2 for a period of 6 months after the final vaccination.
IgG antibody levels will be used to assess immunogenicity.
Measured: 6 months
Analysis of the genetic sequencing of SARS-CoV-2 in patients who test positive for SARS-CoV-2 PCR.
Genetic sequencing of the virus will be carried out, that is, reading the genome of Sars-Cov-2, to evaluate possible new variants.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2021
- Study start20 Mar 2021
- Primary completion1 Oct 2021
- Study completion1 Mar 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for SARS-CoV InfectionStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 3,371 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital do Rim e Hipertensão
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Helio Tedesco Silva Junior, Hospital do Rim e Hipertensão
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04801667
- Sponsor's protocol ID
- TxR Coronavac - Hrim
- Acronym
- TXCoronavac
- Status last verified
- Mar 2022
- First submitted
- 10 Mar 2021
- Last updated
- 18 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Medina-Pestana J, Covas DT, Viana LA, Dreige YC, Requiao-Moura LR, Nakamura MR, Lucena EF, Foresto RD, Tedesco-Silva H, Cristelli MP. Homologous Third Dose of Inactivated Whole-virion Vaccine Fails to Elicit a Robust Immune Response Among Kidney Seronegative Transplant Recipients. Transplantation. 2022 May 1;106(5):e284-e285. doi: 10.1097/TP.0000000000004029. Epub 2021 Dec 28. No abstract available.
PubMed 34974453Medina-Pestana J, Covas DT, Viana LA, Dreige YC, Nakamura MR, Lucena EF, Requiao-Moura LR, Fortaleza CMCB, Foresto RD, Tedesco-Silva H, Cristelli MP. Inactivated Whole-virus Vaccine Triggers Low Response Against SARS-CoV-2 Infection Among Renal Transplant Patients: Prospective Phase 4 Study Results. Transplantation. 2022 Apr 1;106(4):853-861. doi: 10.1097/TP.0000000000004036.
PubMed 34882589Medina-Pestana J, Cristelli MP, Viana LA, Foresto RD, Requiao-Moura LR, Tedesco-Silva H, Covas DT. Clinical Impact, Reactogenicity, and Immunogenicity After the First CoronaVac Dose in Kidney Transplant Recipients. Transplantation. 2022 Jan 1;106(1):e95-e97. doi: 10.1097/TP.0000000000003901. No abstract available.
PubMed 34292214
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Study in a Single Center to Evaluate the Impact, Safety, Tolerability and Immunogenicity of the Coronavac Vaccine in Kidney Transplant Recipients
- ClinicalTrials.gov ID
- NCT04801667
- Acronym / sponsor ID
- TXCoronavac / TxR Coronavac - Hrim
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 3,371 participants (actual)
- Lead sponsor
- Hospital do Rim e HipertensãoUniversity, hospital or other
- Study start
- 20 Mar 2021 (actual)
- Primary completion
- 1 Oct 2021 (actual)
- Study completion
- 1 Mar 2023 (estimated)
- First posted
- 17 Mar 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.
Since the beginning of the SARS-CoV-2 pandemic, 1031 (8.7%) of the 11875 kidney transplant recipients being followed up at Hospital do Rim have been infected. The overall lethality rate was 24%, reaching 53% among those over 70 years old. Among the survivors, there is also a high incidence of renal dysfunction with loss of the renal graft and definitive return to dialysis. Patients receiving pharmacological immunosuppression, including transplant recipients, have not been included in the studies carried out to date. In addition, kidney transplant recipients may have reduced vaccine responses compared to the general population. The severity, the high incidence of renal dysfunction and loss of renal graft, and the high lethality associated with COVD-19 justify the investigation of the epidemiological impact and immunogenicity of the vaccine against SARS-CoV-2 infection.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Coronavac vaccine | Experimental | Biological: CoronavacKidney transplant recipients receiving the coronavac vaccine |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adults over 18 years old;
- Time after transplantation greater than 3 months;
- Time after treatment with anti-thymocyte globulin longer than 4 weeks;
- Able and willing (in the investigator's opinion) to comply with all study requirements;
- Provide written informed consent
Key exclusion criteria (10 listed)
- Planned receipt of any vaccine (authorized or experimental), within 30 days before and after vaccination;
- Prior receipt of an experimental or authorized vaccine with the possibility of impacting the interpretation of the study data (for example, vectorized vaccines by Adenovirus, any vaccines against coronavirus);
- Administration of immunoglobulins and / or any blood products in the three months prior to the planned administration of the candidate vaccine;
- Any history of angioedema or anaphylaxis;
- Pregnancy, lactation or willingness / intention to become pregnant during the study;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CoronavacThe CoronaVac is manufactured by Sinovac Life Sciences Co., Ltd. This vaccine contains the inactivated SARS-CoV-2 virus antigen and is administered intramuscularly. | Biological | Coronavac vaccine |
Primary outcome
Evaluate the incidence of hospitalization or death in 28 days associated with COVID-19 (symptomatic cases confirmed virologically by COVID -19 with positive CRP) 14 ± 2 days after the second dose of the vaccine.
Time frame: 45 days
6 secondary outcomes
Evaluate the impact of the vaccine on the incidence of COVID-19 according to the severity criterion of the World Health Organization.
Time frame: 6 months
Evaluate the impact of the vaccine on the incidence of COVID-19 and hospitalization for COVID-19 disease, confirmed by PCR, for a period of 6 months after the final vaccination.
Time frame: 6 months
Evaluate the vaccine's safety, tolerability, and reactogenicity profile: occurrence of signs and symptoms of local and systemic reactogenicity requested seven days after vaccination.
Time frame: 7 days
Evaluate the incidence of serious adverse events for a period of 6 months after the final vaccination.
Time frame: 6 months
Evaluate immunogenicity by detecting antibodies against SARS-CoV-2 for a period of 6 months after the final vaccination.
Time frame: 6 months
Analysis of the genetic sequencing of SARS-CoV-2 in patients who test positive for SARS-CoV-2 PCR.
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2022.
- Derived from this study: PubMed 34974453Medina-Pestana J, Covas DT, Viana LA, Dreige YC, Requiao-Moura LR, Nakamura MR, Lucena EF, Foresto RD, Tedesco-Silva H, Cristelli MP. Homologous Third Dose of Inactivated Whole-virion Vaccine Fails to Elicit a Robust Immune Response Among Kidney Seronegative Transplant Recipients. Transplantation. 2022 May 1;106(5):e284-e285. doi: 10.1097/TP.0000000000004029. Epub 2021 Dec 28. No abstract available.
- Derived from this study: PubMed 34882589Medina-Pestana J, Covas DT, Viana LA, Dreige YC, Nakamura MR, Lucena EF, Requiao-Moura LR, Fortaleza CMCB, Foresto RD, Tedesco-Silva H, Cristelli MP. Inactivated Whole-virus Vaccine Triggers Low Response Against SARS-CoV-2 Infection Among Renal Transplant Patients: Prospective Phase 4 Study Results. Transplantation. 2022 Apr 1;106(4):853-861. doi: 10.1097/TP.0000000000004036.
- Derived from this study: PubMed 34292214Medina-Pestana J, Cristelli MP, Viana LA, Foresto RD, Requiao-Moura LR, Tedesco-Silva H, Covas DT. Clinical Impact, Reactogenicity, and Immunogenicity After the First CoronaVac Dose in Kidney Transplant Recipients. Transplantation. 2022 Jan 1;106(1):e95-e97. doi: 10.1097/TP.0000000000003901. No abstract available.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Coronavac in people with SARS-CoV Infection and Coronavirus Infection, run by Hospital do Rim e Hipertensão at 1 site in Brazil.
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 5 inclusion and 10 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 18 Mar 2022. 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 Brazil. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Evaluate the incidence of hospitalization or death in 28 days associated with COVID-19 (symptomatic cases confirmed virologically by COVID -19 with positive CRP) 14 ± 2 days after the second dose of the vaccine. (time frame: 45 days). 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 NCT04801667, which also lists 3 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 18 Mar 2022.