Infections, CoronavirusNCT04511429
COVID-19 in Immunosuppressed Children
An observational study of Infections, Coronavirus and Kidney Transplantation, run by D'Or Institute for Research and Education at 2 sites in Brazil.
Trial summary
Viral respiratory infections are common infectious complications after kidney transplantation, especially in the pediatric age group, and immunosuppressed patients may develop more severe disease. Read more about this study
- Who is it for?
- Ages 1 month to 18 years
- Conditions the study is for
- Infections, Coronavirus, Kidney Transplantation, Liver Transplantation
- How many people
- 200 participants
- Where
- 2 sitesBrazil
- Study dates
- 30 Jun 2020to Apr 2021
- How long will I take part?
- 6 Months
- 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 1 month to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Patients aged 0-18 years, immunosuppressed, kidney or liver transplanted, or oncologic patients, in outpatient follow-up or hospitalized.
Who may be able to join
- Renal or liver transplant patients, with functioning graft and using immunosuppression, in outpatient follow-up or hospitalized.
- Patients treating oncohematological disorders, in outpatient follow-up or hospitalized..
Who cannot join
- Patients who or whose parents refuse to sign the Informed Consent Form.
Trial locations and contacts
2 sites in 1 country.
Brazil2 sites, 2 recruiting
- Recruiting
Hospital Federal de Bonsucesso
Rio de Janeiro, Rio de Janeiro, 21041030
Jaqueline LS Gouveia, MD, 5521981737514, jaqueleal@yahoo.com.br
Jaqueline LS Gouveia, MD
- Recruiting
Hospital Estadual da Criança
Rio de Janeiro, Rio de Janeiro, 21321230
Thais L Cleto-Yamane, 5521988046852, thaiscleto@yahoo.com.br
About this study
Viral respiratory infections are common infectious complications after kidney transplantation, especially in the pediatric age group, and immunosuppressed patients may develop more severe disease. Immunosuppressive medications alter the patient's immune response by acting on humoral, cellular immunity and neutrophil function, increasing the risk of serious viral infections. Little is known about how these patients respond to infection by the new coronavirus (SARS-CoV-2).
Experience with SARS caused by the Influenza H1N1 virus suggests that the severity of the disease depends on pre-existing comorbidities and the individual immune response. In more severe cases, an imbalance between the inflammatory system and the immune system is observed, determining direct consequences when pro and anti-inflammatory cytokines reach the systemic circulation in an exacerbated and unbalanced manner. Such fact can generate "cytokine storm syndrome", resulting in multiple organ dysfunction syndrome.
Read more
March 2020 reports from Papa Giovanni XXIII Hospital in Bergamo, Italy - one of the largest pediatric liver transplant centers - showed that the number of transplant patients infected with Coronavirus disease 2019 (COVID- 19) increased progressively. However, they did not see greater severity and complications in this population. Immunosuppression could act as a protective factor.
The present study aims to describe the prevalence of viral infection by SARS-CoV-2 in a sample of immunosuppressed children, from three groups: kidney transplants, liver transplants and oncohematological. The investigators will also look for the epidemiological profile and clinical evolution of these patients, enabling a better understanding of the COVID-19 in this special population. The investigators' hypothesis is that infection with the new coronavirus may be asymptomatic in a large number of children and that immunosuppression, observed in liver and kidney transplant patients and also seen in cancer patients, may act as protection for severe forms of COVID-19.
After obtaining written informed consent from the family, the investigators will include patients from 0-18 years of age, on regular outpatient follow-up, symptomatic or not, and will check for the presence of IgM/IgG antibodies against the SARS-CoV-2. For those symptomatic or with a positive IgM result, material (oro/nasopharyngeal swabs) for RT-PCR trial for the new coronavirus will be collected. Demographic and clinical variables will be registered. The outcomes are: Serology for COVID-19 result; PCR for COVID-19 result; presence of symptoms of COVID-19; proportion of patients with viral shedding on days 3,7,14,21 and 30 after diagnosis; need for hospital admission; need for Intensive care admission; death.
Read the detailed description
Variables to be measured
- Demographic data (initials, record, age, sex, race / ethnicity, weight, height, BMI).
- Epidemiological data:
- For kidney transplant patients: time of transplant, in years and complete months; primary kidney disease; presence and time of onset of respiratory symptoms, in days; presence of risk factors or comorbidities; current immunosuppression (drugs and doses); serum level of calcineurin inhibitor on the day of collection; previous vaccination for Influenza; previous viral infections; date of the last episode of rejection treated.
- For liver transplant patients: time of transplant, in years and complete months; primary liver disease; presence and time of onset of respiratory symptoms, in days; presence of risk factors or comorbidities; current immunosuppression (drugs and doses); serum level of calcineurin inhibitor on the day of collection; previous vaccination for Influenza; previous viral infections; date of the last episode of rejection treated.
- For oncohematological patients: time of diagnosis, in years and complete months; primary oncohematological disease; treatment received for the oncohematological disease; presence and time of onset of respiratory symptoms, in days; presence of risk factors or comorbidities; current cancer treatment; previous vaccination for Influenza; previous viral infections.
- Clinics visit / hospitalization data: clinical picture: syndromic diagnosis / signs and symptoms; initial image exam: chest X-ray and / or chest CT; Treatment performed: antiviral, antibiotic, corticoid (reason / dose / time); respiratory support (oxygen therapy only / Non-Invasive Ventilation / High Flow Nasal Cannula / invasive mechanical pulmonary ventilation / ECMO - time of use (days); days free of oxygen therapy, Non-Invasive Ventilation and invasive mechanical pulmonary ventilation.
- Diagnosis of SARS-CoV-2 infection: rapid test for Covid-19 in the blood: IgM / IgG; rapid test for COVID-19 in nasopharyngeal or tracheal secretion.
- Outcomes: Serology for COVID-19 result; PCR for COVID-19 result; presence of symptoms of COVID-19; proportion of patients with viral shedding on days 3,7,14,21 and 30 after diagnosis; need for hospital admission; need for Intensive care admission; death.
- Keywords
- COVID-19, Kidney transplantation, Liver transplantation, Cancer, Children, Adolescents, Pediatrics
- Medical subject headings
- Coronavirus Infections, Neoplasms, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Kidney transplant patients | Patients submitted to kidney transplantation. | |
| Liver transplant patients | Patients submitted to liver transplantation. | |
| Oncological patients | Oncological patients submitted to chemotherapy. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serology (IgM, IgG) for COVID-19.
percentage of positivity
Measured: 9 months
Secondary outcomes (6)
Hospital admission
percentage of patients admitted to hospital
Measured: 9 months
Intensive care admission
percentage of patients admitted to intensive care unit
Measured: 9 months
Death
percentage of patients who died
Measured: 9 months
Positive PCR for COVID-19
percentage of positivity
Measured: 9 months
Clinical characteristics of patients with COVID-19
Percentage of patients with symptoms of COVID-19
Measured: 9 months
Proportion of patients with viral excretion in respiratory secretion and faeces on days 3, 7, 14, 21 and 30 after confirmation of covid 19.
Percentage of patients with positive PCR in respiratory secretion and feces on days 3, 7, 14, 21 and 30 after confirmation of covid 19.
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2020
- Study start30 Jun 2020
- Primary completionOct 2020 (estimated)
- Study completionApr 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Infections, CoronavirusStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- D'Or Institute for Research and Education
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital Estadual da Criança, Hospital Federal de Bonsucesso, Rio de Janeiro State Research Supporting Foundation (FAPERJ)
- Responsible party
- Sponsor
- Investigators
- Thais L Cleto-Yamane, MD, MSc, Principal investigator, D'Or Institute for Research and Education (IDOR)Arnaldo Prata-Barbosa, MD, PhD, Study director, D'Or Institute for Research and Education (IDOR)Antonio José L A da Cunha, MD, PhD, Study chair, Universidade Federal do Rio de Janeiro
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04511429
- Sponsor's protocol ID
- 062-2020
- Status last verified
- Aug 2020
- First submitted
- 24 Jul 2020
- Last updated
- 13 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Danziger-Isakov L, Steinbach WJ, Paulsen G, Munoz FM, Sweet LR, Green M, Michaels MG, Englund JA, Murray A, Halasa N, Dulek DE, Madan RP, Herold BC, Fisher BT. A Multicenter Consortium to Define the Epidemiology and Outcomes of Pediatric Solid Organ Transplant Recipients With Inpatient Respiratory Virus Infection. J Pediatric Infect Dis Soc. 2019 Jul 1;8(3):197-204. doi: 10.1093/jpids/piy024.
PubMed 29538674Lee KH, Yoo SG, Cho Y, Kwon DE, La Y, Han SH, Kim MS, Choi JS, Kim SI, Kim YS, Min YH, Cheong JW, Kim JS, Song YG. Characteristics of community-acquired respiratory viruses infections except seasonal influenza in transplant recipients and non-transplant critically ill patients. J Microbiol Immunol Infect. 2021 Apr;54(2):253-260. doi: 10.1016/j.jmii.2019.05.007. Epub 2019 Jun 19.
PubMed 31262511D'Antiga L. Coronaviruses and Immunosuppressed Patients: The Facts During the Third Epidemic. Liver Transpl. 2020 Jun;26(6):832-834. doi: 10.1002/lt.25756. Epub 2020 Apr 24. No abstract available.
PubMed 32196933Cortiula F, Pettke A, Bartoletti M, Puglisi F, Helleday T. Managing COVID-19 in the oncology clinic and avoiding the distraction effect. Ann Oncol. 2020 May;31(5):553-555. doi: 10.1016/j.annonc.2020.03.286. Epub 2020 Mar 19. No abstract available.
PubMed 32201224Ronco C, Reis T, De Rosa S. Coronavirus Epidemic and Extracorporeal Therapies in Intensive Care: si vis pacem para bellum. Blood Purif. 2020;49(3):255-258. doi: 10.1159/000507039. Epub 2020 Mar 13. No abstract available.
PubMed 32172242Memoli MJ, Athota R, Reed S, Czajkowski L, Bristol T, Proudfoot K, Hagey R, Voell J, Fiorentino C, Ademposi A, Shoham S, Taubenberger JK. The natural history of influenza infection in the severely immunocompromised vs nonimmunocompromised hosts. Clin Infect Dis. 2014 Jan;58(2):214-24. doi: 10.1093/cid/cit725. Epub 2013 Nov 1.
PubMed 24186906Fitzner J, Qasmieh S, Mounts AW, Alexander B, Besselaar T, Briand S, Brown C, Clark S, Dueger E, Gross D, Hauge S, Hirve S, Jorgensen P, Katz MA, Mafi A, Malik M, McCarron M, Meerhoff T, Mori Y, Mott J, Olivera MTDC, Ortiz JR, Palekar R, Rebelo-de-Andrade H, Soetens L, Yahaya AA, Zhang W, Vandemaele K. Revision of clinical case definitions: influenza-like illness and severe acute respiratory infection. Bull World Health Organ. 2018 Feb 1;96(2):122-128. doi: 10.2471/BLT.17.194514. Epub 2017 Nov 27.
PubMed 29403115Kumar D, Tellier R, Draker R, Levy G, Humar A. Severe Acute Respiratory Syndrome (SARS) in a liver transplant recipient and guidelines for donor SARS screening. Am J Transplant. 2003 Aug;3(8):977-81. doi: 10.1034/j.1600-6143.2003.00197.x.
PubMed 12859532Liang W, Guan W, Chen R, Wang W, Li J, Xu K, Li C, Ai Q, Lu W, Liang H, Li S, He J. Cancer patients in SARS-CoV-2 infection: a nationwide analysis in China. Lancet Oncol. 2020 Mar;21(3):335-337. doi: 10.1016/S1470-2045(20)30096-6. Epub 2020 Feb 14. No abstract available.
PubMed 32066541
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- COVID-19 in Immunosuppressed Children
- ClinicalTrials.gov ID
- NCT04511429
- Acronym / sponsor ID
- 062-2020
- Keywords
- COVID-19, Kidney transplantation, Liver transplantation, Cancer, Children, Adolescents, Pediatrics
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- D'Or Institute for Research and EducationUniversity, hospital or other
- Collaborators
- Hospital Estadual da Criança, Hospital Federal de Bonsucesso, Rio de Janeiro State Research Supporting Foundation (FAPERJ)
- Study start
- 30 Jun 2020 (actual)
- Primary completion
- Oct 2020 (estimated)
- Study completion
- Apr 2021 (estimated)
- First posted
- 13 Aug 2020 (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.
Viral respiratory infections are common infectious complications after kidney transplantation, especially in the pediatric age group, and immunosuppressed patients may develop more severe disease. Immunosuppressive medications alter the patient's immune response by acting on humoral, cellular immunity and neutrophil function, increasing the risk of serious viral infections. Little is known about how these patients respond to infection by the new coronavirus (SARS-CoV-2).
Experience with SARS caused by the Influenza H1N1 virus suggests that the severity of the disease depends on pre-existing comorbidities and the individual immune response. In more severe cases, an imbalance between the inflammatory system and the immune system is observed, determining direct consequences when pro and anti-inflammatory cytokines reach the systemic circulation in an exacerbated and unbalanced manner. Such fact can generate "cytokine storm syndrome", resulting in multiple organ dysfunction syndrome.
March 2020 reports from Papa Giovanni XXIII Hospital in Bergamo, Italy - one of the largest pediatric liver transplant centers - showed that the number of transplant patients infected with Coronavirus disease 2019 (COVID- 19) increased progressively. However, they did not see greater severity and complications in this population. Immunosuppression could act as a protective factor.
The present study aims to describe the prevalence of viral infection by SARS-CoV-2 in a sample of immunosuppressed children, from three groups: kidney transplants, liver transplants and oncohematological. The investigators will also look for the epidemiological profile and clinical evolution of these patients, enabling a better understanding of the COVID-19 in this special population. The investigators' hypothesis is that infection with the new coronavirus may be asymptomatic in a large number of children and that immunosuppression, observed in liver and kidney transplant patients and also seen in cancer patients, may act as protection for severe forms of COVID-19.
After obtaining written informed consent from the family, the investigators will include patients from 0-18 years of age, on regular outpatient follow-up, symptomatic or not, and will check for the presence of IgM/IgG antibodies against the SARS-CoV-2. For those symptomatic or with a positive IgM result, material (oro/nasopharyngeal swabs) for RT-PCR trial for the new coronavirus will be collected. Demographic and clinical variables will be registered. The outcomes are: Serology for COVID-19 result; PCR for COVID-19 result; presence of symptoms of COVID-19; proportion of patients with viral shedding on days 3,7,14,21 and 30 after diagnosis; need for hospital admission; need for Intensive care admission; death.
Detailed description
Variables to be measured
- Demographic data (initials, record, age, sex, race / ethnicity, weight, height, BMI).
- Epidemiological data:
- For kidney transplant patients: time of transplant, in years and complete months; primary kidney disease; presence and time of onset of respiratory symptoms, in days; presence of risk factors or comorbidities; current immunosuppression (drugs and doses); serum level of calcineurin inhibitor on the day of collection; previous vaccination for Influenza; previous viral infections; date of the last episode of rejection treated.
- For liver transplant patients: time of transplant, in years and complete months; primary liver disease; presence and time of onset of respiratory symptoms, in days; presence of risk factors or comorbidities; current immunosuppression (drugs and doses); serum level of calcineurin inhibitor on the day of collection; previous vaccination for Influenza; previous viral infections; date of the last episode of rejection treated.
- For oncohematological patients: time of diagnosis, in years and complete months; primary oncohematological disease; treatment received for the oncohematological disease; presence and time of onset of respiratory symptoms, in days; presence of risk factors or comorbidities; current cancer treatment; previous vaccination for Influenza; previous viral infections.
- Clinics visit / hospitalization data: clinical picture: syndromic diagnosis / signs and symptoms; initial image exam: chest X-ray and / or chest CT; Treatment performed: antiviral, antibiotic, corticoid (reason / dose / time); respiratory support (oxygen therapy only / Non-Invasive Ventilation / High Flow Nasal Cannula / invasive mechanical pulmonary ventilation / ECMO - time of use (days); days free of oxygen therapy, Non-Invasive Ventilation and invasive mechanical pulmonary ventilation.
- Diagnosis of SARS-CoV-2 infection: rapid test for Covid-19 in the blood: IgM / IgG; rapid test for COVID-19 in nasopharyngeal or tracheal secretion.
- Outcomes: Serology for COVID-19 result; PCR for COVID-19 result; presence of symptoms of COVID-19; proportion of patients with viral shedding on days 3,7,14,21 and 30 after diagnosis; need for hospital admission; need for Intensive care admission; death.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 6 Months
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Kidney transplant patients | – | –Patients submitted to kidney transplantation. |
| Liver transplant patients | – | –Patients submitted to liver transplantation. |
| Oncological patients | – | –Oncological patients submitted to chemotherapy. |
Who may qualify
- Ages
- 1 month to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Patients aged 0-18 years, immunosuppressed, kidney or liver transplanted, or oncologic patients, in outpatient follow-up or hospitalized.
Key inclusion criteria (2 listed)
- Renal or liver transplant patients, with functioning graft and using immunosuppression, in outpatient follow-up or hospitalized.
- Patients treating oncohematological disorders, in outpatient follow-up or hospitalized..
Key exclusion criteria (1 listed)
- Patients who or whose parents refuse to sign the Informed Consent Form.
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
Serology (IgM, IgG) for COVID-19.
Time frame: 9 months
percentage of positivity
6 secondary outcomes
Hospital admission
Time frame: 9 months
Intensive care admission
Time frame: 9 months
Death
Time frame: 9 months
Positive PCR for COVID-19
Time frame: 9 months
Clinical characteristics of patients with COVID-19
Time frame: 9 months
Proportion of patients with viral excretion in respiratory secretion and faeces on days 3, 7, 14, 21 and 30 after confirmation of covid 19.
Time frame: 9 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2020.
- Results publication: PubMed 29538674Danziger-Isakov L, Steinbach WJ, Paulsen G, Munoz FM, Sweet LR, Green M, Michaels MG, Englund JA, Murray A, Halasa N, Dulek DE, Madan RP, Herold BC, Fisher BT. A Multicenter Consortium to Define the Epidemiology and Outcomes of Pediatric Solid Organ Transplant Recipients With Inpatient Respiratory Virus Infection. J Pediatric Infect Dis Soc. 2019 Jul 1;8(3):197-204. doi: 10.1093/jpids/piy024.
- Results publication: PubMed 31262511Lee KH, Yoo SG, Cho Y, Kwon DE, La Y, Han SH, Kim MS, Choi JS, Kim SI, Kim YS, Min YH, Cheong JW, Kim JS, Song YG. Characteristics of community-acquired respiratory viruses infections except seasonal influenza in transplant recipients and non-transplant critically ill patients. J Microbiol Immunol Infect. 2021 Apr;54(2):253-260. doi: 10.1016/j.jmii.2019.05.007. Epub 2019 Jun 19.
- Results publication: PubMed 32196933D'Antiga L. Coronaviruses and Immunosuppressed Patients: The Facts During the Third Epidemic. Liver Transpl. 2020 Jun;26(6):832-834. doi: 10.1002/lt.25756. Epub 2020 Apr 24. No abstract available.
- Results publication: PubMed 32201224Cortiula F, Pettke A, Bartoletti M, Puglisi F, Helleday T. Managing COVID-19 in the oncology clinic and avoiding the distraction effect. Ann Oncol. 2020 May;31(5):553-555. doi: 10.1016/j.annonc.2020.03.286. Epub 2020 Mar 19. No abstract available.
- Results publication: PubMed 32172242Ronco C, Reis T, De Rosa S. Coronavirus Epidemic and Extracorporeal Therapies in Intensive Care: si vis pacem para bellum. Blood Purif. 2020;49(3):255-258. doi: 10.1159/000507039. Epub 2020 Mar 13. No abstract available.
- Results publication: PubMed 24186906Memoli MJ, Athota R, Reed S, Czajkowski L, Bristol T, Proudfoot K, Hagey R, Voell J, Fiorentino C, Ademposi A, Shoham S, Taubenberger JK. The natural history of influenza infection in the severely immunocompromised vs nonimmunocompromised hosts. Clin Infect Dis. 2014 Jan;58(2):214-24. doi: 10.1093/cid/cit725. Epub 2013 Nov 1.
- Results publication: PubMed 29403115Fitzner J, Qasmieh S, Mounts AW, Alexander B, Besselaar T, Briand S, Brown C, Clark S, Dueger E, Gross D, Hauge S, Hirve S, Jorgensen P, Katz MA, Mafi A, Malik M, McCarron M, Meerhoff T, Mori Y, Mott J, Olivera MTDC, Ortiz JR, Palekar R, Rebelo-de-Andrade H, Soetens L, Yahaya AA, Zhang W, Vandemaele K. Revision of clinical case definitions: influenza-like illness and severe acute respiratory infection. Bull World Health Organ. 2018 Feb 1;96(2):122-128. doi: 10.2471/BLT.17.194514. Epub 2017 Nov 27.
- Results publication: PubMed 12859532Kumar D, Tellier R, Draker R, Levy G, Humar A. Severe Acute Respiratory Syndrome (SARS) in a liver transplant recipient and guidelines for donor SARS screening. Am J Transplant. 2003 Aug;3(8):977-81. doi: 10.1034/j.1600-6143.2003.00197.x.
- Results publication: PubMed 32066541Liang W, Guan W, Chen R, Wang W, Li J, Xu K, Li C, Ai Q, Lu W, Liang H, Li S, He J. Cancer patients in SARS-CoV-2 infection: a nationwide analysis in China. Lancet Oncol. 2020 Mar;21(3):335-337. doi: 10.1016/S1470-2045(20)30096-6. Epub 2020 Feb 14. No abstract available.
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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.
Thais L Cleto-Yamane, MD, MSc principal investigator
D'Or Institute for Research and Education (IDOR)
Arnaldo Prata-Barbosa, MD, PhD study director
D'Or Institute for Research and Education (IDOR)
Antonio José L A da Cunha, MD, PhD study chair
Universidade Federal do Rio de Janeiro
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Infections, Coronavirus and Kidney Transplantation, run by D'Or Institute for Research and Education at 2 sites 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 2 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 13 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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.
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?
Contact Thais L Cleto-Yamane, MD, MSc (5521988046852, thaiscleto@yahoo.com.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serology (IgM, IgG) for COVID-19. (time frame: 9 months). 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 NCT04511429, which also lists 9 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 13 Aug 2020; AzTrials last refreshed its copy on 3 Nov 2026.