InfectionPhase 3COVID-BCGNCT04384549
Efficacy of BCG Vaccination in the Prevention of COVID19 Via the Strengthening of Innate Immunity in Health Care Workers
A Phase 3 study testing BCG GROUP in people with Infection and Viral, Agent as Cause of Disease Classified Elsewhere, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
Healthcare Workers (HCW) are at high risk for COVID-19. In addition to the risk of serious forms among HCW, significant absenteeism due to illness would have dramatic consequences in our ability to fight COVID-19. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Infection, Viral, Agent as Cause of Disease Classified Elsewhere
- What is being tested?
- BCG GROUP
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,120 participants
- Where
- 1 siteFrance
- Study dates
- 20 May 2020to 20 Feb 2021
- Phase
- Phase 3
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Individual (Male and female) aged 18 or over.
- Healthcare Worker (medical or non-medical) from hospitals in direct contact with COVID-19 patients.
- Participants must give their written consent before any trial procedure.
- Participants covered by social security regimen (excepting AME).
- Healthy according to the opinion of the investigator.
Who cannot join
- Has any BCG vaccine contraindication, known allergy to the BCG vaccine or SAE to prior BCG vaccination.
- History of tuberculosis
- People with acquired or innate immunodeficiency.
- People have already been infected with SARS Cov-2 (virological documentation or TDM or seropositive if serology available).
- People who could not commit to follow-up for 6 months.
- People not in good general condition, as assessed by the investigator.
Show all 19Show fewer
- People included in other clinical trials assessing treatment.
- Pregnant or breastfeeding or positive urine pregnancy at enrolment visit.
- BCG vaccine given within the last year.
- Another live vaccine administered in the month prior to randomization.
- History of anaphylaxis following vaccination.
- Receiving medical treatment that affects the immune response or other immunosuppressive therapy in the last year. These therapies include systemic corticosteroids (more than or equal to 10 mg for more than or equal to 2 weeks), immunosuppressant, biological agents (such as monoclonal antibodies against tumour necrosis factor (TNF)-alpha).
- Another vaccine administered in the month prior to inclusion and randomization.
- Fever > 38°C within the past 24 hours
- People with malignancies (e.g. lymphoma, leukemia, Hodgkin's disease or other tumors of the reticuloendothelial system) or infected with HIV
- Receipt of immune globulins, blood or blood-derived products in the past 3 months
- Acute severe febrile illness
- Generalized infected skin conditions
- People under legal protection measure (tutorship, curatorship or safeguard measures)
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
I-REIVAC/CIC 1417 Cochin Hospital, APHP
Paris, 75014
Odile LAUNAY, Professor, 01 58 41 28 58, odile.launay@aphp.fr
Ahlam SAAD, '01 58 41 33 54, ahlam.saad@aphp.fr
About this study
Official title: Randomized Controlled Trial Evaluating the Efficacy of Vaccination With Bacillus Calmette and Guérin (BCG) in the Prevention of COVID-19 Via the Strengthening of Innate Immunity in Health Care Workers
Healthcare Workers (HCW) are at high risk for COVID-19. In addition to the risk of serious forms among HCW, significant absenteeism due to illness would have dramatic consequences in our ability to fight COVID-19. No coronavirus vaccine is available today and drug treatments are only at the start of clinical evaluation. Available since 1921, the bacillus Calmette and Guérin (BCG) is the most widely used vaccine in the world (> 3 billion doses administered) with an extremely low rate of adverse effects. BCG is indicated for the prevention of tuberculosis (TB), but more recent studies have shown that it also has nonspecific immune properties which may be interesting in the current COVID-19 epidemic. Data in mice and in humans have demonstrated protection conferred by BCG against viral respiratory infections such as influenza. In countries with high endemic TB, BCG decreases the incidence of acute respiratory infections by up to 80%, neonatal BCG vaccination has been shown to greatly reduce the risk of sepsis and of hospitalization of children for reasons other than TB. A recent study conducted in South Africa showed that re-vaccination with BCG in adults reduced the incidence of respiratory infections by 70% compared to unvaccinated controls. Beyond respiratory infections, BCG has also shown protective effects against inflammatory diseases. These non-specific beneficial effects are likely linked to the induction of "trained innate immunity", implying epigenetic and metabolic re-programming of innate immune cells. It is therefore possible that revaccination with BCG could significantly reduce the incidence and severity of COVID-19. Very recent ecological observations indeed suggest an inverse correlation between BCG vaccination coverage and the morbidity and mortality of COVID-19. In this context several trials began in Europe and Australia to evaluate the efficacy of BCG vaccination in populations at risk of exposure (HCW) or severe disease (elderly). This study is aligned with studies carried out in Australia, The Netherlands and Spain. In contrast to these latter studies, virtually all French study participants have been vaccinated in their childhood, since BCG vaccination was mandatory in France in neonates until 2007, and in HCW until recently. Therefore, the French study will be in a unique situation to evaluate the effect of re-vaccination with BCG in the context of BCG priming decades before revaccination.
Read the detailed description
Randomized, multicenter phase III controlled trial, in 2 parallel arms:
- One group vaccinated with BCG
- One group receiving placebo (0.9 % saline) Randomization in a 1: 1 ratio will be stratified on the center. The study will be proposed to all heath care workers eligible. At screening, the investigator will propose the study to the participant and explain the details by providing an information letter. After signature of the consent, evaluations specific for the study will be undertaken, such as clinical examination, blood sampling, nasopharyngeal sampling in case of clinical signs.
At the inclusion visit, participants corresponding to the inclusion criteria will be randomized to receive BCG or placebo.
Participants will receive a single dose of BCG vaccine (or placebo). The adult dose of BCG vaccine (or placebo) is 0.1 mL injected intradermally over the distal insertion of the deltoid muscle onto the humerus (approximately one third down the upper arm).
Follow-up visits will be done respectively at M3 and M6 and phone contacts between these two visits.
Blood samples will be collected prior to randomization (V0) and at 3 and 6 months to determine exposure to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Where required, swab/blood samples will be taken at illness episodes to assess SARS-CoV-2 infection.
Participants will be followed for 6 months with regular mobile phone text messages 2 times weekly to collect local and general reactions until 30 days after vaccination and during the study to identify and detail COVID-19 infection.
Immunological studies will be conducted at a central Laboratory. Analysis will take place after M6 visits.
A nested study will be carried out on blood samples of 72 study subjects in order to evaluate the impact of COVID-19 on innate immunity. These blood samples will be collected at M6 among 6 groups, each containing 12 study subjects:
- One group of subjects vaccinated with BCG that have remained sero-negative for SARS CoV2
- One group of subjects having received placebo that have remained sero-negative for SARS CoV2
- One group of symptomatic subjects vaccinated with BCG
- One group of symptomatic subjects having received placebo.
- One group without symptoms but sero-positive for SARS CoV2 vaccinated with BCG
- One group without symptoms but sero-positive for SARS CoV2 vaccinated with placebo
- Being tested
- BCG GROUP, PLACEBO GROUP
- Keywords
- Vaccinology, Infectiology, COVID-19, Health Workers
- Medical subject headings
- Infections, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BCG GROUPBiological
Also called Experimental GROUP
One intradermal injection of 0.1 ml of BCG vaccine (AJ Vaccine).Each 0.1 ml vaccine contains between 2 to 8 x 105 colony forming units.
PLACEBO GROUPOther
Also called Control GROUP
One intradermal injection of 0.1ml NaCl
| Study group | Role | What they receive |
|---|---|---|
| BCG Arm | Experimental | One intradermal injection of 0.1 ml of BCG vaccine (AJ Vaccine).Each 0.1 ml vaccine contains between 2 to 8 x 105 colony forming units. Receives: Biological: BCG GROUP |
| PLACEBO Arm | Placebo comparator | One intradermal placebo injection. Receives: Other: PLACEBO GROUP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of documented COVID-19 among health care workers exposed to SARS CoV2 and vaccinated with BCG compared to placebo.
Documented COVID-19, i.e. symptomatic COVID-19 confirmed by either
- positive nasopharyngeal tests for SARS CoV2
- and/or by thoracic tomodensitometry compatible with the diagnosis.
- and/or SARS CoV2 seroconversion
Measured: during the study period of 6 months
Secondary outcomes (6)
Numbers of COVID-19 patients requiring hospitalization in ICU and O2, artificial ventilation or extracorporal membrane oxygenation, or deaths in BCG-vaccinated health care workers compared to placebo
Participants having developed a severe form of COVID-19, as defined by the necessity for hospitalization in ICU and O2 or artificial ventilation, or extracorporeal membrane oxygenation, or death
Measured: during the study period of 6 months.
Incidence of asymptomatic SARS CoV2 seropositive subjects among BCG-vaccinated health care workers compared to placebo.
Participants with seroconversion during the study, without symptoms related to COVID-19
Measured: during the study period of 6 months.
Incidence of subjects with any respiratory infection among BCG-vaccinated health care workers compared to placebo.
Participants presenting any kind of respiratory infection due to any cause
Measured: during the study period of 6 months.
Numbers of sick days and numbers of sick leaves among BCG-vaccinated health care workers compared to placebo.
Numbers of sick days and number of sick leaves
Measured: during the study period of 6 months
Numbers of subjects with BCG-related advers events among BCG-vaccinated health care workers compared to placebo.
Local and general events following BCG revaccination after BCG revaccination
Measured: 30 days after BCG revaccination
Numbers and intensity of changes in innate immune markers after SARS CoV2 infection among BCG-vaccinated health care workers compared to placebo.
Potentially modified markers of innate immunity upon SARS CoV-2 infection to be identified
Measured: during the study period of 6 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2020
- Study start20 May 2020
- Primary completion20 Feb 2021 (estimated)
- Study completion20 Feb 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for InfectionStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 1,120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Odile LAUNAY, Professor, Principal investigator, Assitance Publique-Hôpitaux de ParisCamille LOCHT, Professor, Study director, Institut Pasteur de Lille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04384549
- Sponsor's protocol ID
- APHP200462
- Other IDs
- 2020-001678-31
- Acronym
- COVID-BCG
- Status last verified
- Aug 2020
- First submitted
- 6 May 2020
- Last updated
- 18 Aug 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Moorlag SJCFM, Arts RJW, van Crevel R, Netea MG. Non-specific effects of BCG vaccine on viral infections. Clin Microbiol Infect. 2019 Dec;25(12):1473-1478. doi: 10.1016/j.cmi.2019.04.020. Epub 2019 May 2.
PubMed 31055165Nemes E, Geldenhuys H, Rozot V, Rutkowski KT, Ratangee F, Bilek N, Mabwe S, Makhethe L, Erasmus M, Toefy A, Mulenga H, Hanekom WA, Self SG, Bekker LG, Ryall R, Gurunathan S, DiazGranados CA, Andersen P, Kromann I, Evans T, Ellis RD, Landry B, Hokey DA, Hopkins R, Ginsberg AM, Scriba TJ, Hatherill M; C-040-404 Study Team. Prevention of M. tuberculosis Infection with H4:IC31 Vaccine or BCG Revaccination. N Engl J Med. 2018 Jul 12;379(2):138-149. doi: 10.1056/NEJMoa1714021.
PubMed 29996082Kowalewicz-Kulbat M, Locht C. BCG and protection against inflammatory and auto-immune diseases. Expert Rev Vaccines. 2017 Jul;16(7):1-10. doi: 10.1080/14760584.2017.1333906. Epub 2017 May 30.
PubMed 28532186Netea MG, Dominguez-Andres J, Barreiro LB, Chavakis T, Divangahi M, Fuchs E, Joosten LAB, van der Meer JWM, Mhlanga MM, Mulder WJM, Riksen NP, Schlitzer A, Schultze JL, Stabell Benn C, Sun JC, Xavier RJ, Latz E. Defining trained immunity and its role in health and disease. Nat Rev Immunol. 2020 Jun;20(6):375-388. doi: 10.1038/s41577-020-0285-6. Epub 2020 Mar 4.
PubMed 32132681
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial Evaluating the Efficacy of Vaccination With Bacillus Calmette and Guérin (BCG) in the Prevention of COVID-19 Via the Strengthening of Innate Immunity in Health Care Workers
- ClinicalTrials.gov ID
- NCT04384549
- Acronym / sponsor ID
- COVID-BCG / APHP200462
- Keywords
- Vaccinology, Infectiology, COVID-19, Health Workers
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,120 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 20 May 2020 (actual)
- Primary completion
- 20 Feb 2021 (estimated)
- Study completion
- 20 Feb 2021 (estimated)
- First posted
- 12 May 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.
Healthcare Workers (HCW) are at high risk for COVID-19. In addition to the risk of serious forms among HCW, significant absenteeism due to illness would have dramatic consequences in our ability to fight COVID-19. No coronavirus vaccine is available today and drug treatments are only at the start of clinical evaluation. Available since 1921, the bacillus Calmette and Guérin (BCG) is the most widely used vaccine in the world (> 3 billion doses administered) with an extremely low rate of adverse effects. BCG is indicated for the prevention of tuberculosis (TB), but more recent studies have shown that it also has nonspecific immune properties which may be interesting in the current COVID-19 epidemic. Data in mice and in humans have demonstrated protection conferred by BCG against viral respiratory infections such as influenza. In countries with high endemic TB, BCG decreases the incidence of acute respiratory infections by up to 80%, neonatal BCG vaccination has been shown to greatly reduce the risk of sepsis and of hospitalization of children for reasons other than TB. A recent study conducted in South Africa showed that re-vaccination with BCG in adults reduced the incidence of respiratory infections by 70% compared to unvaccinated controls. Beyond respiratory infections, BCG has also shown protective effects against inflammatory diseases. These non-specific beneficial effects are likely linked to the induction of "trained innate immunity", implying epigenetic and metabolic re-programming of innate immune cells. It is therefore possible that revaccination with BCG could significantly reduce the incidence and severity of COVID-19. Very recent ecological observations indeed suggest an inverse correlation between BCG vaccination coverage and the morbidity and mortality of COVID-19. In this context several trials began in Europe and Australia to evaluate the efficacy of BCG vaccination in populations at risk of exposure (HCW) or severe disease (elderly). This study is aligned with studies carried out in Australia, The Netherlands and Spain. In contrast to these latter studies, virtually all French study participants have been vaccinated in their childhood, since BCG vaccination was mandatory in France in neonates until 2007, and in HCW until recently. Therefore, the French study will be in a unique situation to evaluate the effect of re-vaccination with BCG in the context of BCG priming decades before revaccination.
Detailed description
Randomized, multicenter phase III controlled trial, in 2 parallel arms:
- One group vaccinated with BCG
- One group receiving placebo (0.9 % saline) Randomization in a 1: 1 ratio will be stratified on the center. The study will be proposed to all heath care workers eligible. At screening, the investigator will propose the study to the participant and explain the details by providing an information letter. After signature of the consent, evaluations specific for the study will be undertaken, such as clinical examination, blood sampling, nasopharyngeal sampling in case of clinical signs.
At the inclusion visit, participants corresponding to the inclusion criteria will be randomized to receive BCG or placebo.
Participants will receive a single dose of BCG vaccine (or placebo). The adult dose of BCG vaccine (or placebo) is 0.1 mL injected intradermally over the distal insertion of the deltoid muscle onto the humerus (approximately one third down the upper arm).
Follow-up visits will be done respectively at M3 and M6 and phone contacts between these two visits.
Blood samples will be collected prior to randomization (V0) and at 3 and 6 months to determine exposure to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Where required, swab/blood samples will be taken at illness episodes to assess SARS-CoV-2 infection.
Participants will be followed for 6 months with regular mobile phone text messages 2 times weekly to collect local and general reactions until 30 days after vaccination and during the study to identify and detail COVID-19 infection.
Immunological studies will be conducted at a central Laboratory. Analysis will take place after M6 visits.
A nested study will be carried out on blood samples of 72 study subjects in order to evaluate the impact of COVID-19 on innate immunity. These blood samples will be collected at M6 among 6 groups, each containing 12 study subjects:
- One group of subjects vaccinated with BCG that have remained sero-negative for SARS CoV2
- One group of subjects having received placebo that have remained sero-negative for SARS CoV2
- One group of symptomatic subjects vaccinated with BCG
- One group of symptomatic subjects having received placebo.
- One group without symptoms but sero-positive for SARS CoV2 vaccinated with BCG
- One group without symptoms but sero-positive for SARS CoV2 vaccinated with placebo
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BCG Arm | Experimental | Biological: BCG GROUPOne intradermal injection of 0.1 ml of BCG vaccine (AJ Vaccine).Each 0.1 ml vaccine contains between 2 to 8 x 105 colony forming units. |
| PLACEBO Arm | Placebo comparator | Other: PLACEBO GROUPOne intradermal placebo injection. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Individual (Male and female) aged 18 or over.
- Healthcare Worker (medical or non-medical) from hospitals in direct contact with COVID-19 patients.
- Participants must give their written consent before any trial procedure.
- Participants covered by social security regimen (excepting AME).
- Healthy according to the opinion of the investigator.
Key exclusion criteria (19 listed)
- Has any BCG vaccine contraindication, known allergy to the BCG vaccine or SAE to prior BCG vaccination.
- History of tuberculosis
- People with acquired or innate immunodeficiency.
- People have already been infected with SARS Cov-2 (virological documentation or TDM or seropositive if serology available).
- People who could not commit to follow-up for 6 months.
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 |
|---|---|---|
| BCG GROUPAlso: Experimental GROUPOne intradermal injection of 0.1 ml of BCG vaccine (AJ Vaccine).Each 0.1 ml vaccine contains between 2 to 8 x 105 colony forming units. | Biological | BCG Arm |
| PLACEBO GROUPAlso: Control GROUPOne intradermal injection of 0.1ml NaCl | Other | PLACEBO Arm |
Primary outcome
Incidence of documented COVID-19 among health care workers exposed to SARS CoV2 and vaccinated with BCG compared to placebo.
Time frame: during the study period of 6 months
Documented COVID-19, i.e. symptomatic COVID-19 confirmed by either * positive nasopharyngeal tests for SARS CoV2 * and/or by thoracic tomodensitometry compatible with the diagnosis. * and/or SARS CoV2 seroconversion
6 secondary outcomes
Numbers of COVID-19 patients requiring hospitalization in ICU and O2, artificial ventilation or extracorporal membrane oxygenation, or deaths in BCG-vaccinated health care workers compared to placebo
Time frame: during the study period of 6 months.
Incidence of asymptomatic SARS CoV2 seropositive subjects among BCG-vaccinated health care workers compared to placebo.
Time frame: during the study period of 6 months.
Incidence of subjects with any respiratory infection among BCG-vaccinated health care workers compared to placebo.
Time frame: during the study period of 6 months.
Numbers of sick days and numbers of sick leaves among BCG-vaccinated health care workers compared to placebo.
Time frame: during the study period of 6 months
Numbers of subjects with BCG-related advers events among BCG-vaccinated health care workers compared to placebo.
Time frame: 30 days after BCG revaccination
Numbers and intensity of changes in innate immune markers after SARS CoV2 infection among BCG-vaccinated health care workers compared to placebo.
Time frame: during the study period of 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 Aug 2020.
- Background: PubMed 31055165Moorlag SJCFM, Arts RJW, van Crevel R, Netea MG. Non-specific effects of BCG vaccine on viral infections. Clin Microbiol Infect. 2019 Dec;25(12):1473-1478. doi: 10.1016/j.cmi.2019.04.020. Epub 2019 May 2.
- Background: PubMed 29996082Nemes E, Geldenhuys H, Rozot V, Rutkowski KT, Ratangee F, Bilek N, Mabwe S, Makhethe L, Erasmus M, Toefy A, Mulenga H, Hanekom WA, Self SG, Bekker LG, Ryall R, Gurunathan S, DiazGranados CA, Andersen P, Kromann I, Evans T, Ellis RD, Landry B, Hokey DA, Hopkins R, Ginsberg AM, Scriba TJ, Hatherill M; C-040-404 Study Team. Prevention of M. tuberculosis Infection with H4:IC31 Vaccine or BCG Revaccination. N Engl J Med. 2018 Jul 12;379(2):138-149. doi: 10.1056/NEJMoa1714021.
- Background: PubMed 28532186Kowalewicz-Kulbat M, Locht C. BCG and protection against inflammatory and auto-immune diseases. Expert Rev Vaccines. 2017 Jul;16(7):1-10. doi: 10.1080/14760584.2017.1333906. Epub 2017 May 30.
- Background: PubMed 32132681Netea MG, Dominguez-Andres J, Barreiro LB, Chavakis T, Divangahi M, Fuchs E, Joosten LAB, van der Meer JWM, Mhlanga MM, Mulder WJM, Riksen NP, Schlitzer A, Schultze JL, Stabell Benn C, Sun JC, Xavier RJ, Latz E. Defining trained immunity and its role in health and disease. Nat Rev Immunol. 2020 Jun;20(6):375-388. doi: 10.1038/s41577-020-0285-6. Epub 2020 Mar 4.
- Individual participant dataSharing planned: No
Related trials for Infection
Not yet recruitingPhase 1
Phase I Open-Label Safety Trial of Pembrolizumab for Neurological Post- Acute Sequelae of SARS-CoV-2 (PD1-PASC I)
Post-Acute COVID-19 Syndrome
RecruitingObservational study
Effectiveness and Clinical Outcomes of Long-term Bulevirtide Monotherapy in Patients With HDV-related Compensated Cirrhosis
Hepatitis D
RecruitingObservational study
VIRal Pulmonary Infections in Older AGE
Viral Pulmonary Infections
Not yet recruitingPhase 2/3
A Pivotal Safety and Immunogenicity GBS-NN/NN2 Vaccine Maternal Immunisation Trial
Streptococcus Agalactiae Infection, Neonatal Sepsis
Active, not recruitingPhase 1
A Safety and Immunogenicity Trial of OCU500, ChAd36 Vector Encoding SARS-CoV-2 Spike Vaccine Via Intranasal and Inhalational Routes in Previously Vaccinated Adults
COVID-19
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.
Odile LAUNAY, Professor principal investigator
Assitance Publique-Hôpitaux de Paris
Camille LOCHT, Professor study director
Institut Pasteur de Lille
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing BCG GROUP in people with Infection and Viral, Agent as Cause of Disease Classified Elsewhere, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
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 19 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 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 1 site in France. 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. Some participants in this study may receive a placebo. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Contact Odile LAUNAY, Professor (01 58 41 28 58, odile.launay@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of documented COVID-19 among health care workers exposed to SARS CoV2 and vaccinated with BCG compared to placebo. (time frame: during the study period of 6 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 NCT04384549, which also lists 4 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 Aug 2020.