Trial · NCT04542330

Using BCG to Protect Senior Citizens During the COVID-19 Pandemic

NCT04542330, Phase 3, Completed, Bandim Health Project; results first posted 2024-08-22

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Using BCG to Protect Senior Citizens During the COVID-19 Pandemic. Trials, record NCT04542330. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04542330

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Using BCG to Protect Senior Citizens During the COVID-19 Pandemic
NCT number: NCT04542330
Status: Completed
Phases: Phase 3
Enrollment: 1,700 participants, actual
Lead sponsor: Bandim Health Project
Conditions: Covid19, Non-specific Effects of Vaccines, Heterologous Immunity, Morbidity, Immunosenescence, Vaccine Preventable Disease
Interventions: BCG-Denmark, Saline
First posted: 2020-09-09
Last updated: 2024-08-22
Results first posted: 2024-08-22

Source ClinicalTrials.gov

Registered outcomes4

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Acute Infection	12 months after inclusion	The primary outcome was a composite outcome of acute infection (recurrent events) defined as "infection attended by a physician", "use of antibiotics", "hospitalisation due to infection", or "death due to infection". All subcomponents were also analysed separately.
Secondary	Verified SARS-CoV-2 Infection (First Event)	12 months after inclusion	Verified SARS-CoV-2 infection was defined as having a positive SARS-CoV-2 Polymerase Chain Reaction (PCR) test or rapid antigen test.
Secondary	Self-reported Respiratory Symptoms (Recurrent Events)	12 months after inclusion	Self-reported respiratory symptoms were identified from questionnaires, where participants reported having had a respiratory illness such as common cold, influenza, pneumonia, or similar term, and/or reported one or more of the following symptoms: cough, sore throat, runny nose/nasal congestion (common cold symptoms), loss of smell or taste sense, or dyspnoea, with or without general symptoms such as fever, chills, muscle ache, headache, and fatigue (dyspnoea only if in combination with fever). This outcome also included symptoms not requiring medical attention.
Secondary	All-cause Hospitalisation (First Event)	12 months from inclusion.	All-cause hospitalisation (first event) included all hospital admissions with overnight stay regardless of duration. Overnight stay was chosen as a condition to exclude contacts such as planned procedures and visits to outpatient clinics.

Source ClinicalTrials.gov

Outcomes4

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Units	Measured as
PRIMARY	Acute Infection	12 months after inclusion	Events	NUMBER
SECONDARY	Verified SARS-CoV-2 Infection (First Event)	12 months after inclusion	Events	NUMBER
SECONDARY	Self-reported Respiratory Symptoms (Recurrent Events)	12 months after inclusion	Events	NUMBER
SECONDARY	All-cause Hospitalisation (First Event)	12 months from inclusion.	Events	NUMBER

Source ClinicalTrials.gov

Results by group16

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Units
Acute Infection	BCG-Denmark	Acute infection (composite)	424	Events
Acute Infection	Control	Acute infection (composite)	469	Events
Acute Infection	BCG-Denmark	Infection attended by a physician	212	Events
Acute Infection	Control	Infection attended by a physician	236	Events
Acute Infection	BCG-Denmark	Use of antibiotics	338	Events
Acute Infection	Control	Use of antibiotics	341	Events
Acute Infection	BCG-Denmark	Hospitalisation due to infection	23	Events
Acute Infection	Control	Hospitalisation due to infection	29	Events
Acute Infection	BCG-Denmark	Death due to infection	0	Events
Acute Infection	Control	Death due to infection	0	Events

1 to 10 of 16Source ClinicalTrials.gov

See all 16 results by group

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	BCG-Denmark	838
Overall Study	STARTED	Control	838
Overall Study	COMPLETED	BCG-Denmark	838
Overall Study	COMPLETED	Control	838
Overall Study	NOT COMPLETED	BCG-Denmark	0
Overall Study	NOT COMPLETED	Control	0

Source ClinicalTrials.gov

Adverse events34

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Vaccination site reactions	General disorders	BCG-Denmark	52	838	52
other	Vaccination site reactions	General disorders	Control	8	838	8
serious	Neoplasms	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	BCG-Denmark	5	838	6
serious	Neoplasms	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Control	8	838	8
serious	Vascular	Vascular disorders	BCG-Denmark	7	838	7
serious	Vascular	Vascular disorders	Control	7	838	9
serious	Procedures	Surgical and medical procedures	BCG-Denmark	0	838	0
serious	Procedures	Surgical and medical procedures	Control	1	838	1
serious	General disorders	General disorders	BCG-Denmark	8	838	8
serious	General disorders	General disorders	Control	8	838	8

1 to 10 of 34Source ClinicalTrials.gov

See all 34 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	BCG-Denmark	1	838
Total, all-cause mortality	Control	3	838
Total, other adverse events	BCG-Denmark	52	838
Total, other adverse events	Control	8	838
Total, serious adverse events	BCG-Denmark	78	838
Total, serious adverse events	Control	63	838

Source ClinicalTrials.gov

Papers2

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
32645296	BACKGROUND	PubMed
39423874	DERIVED	PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons2

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
BCG-Denmark vs Control: deaths from any cause	Trial comparisons
BCG-Denmark vs Control: serious adverse events	Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT04542330

GET https://conductscience.org/api/trials/v1/NCT04542330/events?page=2

API reference For AI assistants