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Old tuberculosis vaccine put to test against COVID-19 – but trial never got off the ground

NCT ID NCT04362124

Prevention Sponsor: Universidad de Antioquia Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled This study
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study aimed to see if the BCG vaccine, originally for tuberculosis, could reduce the severity of COVID-19 in healthcare workers in Medellín, Colombia. It planned to give a single dose of BCG or a placebo to 0 participants (doctors, nurses, and nursing assistants) who were directly caring for COVID-19 patients. However, the trial was withdrawn before enrolling anyone, so no results were obtained.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
BCG vaccine (tuberculosis vaccine)
What this could lead to
If it had worked, this could have pointed toward a way to protect healthcare workers from severe COVID-19 using an existing, cheap vaccine.
What could go wrong
The trial was withdrawn before it started, so no results are available. Even if it had run, BCG's effect on COVID-19 was uncertain and early studies showed mixed outcomes.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Expected to start

Aug 2020

An estimate. Start dates often move.

Expected to finish

Nov 2021

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 65 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion criteria * Men and women * Between ≥18 and ≤ 65 years old * Healthcare workers (doctors, nurses and nursing assistants) from clinics and hospitals in Medellín, who are directly involved in the care of patients with COVID-19 * A negative test for COVID-19 and being asymptomatic at baseline * Are able and willing to give signed informed consent (Subjects whom the investigator believes are able to understand and are willing to comply with the requirements of the protocol) Exclusion Criteria * Have a previous diagnosis (probable or confirmed) of COVID-19 * Immunosuppression (pharmacological or clinical) * Are taking immunosuppressive medications * Pregnant or lactating women; or women of childbearing age who do not agree to take contraceptives during the month following vaccination. * Have received any live or replicative vaccine one month before the time of screening. * Permanent teleworking activity. * History of active tuberculosis * Currently are receiving Hydroxychloroquine, Chloroquine, Lopinavir/ritonavir, Tocilizumab, or Azithromycin. * Known or suspected history of hypersensitivity to vaccines. * Patients who do not wish to attend or who cannot keep up with the follow-up visits.

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Conditions

The condition(s) this trial relates to.

Coronavinae infectious disease COVID-19 prevention target

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

COVID-19

Contacts and locations

Locations

  • Program for Research and Control in Tropical Diseases - PECET

    Medellín, Antioquia, 0004, Colombia

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