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Phase II Clinical trial for Evaluation of BCG as potential therapy for COVID-19

Our take —

This is a promising report, available as a preprint and thus not yet peer reviewed, on the usea small trial of intradermal BCG injection for patients requiring hospitalization for COVID-19 in India. Patients who received BCG during their hospitalization showed improvement in their blood oxygen saturation and resolution of imaging findings of pneumonia, without causing a cytokine storm, compared to those receiving standard of care. This study trial supports exploring BCG in larger trials as a possible treatment option for COVID-19, even in countries that do not have national BCG vaccination programs.

Study design

Randomized Controlled Trial

Study population and setting

This phase 2 study took place in Pune, India, and the aim was to study effectiveness and safety of intradermal Bacillus Calmette-Guerin(BCG) injection in adults hospitalized with hypoxia and pneumonia from COVID-19. Participants were PCR-confirmed men and non-pregnant women between the ages of 18 and 60 years that had COVID-19 symptom onset within 12 days prior to enrollment. The 60 participants were randomized 1:1 into the BCG + standard of care (BCG + SoC) and placebo (SoC) groups. A single dose of BCG was administered on day 0, and blood and nasopharyngeal swabs were collected on days 0, 7, and 15. The study was divided into two patient cohorts: one from May 6 to June 15, 2020, and one from June 15 to August 5, 2020.

Summary of Main Findings

Blood oxygen saturation was higher in the BCG+SoC group compared to the SoC only group, with roughly two-fold faster resolution of COVID-19 induced hypoxia. The BCG+SoC group also experienced greater improvement in their chest CT findings compared to the SoC group. Those in the SoC group who had received BCG vaccination in the past appeared to have better improvement of oxygenation during the study. There were less ICU admissions and mortalities in the BCG+SoC group, and the administration of BCG did not cause a cytokine storm in patients. Viral load appeared to decrease over time in the BCG+SoC group in the first cohort of patients, but this did not hold true in the second cohort.

Study Strengths

Few adverse effects were recorded in this study. The trial included a placebo group that received saline injection in the place of the BCG vaccination. Additionally, the participants were patients actually hospitalized with COVID-19.

Limitations

The study only included 60 participants, with an unequal distribution of men and women. There was also no data on the ethnicity of the participants provided. Finally, slightly different results regarding clearance of viral load were found in the two different testing time periods, and therefore the authors posit that there may have been two different SARS-CoV-2 strains involved. However, viral samples will need to be sequenced in order to determine if this is the case.

Value added

Study showing potential benefits of BCG vaccination as treatment for COVID-19 illness.

This review was posted on: 11 December 2020