Additional consent provisions for collection and use of participant data and biological specimens
SARS-CoV-2 infection, COVID-19 disease
DISEASE, SARS-COV-2 INFECTION, DISEASE COURSE
The medical history will be obtained from the patient medical record/clinical chart. Informed consent will be obtained to access these records. When information cannot be obtained or is not available from the patient medical record/clinical chart, it will be obtained via patient interview. Visual examination will be conducted solely to look for existing BCG vaccination scars. Symptom evaluation will be conducted via an electronic survey administered to participants every 7 days. Height, weight, HIV status, and pregnancy status will be collected as self-reported information. If unknown, a urine pregnancy test will be performed. Nasopharyngeal, oral, and/or rectal swabs will be collected for rt-PCR test for SARS-CoV-2 infection if a participant develops symptoms consistent with COVID-19. If a participant does not know their PPD/IGRA status from within the last 24 months (all healthcare providers should have this information), an IGRA can be performed to evaluate eligibility. Study participants have the option of donating blood via phlebotomy (for serological test for COVID-19 disease and PBMCs for immune correlates) or providing a fingerstick and dried blood spot (for serologic test for COVID-19). Data will be collected at four time points/periods: (1) after consent, (2) at baseline, (3) during the follow-up period, and (4) at study end. Data to be collected during screening includes medical history, visual exam results, results of rt-PCR, and serological test results. Data to be collected during baseline enrollment includes eligibility confirmation, demographic information, risk factors, randomization assignment, confirmation of BCG vaccination/placebo, and any immediate reactions to BCG vaccination/placebo. Subjects may also be asked to share a picture of just the injection site. Sharing the picture of the injection site is optional and will not be available to blinded staff members until the end of the study. Data to be collected during follow-up includes intermittent surveys about the presence of flu-like symptoms, rt-PCR test results if done, serological test results, if testing positive for COVID-19 information regarding their disease course, and disease outcome status.