Available clinical data
The BQC19’s mission is to make available to the scientific community biological samples, and the clinical data associated with them. In a pandemic situation that has often been limiting, the BQC19 has emphasized data collection, even when no biological samples could be obtained on a given patient visit.
Data collection is carried out through the compilation of data collection files (case report forms, CRFs). The BQC19 has two types of files, the first relating to the hospital stays of participants who developed severe illness, and the second relating to longitudinal follow-ups. Data collection can be done on paper and then inputted to electronic files, or entered directly into the BQC19’s REDCap application, which is the electronic counterpart of the CRFs.
Data collection is carried out by clinical teams at the various sites, either by correlation with data from hospital stays, or by the gathering of data in real time.
Data collected during hospital stays – severe illness
Clinical data are gathered at fixed points during a participant’s hospitalization. These are as follows:
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Upon arrival
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Day 0 (recruitment)
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Day 2 of hospitalization (from the date of recruitment, if patient is still in hospital)
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Day 7 of hospitalization (from the date of recruitment, if patient is still in hospital)
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Day 14 of hospitalization (from the date of recruitment, if patient is still in hospital)*
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Day 30 of hospitalization (from the date of recruitment, if patient is still in hospital)*
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Upon discharge
*These visits were not part of the procedure for participants who were recruited between April 1, 2020 and June 15, 2020.
Identification of the participant
The data referred to in this section relate to the participant’s consent and also cover their contact information. These are purely for internal use, and are not shared by the sites involved.
The demographic data collected in this section, which are available through the data access process, include:
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Patient type and profile: COVID status, severe or mild illness, age, sex, weight, height, smoking status, drug use, including whether the individual is a health care worker.
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Pediatric component: weight at birth, duration of gestation.
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Obstetrical component: post-partum state, pregnancy outcome, COVID status of the baby, presence of other infectious pathogens from the mother.
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Medical history.
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COVID-19 symptoms reported if present, as well as the date on which they presented themselves.
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COVID-19 test and degree of severity of the illness (WHO severity index).
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Clinical frailty score.
This section is also filled out for participants who present mild illness, or are asymptomatic when they are recruited. It is the same for all types of participants.
Upon arrival
Some data are compiled when the participant arrives, that is, even before admission. They relate to
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Vital signs: body temperature, blood pressure, breathing rate/heart rate, oxygen saturation on room air and oxygen therapy, as needed.
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Results of any routine laboratory tests ordered by the attending physician.
During hospitalization
Data collected during hospitalization include the following:
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Description of the visit and the sampling carried out for the BQC19, including a calculation of the time elapsed between the visit and the recruitment, and between the visit and the manifestation of symptoms.
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Vital signs including, if available, AVPU score, Glasgow score and urinary output over 24 hours.
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Arterial Blood Gases test results, as the case may be.
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Data on respiratory support measures and adjuvant therapies, as the case may be.
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Results of routine laboratory tests ordered by an attending physician. While the list of routine laboratory tests is available, some test results are not recorded because they were not ordered by the attending physician. Only results of tests that were ordered are included.
Discharge
This section compiles and summarizes data obtained during hospitalization.
The data collected include the following:
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Summary of the hospital stay: time in Emergency, admission to hospital and length of hospitalization, admission to intensive care with length of stay, transfer from one institution to another, vital status upon discharge, destination after hospital (home, CHSLD, …), final diagnosis, level of care at end of stay.
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Complications observed.
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Treatments, medication records and tests carried out during hospitalization (test results are not recorded).
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A summary of respiratory support measures and adjuvant therapies used during hospitalization, including the duration of the treatment (in the case of respiratory support).
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A summary of all routine laboratory tests carried out during hospitalization.
Data collected during longitudinal follow-ups
The data collected are identical for all cohorts. These follow-ups are carried out over a 24-month period following discharge from hospital for participants having developed severe illness, or following the PCR screening test for SARS-CoV-2 for participants who had mild illness or were asymptomatic.
Follow-ups are carried out according to the following timeframe:
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After 30 days (M01)
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After 90 days (M03)
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After 180 days (M06)
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After 365 days (M12)
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After 540 days (M18)
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After 730 days (M24)
The data collected during these visits are:
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Description of the visit and the sampling carried out for the BQC19, including a calculation of the time elapsed between the visit and the recruitment, and between the visit and the manifestation of symptoms.
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Essential follow-up information: time elapsed between the diagnosis and the follow-up, status of ongoing consent, vital status.
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Follow-up: New COVID-19 diagnosis, unexpected hospital visit after discharge, current symptoms, Functional Status Questionnaire.
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Post-COVID complications.
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Tests administered in a clinical setting.
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Routine laboratory tests carried out in a clinical setting.
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Clinical frailty score.
Data collected during the final visit for the study
These data will be collected during the visit that takes place at the 730-day mark, except for patients who decide to withdraw from the project prior to this time.
This section will also include vaccination data:
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Type of vaccine administered (e.g. Pfizer, Moderna, AstraZeneca)
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Number of doses received.
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Any side effects described.