Study Design

Study Design

Management Framework

The Management Framework includes all the policies and procedures for the Biobanque québécoise de la COVID-19 (BQC19). It is available in section "Available documents".

Biological samples and data access

Access to biological specimens and to high quality data from SARS-CoV-2 positive and negative patients is essential to better understand the determinants of COVID-19. Collected biospecimens are a limited, very valuable and non renewable resource. Therefore, requests for access to these samples will be examined rigorously to maximize the sample use and to ensure that the proposed analyses are fully justified and will have a potentially important impact on the advancement of research on COVID-19. All biological samples collected will be processed in one of the BQC19 participating institutions according to the Standard Operating Procedures (SOPs) in place to ensure optimal preservation of the samples. These SOPs also require all clinical data to be electronically linked to the biospecimens in the BTRSRV2 data storage and management system, which will provide a regularly updated inventory of all specimens and data.

Data and scientific knowledge are common assets and as such must be shared within an appropriate framework. The BQC19 fully subscribes to the Wellcome Trust statement: “Sharing research data and findings relevant to the novel coronavirus (COVID-19) outbreak” disponible sur: https://wellcome.ac.uk/press-release/sharing-research-data-and-findings-relevant-novel-coronavirus-covid-19-outbreak. COVID-19 represents an important and urgent threat to global health and the BQC19 is committed to ensuring that research results derived from access to its resources and data are rapidly and openly shared to inform public health response and contribute to saving lives.

Specifically, and in alignment with the Wellcome Trust statement:

  • Data will be shared with the scientific community, public health agencies and the WHO as quickly and as widely as possible, along with the protocols and standards used in collecting these data.
  • All peer reviewed research publications that are relevant to the current pandemic will be immediately released in Open Access or be accessible free of charge at least for the duration of the outbreak.

Researchers who have been granted access to the BQC19 biological samples and data to conduct research will be required to provide the BQC19 a copy of all the data derived from this research. This will be specified in the Material/Data Transfer Agreements (MTAs/DTAs) that will be put in place. The exact nature of these data and the time frame to provide them will be determined during the access granting process and will be specified in the MTAs/DTAs. These data will become an integral part of the BQC19 and will be made available to future researchers accessing BQC19 data, thereby enabling them to access these rich datasets.

Researchers who will use the BQC19 biological samples and data will be required to acknowledge their source, i.e., the BQC19, in all related oral or written scientific communications. They will also be required to acknowledge the BQC19 funders, i.e., the Fonds de recherche du Québec-Santé (FRQS), Génome Québec, and the Public Health Agency of Canada. A copy of all publications and of documents referencing them, e.g., media releases, will be sent to the Manager of the BQC19. This mandatory requirement will also be included in the MTAs/DTAs.

Available Material

Available material (currently)
For adults
RNA extract (from PAXgene tube)
Whole blood 
DNA extract (from whole blood on ACD)
Plasma (from ACD tubes)
PMBC (in very limited supply)
Serum
For children
RNA extract (from PAXgene tube)
Whole blood 
DNA extract (from whole blood on ACD)
Plasma (from ACD tubes)
PMBC (in very limited supply)
Serum
Urine (possible)
Feces
Nasal swab (possible)
Available material (to come)
For pregnant women (in very limited quantity)
Vaginal swabs
Amniotic fluid sample
Cord blood sample
Breast milk sample

Clinical Data

    Hospitalized   Follow up post discharge/diagnostic
  Arrival J0 J2 J7 J14 J30 Leave 1M 3M 6M 12M 18M 24M
Participant                          
Sex at birth                        
Country of birth                        
Vital status
Date of last known vital status
Date of death
Time of death
Location of death
Cause of death
Pediatric Participant                          
Infant (Less than 1 year old)                        
Birth weight                        
Gestational Outcome                        
Obstetrics (if applicable)                          
Patient pregnant ?                        
Expected date of delivery                        
Post-partum (childbirth in the last year)                        
Pregnancy Outcome                        
Delivery date                        
COVID status of the baby                        
Baby tested for mother's ARI infection                        
Result                        
Method                        
Type of participant                          
Type of participant                        
Main (or primary) diagnosis related to hospitalization                        
employed as a healthcare worker                        
employed in a microbiology laboratory                        
living where                        
living with                        
Demographics                          
Age at time of visit
Height                        
Weight                        
BMI                        
Smoking and drug use                          
Smoking status                        
Electronic cigarette                        
Comments about smoking history                        
Drug use                        
Type of drug                        
Vital signs and daily assessment form (within the previous 24 hours)                          
Temperature              
Respiratory rate              
Heart rate               
O2 saturation at room air              
Oxygen administered               
O2 saturation with oxygen therapy              
FiO2              
Systolic / Diastolic blood pressure              
AVPU scale                
Glasgow score (GCS/15)                
Urine output over 24h                
Documented symptoms                          
Asymptomatic            
Date of earliest symptoms            
Fever            
Sore throat            
Cough            
Shortness of breath (Dyspnea)            
Bloody sputum/haemoptysis            
Runny nose (Rhinorrhea)            
Pharyngitis            
Ear pain            
Joint pain (Arthralgia)            
Fatigue            
Chest pain            
Abdominal pain            
Muscle aches (Myalgia)            
Wheezing            
Nausea / vomiting            
Headache            
Confusion/altered mental status            
Diarrhea            
Seizures            
Red eye (Conjunctivitis)            
Skin rash            
Anorexia              
Leg swelling (edema)            
Trouble speaking (aphasia/dysphagia)            
Loss of taste / loss of smell            
Weakness or numbness at the extremities            
Past medical conditions                          
Prior stroke                        
Previous transient ischemic attack (TIA)                        
Atrial fibrillation or flutter                        
Other chronic neurological disorder (other than stroke/TIA)                        
Prior myocardial infarction                        
Coronary artery disease                        
Heart failure                        
Left ventricular pre-hospitalization ejection fraction                        
Other chronic cardiac disease                        
Chronic hematologic disease                        
Diabetes                        
Obesity                          
Hypertension                        
Asthma                        
Rheumatologic disease                        
Chronic kidney disease                        
Dialysis                        
COPD (emphysema, chronic bronchitis)                        
Severity of COPD                        
Pulmonary hypertension                        
Other chronic lung disease                        
Dementia                        
Psychiatric disease                        
Chronic liver disease                        
Malnutrition                          
Malignant neoplasm                        
Type of cancer                        
Metastatic                        
Receiving Tx                        
AIDS/HIV                        
Imunossupressed state                        
Other past medical cond.                        
Home medications                          
                         
ACE Inhibitor or Angiotensin receptor blocker
Systemic steroids                        
Anticoagulants                        
Colchicine                        
Other(s) immunosuppressive medications including anti-rejection Rx, and chemotherapy                         
Laboratory results                          
White blood cells count   max            
Neutrophils count   max            
Lymphocytes count   min            
Monocytes count   max            
Eosinophils count   max            
Basophils count   max            
Platelet count   min            
Hemoglobin measurement   min            
Urea   max            
Creatinine   max            
NT-proBNP   max            
BNP   max            
Sodium Na+   max            
Potassium K+   max            
C-reactive protein (CRP)   max            
Lactate dehydrogenase (LDH or LD)   max            
Creatine Phosphokinase (CPK)   max            
Albumin   min            
AST   max            
ALT   max            
Procalcitonine (PCT)   max            
Troponine T hs (high sensitivity)   max            
Troponine I hs (high sensitivity)   max            
Troponine T   max            
Troponine I   max            
APTT   max            
International Normalized Ratio (INR)   max            
Triglycerides   max            
Total Bilirubin   max            
Direct bilirubin (conjugated)   max            
Glucose   max            
Venous lactate   max            
D-Dimer   max            
Fibrinogen   max            
Ferritin   max            
IL-6   max            
CD4   min            
CD8   min            
Support                          
Ventilatory support              
Oxygen therapy with cannula/mask              
High-flow nasal cannula (HFNC)              
Non-invasive ventilation CPAP/BPAP              
 Invasive with mecanical ventilation              
Number of days                        
SpO2 (the lowest associated ith the highest support)              
FiO2 (associated with the previous SPO2)              
Adjuvant therapy              
Vasopressor / inotropic support              
Number of days                        
Prone positioning              
iNO                
ECMO                
HFOV                
Tracheostomy              
Blood transfusion              
Neuromuscular blocking agents              
Dialysis / hemofiltration              
Other(s), specify              
Frailty                          
Clinical Frailty Scale   *        
Hospitalization summary                          
Date and time of arrival at this hospital                        
Emergency visit only                        
Is it a transfer from another establishment?                        
Facility name                        
If transferred from other facility, date of initial admission                        
Date of ICU admission (if applicable)                        
Date of ICU discharge (if applicable)                        
Date of hospital discharge                        
Disposition                        
Discharge status                        
If COVID positive, what is the most severe degree of severity reached? (according to the WHO)                        
Ability to self-care at discharge vs pre-COVID                        
Level of care (last status)                        
COVID diagnosis and pathogen test                          
Date of diagnostic test for COVID19                        
Result                        
Type of sampling                        
Documented positive viral infections during hospitalization                        
Adenovirus                        
Influenza                        
RSV                        
Parainfluenza                        
Rhinovirus / Enterovirus                        
Metapneumovirus                        
Other, specify                          
Documented positive bacterial cultures during hospitalization                        
Complications at any time during hospitalization                          
ARDS                          
Specify severity                         
Bacterial pneumonia                        
Viral pneumonia                        
Bronchiolitis                        
Cryptogenic organizing pneumonia (COP)                        
Pulmonary embolism (PE)                        
Deep vein thrombosis (DVT)                        
Pneumothorax                        
Pleural effusion                        
Left ventricular function                        
LVEF                        
Decompensated heart failure                        
Myocarditis                        
Endocarditis                        
Pericarditis                        
New atrial fibrillation or flutter (AF)                        
Ventricular tachycardia or fibrillation (VT/VF)                        
Other type of cardiac arrythmia                        
Specify                        
Cardiac arrest                        
Cardiac ischaemia STEMI                        
Cardiac ischaemia NSTEMI                        
Stroke / Cerebrovascular accident                        
Pancreatitis                        
Transient ischemic attack (TIA)                        
Seizure                        
Meningitis / Encephalitis                        
Rhabdomyolysis / Myositis                        
                         
Coagulation disorder / Disseminated Intravascular Coagulation
Bacteremia                        
Anemia                        
Gastrointestinal haemorrhage                        
Liver dysfunction                        
Acute renal injury/ Acute renal failure                        
Hyperglycemia                        
Hypoglycemia                        
Other                         
Specify                          
Other tests performed during hospital stay                          
Chest X-Ray                        
CT Thorax                        
CT Abdomen                        
CT Head                        
ECG                        
Point of care ultrasound (POCUS)                        
Echocardiogram                        
Echocardiography
Coronary angiography (Cardiac catheterization)                        
Percutaneous coronary vintervention (stented)                        
Other imaging tests                        
Medication (at any time during hospitalisation )                        
Remdesivir                        
Ribavirin                        
Lopinavir/Ritonavir ("Kaletra")                        
Interferon alpha                        
Interferon beta                        
Neuraminidase inh                        
Other antiviral                        
Specify                        
Azithromycin ("Zithromax")                        
Other antibiotic                        
Antifungal                        
Systematic corticosteroid                        
Hydroxychloroquine ("Plaquenil")                        
Chloroquine ("Aralen")                        
Ivermectin ("Stromectol")                        
Tocilizumab ("Actemra")                        
Sarilumab ("Kevzara")                        
Kineret ("Anakinra")                        
Other immunomudulator                        
Colchicine                        
Plasma                        
Stem cells                        
IVIG                        
IVIG                        
Follow up                          
Have you been re-hospitalized since your initial visit for COVID?              
Date of admission              
Facility              
Cause              
Functional status                          
Mobility              
Self-care              
Usual activities (i.e. work, study, housework, family or leisure activities)              
Pain and discomfort              
Anxiety and depression              
Breathlessness              
Health status              
How much difficulty do you have                          
lifting or carrying 10 lbs?              
walking across a room?              
transferring from a chair to a bed?              
climbing a flight of 10 stairs?              
fallen in the past year?