Introduction
Methods
Study design
Inclusion criteria
Exclusion criteria
Data collection
Harmonized scalable dataset/electronic Case Report Form (eCRF)
Visit | Enrolment | |||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|
V1 | V2 | V3 | V4 | V5 | V6 | V7 | V-discharge | V8a | V9a | V10a | V11a | |
Visits will be conducted three times a week until discharge from hospitale | Monday/Wednesday/Friday starting day of enrolment | Day of discharge | 6 weeks after enrolment | 3 months after enrolment | 6 months after enrolment | 12 months after enrolment | ||||||
Visit windows | – | – | – | – | – | – | – | ± 1 week | ± 2 week | ± 3 weeks | ± 3 weeks | |
Informed consent/authorization | × | |||||||||||
Epidemiological data | ×d | |||||||||||
Demographics | ×d | |||||||||||
Medical history | ×d | ×d | ×d | ×d | ×d | |||||||
Vital signs | × | × | × | × | × | × | × | × | × | |||
Clinical symptoms | ×d | ×d | ×d | ×d | ×d | ×d | ×d | ×d | ×d | ×d | ×d | ×d |
Documentation of clinical blood sample results (chemistry, haematology)b/routine blood testing | × | × | × | × | × | × | × | × | × | × | × | × |
Recording of SARS-CoV-2 PCR testingb | × | × | × | × | ||||||||
SARS-CoV-2 antibody testingc | × | × | × | × | × | × | × | × | × | × | ||
Serum cytokines and chemokines, quantitative proteomics, circulating myeloid and lymphoid cellsc | × | × | × | × | × | × | × | × | × | × | × | × |
Banked bio-materialsc | × | × | × | × | × | × | × | × | × | × | × | × |
Concomitant medications | × | × | × | × | × | × | × | × | ×d | ×d | ×d | ×d |
Documentation of clinical records from patient charts, e.g., parameters of mechanical ventilation, haemodynamics, etc.b | × | × | × | × | × | × | × | × | ||||
Additional clinical data collection, e.g., chest X-ray, CT, echocardiographyb | × | × | × | × | × | × | × | × | ||||
Lung function test, echocardiography | × | × | × | × | ||||||||
Record of any additional hospitalizations or ER visits | ×d | ×d | ×d | ×d | ||||||||
Clinical severity scores (GCS, SOFA, etc.)b | × | × | × | × | × | × | × | × | ||||
WHO Clinical Ordinal Scale | × | × | × | × | × | × | × | × | ×d | ×d | ×d | ×d |
Quality of life | ×d | ×d | ×d | ×d | ×d | ×d |