Table 1.
Study procedures: each visit during the patient's hospital stay will register as a new visit
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 |
aVisits may be conducted by phone
bThese assessments are optional, only to be obtained if performed as part of standard of care
cOnly performed if routine blood sampling is indicated
dPatient reported data that can be collected by phone due to isolation restrictions and follow-up visits conducted by phone
ePatients that remain in hospital beyond visit 7 will be assessed clinically. If no recovery is seen, study visits will continue until recovery or discharge. Else, in hospital, visits will end with V7