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Table 3 During the study, laboratory tests and other complementary tests will be performed according to the clinical criteria of the physician in charge. (1) According to medical criteria. (2) This visit will be conducted by phone call or face-to-face if the physician in charge deems necessary. (3) Before administering treatment. (4) Fever in hospitalized patients with SARS-CoV-2 pneumonia is usually measured on the forehead with an infrared thermometer every 6 h or on demand, if the patient’s status so requires. (5) Fever in patients hospitalized for SARS-CoV-2 pneumonia, generally, is taken on the forehead with an infrared thermometer every 6-8 hours or on demand if the patient’s status so requires. Respiratory parameters: O2 saturation and respiratory rate. (6) Includes complete cell blood count, D-dimer, sedimentation rate, AST, ALT, bilirubin, creatinine, creatinine clearance, LDH, PT, aPTT, fibrinogen, ferritin, HDL, LDL, triglycerides, troponin, creatine-kinase, PCR, complement factor C4, C1 inhibitor antigen, and C1 inhibitor functional activity

From: A multicenter, open-label, randomized, proof-of-concept phase II clinical trial to assess the efficacy and safety of icatibant in patients infected with SARS-CoV-2 (COVID-19) and admitted to hospital units without invasive mechanical ventilation: study protocol (ICAT-COVID)

   Visit 1 Visit 2 Visit 3 Visit 4 Visit 5 Visit 6 Visit 7 (2)
Patient screening Treatment start Hospitalization Efficacy assessment Hospital discharge Study end
Days of treatment   Day 1 Day 2 Day 3 (last dose)     
Days since the beginning of treatment administration   Day 0 Day 1 Day 2 Day 3 Day 10 (±1)   Day 28 (±3) from hospital discharge
Obtaining informed consent        
Eligibility criteria assessment        
Demographic data        
Acute illness information (SARS-CoV-2 pneumonia):       
▫ New-onset radiological infiltrates (4)
▫ RT-PCR or antigen testing: positive
General examination [respiratory parameters, fever] (5)  
General laboratory tests (6) (1) (1) (1)
12-lead EKG
▫ Patient Clinical Status Scale
▫ Clinical Severity Assessment Scale
Treatment administration      
Biomarker samples  (3)  
AE, SAE and SUSAR notification
Concomitant treatment recording