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Table 1 Study timeline of participant assessments/interventions

From: Evaluation of the efficacy and safety of intravenous remdesivir in adult patients with severe COVID-19: study protocol for a phase 3 randomized, double-blind, placebo-controlled, multicentre trial

ProcessScreening/baseline/randomizationTreatment phaseFollow-up phase
B/L/D0D1–D10D14
±1
D21
±3
D28
±3
Inclusion/exclusion criteriaX    
Written informed consentX    
DemographicsX    
Assessment of concomitant chronic diseasesX    
Efficacy/safety assessment
 ECGX X  
 Chest imagingXX (only on D10)  X
 Vital signs
(body temperature, heart rate, blood pressure, breathing rate, oxygen saturation, etc.)
XXXXX
 Clinical symptoms assessment
(fever, cough, diarrhea, dyspnea)
XXXXX
 Primary endpoint assessmentXXXXX
 Adverse eventsXXXXX
Laboratory test
 Diagnosis
(clinical diagnosis, antibody diagnosis, or pathogen diagnosis)
X    
 Whole blood count
(sampling time)
XX (only on D3, D7, and D10)   
 Coagulation routine
(sampling time)
XX (only on D3, D7, and D10)   
 Kidney and liver function tests
(sampling time)
XX (only on D3, D7, and D10)   
 Arterial blood gas analysisX    
 Pregnancy test
(urine/blood, for women of childbearing age only)
X    
 Nasopharyngeal/ oropharyngeal swabXXXXX
 Lower respiratory tract specimen
(sputum/tracheal aspirate/bronchial alveolar lavage fluid) if available
XXXXX
 Feces/anal swabsXXXXX
 Pharmacokinetic sampling
(approximately 4 ml whole blood)
 X (only on D1, D3, D7 [as needed], and D10)   
Interventions
 Remdesivir/placebo X   
 Concomitant medications
(record only)
XXXXX