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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

Process

Screening/baseline/randomization

Treatment phase

Follow-up phase

B/L/D0

D1–D10

D14

±1

D21

±3

D28

±3

Inclusion/exclusion criteria

X

    

Written informed consent

X

    

Demographics

X

    

Assessment of concomitant chronic diseases

X

    

Efficacy/safety assessment

 ECG

X

 

X

  

 Chest imaging

X

X (only on D10)

  

X

 Vital signs

(body temperature, heart rate, blood pressure, breathing rate, oxygen saturation, etc.)

X

X

X

X

X

 Clinical symptoms assessment

(fever, cough, diarrhea, dyspnea)

X

X

X

X

X

 Primary endpoint assessment

X

X

X

X

X

 Adverse events

X

X

X

X

X

Laboratory test

 Diagnosis

(clinical diagnosis, antibody diagnosis, or pathogen diagnosis)

X

    

 Whole blood count

(sampling time)

X

X (only on D3, D7, and D10)

   

 Coagulation routine

(sampling time)

X

X (only on D3, D7, and D10)

   

 Kidney and liver function tests

(sampling time)

X

X (only on D3, D7, and D10)

   

 Arterial blood gas analysis

X

    

 Pregnancy test

(urine/blood, for women of childbearing age only)

X

    

 Nasopharyngeal/ oropharyngeal swab

X

X

X

X

X

 Lower respiratory tract specimen

(sputum/tracheal aspirate/bronchial alveolar lavage fluid) if available

X

X

X

X

X

 Feces/anal swabs

X

X

X

X

X

 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)

X

X

X

X

X