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Table 2 Time schedule of recruitment, enrollment, intervention, assessments, and visits

From: Double-blind placebo-controlled randomized clinical trial to assess the efficacy of montelukast in mild to moderate respiratory symptoms of patients with long COVID: E-SPERANZA COVID Project study protocol

 

Study period

Enrollment

Allocation

Post-allocation

Close-out

Time point**

t0

0

t1

t2*

t3

t4*

t5

tf*

Enrollment

 Eligibility screen

X

X

      

 Informed consent

 

X

      

 Allocation

 

X

      

Interventions

        

 Intervention [montelukast]

        

 Control [placebo]

        

Assessments

 CAT scale

X

 

X

X

X

X

X

X

 PCF Scale

  

X

X

X

X

X

X

 1MSTS test

  

X

 

X

 

X

 

 Severity of symptoms

  

X

X

X

X

X

X

 Health services use

   

X

X

X

X

X

 Mortality

   

X

X

X

X

X

 Sick leave days

      

X

 

 Side effects and concomitant medication

   

X

X

X

X

X

 Treatment compliance

   

X

X

X

X

 
  1. *Phone call visits
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Trials

ISSN: 1745-6215