Study to compare the effect of different antiviral medicines in COVID-19 infected sick childre

Phase 4

• Conditions: Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere

• Registration Number: CTRI/2020/10/028234
• Lead Sponsor: Dept of Pediatrics Medical College Kolkata

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 4 March 2024

Recruitment & Eligibility

• Status: Closed to Recruitment of Participants
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

1) High initial clinical suspicion by physician as SARI based on signs and symptoms (fever, cough, myalgias, fatigue, shortness of breath) followed by positive RT-PCR/ True NAAT/ Antigen test in Nasopharyngeal/ oropharyngeal swab for confirmation of COVID-19 diagnosis

OR

Referred from other center as COVID-19 + by RT-PCR/ True NAAT/ Antigen in NPS/OPS

2) Moderate to severe COVID-19 symptoms

3) Willing to give informed written consent

Exclusion Criteria

i.Unable to take enteral drug (orally or by NG tube)

ii.Known hypersensitivity to HCQs or other 4-aminoquinoline compounds, or doxycycline

iii.Already taking HCQs or chloroquine within 1 month due to any reason

iv.Known G6-PD deficiency

v.History of retinopathy

vi.History of congenital cardiac diseases

vii.QTc > 440 mS at admission, abnormal cardiac rhythm at screening

viii.Suspected or proven scrub typhus

ix.Suspected or proven malaria

x.Patient terminally moribund and unlikely to survive beyond 24 hrs as per physician’s discretion

xi.Participation in any other clinical trial of an experimental agent treatment for COVID-19

xii.Concurrent treatment with other agents with direct acting antiviral activity against COVID-19

xiii.Requiring mechanical ventilation at screening

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To determine the efficacy of HCQs vs doxycycline vs standard conservative treatment in respect to improvement of clinical status from day 1 to day 10 of hospitalization/ final outcome day as assessed by improvement in the 8-point ordinal scale score (defined below) ranging from death (category 1) to discharged (category 8) in patients 1-12 years of age with moderate to severe COVID-19 infectionTimepoint: from day 1 to day 10