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Clinical Trials/CTRI/2020/10/028234
CTRI/2020/10/028234
Active, not recruiting
Phase 4

Efficacy of antiviral agents in moderate to severe COVID-19 in pediatrics – a pilot RCT

Dept of Pediatrics Medical College Kolkata0 sites0 target enrollmentTBD
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ConditionsHealth Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere

Overview

Phase
Phase 4
Intervention
Not specified
Conditions
Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
Sponsor
Dept of Pediatrics Medical College Kolkata
Status
Active, not recruiting
Last Updated
2 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
2 years ago
Study Type
Interventional

Investigators

Sponsor
Dept of Pediatrics Medical College Kolkata

Eligibility Criteria

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
  • •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

Outcomes

Primary Outcomes

Not specified

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