Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
Conditions
Interventions
Intervention1: hydroxychloroquine (HCQ): HCQ 8 mg/kg/dose loading followed by 4 mg/kg/dose BD for 5 days per oral or NG tube along with standard conservative treatment (syr zinc 20 mg OD and multivi
Sponsors
Dept of Pediatrics Medical College Kolkata
Eligibility
Inclusion 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 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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. To compare the 3 groups in respect to proportion of patients symptoms free at day 10 Timepoint: from day 1 to day 10;10. To compare the 3 groups in respect to proportion of patients showing improvement in =2 score in a 8-point ordinal scale of clinical assessment at day 10/final outcome day if it is prior to day 10 Timepoint: day 10;11. To compare the 3 groups in respect to time to clinical improvement in =2 score in a 8-point ordinal scale Timepoint: till death/discharge/transfer out;2. To compare the 3 groups in respect to time to resolution of symptoms relative to baseline (i.e. day 1 of trial) Timepoint: day 10;3. To compare the 3 groups in respect to time to oxygen independencyTimepoint: within day 10;4. To compare the 3 groups in respect to number of participants with adverse events due to drug regimen Timepoint: within day 10;5. To compare the 3 groups in respect to number of participants with QTc prolongation 440ms at day 5 Timepoint: day 5;6. To compare the 3 groups in respect to proportion of patients who are symptoms free at day 5 Timepoint: day 5;7. To compare the 3 groups in respect to days of hospital stay Timepoint: till death / discharge/transfer out;8. To compare the 3 groups in respect to days of PICU stay Timepoint: till death/discharge/ transfer out;9. To compare the 3 groups in respect to improvement in pediatric SOFA score at day 10 from baseline • Timepoint: day 10 | — |
Countries
India
Contacts
Public ContactDr Sumantra Kumar Raut
Medical College, Kolkata
Outcome results
None listed