COVID-19 trials registries data warehouse

http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=47844

Dr Sumantra Kumar Raut

drsuman.raut@gmail.com

2020-10-05

Not recruiting

RCT

Randomized

Parallel

Open label

single-center

Treatment

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 <br/ >OR <br/ >Referred from other center as COVID-19 + by RT-PCR/ True NAAT/ Antigen in NPS/OPS <br/ > <br/ >2) Moderate to severe COVID-19 symptoms <br/ >3) Willing to give informed written consent

i. Unable to take enteral drug (orally or by NG tube) <br/ >ii. Known hypersensitivity to HCQs or other 4-aminoquinoline compounds, or doxycycline <br/ >iii. Already taking HCQs or chloroquine within 1 month due to any reason <br/ >iv. Known G6-PD deficiency <br/ >v. History of retinopathy <br/ >vi. History of congenital cardiac diseases <br/ >vii. QTc > 440 mS at admission, abnormal cardiac rhythm at screening <br/ >viii. Suspected or proven scrub typhus <br/ >ix. Suspected or proven malaria <br/ >x. Patient terminally moribund and unlikely to survive beyond 24 hrs as per physicianâ??s discretion <br/ >xi. Participation in any other clinical trial of an experimental agent treatment for COVID-19 <br/ >xii. Concurrent treatment with other agents with direct acting antiviral activity against COVID-19 <br/ >xiii. Requiring mechanical ventilation at screening <br/ >

3

Dept of Pediatrics Medical College Kolkata

1

12

India

Moderate/severe disease at enrollment

4: Moderate/severe disease at enrollment

45

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

| Declared number of arm (3.0) differs from found arms (4.0)

Phase 4

[{"arm_notes": "", "treatment_id": 607, "treatment_name": "Hydroxychloroquine", "treatment_type": "Antimalarials", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 418, "treatment_name": "Doxycycline", "treatment_type": "Antibiotics", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2188, "treatment_name": "Standard of care", "treatment_type": "Standard of care", "pharmacological_treatment": "Standard of care"}]