COVID-19 trials registries data warehouse

http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=43076

Prasan Kumar Panda

prasan.med@aiimsrishikesh.edu.in

2020-06-03

Recruiting

RCT

Randomized

Parallel

Open label

single-center

Treatment

1. Age â?¥18 years at time of participation in the study <br/ >2. Laboratory (RT-PCR) confirmed infection with 2019-nCoV <br/ >3. Willingness of study participant to accept randomization to any assigned treatment arm <br/ >4. Must agree not to enrol in another study of an investigational agent prior to completion of the present study <br/ >

1. Use of medications that are contraindicated with lopinavir/ritonavir, Hydroxychloroquine/ Chloroquine and that cannot be replaced or stopped <br/ >4. Physicianâ??s decision that participation in the trial is not in patientsâ?? best interest, or any condition that does not allow the protocol to be followed safely <br/ >5. Patient already on antiretroviral therapy with Lopinavir-Ritonavir based regimen or on Hydroxychloroquine/Chloroquine <br/ >6. Any known contraindication to test drugs such as retinopathy and QT prolongation <br/ >7. Known allergic reaction to Lopinavir-ritonavir, Hydroxychloroquine/ Chloroquine <br/ >8. Pregnant or breastfeeding females <br/ >9. Receipt of any experimental treatment for 2019-nCoV (off-label, compassionate use, or trial related) within 30 days prior to participation in the present study <br/ >

3

AIIMS Rishikesh

18

99

India

No restriction on type of patients

0: No restriction on type of patients

175

1. Time to Clinical recovery (TTCR) <br/ >TTCR is defined as the time (in hours) from initiation of study treatment (active or placebo) until normalisation of fever; respiratory rate; and oxygen saturation; and alleviation of cough; sustained for at least 72 hours. <br/ > <br/ >2. Time to 2019-nCoV RT-PCR negative in upper respiratory tract specimenTimepoint: 72hrly

Phase 3/Phase 4

[{"arm_notes": "", "treatment_id": 1571, "treatment_name": "Hydroxychloroquine+ribavirin", "treatment_type": "Antimalarials+antivirals", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 1694, "treatment_name": "Lopinavir+ribavirin+ritonavir", "treatment_type": "Antivirals", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2188, "treatment_name": "Standard of care", "treatment_type": "Standard of care", "pharmacological_treatment": "Standard of care"}]