COVID-19 trials registries data warehouse

http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=50013

Dr Deven Juneja

devenjuneja@gmail.com

2020-12-28

Not recruiting

RCT

Randomized

Parallel

Open label

multi-center

Treatment

Age â?¥18 years <br/ >2. Patients with onset of symptoms ï?£15 days <br/ >3. Laboratory (RT-PCR) confirmed infection with 2019-nCoV.

<br/ >1. Pregnant or breast feeding, <br/ >2. On specific monoclonal antibodies, or other drug trial treatment for COVID-19 within one week prior to study enrolment, <br/ >3. Liver function tests >2 fold of upper limits of normal (ULN) reference levels of the respective testing assay. <br/ >4. Patients with known hypersensitive to leflunomide <br/ >5. Patients with severe immunodeficiency syndrome and hypoalbuminaemia.

2

Research and Development Department RD

18

85

India;United Kingdom

No restriction on type of patients

0: No restriction on type of patients

178

1.Time to Clinical Improvement (TTCI; censored at Day 28; time frame: up to 28 days) <br/ >TTCI is defined as the time (in days) from initiation of study treatment (active or placebo) until a decline of two categories from status at randomisation on a 7 category ordinal scale of clinical status which ranges <br/ >from 1 (discharged) to 7 (death) as per WHO R&D Blueprint expert group. The 7-category ordinal scale <br/ >Timepoint: Day 1- Day 28

| Declared number of arm (2.0) differs from found arms (3.0)

Not reported

[{"arm_notes": "", "treatment_id": 724, "treatment_name": "Leflunomide", "treatment_type": "Other targeted therapies", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2188, "treatment_name": "Standard of care", "treatment_type": "Standard of care", "pharmacological_treatment": "Standard of care"}]