Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
Conditions
Interventions
Intervention1: Leflunomide tablet and Standard Of Care: loading dose of oral Leflunomide 100mg daily for 3 days, followed by leflunomide 10-20mg daily, to maintain a total course of 10 days.
Control I
Sponsors
Research and Development Department RD
Eligibility
Inclusion criteria
Inclusion criteria: Age =18 years 2. Patients with onset of symptoms ?15 days 3. Laboratory (RT-PCR) confirmed infection with 2019-nCoV.
Exclusion criteria
Exclusion criteria: Exclusion criteria: 1. Pregnant or breast feeding; 2. On specific monoclonal antibodies, or other drug trial treatment for COVID-19 within one week prior to study enrolment; 3. Liver function tests >2 fold of upper limits of normal (ULN) reference levels of the respective testing assay. 4. Patients with known hypersensitive to leflunomide 5. Patients with severe immunodeficiency syndrome and hypoalbuminaemia.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1.Time to Clinical Improvement (TTCI, censored at Day 28; time frame: up to 28 days) 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 from 1 (discharged) to 7 (death) as per WHO R&D Blueprint expert group. The 7-category ordinal scale Timepoint: Day 1- Day 28 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Proportion of SARS-CoV-2 negativity by RT-PCR at 7-, 11- and 15-days post initiation of treatment Change in viral load in upper respiratory tract specimens. 2. To evaluate the impact of leflunomide on overall clinical outcomes, viral clearance, organ dysfunction, and physiological measures reflecting pulmonary, cardiac and renal function. 3. To monitor physiological surrogates of infection and lung injury and to quantitatively assess inflammatory markers.Timepoint: Day 1- Day 28 | — |
Countries
India, United Kingdom
Contacts
Public ContactDr Deven Juneja
Max Smart super specialty Hospital
Outcome results
None listed