Leflunomide treatment for patients hospitalised with COVID-19: DEFEAT-COVID randomised controlled trial.

ABSTRACT:

Objective

To evaluate the clinical efficacy and safety of leflunomide (L) added to the standard-of-care (SOC) treatment in COVID-19 patients hospitalised with moderate/critical clinical symptoms.

Design

Prospective, open-label, multicentre, stratified, randomised clinical trial.

Setting

Five hospitals in UK and India, from September 2020 to May 2021.

Participants

Adults with PCR confirmed COVID-19 infection with moderate/critical symptoms within 15 days of onset.

Intervention

Leflunomide 100 mg/day (3 days) followed by 10-20 mg/day (7 days) added to standard care.

Primary outcomes

The time to clinical improvement (TTCI) defined as two-point reduction on a clinical status scale or live discharge prior to 28 days; safety profile measured by the inci

SUBMITTER: Kralj-Hans I 

PROVIDER: S-EPMC10105917 | biostudies-literature | 2023 Apr

REPOSITORIES: biostudies-literature