Title: Evaluating the efficacy of Tasquinimod in COVID-19

Abstract

Scope: Quite disturbing is the huge public health impact of COVID-19: As at today [April 4th, 2021], the COVID-19 global burden shows over130 million cases and over 2.8 million deaths worldwide. Recent evidence shows calprotectin’s potential as a therapeutic target, stating that tasquinimod, from the Quinoline-3-Carboxamide family is capable of blocking the interaction between calprotectin and TLR4& RAGE.Hence preventing the cytokine release syndrome, that heralds the functional exhaustion in COVID-19. Early preclinical studies showed that tasquinimod inhibit tumor growth and prevent angiogenesis/cytokine storm. Phase I – III clinical studies in prostate cancer showed it has a good safety profile with good radiologic progression free survival but no effect on overall survival. Objectives: Though strategic endeavours have been amplified globally to assess new therapeutic interventions for COVID-19 treatment, the efficacy and safety of tasquinimod in COVID-19 remains to be explored. Hence the primary objective of this trial will be to evaluate the efficacy of tasquinimod in the treatment of adult patients with severe COVID-19 infections. Therefore, wehypothesize that in COVID19 adult patients, tasquinimod will reduce the severe respiratory distress associated with COVID-19 compared to placebo, over a 28-day study period. Methods: The setting is in Europe. Design –a randomized,placebo-controlled, phase II double-blinded trial.Trial lasts for 28 days from randomization, Tasquinimod capsule given as 0.5mg daily 1st fortnight, then 1mg daily 2nd fortnight. I0 outcome - assessed using six-point ordinal scale alongside eight 20 outcomes. 125 participants to be enrolled, data collection at baseline and subsequent data points, and safety reporting monitored via serological profile. Significance: This work could potentially establish tasquinimod as an effective and safe therapeutic agent for COVID-19 by reducing the severe respiratory distress, related time to recovery, time on oxygen/admission.It will also drive future research – as in larger multi-centre RCT.