CLARITY 2.0
Background:
The coronavirus causes a respiratory infection with symptoms such as fever, cough, and sore throat. While most people experience mild illness, some cases can be severe and include difficulty breathing. Currently, there is no proven treatment for COVID-19, but medical care can help manage the symptoms while the body fights the infection.
Candesartan is a medication used to treat high blood pressure, kidney disease, and heart disease. DMX-200 is a new medication that has been tested in various trials for different diseases. However, we do not yet know if Candesartan or DMX-200 are effective in treating COVID-19. This study aims to determine if taking DMX-200 with Candesartan can reduce the severity of infection in people hospitalized with COVID-19. The trial aims to enroll 80 participants in Phase II.
Aim:
The goal of this study is to assess the safety and effectiveness of using both DMX-200 and candesartan compared to a placebo as a treatment for patients hospitalized with COVID-19.
Design:
This is a Phase II trial that follows a prospective, multi-centre, multi-arm, multi-stage, randomized, double-blind, placebo-controlled design. The trial will use adaptive sample size re-estimation. Phase II will involve 80 participants from India for a safety analysis. The decision to expand to a full Phase III study will depend on the review of accumulated Phase II data. The study will include adults with a confirmed diagnosis of SARS-CoV-2 infection who require hospital admission for COVID-19 management. The diagnosis should have been within 10 days prior to randomization.
Method:
The trial is conducted exclusively in India. Participants are recruited from hospitals at the time of or shortly after their admission for COVID-19 management. Randomization is done centrally by the trial management team using the Medidata database. Participants are randomly assigned to one of two treatment arms: Candesartan + repagermanium (Investigational Arm) or Candesartan + placebo [repagermanium] (Control Arm), with equal allocation.
Current Status:
The trial has recruited 49 participants in India and is currently in the data cleaning/analysis stage.
