Pyramax in COVID19 patients
Research type
Research Study
Full title
A multi-centre, randomised, double-blind, parallel, placebo-controlled, phase III clinical study to evaluate the efficacy and safety of Pyramax in mild-to-moderate COVID-19 patients
IRAS ID
317335
Contact name
Martin Johnson
Contact email
Sponsor organisation
Shin Poong Pharmaceuticals Inc
Clinicaltrials.gov Identifier
Duration of Study in the UK
0 years, 4 months, 31 days
Research summary
SARS-CoV2 disease (COVID-19) is an infection caused by the SARS-CoV2 virus. COVID19 was declared a pandemic by the World Health Organisation in March 2020.
COVID-19 infection may cause no symptoms, mild to moderate symptoms such as fever, malaise, cough, shortness of breath, or progress to pneumonia, acute respiratory distress syndrome, multiple organ failure or death. People at higher risk of developing severe COVID19 infection include the elderly, the immunosuppressed, people with obesity, and patients with underlying diseases such as cardiovascular disease, diabetes and chronic obstructive pulmonary disease.
There are many available treatments for hospitalized patients with severe COVID19 symptoms. Treatments for mild-moderate infection may prevent progression to severe disease, particularly in high risk people.
Pyramax is an antimalarial tablet widely used globally. It’s antiviral effects have been demonstrated in prior non-clinical trials. It has also recently been used in a smaller study in mild to moderate COVID19 infection.
This study aims to assess the effectiveness and safety of Pyramax compared to a placebo as an oral, early treatment for COVID-19 with mild-to-moderate symptoms who do not require oxygen therapy. The data from this study will inform decisions for the clinical development of Pyramax for the treatment of mild-to-moderate COVID-19.
The primary aim of the trial is to assess effectiveness of Pyramax treatment compared to placebo on prevention of hospitalization for oxygen therapy or death due to COVID19 infection. Improvement in symptoms, viral load and safety of Pyramax will also be assessed.After consenting and screening for suitability to take part, participants with confirmed COVID19 infection will take either Pyramax tablets or a placebo tablet orally for 3 days. They will be seen regularly by the study team where blood tests and COVID19 swabs are taken, and symptoms and safety assessments will be done for a total of 29 days.
REC name
London - Brent Research Ethics Committee
REC reference
22/HRA/2447
Date of REC Opinion
25 Aug 2022
REC opinion
Further Information Favourable Opinion