"SFDA" Approved WHO Solidarity clinical trial for COVID-19 to be conducted in Saudi Arabia by the Ministry of Health

4/12/2020
 
A WHO Solidarity clinical trial for COVID-19 entitled as (An international randomized trial of additional treatments for COVID-19 in hospitalized patients who are all receiving the local standard of care) has been approved by the Saudi Food and Drug Authority (SFDA) to be conducted in Saudi Arabia. This trial is submitted and led by the Ministry of Health to be conducted in seven local hospitals.
The study aims to obtain reliable data on the effectiveness and safety of a number of antiviral drugs that may contribute to treat the new Coronavirus (COVID19) against standard of care. These drugs are (Remdicivir), (Chloroquine) and (Lopinavir with Ritonavir) and (Interferon β1b).
The Ministry of Health in cooperation with the World Health Organization (WHO) is aiming to conduct the trial in Saudi Arabia following the SFDA Good Clinical Practices (GCP) and Good Laboratory Practices (GCP) to ensure the safety and effectiveness of the aforementioned drugs. The MOH of health in conjunction with the SFDA will ensure the safety and wellbeing of all recruited patients.
The SFDA is strategically targeting potential COVID19 treatment by facilitating the regulatory framework of clinical trial and advising local research facility and hospitals on Good Clinical and Laboratory Practices.
For any question regarding this trial or any clinical trial related inquiry, please contact our clinical trial team via (ct.drug@sfda.gov.sa) or by SFDA call center (19999).