Study will also evaluate drug’s potential to reduce the risk of Long COVID

South Africa has experienced just over four million confirmed cases of COVID-19 since 2020.Adults 18 years and older who have chronic diseases, for example diabetes, obesity, hypertension, or cardiovascular disease, have received a positive diagnosis of COVID-19 within three days, and are currently experiencing one or more symptoms, may be eligible to participate in the study.People aged 65 years and over or who are immunocompromised or undergoing immunosuppressive treatments, are also eligible.The study, which is taking place in 20 countries, was approved by the South African Health Products Regulatory Authority, the WITS Health Research Ethics Committee, and the Pharma-Ethics Independent Research Ethics Committee.

Johannesburg, South Africa, June 2023 - South Africa is one of 20 countries in the world to participate in a clinical study of an investigational drug for the treatment of COVID-19 and its effect on Long COVID symptoms.  

South Africa has experienced just over four million confirmed cases of COVID-19 since 2020, according to the World Health Organisation1. Well-organised clinical studies that may potentially discover new medicines to treat COVID-19 are still highly relevant for the country.   

The purpose of the SCORPIO-HR study, a global Phase 3 study in non-hospitalized, symptomatic patients infected with SARS-CoV-2, the pathogen that causes COVID-19, is to evaluate the efficacy of an investigational drug in treating COVID-19 in adults with mild or moderate infection.  

The study is being administered in 16 sites across South Africa, including the Ubuntu Clinical Research in Lenasia, Medicross Roodepoort Clinical Research, Tamboti Medical Centre in Limpopo, Be Part Yoluntu Centre in Paarl and the Helen Joseph Hospital in Johannesburg.

Adults 18 years and older who have chronic diseases, for example diabetes, obesity, hypertension, or cardiovascular disease, have received a positive diagnosis of COVID-19 within three days and are currently experiencing one or more symptoms, may be eligible to participate. People aged 65 years and over or who are immunocompromised or undergoing immunosuppressive treatments, are also eligible.

“The study was approved by the South African Health Products Regulatory Authority, the WITS Health Research Ethics Committee, the Pharma-Ethics Independent Research Ethics Committee, and the National Principal Investigator for the South African investigators team following all protocols for the safety and well-being of the participants,” highlights Dr. Elizabeth Hellstrom, the study centre coordinator of Be Part Yoluntu Centre. “It is important for us to discover new ways to treat COVID-19 and understand if we can reduce the risk of Long COVID because it can be devastating to many healthy people,” she explains. 

Lasting approximately 24 weeks, SCORPIO-HR is a clinical research study with an intervention group, in which the investigational drug is administered for five days, and a control group, which will receive a placebo for the same period. After enrolment, participants must have at least eight visits at the research centers to monitor the results and will have their study-related expenses reimbursed. Visits will be in person as well as virtual.

It is important to note that there are some exclusions for participation in the study. Patients are not eligible to take part in the research if they have been hospitalized for the treatment of the current SARS-CoV-2 infection, are currently hospitalized or being provided emergency medical care, plan to use Paxlovid™ (nirmatrelvir/ritonavir), have a history of cirrhosis or liver problems, or have already used another oral, inhaled, or injectable medication to treat this episode of SARS-CoV-2 infection.

The SCORPIO-HR global study has been approved by an Institutional Review Board/Independent Ethics Committee in each country where it is conducted, which confirms the guarantee of the rights, safety and well-being of participants.

“Clinical studies are essential for identifying additional approaches to protect our communities against major health threats. During the emergency phase of the COVID-19 pandemic, the participation of thousands of people in clinical studies was a key factor in the safe and efficient development of vaccines, as studies strictly adhered to international research ethics protocols,” notes Dr. Mashudu Mofokeng, the Sub – Investigator at Right to Care. “Right to Care is proud to participate in advancing the development of novel therapies for COVID-19 through our involvement in SCORPIO-HR,” she concludes.  

SCORPIO-HR is sponsored by Shionogi & Co., Ltd., a Japanese research-driven pharmaceutical company. It is supported by the National Institutes of Health in the United States of America, and is part of its Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV) public-private partnership. It is being conducted by the AIDS Clinical Trials Group (ACTG), the largest global HIV research network, which expanded its focus to include evaluating outpatient treatments for COVID-19.

For more information about the SCORPIO-HR global study, including exclusionary criteria, please visit clinicaltrials.gov (study number NCT05305547).

-- END --

Reference: 1WHO (COVID-19) Homepage. World Health Organization Web site.  https://covid19.who.int/region/afro/country/za. Updated May 31, 2023. Accessed June 1, 2023.