An open-label, clinical feasibility study of the efficacy of Remdesivir for Long-COVID
BACKGROUND
Long COVID (LC) affects around two million people in the UK and over 65 million people globally. Antiviral medications have shown positive effects in reducing the risk of progression to severe disease in high-risk patients during an acute SARS-CoV-2 infection and have improved outcomes in those living with LC. Research testing the feasibility and efficacy of antiviral medications is ongoing, and clinical trials should determine the use of Remdesivir and its impact on LC symptoms, patient-reported outcomes, quality of life and functional status.
METHODS
Seventy-two patients ≥ 18 years of age who have a confirmed LC diagnosis will be recruited across two sites to trial RemdesivirTM treatment delivered via intravenous infusion over 5 days. This feasibility study will provide high-quality data to estimate screening rates, recruitment through different pathways, retention and treatment adherence. The study will also determine the definitive trial’s most clinically relevant primary outcome. After a detailed screening process, patient-reported and clinical outcome measures (including EQ-5D-5L, Symptom Burden Questionnaire™ for LC (SBQ™), cardiopulmonary exercise tests (CPET), lung function, biomarkers and inflammatory profiles) will be collected to determine symptoms and impact of their condition, which will be repeated post-treatment. A subset of 20 participants will undergo whole-body parametric Fluorodeoxyglucose (FDG) PET/CT to measure multi-organ metabolic activity. Due to the established physical, cognitive and clinical impairment impacts of LC, patient involvement has been extensively embedded within the design and implementation of all study processes to increase patient safety and delivery.
DISCUSSION
This study will provide data on the feasibility of a trial of 5-day intravenous treatment with Remdesivir for patients with LC. The treatment is already effective in the treatment of patients with acute severe cases of SARS-CoV-2. Remdesivir has an established safety profile and carries no higher risk to patients than standard medical care. The findings will inform the design of a future definitive study.
TRIAL REGISTRATION
ISRCTN Number: 72940450. Date registered: 07/06/2024. ClinicalTrials.gov Number: NCT05911906.
Web | DOI | PDF | Pilot and Feasibility Studies | Open Access
Neilens, Helen; Allgar, Victoria; Sands, Kayle-Anne; Chynoweth, Jade; Lord, Amber; Aspinall, Paigan J; Hambly, Helen; Barnett, Anton; Skipper, Lindsay; Bewick, Tom; Maidment, Ian; Razak, Hairil Abdul; Ashton, Ruth; Strain, David; Knapp, Karen; Faghy, Mark A
BACKGROUND
Long COVID (LC) affects around two million people in the UK and over 65 million people globally. Antiviral medications have shown positive effects in reducing the risk of progression to severe disease in high-risk patients during an acute SARS-CoV-2 infection and have improved outcomes in those living with LC. Research testing the feasibility and efficacy of antiviral medications is ongoing, and clinical trials should determine the use of Remdesivir and its impact on LC symptoms, patient-reported outcomes, quality of life and functional status.
METHODS
Seventy-two patients ≥ 18 years of age who have a confirmed LC diagnosis will be recruited across two sites to trial RemdesivirTM treatment delivered via intravenous infusion over 5 days. This feasibility study will provide high-quality data to estimate screening rates, recruitment through different pathways, retention and treatment adherence. The study will also determine the definitive trial’s most clinically relevant primary outcome. After a detailed screening process, patient-reported and clinical outcome measures (including EQ-5D-5L, Symptom Burden Questionnaire™ for LC (SBQ™), cardiopulmonary exercise tests (CPET), lung function, biomarkers and inflammatory profiles) will be collected to determine symptoms and impact of their condition, which will be repeated post-treatment. A subset of 20 participants will undergo whole-body parametric Fluorodeoxyglucose (FDG) PET/CT to measure multi-organ metabolic activity. Due to the established physical, cognitive and clinical impairment impacts of LC, patient involvement has been extensively embedded within the design and implementation of all study processes to increase patient safety and delivery.
DISCUSSION
This study will provide data on the feasibility of a trial of 5-day intravenous treatment with Remdesivir for patients with LC. The treatment is already effective in the treatment of patients with acute severe cases of SARS-CoV-2. Remdesivir has an established safety profile and carries no higher risk to patients than standard medical care. The findings will inform the design of a future definitive study.
TRIAL REGISTRATION
ISRCTN Number: 72940450. Date registered: 07/06/2024. ClinicalTrials.gov Number: NCT05911906.
Web | DOI | PDF | Pilot and Feasibility Studies | Open Access
