Evaluating the Efficacy of Remdesivir for Long COVID Following a Confirmed COVID-19 Infection. (ERASE-LC)
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|ClinicalTrials.gov Identifier: NCT05911906|
Recruitment Status : Not yet recruiting
First Posted : June 22, 2023
Last Update Posted : September 6, 2023
|Condition or disease||Intervention/treatment||Phase|
|SARS-CoV-2 Infection COVID-19||Drug: Remdesivir||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||98 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||
Two groups within the model.
One will receive remdesivir, the other group will not. Allocation to the treatment group to be randomised.
|Masking:||None (Open Label)|
|Masking Description:||Open label.|
|Primary Purpose:||Basic Science|
|Official Title:||Evaluating the Safety and Feasibility of Remdesivir for the Improvement of Lung Function, Perfusion, and Symptom Profile in Long-covid Patients: a Pilot Randomised Controlled Trial.|
|Estimated Study Start Date :||January 1, 2024|
|Estimated Primary Completion Date :||January 1, 2025|
|Estimated Study Completion Date :||October 1, 2025|
Experimental: Treatment Group
Remdesivir infusion delivered by IV.
To be confirmed.
Other Name: Veklury
No Intervention: Non-treatment group
- Observe changes in quality of life, functional status, and post-exertional symptoms. [ Time Frame: 53 days ]Health-related quality of life (EQ-5D-5L), & Symptom Burden Questionnaire for Long COVID.
- Assess feasibility and acceptability of patients completing/engaging with all trial activities including a willingness to be randomised and receiving of 5 consecutive days of remdesivir intravenous infusion [ Time Frame: 53 days ]The proportion of patients excluded at screening, number of patients randomised, drop-out rates, patients who complete the study as per protocol, compliance with allocated treatment.
- Collect safety data from all baseline tests and a 5-day course of remdesivir [ Time Frame: 53 days ]Total reported and severity of adverse/serious adverse events/reactions /SUSARs
- Observe changes in exercise tolerance and reduced post-exertional symptom exacerbation following incremental exercise [ Time Frame: 53 days ]Modified De Paul Symptom Questionnaire-Post Exertional Malaise (DSQ-PEM), symptom Burden Questionnaire for Long COVID
- Functional Status [ Time Frame: 4 weeks ]Post COVID Functional Status Scale, Impact on daily life subscale of the Symptom Burden Questionnaire for Long COVID
- Explore whole-body FDG uptake using PET/CT methods in patients with Long COVID. [ Time Frame: 53 days ]The standardised uptake volume (SUV) and Ki of 18FDG uptake observed during PET/CT scans.
- Physical & Physiological function: [ Time Frame: 53 days ]Impact on daily life subscale of the Symptom Burden Questionnaire for Long COVID, & DSQ-PEM. Fatigue Assessment Scale (FAS), Medical Research Council (MRC) Dyspnoea Scale. Maximum inspiratory and expiratory mouth pressure, lung function, blood pressure, oxygen saturation, breathing rate, and resting heart rate, rate of perceived exertion and oxygen saturation.
- Functional Status [ Time Frame: 53 days ]Post-COVID Functional Status Scale, 6-minute walk test and timed up and go.
- Cognitive Function [ Time Frame: 53 days ]Perceived Deficit Questionnaire (PDQ-5) and Montreal Cognitive Assessment 'Blind' version (MoCA-Blind)
- Biochemical/inflammatory markers [ Time Frame: 4 weeks ]Full blood count, eGFR, LFTs, CRP, d-dimers, IL6, IL16, IL18, PCT, IFN-Y, TNF-A, VEGF-D, CRP, HLA-DP, and Vitamin D.
- Emotional Status [ Time Frame: 53 days ]Generalised Anxiety Disorder (GAD-7)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05911906
|Contact: Mark Faghy, PhDfirstname.lastname@example.org|
|Contact: Ruth Ashton, PhD||01332592109||R.Ashton@Derby.ac.uk|
|University of Derby|
|Derby, United Kingdom, DE22 1GB|
|Contact: Mark A Faghy, PhD 01332592109 email@example.com|
|Contact: Ruth Ashton, PhD 01332592109 R.Ashton@Derby.ac.uk|
|Principal Investigator: David Strain, MD|
|Sub-Investigator: Karen Knapp, PHD|
|Sub-Investigator: Hairil Razak, PhD|
|Sub-Investigator: Tom Bewick, MD|
|Study Chair:||Victoria Allgar, PhD||Pen CTU|