This is the classic website, which will be retired eventually. Please visit the modernized instead.
Working… Menu

Evaluating the Efficacy of Remdesivir for Long COVID Following a Confirmed COVID-19 Infection. (ERASE-LC)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT05911906
Recruitment Status : Not yet recruiting
First Posted : June 22, 2023
Last Update Posted : September 6, 2023
University of Exeter
Peninsula Clinical Trials Unit
University Hospitals of Derby and Burton NHS Foundation Trust
Information provided by (Responsible Party):
Mark Faghy, University of Derby

Brief Summary:
One in ten people following a COVID-19 infection develop ongoing symptoms which can last for months and even years. These symptoms affect people in different ways and have been demonstrated to broadly impact physical, mental and cognitive health. Currently, there are no treatments available to address the issues that patients experience but anti-viral medications have been suggested as being potentially effective. This pilot study will test how effective an existing anti-viral medication (Remdesivir) is at reducing the impact of Long COVID in patients.

Condition or disease Intervention/treatment Phase
SARS-CoV-2 Infection COVID-19 Drug: Remdesivir Phase 1

Show Show detailed description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 98 participants
Allocation: Randomized
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

Arm Intervention/treatment
Experimental: Treatment Group
Remdesivir infusion delivered by IV.
Drug: Remdesivir
To be confirmed.
Other Name: Veklury

No Intervention: Non-treatment group
No intervention.

Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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

Secondary Outcome Measures :
  1. 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

  2. Functional Status [ Time Frame: 4 weeks ]
    Post COVID Functional Status Scale, Impact on daily life subscale of the Symptom Burden Questionnaire for Long COVID

  3. 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.

  4. 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.

  5. Functional Status [ Time Frame: 53 days ]
    Post-COVID Functional Status Scale, 6-minute walk test and timed up and go.

  6. Cognitive Function [ Time Frame: 53 days ]
    Perceived Deficit Questionnaire (PDQ-5) and Montreal Cognitive Assessment 'Blind' version (MoCA-Blind)

  7. 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.

  8. Emotional Status [ Time Frame: 53 days ]
    Generalised Anxiety Disorder (GAD-7)

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Primary Inclusion Criteria:

  • ≥18 years of age at the time of enrolment
  • Previously confirmed SARS-CoV-2 infection via PCR and/or lateral flow test.
  • Confirmed or suspected diagnosis of Long COVID according to the definition provided by the World Health Organisation and subsequent referral to an established Long COVID clinic for persistent symptoms following a confirmed SARS-CoV-2 infection.
  • Evidence of persistent symptom profile relative to pre-COVID-19 status as derived from patient reported outcome measures.
  • No treatment history of Remdesivir or anti-viral treatment
  • Not engaged in any rehabilitation programme or intervention to improve Long COVID outcomes.
  • Willing and able to provide informed consent, complete the surveys, and complete all planned clinical assessments, and return for scheduled study visits.

Secondary Screening Criteria (diagnostic testing):

  • Evidence of residual viral load derived by RNA and E-gene sequencing.
  • Not pregnant or attempting to become pregnant.
  • eGFR>30mL/min
  • Not currently taking or being prescribed chloroquine phosphate or hydroxychloroquine.

Exclusion Criteria:

  • Evidence of treatment history of Remdesivir or any other anti-viral medication.
  • Confirmed compromised immune system/function.
  • No evidence of persistent symptom profile and severity consistent with Long COVID.
  • Engaged or previously engaged (<6 months) in a rehabilitation programme or intervention to improve Long COVID outcomes.
  • Lack of mental capacity to provide informed consent.

Secondary Screening Criteria:

  • No evidence of residual viral load derived by RNA and E-gene sequencing.
  • Currently pregnant, breastfeeding or attempting to get pregnant (i.e., not using effective methods of contraception).
  • History of Hepatic or Renal Impairment (eGFR (<30ml/min) and LFTs ALT>x5 ULN).
  • Currently taking medications known to have an interaction with Remdesivir (e.g., chloroquine phosphate or hydroxychloroquine) as defined by British National Formulary (BNF) information on the selection, prescribing, dispensing and administration of medicines:

Information from the National Library of Medicine

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 identifier (NCT number): NCT05911906

Layout table for location contacts
Contact: Mark Faghy, PhD 01332592109
Contact: Ruth Ashton, PhD 01332592109

Layout table for location information
United Kingdom
University of Derby
Derby, United Kingdom, DE22 1GB
Contact: Mark A Faghy, PhD    01332592109   
Contact: Ruth Ashton, PhD    01332592109   
Principal Investigator: David Strain, MD         
Sub-Investigator: Karen Knapp, PHD         
Sub-Investigator: Hairil Razak, PhD         
Sub-Investigator: Tom Bewick, MD         
Sponsors and Collaborators
University of Derby
University of Exeter
Peninsula Clinical Trials Unit
University Hospitals of Derby and Burton NHS Foundation Trust
Layout table for investigator information
Study Chair: Victoria Allgar, PhD Pen CTU
Layout table for additonal information
Responsible Party: Mark Faghy, Associate Professor in Respiratory Physiology, University of Derby Identifier: NCT05911906    
Other Study ID Numbers: UoD/ERASE-LC/23
First Posted: June 22, 2023    Key Record Dates
Last Update Posted: September 6, 2023
Last Verified: September 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: No plan to share IPD.

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by Mark Faghy, University of Derby:
Long COVID Symptoms
Additional relevant MeSH terms:
Layout table for MeSH terms
Post-Acute COVID-19 Syndrome
Disease Attributes
Pathologic Processes
Pneumonia, Viral
Respiratory Tract Infections
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases
Post-Infectious Disorders
Chronic Disease
Molecular Mechanisms of Pharmacological Action
Antiviral Agents
Anti-Infective Agents