An Open-label, Clinical Feasibility Study of the Efficacy of Remdesivir for Long-COVID.

Summary

Following an infection with Severe Acute Respiratory Syndrome coronavirus 2 (SARS-CoV2), one in ten people will experience persisting symptoms, or develop 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. This is called Long COVID. 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 study will recruit patients that have confirmed long COVID and participants will undertake a series of tests to determine their symptoms and the impact that their condition has had on their bodily systems. The total duration of each participant's involvement is approximately 8 weeks, and this will involve 13 visits (15 visits if taking part in Exeter) at the closest study location (Derby or Exeter). Initial assessments are conducted over three separate visits and then all participants will be scheduled to receive five consecutive days of a medication that has been identified as having the potential to reduce the impact of Long COVID. Following a period of 28 days, participants will be invited to repeat the same tests that were conducted before receiving the medication so that it can be determined how well the drug has worked. In this study we are specifically collecting information to understand how feasible this medication could be to help patients improve their condition and this will help us to determine how likely this drug is able to be used within the wider Long COVID community.

The medication that will be used within this study is an existing anti-viral medication (Remdesivir). If we find patients are able to tolerate the treatment and the research tasks we will use this information to conduct a larger trial to determine how well this drug can be used to reduce the impact of Long COVID in a greater number of patients.

Conditions

• SARS-CoV-2 Infection
• COVID-19

Interventions

DRUG

Remdesivir

Remdesivir is a prodrug that is intended to allow intracellular delivery of GS-441524 monophosphate and subsequent biotransformation into GS-441524 triphosphate, a ribonucleotide analogue inhibitor of viral RNA polymerase. Participants will receive a single loading dose of 200 milligrams of Remdesivir in 250ml sodium chloride 0.9% bag via IV over 60 minutes on day 1, followed by, on days 2 - 5, a dose of 100 milligrams of Remdesivir in 250ml sodium chloride 0.9% bag via IV once daily over 30 minutes.

Sponsors & Collaborators

• University of Exeter

  collaborator OTHER

• University of Plymouth

  collaborator OTHER

• University Hospitals of Derby and Burton NHS Foundation Trust

  collaborator OTHER

• Aston University

  collaborator OTHER

• Royal Devon and Exeter NHS Foundation Trust

  collaborator OTHER

• University of Derby

  lead OTHER

Principal Investigators

• Victoria Allgar, PhD · Pen CTU

Study Design

Allocation

NA

Purpose

BASIC_SCIENCE

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-10-08

Primary Completion

2025-09-17

Completion

2025-09-17

FDA Drug

Yes

Countries

• United Kingdom

Study Locations