Trial · NCT05007678
Targeting de Novo Pyrimidine Biosynthesis by Leflunomide for the Treatment of COVID-19 Virus Disease
NCT05007678, Phase 3, Completed, Ashford and St. Peter's Hospitals NHS Trust
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Targeting de Novo Pyrimidine Biosynthesis by Leflunomide for the Treatment of COVID-19 Virus Disease. Trials, record NCT05007678. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05007678
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Targeting de Novo Pyrimidine Biosynthesis by Leflunomide for the Treatment of COVID-19 Virus Disease
- NCT number
- NCT05007678
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 178 participants, actual
- Lead sponsor
- Ashford and St. Peter's Hospitals NHS Trust
- Conditions
- COVID-19
- Interventions
- leflunomide
- First posted
- 2021-08-16
- Last updated
- 2023-02-27
Source ClinicalTrials.gov
Registered outcomes17
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Time to clinical improvement | 28 days from randomisation | TTCI is defined as the time (in days) from initiation of trial treatment (for participants in the treatment arm), or day of randomisation (for participants in the control arm), until the first occurrence of; 1. an improvement of two points on a seven-category ordinal scale of clinical status categories.All surviving patients who have not reached any TTCI ordinal level by Day 28 will be right-censored at that point. 2. live discharge from hospital. |
| Primary | Incidence of adverse events | 28 days from randomisation | All adverse events within 28 days will be recorded and incidence of serious adverse events (SAEs) and Grade 3 and 4 adverse events (AEs)\* will be reported. \*Grade 3 adverse events: Severe or medically significant but not immediately life-threatening; or hospitalisation or prolongation of hospitalisation indicated; or disabling; or limiting self-care activity of daily living. Grade 4 Life-threatening consequences; urgent intervention indicated. |
| Secondary | Changes in virological load over time | Days 0/1, 7,11 and 15 days post randomisation | Comparing changes in virological load at predefined time periods by comparing proportions of SARS-CoV-2 negativity by RT-PCR and changes in viral load in upper respiratory tract specimens. |
| Secondary | Time to hospital discharge | Daily assessments during hospitalisation up to 28 days or discharge | Number of days from randomisation to discharge |
| Secondary | All-cause mortality | From randomisation to the event within 28 days | Recorded incidence of mortality due to any cause |
| Secondary | Duration of intensive care stay | From randomisation to 28 days or discharge | Time from admission to ITU to discharge to another care environment will be recorded for each patient, noting that the start of this period may ante-date the time of randomisation. |
| Secondary | Duration of invasive and non-invasive ventilation | From randomisation to discharge or 28 days | Time from initiation to withdrawal of mechanical ventilation will be recorded, subdivided by whether the ventilation was invasive. |
| Secondary | Incidence of re-intubation | From randomisation to 28 days or discharge | The proportion of patients requiring re-intubation following a decision to extubate |
| Secondary | Incidence of tracheostomy | From randomisation to 28 days or discharge | The proportion of patients requiring tracheostomy |
| Secondary | Degree of acute lung injury | At baseline, 15 and 28 days or discharge | Proportions of patients with mild, moderate and severe lung impairment based on Berlin definition |
1 to 10 of 17Source ClinicalTrials.gov
See all 17 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 37055207 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT05007678
GET https://conductscience.org/api/trials/v1/NCT05007678/registered