Targeting de Novo Pyrimidine Biosynthesis by Leflunomide for the Treatment of COVID-19 Virus Disease
Trial · NCT05007678
Registered outcomes17
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 17 of 17
Download this page as JSON| 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 |
| Secondary | Evaluation of surrogate of inflammation and lung recovery | Daily measurements from randomisation to discharge or 28 days | Ratios of arterial and peripheral oxygen saturation divided by fraction of inspired oxygen: * P/F ratio, (i.e. arterial pO2 divided by the FIO2) * S/F ratio, (i.e. oxygen saturation divided by the FIO2) |
| Secondary | Incidence of inotropic/vasoactive support | From randomisation to discharge or 28 days | The proportion of patients needing inotropic/vasoactive support |
| Secondary | Incidence of acute kidney injury | From randomisation to discharge or 28 days | Proportion of patients diagnosed with acute kidney injury by the KDIGO criteria |
| Secondary | Need for renal replacement therapy | From randomisation to discharge or 28 days | Proportion of patients needing renal replacement therapy |
| Secondary | Characterisation of biomarkers including high sensitivity CRP, ferritin, procalcitonin, troponin, BNP, creatinine and kidney biomarkers. | Daily measurements during hospitalisation to 28 days or discharge | Measurements of these markers will be collected daily |
| Secondary | Changes in cytokine profile including pro- and anti-inflammatory cytokines | Days 0, 1, 3 and 11 | Measurements for each of the cytokines will be collected at predetermined time points. |
| Other | Evaluation of patient reported symptoms in follow up | 30 and 90 days after discharge | Completion of questionnaires to examine persistence of any COVID-19 related symptoms of COVID-19 persisted |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
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 list from software.
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GET https://conductscience.org/api/trials/v1/NCT05007678/registered