Trial · NCT04397497
Registered outcomes20
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 20
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Reduction in the dependency on oxygen supplementation | within day 14 of treatment | Time to the absence of need for oxygen supplementation (time to first period of 24 hrs with a SpO2 of 94%) within day 14 of treatment, stated as Kaplan- Mayer estimates of the proportion of patients on room air at day 14 and median time to room air attainment in each arm |
| Secondary | Proportion of responders (using the WHO 7-point ordinal scale) | Day 7, 14, and 28 | Response is defined as a 7-point ordinal scale of 3 or less, i.e. no supplemental oxygen |
| Secondary | Time to response (using the WHO 7-point ordinal scale) | Within day 28 of intervention | Time from date of randomization to the date with a 7-point ordinal scale of 3 or less, i.e. no supplemental oxygen |
| Secondary | Proportion of improving patients (using the WHO 7-point ordinal scale) | At day 7, 14, and 28 | Proportion of patients with at least two-point improvement in clinical status |
| Secondary | Time to resolution of fever | Within day 28 of intervention | Time to resolution of fever (for at least 48 hours) in absence of antipyretics, or discharge, whichever is sooner |
| Secondary | Reduction in case fatality | Within day 28 of intervention | COVID-19-related death |
| Secondary | Proportion of patient requiring mechanical ventilation/deaths | Within day 14 of intervention | Proportion of hospitalized patients who died or required mechanical ventilation (WHO Categories 6 or 7) |
| Secondary | Change in biochemical markers | Within day 28 of intervention or discharge -whatever comes first | Change of the following serological markers over follow-up (C-reactive protein; Ferritin; D-Dimer) |
| Secondary | Median changes in the National Early Warning Score 2 (NEWS2) | At day 7, 14, and 28 | Median changes of NEWS2 score from baseline |
| Secondary | Time to clinical improvement as evaluated with the National Early Warning Score 2 (NEWS2) | Within day 28 of intervention or discharge -whatever comes first | Time to clinical improvement (as defined as a NEWS2 score of 2 or less maintained for at least 24 hours or discharge, whichever comes first) |
| Secondary | Variations in radiological findings | Within day 28 of intervention or discharge -whatever comes first | Variations from baseline to subsequent timepoints (when available) in terms of percentage of lung involvement, modifications in the normal parenchyma, ground glass opacities (GGO), crazy paving pattern,parenchymal consolidations, and evolution towards fibrosis. |
| Secondary | Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] | By day 84 | Number of patients with treatment- related side effects (as assessed by Common Terminology Criteria for Adverse Event (CTCAE) v.5.0), serious adverse events, adverse events of special interest, clinically significant changes in laboratory measurements and vital signs |
| Other | Clinical efficacy of mavrilimumab compared to the control arm by clinical severity | Within day 28 of intervention | To evaluate the primary and secondary endpoints in different subgroups of patients: * mild respiratory failure: PaO2/FiO2 ≤ 300 and \> 200 mmHg; * moderate respiratory failure: PaO2/FiO2 ≤ 200 and \> 100 mmHg |
| Other | Changes in serum IL-6 (exploratory biomarker) | By day 84 | Median changes in serum IL-6 |
| Other | Changes in serum IL-1RA (exploratory biomarker) | By day 84 | Median changes in serum IL-1 receptor antagonist |
| Other | Changes in serum TNF-alpha (exploratory biomarker) | By day 84 | Median changes in serum TNF-alpha |
| Other | Changes in CBC + differential (exploratory biomarker) | By day 84 | Median variations in haemoglobin and leucocyte counts |
| Other | Level of anti-SARS-CoV2 antibodies (exploratory biomarker) | By day 84 | Median titres od anti-SARS-CoV2 antibodies |
| Other | Virus eradication (exploratory biomarker) | By day 84 | Proportion of patients with a positive swab for SARS-CoV2 by PCR |
| Other | Anti-drug antibodies (exploratory biomarker) | By day 84 | Proportion of patients who developed anti-drug antibodies |
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/NCT04397497/registered