Trial · NCT04397497
Mavrilimumab in Severe COVID-19 Pneumonia and Hyper-inflammation (COMBAT-19)
NCT04397497, Phase 2, Unknown, Ospedale San Raffaele
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Mavrilimumab in Severe COVID-19 Pneumonia and Hyper-inflammation (COMBAT-19). Trials, record NCT04397497. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04397497
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Mavrilimumab in Severe COVID-19 Pneumonia and Hyper-inflammation (COMBAT-19)
- NCT number
- NCT04397497
- Status
- Unknown
- Phases
- Phase 2
- Enrollment
- 50 participants, estimated
- Lead sponsor
- Ospedale San Raffaele
- Conditions
- Covid-19, Acute Respiratory Failure, ARDS, Human, Sars-CoV2, Viral Pneumonia
- Interventions
- Mavrilimumab, Placebo
- First posted
- 2020-05-21
- Last updated
- 2020-05-26
Source ClinicalTrials.gov
Registered outcomes20
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| 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) |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 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.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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/NCT04397497
GET https://conductscience.org/api/trials/v1/NCT04397497/registered