Event Date |
Event Type |
Comment |
19 Feb 2021 |
Other trial event
|
Last checked against European Clinical Trials Database record.
Updated 19 Feb 2021
|
04 Nov 2020 |
Other trial event
|
Last checked against the ClinicalTrials.gov record.
Updated 04 Nov 2020
|
29 Oct 2020 |
Results
|
According to an InflaRx media release, data from the Phase II part of the study were published in the peer-reviewed journal, The Lancet Rheumatology.
Updated 03 Nov 2020
|
16 Sep 2020 |
Completion date
|
Planned End Date changed from 31 Dec 2020 to 31 Aug 2021.
Updated 21 Sep 2020
|
16 Sep 2020 |
Other trial event
|
Planned primary completion date changed from 31 Oct 2020 to 31 May 2021.
Updated 21 Sep 2020
|
14 Sep 2020 |
Other trial event
|
According to an InflaRx media release, Additional sites to be added in the US, EU and other regions
Updated 17 Sep 2020
|
14 Sep 2020 |
Other trial event
|
According to an InflaRx media release, the phase II results have been accepted for publication in the peer-reviewed journal, The Lancet Rheumatology.
Updated 15 Sep 2020
|
14 Sep 2020 |
Other trial event
|
According to an InflaRx media release, the company announced today the start of the global Phase III part of this Phase II/III trial with the initiation of the first clinical site in the Netherlands. And, German regulatory authority, the Paul-Ehrlich-Institut (PEI), has approved the Phase III clinical trial in Germany
Updated 15 Sep 2020
|
04 Sep 2020 |
Other trial event
|
Planned number of patients changed from 130 to 390.
Updated 04 Sep 2020
|
21 Jul 2020 |
Other trial event
|
According to an InflaRx media release, phase III part of this study is subject to regulatory approval.
Updated 23 Jul 2020
|
21 Jul 2020 |
Other trial event
|
According to an InflaRx media release, other planned key endpoints for phase III part are assessments of organ support and assessment of disease improvement on the ordinal scale.
Updated 23 Jul 2020
|
21 Jul 2020 |
Other trial event
|
According to an InflaRx media release, the Company plans to enroll approximately 360 early intubated, critically ill patients with COVID-19 induced pneumonia in phase III part. The company plans to conduct the study at sites in the US, Europe, South America and potentially other regions and an interim analysis is currently planned after enrollment of 180 patients, with the potential for an early stop for efficacy or futility.
Updated 23 Jul 2020
|
21 Jul 2020 |
Other trial event
|
According to an InflaRx media release, the phase II results have been submitted for publication to a peer-reviewed medical journal along with a preprint server.
Updated 23 Jul 2020
|
21 Jul 2020 |
Other trial event
|
According to an InflaRx media release, the company will initiate the phase III part in the coming months.
Updated 23 Jul 2020
|
17 Jun 2020 |
Other trial event
|
According to an InflaRx media release, upon review of the safety data, the independent data safety monitoring board recommended continuation of the trial into the Phase III part.
Updated 19 Jun 2020
|
17 Jun 2020 |
Other trial event
|
According to an InflaRx media release, data are being prepared for submission to a scientific journal.
Updated 19 Jun 2020
|
17 Jun 2020 |
Interim results
|
Interim results (n=30) presented in an InflaRx Media Release.
Updated 19 Jun 2020
|
29 Apr 2020 |
Other trial event
|
According to an InflaRx media release, after all patients have been treated in the first part of the trial, an interim analysis will be performed to assess the clinical benefit of the treatment using the assessed clinical parameters in order to potentially adapt the confirmatory second part of the study. Part 1 is fully enrolled with 30 patients as of April 24, 2020. Additional centers have been opened in the Netherlands, since March 2020.
Updated 04 May 2020
|
08 Apr 2020 |
Other trial event
|
New source identified and integrated (European Clinical Trials Database; EudraCT2020-001335-28)
Updated 08 Apr 2020
|
07 Apr 2020 |
New trial record
|
New trial record
Updated 07 Apr 2020
|
31 Mar 2020 |
Other trial event
|
According to an InflaRx media release, InflaRx has dosed the first patient this study.
Updated 07 Apr 2020
|