Trial NCT04351152
Publication Temesgen Z, Lancet Respir Med, 2021 (published paper)
Dates: 2020-05-05 to 2021-01-27
Funding: Private (Humanigen, Inc.)
Conflict of interest: Yes
| Methods | |
| RCT Blinding: double blinding | |
| Location :
Multicenter / Brazil, USA Follow-up duration (days): 28 | |
| Inclusion criteria | At least 18 years of age; Informed consent; SARS-CoV-2 infection virologically confirmed; Pneumonia diagnosed by chest x-ray or computed tomography; Clinical ordinal score of 4 or 5 (oxygen saturation [SpO2] ≤94% on room air or in need of supplemental oxygen in the form of low-flow oxygen, or both, adapted from the NIH-sponsored Adaptive COVID-19 Treatment Trial [ACTT], NCT042807057) or clinical ordinal score of 3 (high-flow oxygen or noninvasive positive pressure ventilation [NPPV]); Women of childbearing potential if they had a negative urine or serum pregnancy test at screening/baseline and agreed to adequate contraception following their last dose of study drug |
| Exclusion criteria | Required invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); pregnant; In the view of the treating investigator, not expected to survive the following forty-eight hours from the time of randomization; Confirmed diagnosis of bacterial pneumonia or other active/uncontrolled fungal or viral infection other than SARS-CoV-2 |
| Interventions | |
| Treatment
Lenzilumab 600 mg IV, 3 doses 8 hours apart |
|
| Control
Placebo | |
| Participants | |
| Randomized 520 participants (n1=261 / n2= 259) | |
| Characteristics of participants N=520 Mean age : 61 311 males Severity : Mild: n=0 / Moderate: n=282/ Severe: n=197 Critical: n=0 | |
| Primary outcome | |
| In the register Ventilator-free Survival [ Time Frame: Up to Day 28 ] | |
| In the report Ventilator-free survival (survival without ventilation) by Day 28 | |
| Documents available |
Protocol NR Statistical plan NR Data-sharing stated No |
| Risk of bias Overall The overall risk of bias reported in the table corresponds to the highest risk of bias for the outcomes assessed for the systematic review |
Some concerns |
| General comment |
In addition to the published and pre-print articles, the prospective trial registry was used in data extraction and assessment of risk of bias. Neither protocol nor statistical analysis plan was available. There were no differences between the registry and the pre-print article in population, procedures or interventions. The primary outcome indicated in registry reflects the primary outcome reported in the paper. A number of day 28 secondary outcomes in the registry were not reported (ventilator-free days; duration of Intensive Care Unit (ICU) stay; incidence of severe acute respiratory distress syndrome; duration of hospitalization; time to improvement in 1 or 2 categories using 8-point Ordinal Scale). The study achieved its target sample size.
This study was updated with data from contact with authors and the published report on June 22nd, 2021. This study was updated on the 23rd of December, 2021 with data from the published report. |