Trial NCT04412057
Publication Perlin DS , J Clin Invest, 2021 (published paper)
Dates: 2020-07-17 to 2021-01-19
Funding: Private (The study was sponsored by Avalo Therapeutics. Editorial assistance was provided to the authors by Donna Simcoe of Simcoe Consultants, Inc., and Autumn Kelly of AHK Communications, and was funded by Avalo Therapeutics. Neither honoraria nor payments were made for authorship.)
Conflict of interest: Yes
| Methods | |
| RCT Blinding: double blinding | |
| Location :
Multicenter / USA Follow-up duration (days): 60 | |
| Inclusion criteria | Hospitalized adults (≥18 years old) diagnosed COVID-19 infection through an approved testing method; Clinical evidence of pneumonia with acute lung injury, defined as diffuse bilateral radiographic infiltrates with a partial pressure of arterial oxygen/percentage of inspired oxygen ratio (PaO2/FiO2) above 100 and below 300 (i.e., mild to moderate ARDS); If data on oxygen saturation were available, the value at rest in ambient air must have been below 93%. |
| Exclusion criteria | Intubated with mechanical ventilation; Currently taking immunomodulators or anti-rejection medications; Received an immunomodulating biologic drug within 60 days of baseline; Were in septic shock defined as persistent hypotension requiring vasopressors to maintain mean arterial pressure of 65 mmHg or higher and a serum lactate level above 2 mmol/l (18 mg/dl) despite adequate volume resuscitation; Received any live attenuated vaccine, such as varicella-zoster, oral polio, or rubella, within 3 months prior to the baseline visit; Pregnant or lactating females. |
| Interventions | |
| Treatment
CERC-002 16 mg/kg (maximum 1200 mg) subcutaneously once-off |
|
| Control
Placebo | |
| Participants | |
| Randomized 83 participants (n1=41 / n2= 42) | |
| Characteristics of participants N=83 Mean age : 58.6 57 males Severity : Mild: n=0 / Moderate: n=0/ Severe: n=83 Critical: n=0 | |
| Primary outcome | |
| In the register Proportion of patient alive and free of respiratory failure [ Time Frame: Baseline to Day 28 ] | |
| In the report Proportion of subjects who were alive and free of respiratory failure through day 28. | |
| Documents available |
Protocol NR Statistical plan NR Data-sharing stated NR |
| 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 article and pre-print, the prospective study registry was used in data extraction and risk of bias assessment. The pre-print article reports several outcomes not included in the registry (PaO2/FiO2 ratio, time to invasive ventilation, duration of ventilatory support, duration of ICU stay, hospital length of stay, time to return to oxygen saturation >93%, peak PaO2/FiO2 ratio, partial pressure of oxygen (PO2), change in SOFA score, change in body temperature, Serum Cytokines Levels, adverse events, and safety laboratory determination). The study achieved the target sample size specified in the trial registry. There is no change from the trial registration in the intervention and control treatments.
The study was updated on December 14th, 2021 with data from the published report. |