Trial NCT04341415
Publication Rangon CM, Front Physiol, 2021 (published paper)
Dates: 2020-04-09 to 2020-11-30
Funding: Private (SEDATELEC (manufacturer))
Conflict of interest: Yes
| Methods | |
| RCT Blinding: double blinding | |
| Location :
Multicenter / France Follow-up duration (days): 14 | |
| Inclusion criteria | 1) Adults of both sex (over 18 years old); 2) confirmed COVID-19 ARDS, based on the positive PCR for SARS-CoV2 and/or a suggestive chest scan and the following clinical criteria (i.e., abnormal lung auscultation OR SpO2 <94% OR oxygen supplementation OR non-invasive ventilation); 3) admitted to the Hôpital Fondation Adolphe de Rothschild (Paris) or the Hôpital Simone Veil (Beauvais, France); within the first 72 h; Former critical inpatients could secondarily be included within 72 h after their transfer to a non-ICU; informed consent. |
| Exclusion criteria | Pregnant or breastfeeding women |
| Interventions | |
| Treatment
Auricular Neuromodulation 4 semipermanent needles implanted on each auricle for duration of hospitalization |
|
| Control
Placebo | |
| Participants | |
| Randomized 29 participants (n1=14 / n2= 15) | |
| Characteristics of participants N=29 Mean age : 70.9 18 males Severity : Mild: n=0 / Moderate: n=*/ Severe: n=* Critical: n=1 | |
| Primary outcome | |
| In the register Comparison of the percentage of clinically improved inpatients between D0 and D14 [ Time Frame: 14 day after intervention ] Inpatients are considered as clinically improved if they have gained at least 2 points on the clinical evaluation scale, or if they went back home | |
| In the report 7-category ordinal Clinical Progression Scale or hospital discharge | |
| Documents available |
Protocol NR Statistical plan NR Data-sharing stated
|
| 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, the prospective registry was used in data extraction and assessment of risk of bias. Neither protocol nor statistical analysis plan was available. There were some differences in inclusion criteria between the registry and the article: in the registry COVID-19 confirmed by PCR or other certified test was mandatory whereas in the article the criteria allowed for test-confirmed or clinically diagnosed COVID-19; in the article the criteria allowed for former critical patients to be recruited once discharged from ICU. The primary outcome in the article reflected that in the registry; the secondary outcomes in the article (rate of transfer to the intensive care unit (ICU) and on the survival rate at D14) were not included in the registry. The trial was terminated after interim analysis at 50% recruitment because the primary efficacy endpoint showed no significant difference between groups. |