Trial NCT04598581
Publication Papachristofilou A, Int J Radiat Oncol B, 2021 (published paper)
Dates: 2020-11-02 to 2020-12-30
Funding: Not reported/unclear
Conflict of interest: No
| Methods | |
| RCT Blinding: double blinding | |
| Location :
Single center / Switzerland Follow-up duration (days): 91 | |
| Inclusion criteria | Male patients >40 years; female patients >50 years; confirmed SARS-CoV-2 requiring mechanical ventilation; Informed consent obtained by the legal representative of the patient. |
| Exclusion criteria | Pregnancy |
| Interventions | |
| Treatment
Low-Dose Radiation Therapy 0.5 to 1.0 Gy whole lung Low-dose radiation therapy once-off |
|
| Control
Sham Radiation Therapy ( / ) | |
| Participants | |
| Randomized 22 participants (n1=11 / n2= 11) | |
| Characteristics of participants N=22 Mean age : NR 17 males Severity : Mild: n=0 / Moderate: n=0/ Severe: n=9 Critical: n=13 | |
| Primary outcome | |
| In the register Ventilator free days (VFD) [Time Frame: at day 15 after LD-RT] | |
| In the report ventilator-free days at day 15 postintervention | |
| 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 trial registry was used in data extraction and assessment of risk of bias. A study protocol and statistical analysis plan were not available. There were no changes in intervention and control treatments, outcome measures and time points from the registry to published article. The primary outcome indicated in registry reflects the primary outcome reported in the paper The trial achieved its pre-planned target sample size. |