Trial NCT04386694
Publication De Marchi T, J Inflamm Res, 2021 (published paper)
Dates: 2020-05-01 to 2020-07-30
Funding: Mixed (Multi Radiance Medical (Solon, OH, USA) provided financial support and therapeutic devices. Brazilian Council of Science and Technology Development (CNPq).)
Conflict of interest: Yes
| Methods | |
| RCT Blinding: triple blinding | |
| Location :
Single center / Brazil Follow-up duration (days): 60 | |
| Inclusion criteria | Patients with laboratory-confirmed COVID-19 through RT-PCR; aged 15 years or older; admitted to the adult ICU and requiring invasive mechanical ventilation through orotracheal intubation due to respiratory failure. |
| Exclusion criteria | Suspected patients who had a negative result of the diagnostic examination for COVID-19 infection; Patients positioned in pronation for more than 24 hours; Cancer patients; Pregnancy. |
| Interventions | |
| Treatment
Photobiomodulation therapy 31.50 J during 60 seconds per site (total dose: 189 J), once a day until discharge or death |
|
| Control
Placebo Duration : Until discharge | |
| Participants | |
| Randomized 30 participants (n1=15 / n2= 15) | |
| Characteristics of participants N=30 Mean age : 66.1 14 males Severity : Mild: n=0 / Moderate: n=0/ Severe: n=0 Critical: n=30 | |
| Primary outcome | |
| In the register Time until discharge [ Time Frame: From date of randomization until the date of discharge or date of death from any cause, whichever came first, assessed up to 20 days. ] Number of days hospitalized in the ICU until discharge or death. | |
| In the report Length of ICU stay: The length of ICU stay was measured by the number of days of ICU admission from randomization to discharge or death from any cause | |
| Documents available |
Protocol NR Statistical plan NR Data-sharing stated Yes |
| 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 pre-print/published article, the trial registry as well as responses from contact with authors were used in data extraction and assessment of the risk of bias. Supplementary materials, study protocol and statistical analysis plan were not available at time of extraction. The study achieved its pre-stated sample size. There is no change from the trial registration in the intervention and control treatments. No adverse events and serious adverse events were found, though these outcomes were not included in the trial registry. The authors reported two deviations from the registered protocol (one was that the endpoint assessment would be up to 20 days after randomization; however, this assessment took more than 20 days in some cases, and the second deviation was not assessing IgG, IgM and D-dimmer because the third part laboratory in charge to carry out the blood analysis was not able to implement the necessary routines before the beginning of our trial). The author reponse included results followed until day 60 (mortality and clinical improvement)
On February 10th, 2021, we received additional information from authors on this study. This study was updated with data from contact with authors on March 30th, 2021. On 10th of August, 2021, this study was updated based on the published report. |