Trial NCT04391712
Publication Vetrici MA, J Inflamm Res, 2021 (published paper)
Dates: 2020-03-01 to 2020-05-31
Funding: No specific funding (This research did not receive any specific grant from funding agencies in the public, commercial, or not-for-profit sectors)
Conflict of interest: Yes
| Methods | |
| RCT Blinding: Unblinded | |
| Location :
Single center / USA Follow-up duration (days): 152 | |
| Inclusion criteria | SARS-CoV-2 infection confirmed by nasopharyngeal swab and RT-PCR on an Abbott ID system upon hospitalization; age 18–90 years; and pulmonary compromise requiring oxygen support. Patients had to be able to self-prone or support themselves in a self-sitting position to facilitate the administration of PBMT. |
| Exclusion criteria | Patients who required ventilator management; those with autoimmune disorders or inflammatory conditions not related to COVID-19; and pregnancy. |
| Interventions | |
| Treatment
Photobiomodulation therapy 7.18 J/cm2 for 28 minutes once a day for 4 days (over an area of 250 cm2 of each lung ) |
|
| Control
Standard care ( / ) Definition of Standard care: Standard clinical care (oxygen supplementation, fluid and electrolyte balance, standard nursing care), and no additional corticosteroid, antiviral, pharmacological or antibody treatment was provided. | |
| Participants | |
| Randomized 10 participants (n1=5 / n2= 5) | |
| Characteristics of participants N=10 Mean age : 53.3 8 males Severity : Mild: n=0 / Moderate: n=*/ Severe: n=* Critical: n=0 | |
| Primary outcome | |
| In the register Patient Disposition Post treatment [ Time Frame: 7 days ] ICU on vent, ICU not requiring ventilation, Discharge to Rehab requiring assistance, Discharge to Home unable to perform ADL's, Discharge to Home able to perform ADL's oxygenation [ Time Frame: Daily for 4 days ] Patients oxygen requirements pulse oximetry will be evaluated for change from pre and post individual treatment as well as end of protocol IL-6 levels [ Time Frame: First four days of trial ] The change in pre treatment levels and 24 hours post final treatment Chest Xray radiographic results [ Time Frame: 7 Days ] Pre treatment CXR will be compared to post treatment CXR using the RALE CXR evaluation scale Brescia-COVID Respiratory Severity Scale [ Time Frame: 7 days ] The change in pretreatment and post treatment BCRSS will be evaluated SMART-COP Score [ Time Frame: 7 days ] The change in pretreatment and post treatment scores will be evaluated PSI Score [ Time Frame: 7 days ] The change in pretreatment and post treatment scores will be evaluated CRP levels [ Time Frame: 7 days ] The change in pretreatment and post treatment levels will be evaluated The change in pretreatment and post treatment levels will be evaluated | |
| In the report An improvement in patient clinical status, which was mea-sured using a series of scoring tools used in critical care (The SMART-COP score, The Brescia-COVID respiratory severity scale (BCRSS),The Community-Acquired Pneumonia (CAP) assessment tool, Chest X-rays (CXR) ) | |
| 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 published article, the study registry was used in data extraction and risk of bias assessment. The target sample size specified in the trial registry was not achieved. There is no change from the trial registration in the intervention and control treatments. The registry's primary outcomes reflect the report's primary outcomes, but include other measures in addition to the primary outcomes stated in the report (e.g., Patient Disposition Post treatment [ Time Frame: 7 days ], oxygenation [ Time Frame: Daily for 4 days ], IL-6 levels [ Time Frame: First four days of trial ], Chest Xray radiographic results [ Time Frame: 7 Days ]). |