Trial NCT04358926
Publication Hadanny A, SSRN, 2021 (preprint)
Dates: 2020-05-01 to 2020-10-15
Funding: Public/non profit (Shamir Medical Center)
Conflict of interest: Yes
| Methods | |
| RCT Blinding: single blinding | |
| Location :
Single center / Israel Follow-up duration (days): 30 | |
| Inclusion criteria | Patients 18 years or older with a SARS-CoV-2 RT-PCR-confirmed diagnosis of COVID-19 were eligible for enrollment. Patients had to have respiratory insufficiency of either room saturation lower than 94% on room air or PaO2/FiO2<300mmHg in addition to at least one risk factor (hypertension, moderate-severe asthma, diabetes mellitus, cardiac conditions, severe obesity (BMI>40), age>65, immunodeficiency, chronic liver disease) |
| Exclusion criteria | Patients were excluded if they were pregnant; had a pneumothorax; pneumomediastinum, claustrophobia; ear/sinus diseases which aren't allowed in HBOT; severe emphysema or known pulmonary bullae; or an inability to sign the informed consent. |
| Interventions | |
| Treatment
Hyperbaric oxygen therapy 100% O2 at 2.2 ATA 60 minutes sessions twice daily for 4 days |
|
| Control
Standard care ( / ) Definition of Standard care: Remdesivir, COVID-convalescent plasma therapy oxygen, steroids, antibiotics and low-molecular weight heparin (LMWH) | |
| Participants | |
| Randomized 29 participants (n1=20 / n2= 9) | |
| Characteristics of participants N=29 Mean age : 65.3 15 males Severity : Mild: n=0 / Moderate: n=0/ Severe: n=25 Critical: n=0 | |
| Primary outcome | |
| In the register SpO2 [ Time Frame: 5 days after randomization ] Oxygen saturation measured in % by oxygen apparatus NEWS Score [ Time Frame: 5 days after randomization ] Early Warning Score (NEWS) calculated by the patient's vitals and condition Inflammation level -CRP [ Time Frame: 5 days after randomization ] blood CRP level white blood cells number [ Time Frame: 5 days after randomization ] white blood cells number Cytokines - IL1 [ Time Frame: 5 days after randomization ] blood IL1 level Cytokines - IL2 [ Time Frame: 5 days after randomization ] blood IL2 level Cytokines - IL6 [ Time Frame: 5 days after randomization ] blood IL6 level Cytokines - IL10 [ Time Frame: 5 days after randomization ] blood IL10 level Cytokines - TNFalpha [ Time Frame: 5 days after randomization ] blood TNFalpha level Inflammation level - procalcitonin [ Time Frame: 5 days after randomization ] blood procalcitonin level Inflammation level - ferritin [ Time Frame: 5 days after randomization ] blood ferritin level | |
| In the report Not reported | |
| 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 |
High |
| General comment | In addition to the pre-print article, the study prospective registry was used in data extraction and risk of bias assessment. The study nearly achieved the target sample size specified in the trial registry(30 targeted, 29 enrolled). There is no change from the trial registration in the intervention and control treatments. The primary outcome indicated in registry reflects the primary outcome reported in the paper. Some outcomes (e.g. discharge, hospitalization length) are reported in the paper, but was not pre-specified in the trial registry. Blinding of assessor only reported for laboratory outcomes and assessments of x-rays (in report). Registry reports that outcome assessors in general are blinded. Risk that some outcomes (i.e. discharge) were assessed unblinded. |