Trial *
Publication Shogenova LV, Pulmonologiya, 2020 (published paper)

Funding:
Conflict of interest: Yes

Methods
RCT
Location : Single center / Russia
Follow-up duration (days): *
Inclusion criteriaAge > 18 years; Positive RNA test of SARS-CoV-2 coronavirus; CT signs of viral pneumonia (CT1, CT2); Oxygenation index = 150 according to the Berlin clas sification; Increased CRP and ESR.
Exclusion criteriaOxygenation index < 150; mechanical ventilation; severe impairment of consciousness (score on the Glasgow scale less than 10); unstable hemodynamics (systolic blood pressure < 90 mm Hg, heart rate < 50 min or > 160 min); hemoglobin < 115; profuse sputum secretion; vomiting that interfered with the use of masks; acute cerebrovascular accident (ACV); acute myocardial infarction (AMI) within the last 6 months, and pregnancy.
Interventions
Treatment
Thermal helium-oxygen mixture
79-50% (He); 21-50% (O2) inhalation 4 times a day
Control
Standard care
Definition of Standard care: Standard treatment in accordance with the clinical recommendations of the Ministry of Health of the Russian Federation “Prevention, diagnostics, and treatment of the novel coronavirus infection COVID-19”.
Participants
Randomized
60 participants (n1=30 / n2= 30)
Characteristics of participants
N=60
Mean age : NR
33 males
Severity : Mild: n=0 / Moderate: n=13/ Severe: n=47 Critical: n=0
Primary outcome
In the register
NR
In the report
NR
Documents
available

Protocol

NR

Statistical plan

NR

Data-sharing stated

NR
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 The available version of the published paper was used in data extraction and risk of bias assessment. Neither the registry, the protocol nor the statistical analysis plan was available. The follow-up period of the study was unclear as well as the treatment duration. The primary outcome was not reported.