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

Funding:
Conflict of interest: Yes

Methods
RCT
Location : Single center / Russia
Follow-up duration (days): *
Inclusion criteria
  • Age > 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 criteria
  • Oxygenation 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
t-He/O2
79-50% (He); 21-50% (O2) inhalation 4 times a day

Control
Standard care

Participants
Randomized
participants :
t-He/O2=30
Standard care=30
Characteristics of participants
N= 60
Mean age : NR
33 males
Severity : Mild: n=0 / Moderate: n=13 / Severe: n=47 Critical: n=0
Number of vaccinated participants: NR
Primary outcome
In the register
NR
In the report
NR
Documents
available

Protocol

NR

Statistical plan

NR

Data-sharing willing stated in the publication:
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.