Trial ChiCTR2000029972
Publication Huang L, medRxiv (2021) (preprint)
Dates: 2020-02-18 to 2020-04-20
Funding: Public/non profit (National Key Research and Development program)
Conflict of interest: No

Methods
RCT
Blinding: single blinding
Location : Single center / China
Follow-up duration (days): 28
Inclusion criteria
  • Aged 18 to 65 years
  • Positive SARS-CoV-2 nucleic acid test by nasopharyngeal swabs
  • Multiple patchy ground-glass shadows or other typical manifestations in both lungs diagnosed in chest computed tomography (CT)
Exclusion criteria
  • Positive tests for other pathogens, such as tuberculosis, mycoplasma, etc.
  • Patients with metal implants or pacemakers
  • Respiratory failure or requiring mechanical ventilation
  • Multiple organ failure requiring intensive care unit (ICU) monitoring and treatment
  • Bleeding tendency or active bleeding in the lungs
  • Shock
  • Cancer and severe underlying diseases
  • Severe cognitive impairment
  • Pregnancy or lactation
  • Those without signed informed consent
  • Those with other contraindications to short-wave diathermy
Interventions
Treatment
SWD
10 minutes therapy twice a day for 12 days using ultra–short-wave therapy electrodes in continuous mode with a frequency of 27.12MHz and a power of 200W
Control
Standard care

Participants
Randomized
participants :
SWD=25
Standard care=25
Characteristics of participants
N= 50
Mean age : NR
22 males
Severity : Mild: n=4 / Moderate: n=46 / Severe: n=0 Critical: n=0
Number of vaccinated participants: NR
Primary outcome
In the register
1) the rate of Coronary virus nucleic acid negative at 7 days, 14 days, 21 days, and 28 days after Ultra Short Wave Electrotherapy; 2) systemic inflammatory response syndrome (SIRS) scores at 7 days, 14 days, 21 days, and 28 days after Ultra Short Wave Electrotherapy
In the report
1) The length of recovery from symptoms measured by seven-category ordinal, systemic inflammatory response syndrome (SIRS) scale; 2) negative conversion rate of the SARS-CoV-2 nucleic acid test by reverse transcription PCR (RT-PCR), after 7, 14, 21, and 28 days of treatment.
Documents
available

Protocol

NR

Statistical plan

NR

Data-sharing willing stated in the publication:

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 article, the prospective trial registry was used in data extraction and assessment of risk of bias. Neither protocol nor statistical analysis plan was available. The co-primary and secondary outcomes in the article reflect those in the registry. The trial (n = 50) did not achieve it target sample size (n = 66) due to shortage of COVID-19 patients.