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 | (1) aged 18 to 65 years, (2) positive SARS-CoV-2 nucleic acid test by nasopharyngeal swabs, and (3) multiple patchy ground-glass shadows or other typical manifestations in both lungs diagnosed in chest computed tomography (CT). |
| Exclusion criteria | (1) positive tests for other pathogens, such as tuberculosis, mycoplasma, etc.; (2) patients with metal implants or pacemakers; (3) respiratory failure or requiring mechanical ventilation; (4) multiple organ failure requiring intensive care unit (ICU) monitoring and treatment; (5) bleeding tendency or active bleeding in the lungs; (6) shock; (7) cancer and severe underlying diseases; (8) severe cognitive impairment; (9) pregnancy or lactation; (10) those without signed informed consent; and (11) those with other contraindications to short-wave diathermy. |
| Interventions | |
| Treatment 1 Short-wave diathermy 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 50 participants n1=/ n2= | |
| Characteristics of participants N=50 Mean age : 53.5 22 males Severity : Mild: n=4 / Moderate: n=46/ Severe: n=0 Critical: n=0 | |
| 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 stated
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| 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. |