Covid-19 living Data

Inhaled corticosteroids vs Standard care/Placebo (RCT)

Hospitalized patients

Studies included but not extracted/included in the analysis: Terada J, Drug Discov Ther, 2022

FOREST PLOTS -2022-10-07

Studies description

Trial *
Publication Alsultan M, Interdiscip Perspect Infect Dis (2021) (published paper)
Dates: 2021-08-01 to 2021-08-30
Funding: Not reported/unclear
Conflict of interest: No

Trial NCT04330586
Publication Song JY, J Clin Med (2021) (published paper)
Dates: 2020-05-08 to 2021-03-31
Funding: Mixed (National Research Foundation of Korea; Korea University Guro Hospital grant that was underwritten by the SK Chemicals Corporation)
Conflict of interest: No

Methods
	RCT Blinding: Unblinded
	Location : Multicenter / South Korea Follow-up duration (days): 28
Inclusion criteria	Aged ≥19 years mild-to-moderate COVID-19, confirmed by quantitative reverse transcription polymerase chain reaction (qRT-PCR) 3 days of diagnosis or within 7 days from symptom onset low National Early Warning Score (NEWS) ranging from 0 to 4
Exclusion criteria	oxygen saturation <95% breathing room air pregnancy or breastfeeding renal impairment (estimated creatinine clearance <30 mL/min) hepatic dysfunction (alanine aminotransferase or aspartate aminotransferase levels more than five times the upper limit of normal) immunocompromising conditions severe uncontrolled comorbidities chronic airway diseases (asthma and chronic obstructive lung disease) and contraindications for use of ciclesonide inhaler.
Interventions
	Treatment Ciclesonide 320 mcg inhaled twice daily for 14 days
	Control Standard care
Participants
	Randomized NR Analyzed 61 participants Ciclesonide=35 Standard care=26
	Characteristics of participants N= 61 Mean age : NR 20 males Severity : Mild: n=* / Moderate: n=* / Severe: n=0 Critical: n=0
Primary outcome
	In the register Rate of SARS-CoV-2 eradication at day 14 from study enrollment [ Time Frame: Hospital day 14 ] Viral load
	In the report SARS-CoV-2 eradication rate based on qRT-PCR on day 14 of study enrollment
Documents avalaible	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	High
General comment	In addition to the published article, the prospective registry was used in data extraction and assessment of risk of bias. Neither protocol not statistical analysis plan was available. The primary outcome reported reflects that in the registry. There were no substantive differences between the registry and the article in outcomes. During the trial period, evidence of the ineffectiveness of hydroxychloroquine was published and a third ciclesonide plus hydroxychloroquine arm was combined with the ciclesonide alone arm. Eight patients in the ciclesonide group received oral HCQ treatment concomitantly for 10 days. 68 participants were randomized and only 61 were analyzed. Reasons for exclusion from analysis are reported but arms are not indicated.

Methods
	RCT Blinding: Unblinded
	Location : Single center / Syria Follow-up duration (days): *
Inclusion criteria	Oxygen saturation ≤93% plus at least one of the following: (1) respiratory rate ≥30 breaths/min, (2) infiltrates >50% on CT scan, and (3) arterial partial pressure of oxygen (PaO2)/fraction of inspired oxygen ratio (FiO2) <300 mmHg Adults (aged ≥18 years) positive PCR test of COVID-19 virus in specimens taken from the respiratory tracts patients with negative PCR test but had clinical signs and symptoms of viral illness accompanied with chest CT scan showing the radiologic findings of viral pneumonia, which was defined as new, unexplained, and bilateral infiltrates on the lungs
Exclusion criteria	Admitted for other conditions with oxygen saturation ≥94% without viral symptoms but had infiltrations on chest CT scan (mild form of COVID-19) received other antiviral or investigational therapies for COVID-19 expired or transmitted to ICU during the first 24 hours patients who committed with persistent treatment of steroid inhalers
Interventions
	Treatment Colchicine Initial dose : 1.5 mg orally followed by 0.5 mg 1 hour later on day 1, Maintenance dose: 0.5 mg orally twice daily for 4 days Budesonide 200 mcg inhaled twice daily for 5 days
	Control Standard care
Participants
	Randomized participants : Colchicine=14 Budesonide =14 Standard care=21
	Characteristics of participants N= 49 Mean age : NR 19 males Severity : Mild: n=0 / Moderate: n=* / Severe: n=* Critical: n=0
Primary outcome
	In the register NR
	In the report NR
Documents avalaible	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	*
General comment	Only the published article was available for data extraction and assessment of risk of bias. No registry, protocol or statistical analysis plan was available. No outcome was identified as primary in the article. It is not clear whether the study achieved a target sample size. No outcomes with clear time points relevant for COVID-NMA were reported.