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

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
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:

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.