Trial RBR-8jyhxh
Publication Lopes MIF, RMD Open (2021) (preprint)
Dates: 2020-04-11 to 2020-08-30
Funding: Public/non profit (FAPESP, CNPq and CAPES grants.)
Conflict of interest: No

Methods
RCT
Blinding: Double blinded, no restrictions
Location : Single center / Brazil
Follow-up duration (days): 15
Inclusion criteria
  • Individuals hospitalized with moderate or severe forms of COVID-19 diagnosed by RT-PCR in nasopharyngeal swab specimens and lung computed tomography scan involvement compatible with COVID-19 pneumonia
  • older than 18 years
  • body weight > 50 kg
  • normal levels of serum Ca2+ and K+
  • QT interval < 450 ms at 12 derivations electrocardiogram (according to the Bazett formula) and negative serum or urinary β-HCG if woman under 50.
Exclusion criteria
  • Mild form of COVID-19 or in need for ICU admission
  • diarrhea resulting in dehydration
  • known allergy to colchicine
  • diagnosis of porphyria, myasthenia gravis or uncontrolled arrhythmia at enrollment
  • pregnancy or lactation
  • metastatic cancer or immunosuppressive chemotherapy
  • regular use of digoxin, amiodarone, verapamil or protease inhibitors
  • chronic liver disease with hepatic failure
  • inability to understand the Consent Form.
Interventions
Treatment
Colchicine
0.5 mg orally, twice daily for 5 days, then 0.5 mg twice daily for 5 days; if body weight ≥80 kg, the first dose was 1.0 mg
Control
Placebo

Participants
Randomized
participants :
Placebo=37
Colchicine=38
Characteristics of participants
N= 75
Mean age : NR
33 males
Severity : Mild: n=0 / Moderate: n=* / Severe: n=* Critical: n=*
Number of vaccinated participants: NR
Primary outcome
In the register
To evaluate the duration of oxygen therapy for both groups, measured in number of days of need of supplemental oxygen by catheter or masks.
To evaluate the hospitalization time for both groups, measured in number of days from the admission to th
In the report
Time of need for supplemental oxygen; time of hospitalization; need for admission and length of stay in ICU; and death rate and causes of mortality
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 all available versions of the published/pre-print article, the study registry were used in data extraction and risk of bias assessment. No pre-specified statistical analysis plan nor protocol was available at the time but authors state that they will be made available as supplementary files in the journal. There is no change from the trial registration in the primary and secondary outcomes. The trial registry reported the intervention treatments as both chloroquine or hydroxychloroquine plus colchicine and the control treatments as both choloroquine or hydroxychloroquine plus placebo. The pre-print reported the intervention arm as colchicine and the control as placebo with choloroquine or hydroxychloroquine, among other drugs (azithromycin, unfractioned heparin and (if needed) methylprednisolone) as standard of care for the institution.
The study was updated on March 19th, 2021 with data from the RMD Open publication. Results based on previous author contact were not considered, since recruitment was not done. Therefore, all results presented are based on the final and published report.