Trial NCT04367168
Publication COLCHIVID - Absalon-Aguilar A, J Gen Intern Med (2021) (published paper)
Dates: 2020-05-01 to 2021-04-30
Funding: Public/non profit (Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán.)
Conflict of interest: No

Methods
RCT
Blinding: triple blinding
Location : Multicenter / Mexico
Follow-up duration (days): 100
Inclusion criteria
  • Hospitalized
  • Adult patients aged 18 to 70 years
  • Tested positive for at least one of the following COVID-19 diagnostic assays - polymerase chain reaction (PCR) for SARS-CoV-2 in nasopharyngeal swab, rapid antigen test, or serum anti-SARS-CoV-2 IgG antibodies
  • Severe COVID-19 according to the following definition - respiratory failure, respiratory rate ≥ 30 bpm, oxygen saturation (SpO2) ≤ 93% at rest, PaO2/FiO2 ≤ 300 mmHg
Exclusion criteria
  • Over 70 years old
  • Chronic liver or kidney failure
  • Pregnant
  • Have puerperium
  • Receiving any drug with known interaction with colchicine
  • Patients treated with antimalarial drugs, azithromycin, convalescent plasma, remdesivir, tocilizumab, or baricitinib
Interventions
Treatment
Colchicine
Initial dose: 1.5 mg orally once-off - Maintenance dose: 0.5 mg orally twice a day for 10 days.
Control
Placebo

Participants
Randomized
participants :
Colchicine=56
Placebo=60
Characteristics of participants
N= 116
Mean age : NR
76 males
Severity : Mild: n=0 / Moderate: n=0 / Severe: n=116 Critical: n=0
Number of vaccinated participants: NR
Primary outcome
In the register
Number of patients with improvement in body temperature, myalgia, arthralgia, total lymphocyte count, D-dimer, fibrinogen and ferritin levels [ Time Frame: Up to 24 days ] Progression to severe disease [ Time Frame: Up to 10 days ]
In the report
Death or progression to critical disease, defined as multiple organ failure, shock, or need for invasive mechanical ventilation.
Documents
available

Protocol

NR

Statistical plan

NR

Data-sharing willing stated in the publication:

Not reported
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 published article, the study registry and contact with authors was used in data extraction and risk of bias assessment. The protocol and statistical analysis plan were not available. The registry primary outcome does not reflect the reported primary outcome. Some outcomes in the paper (e.g. adverse events, mortality) were not in the registry but were defined in the protocol. There is no change from the trial registration in the intervention and control treatments, however the inclusion criteria has both mild and severe patients in the registry, while the paper only included severe patients. The study (n=116) did not achieve the target sample size specified in the trial registry (n=174) as the trial was terminated early because the treatment showed not effect on the primary outcome after the second interim analysis.
The study was updated on April 13th, 2022 with data gained from contact with authors.