Trial NCT04328480
Publication ECLA PHRI COLCOVID - Diaz R, JAMA Netw Open (2021) (published paper)
Dates: 2020-04-17 to 2021-03-28
Funding: Mixed (The Population Health Research Institute contributed fees to the investigators. Fundacion ECLA funded all other aspects of the trial. Colchicine was donated by Spedrog Caillon to some centers lacking it.)
Conflict of interest: Yes

Methods
RCT
Blinding: Unblinded
Location : Multicenter / Argentina
Follow-up duration (days): 28
Inclusion criteria
  • Hospitalized
  • adults (age 18 years)
  • confirmed or suspected SARS-CoV-2 infection
  • admitted to the hospital with symptoms suggestive of COVID-19 (eg, fever or equivalent, loss of smell and/or taste, fatigue)
  • severe acute respiratory syndrome characterized by shortness of breath (dyspnea) or typical or atypical pneumonia on imaging, or oxygen desaturation (as measured by pulse oximetry [SpO2] <= 93%).
Exclusion criteria
  • Clear indications or contraindications for the use of colchicine
  • pregnancy or breastfeeding
  • chronic kidney disease (creatinine clearance <15 mL/min/m2 [to convert to mL/s/m2, multiply by 0.0167])
  • negative result on a reverse transcription–polymerase chain reaction (RT-PCR) test for SARS-COV-2 available before randomization.
Interventions
Treatment
Colchicine
Initial dose: 1.5 mg orally followed by 0.5 mg orally within 2 hours - Maintenance dose: 0.5 mg orally twice a day for 14 days or until discharge.
Control
Standard care

Participants
Randomized
participants :
Standard care=639
Colchicine=640
Characteristics of participants
N= 1279
Mean age : NR
830 males
Severity : Mild: n=196 / Moderate: n=995 / Severe: n=23 Critical: n=65
Number of vaccinated participants: NR
Primary outcome
In the register
All-cause mortality [ Time Frame: During hospitalization or until death, whichever comes first, assessed up to 30 days ]
In the report
1) Composite of a new requirement for mechanical ventilation or death evaluated at 28 days after randomization; 2) Death assessed at 28 days after randomization.
Documents
available

Protocol

Yes. In English

Statistical plan

Yes

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 the published article, the trial registry, protocol, statistical analysis plan and supplementary appendices were used in data extraction and assessment of risk of bias. The primary outcome in the article reflected that in the registry, but differed from that in the original protocol. Due to low recruitment and low likelihood of reaching the original estimated sample size of 2500 patients, with the aim of reducing the trial sample size and prior to knowing the results, the executive committee decided to change the single primary outcome to two co-primary outcomes: the original primary outcome (all-cause mortality); a composite secondary outcome (new need for mechanical ventilation or death). The trial (n = 1279) achieved its amended target sample size (n = 1200).