Covid-19 Living Data

Trial NCT04350320 ; EUDRACT 2020-001511-2
Publication COL-COVID - Pascual-Figal DA, Int J Gen Med (2021) (published paper)
Dates: 2020-04-30 to 2020-12-04
Funding: Public/non profit (1) “Cardiology Research group” at the IMIB-Arrixaca and the University of Murcia, Murcia, Spain; 2) Centro Nacional de Investigaciones Cardiovasculares (CNIC), Madrid, Spain. Centro Nacional de Investigaciones Cardiovasculares (CNIC) is supported by the Spanish Ministry of Economy and Competitiveness (MINECO) and Pro-CNIC Foundation.)
Conflict of interest: No

Methods
	RCT Blinding: Unblinded
	Location : * / Spain Follow-up duration (days): 28
Inclusion criteria	1) above 18 years old 2) SARS-CoV-2 infection confirmed by reverse-transcriptase polymerase chain reaction on nasal swab (RT-PCR) 3) admitted in hospital in the previous 48 hours with COVID-19 diagnosis 4)7-points WHO clinical status of 3, 4 or 5 (3. Hospitalized, not requiring supplemental oxygen 4. Hospitalized, requiring supplemental oxygen by mask or nasal prongs 5. Hospitalized, non-invasive ventilation or high flow oxygen)
Exclusion criteria	1) invasive or noninvasive mechanical ventilation needed 2) established limitation of therapeutic effort 3)inflammatory bowel disease, chronic diarrhea or malabsorption 4)previous neuromuscular disease 5)any disease with an estimated vital prognosis under 1 year 6) severe renal insufficiency (glomerular filtration rate <30 mL/min/1.73m2) 7) medical history of cirrhosis, active chronic hepatitis or severe hepatic disease defined by liver transaminases levels threefold above the normal upper limit 8)previous colchicine treatment for other diseases 9) history of allergic reaction or significant sensitivity to colchicine 10) immunosuppressive agents, including corticoids, within the previous 6 months.
Interventions
	Treatment Colchicine Initial dose: 1.5 mg (1 mg and 0.5 mg two hours after) - first maintenance dose: 0.5 mg twice a day for 7 days - second maintenance dose: 0.5 mg once a day for 21 days. (Dose reduced by half in patients receiving ritonavir or lopinavir or with at least one of the following: reduced renal clearance (<50 mL/min/1.37m2), weight <70 kg or age >75 years old.)
	Control Standard care
Participants
	Randomized participants : Standard care=51 Colchicine=52
	Characteristics of participants N= 103 Mean age : NR 54 males Severity : Mild: n=34 / Moderate: n=69 / Severe: n=0 Critical: n=0 Number of vaccinated participants: NR
Primary outcome
	In the register 1) Changes in the patients' clinical status through the 7 points ordinal scale WHO R&D Blueprint expert group [ Time Frame: 7,14,28 Days ]; 2) Changes in IL-6 concentrations [ Time Frame: up to day 28. ]
	In the report 1) Change in the WHO 7-points ordinal clinical scale during the 28 days of treatment; 2) effect on IL-6 levels, as main surrogated marker of inflammatory response
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 the published article, the trial registries and supplementary materials were used in data extraction and assessment of risk of bias. Neither protocol not statistical analysis plan was available. The primary outcomes in the article reflected those in the registry. Some secondary outcomes in the registry were not reported in the article. There was no change from the trial registration in the intervention and control treatments. The study (n = 103) achieved its target sample size (n = 102).