Covid-19 Living Data

Trial IRCT20190810044500N5
Publication Pourdowlat G, Phytother Res (2022) (published paper)
Dates: 2020-03-26 to 2020-09-30
Funding: Not reported/unclear
Conflict of interest: No

Methods
	RCT Blinding: single blinding
	Location : Multicenter / Iran Follow-up duration (days): 14
Inclusion criteria	Aged 18–80 years confirmed to be COVID-19 positive according to PCR results or manifestations in CT scan evidence of moderate to severe lung involvement based on CT scan Female patients were informed they should not become pregnant until 30 days after the end of the study not taking colchicine during the last week (due to the half-life of 20–40 hr of the drug)
Exclusion criteria	Shock or hemodynamic instability a history of Crohn's or ulcerative colitis, diarrhea, or chronic malabsorption neuromuscular diseases eGFR <30 ml/min a history of cirrhosis, hepatitis, or severe liver disease had used colchicine for other conditions such as gout or Mediterranean fever a history of an allergic reaction to colchicine were receiving chemotherapy for cancer were pregnant or lactating
Interventions
	Treatment Colchicine Initial dose: 0.5 mg/day orally for up to 3 days -Maintenance dose: 1 mg/day orally for 12 days
	Control Standard care
Participants
	Randomized participants : Colchicine=102 Standard care=100
	Characteristics of participants N= 202 Mean age : NR 93 males Severity : Mild: n=0 / Moderate: n=* / Severe: n=* Critical: n=0 Number of vaccinated participants: 0
Primary outcome
	In the register Clinical symptoms including fever, cough, shortness of breath. Timepoint: The first, third, seventh, fourteenth and 6-8 days after entering the study. Method of measurement: questionnaire. Laboratory symptoms (ESR, CRP, NLR, LDH, ferritin, D-dimer, CBC diff). Timepoint: Hospitalization time and discharge time. Method of measurement: Blood test. O2sat at the time of hospitalization and discharge. Timepoint: The first, third, seventh, fourteenth and 6-8 days after entering the study. Method of measurement: Pulse Oximeter. Pulmonary infiltration findings on CT scan. Timepoint: Two weeks later and 6-8 weeks later. Method of measurement: CT-scan.
	In the report Clinical status distribution on chest CT evaluations
Documents available	Protocol NR Statistical plan NR Data-sharing willing stated in the publication: N
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 retrospective study registry was used in data extraction and risk of bias assessment. The protocol and statistical analysis plan were not available. As the registry was retrospective we were unable to determine if the intervention, sample size and analysis plan were determined a-priori. The primary outcome for the paper was unclear, while the registry had four primary outcomes. Some outcomes from the registry are not reported in the paper (e.g., Mortality and Need hospitalization in ICU).