Trial IRCT20200418047126N1
Publication Salehzadeh F, Research Square (2020) (preprint)
Dates: 2020-05-21 to 2020-06-20
Funding: Public/non profit (Ardabil University of Medical Sciences)
Conflict of interest: No

Methods
RCT
Blinding:
Location : Single center / Iran
Follow-up duration (days): 22
Inclusion criteria
  • Pulmonary involvement seen in CT-Scan compatible with COVID-19 and Positive PCR of COVID-19
Exclusion criteria
  • Sensitivity to any medications of regimens, renal failure, heart failure, pregnancy, participating in another clinical study and refusal to participate in the study before or during the follow-up period
Interventions
Treatment
Colchicine
1 mg orally once a day for 6 days.
Control
Placebo

Participants
Randomized
participants :
Colchicine=50
Placebo=50
Characteristics of participants
N= 100
Mean age : NR
41 males
Severity : Mild: n=0 / Moderate: n=* / Severe: n=* Critical: n=*
Number of vaccinated participants: NR
Primary outcome
In the register
Hospitalization outcome, fever cessation, hospitalization time
In the report
(1) Length of hospitalization; (2) symptoms and (3) Co-existed disease.
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 preprint article, the trial registration was used for data extraction and risk of bias assessment. There were considerable differences between outcomes reported in the pre-print article and those in the study registry. Symptoms and co-existed disease were outcomes in the report but they were not specified in the registry. There was a difference in treatment duration between study registry and pre-print article.