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 Duration : 6 days | |
| Participants | |
| Randomized 100 participants (n1=50 / n2= 50) | |
| Characteristics of participants N=100 Mean age : 56.1 41 males Severity : Mild: n=0 / Moderate: n=*/ Severe: n=* Critical: n=* | |
| 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 stated NR |
| 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. |