Trial NCT04591600
Publication Hashim A, medRxiv, 2020 (preprint)
Dates: 2020-07-01 to 2020-09-30
Funding: Public/non profit (Baghdad-Alkarkh General Directorate of Health in Bghadad, Iraq)
Conflict of interest: No
| Methods | |
| RCT Blinding: single blinding | |
| Location :
Multicenter / Iraq Follow-up duration (days): 56 | |
| Inclusion criteria | COVID-19 patients at any stage of this disease;
Symptomatic for no more than three days for mild-moderate cases, no more than two days after being severe cases, and no more than one day after being critical cases |
| Exclusion criteria | Patients of allergic history to Ivermectin or to doxycyline |
| Interventions | |
| Treatment
Ivermectin+Doxycycline (200 mcg/kg+100 mg/ )Co-Intervention: Standard care Duration : |
|
| Control
Standard care Definition of Standard care: - Acetaminophen 500 mg on need - Vitamin C 1000 mg twice/ day - Zinc 75-125 mg/day - Vitamin D3 5000IU/day - Azithromycin 250mg/day for 5 days - Oxygen therapy/ C-Pap if needed - Dexamethasone 6 mg/day or methylprednisolone 40mg twice per day, if needed - Mechanical ventilation, if needed | |
| Participants | |
| Randomized 140 participants (n1=* / n2= *) | |
| Characteristics of participants N=140 Mean age : NR 73 males Severity : Mild: n=* / Moderate: n=*/ Severe: n=* Critical: n=* | |
| Primary outcome | |
| In the register 1. Mortality rate [ Time Frame: Up to 8 weeks ] The effect of the experimental drugs to reduce the mortality rate (death rate) of treated patients. 2. Rate of progression disease [ Time Frame: up to 8 weeks ] Rate of patients under treatment who undergo progression of disease to a more advanced stage | |
| In the report NR | |
| Documents available |
Protocol NR Statistical plan NR Data-sharing stated Unclear |
| 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 |
High |
| General comment | In addition to all available versions of the pre-print, the study register was used in data extraction and risk of bias assessment. No sample size calculation was reported.The study used quasi-randomized allocation, with participants allocated to treatments according to their day of recruitment; this method was compromised in that all critical patients were allocated to the experimental treatment arm, reported as being for ethical reasons. The type of blinding extracted for the study was based on the registry as no information was stated in the report regarding this. There was also no primary or secondary outcomes reported in the paper, nor a flow chart or explicit mention of the absolute number of patients randomized per arm. |