Trial NCT04403555
Publication Abd-Elsalam S, J Med Virol, 2021 (published paper)
Dates: 2020-03-01 to 2020-10-30
Funding: Not reported/unclear
Conflict of interest: No
| Methods | |
| RCT Blinding: Unblinded | |
| Location :
Multicenter / Egypt Follow-up duration (days): 30 | |
| Inclusion criteria | adult patients from ages 20 to 65; mildly to moderately affected COVID-19 infection confirmed by pharyngeal swab polymerase chain reaction |
| Exclusion criteria | allergy or contraindication to the drugs used in the study; pregnant and lactating mothers; patients with cardiac problems |
| Interventions | |
| Treatment
Ivermectin 12 mg per day orally for 3 days |
|
| Control
Standard care ( / ) Definition of Standard care: standard protocol of treatment according to the Egyptian Ministry of Health protocol of COVID-19 treatment: paracetamol, oxygen, fluids (according to the condition of the patient), empiric antibiotic, oseltamivir if needed (75 mg/12 h for 5 days), and invasive mechanical ventilation with hydrocortisone for severe cases if PaO2 less than 60 mm Hg, O2 saturation less than 90% despite oxygen or noninvasive ventilation, progressive hypercapnia, respiratory acidosis (pH < 7.3), and progressive or refractory septic shock | |
| Participants | |
| Randomized 164 participants (n1=82 / n2= 82) | |
| Characteristics of participants N=164 Mean age : 40.9 82 males Severity : Mild: n=* / Moderate: n=*/ Severe: n=* Critical: n=* | |
| Primary outcome | |
| In the register The number of patients with resolved viral infection [Time Frame: 6 months] (2020-05-23) The number of patients with mortality [Time Frame: 1 month] (2021-03-03) | |
| In the report All-cause mortality within 1 month after randomization | |
| Documents available |
Protocol NR Statistical plan NR Data-sharing stated
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| 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 registry was used in data extraction and risk of bias assessment. Neither protocol not statistical analysis plan was available. The trial was first registered during the conduct of the study. There were substantial changes to methods during and after the conduct of the study from the initial trial registration to the final registration and report. The sample size was reduced. Intervention and control treatments changed from ivermectin with doxycycline compared with chloroquine to ivermectin compared with standard care. The ivermectin dosage was changed. The primary outcome changed from resolved viral infection to mortality, and additional outcomes were added after the study had been completed. |