Trial NCT04668469
Publication Elgazzar A, Research Square, 2020 ( double blinding)
Funding: No specific funding (No Funding/Support)
Conflict of interest: No
| Methods | |
| RCT Blinding: preprint | |
| Location :
Multicenter / Egypt Follow-up duration (days): 31 | |
| Inclusion criteria | diagnosed with COVID-19 infection with at least one positive rt-PCR result from nasopharyngeal/oropharyngeal swab; AND have either mild symptoms such as anosmia, loss of taste, fever or respiratory tract symptoms, gastrointestinal symptoms, etc. and free chest imaging; OR have symptoms such as fever, respiratory tract symptoms, gastrointestinal symptoms, etc. and pneumonia manifestations can be seen in chest imaging; 18 years up to 80 years old; not participating in other clinical trials within 30 days from administration of the study drugs. |
| Exclusion criteria | pregnancy; lactation; critical cases defined as: occurrence of respiratory failure requiring mechanical ventilation; Presence of shock; other organ failure that requires monitoring and treatment in the ICU; Severe COVID-19 confirmed cases; Respiratory rate more than 30/min; Blood oxygen saturation of less than 93%; PaO2/FiO2 ratio of less than 200; Lung infiltrates >50% of the lung fields or rapid progression within 24-48 hours; need respiratory support e.g. high flow oxygen noninvasive or invasive mechanical; hydroxychloroquine contra-indications: QTc > 500 m/sec, myasthenia gravis, porphyria, retinal pathology, epilepsy, G6PD deficiency, allergy to 4-aminoquinolone, chronic heart, kidney or liver disease, and arrhythmias. |
| Interventions | |
| Treatment
Ivermectin (0.4 mg/kg body weight to maximum 24 mg/ *)Co-Intervention: Standard care Duration : * |
|
| Control
Hydroxychloroquine (200 mg/ *) Duration : * | |
| Participants | |
| Randomized 200 participants (n1=100 / n2= 100) | |
| Characteristics of participants N=200 Mean age : 55.2 139 males Severity : Mild: n=* / Moderate: n=*/ Severe: n=0 Critical: n=0 | |
| Primary outcome | |
| In the register 1. Number of participants with improvement of clinical condition (symptoms and signs) [Time Frame: 3 months]: improvement of dyspnea using mMRC scale, disappearance of fever using thermometer, Fatigue using Fatigue Assessment Scale (FAS), and improvement of Oxygen saturation using pulse oximeter. 2. Reduction of recovery time, hospital stay days and mortality rate [Time Frame: 3 months]: recording days of clinical improvement (recovery time), hospital stay days and mortality rate. | |
| In the report clinical, laboratory investigations improvement and/or 2 consecutive negative PCR tests taken at least 48 hours apart. | |
| Documents avalaible |
Protocol NR Statistical plan NR Data-sharing stated Yes |
| 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 | The treatment groups in this report were extracted as 2 RCTs based on baseline severity: mild/moderate and severe COVID-19. In addition to the pre-print article, the study registry was used in data extraction and risk of bias assessment. The trial was registered after the study was completed. A participant flow diagram was not presented. Mortality was one of the primary outcomes in the registry but was not primary in the report. The method of analysis was not reported. There were no other substantive differences between the registry and pre-print in study population, procedures, or interventions. |