Trial NCT04716569
Publication Aref ZF, Int J Nanomed (2021) (published paper)
Dates: 2021-02-20 to 2021-03-30
Funding: Public/non profit (South Valley University, Faculty of Medicine)
Conflict of interest: No

Methods
RCT
Blinding: Unblinded
Location : Single center / Egypt
Follow-up duration (days): *
Inclusion criteria
  • Diagnosed as mild COVID-19 - defined as symptomatic case with lymphopenia or leucopenia with no radiological signs for pneumonia
  • confirmed by real-time PCR test positive for SARS-CoV-2 using upper respiratory tract swabs
  • written informed consent.
Exclusion criteria
  • Patients with severe COVID-19 - severe or critical COVID-19 was diagnosed by the presence of one or more of the following
  • (1) respiratory rate 30 cycles per minute or more,
    (2) resting room air oxygen saturation of 93% or less,
    (3) PaO2/FiO2 is 300 mmHg or less,
    (4) respiratory failure requiring mechanical ventilation, shock, organ dysfunction syndrome and ICU admission.
    Patients indicated to receive systemic ivermectin according to the Egyptian management protocol for COVID-19 patients
  • chronic ENT disorders such as chronic sinusitis, nasal allergy, patients using nasal spray preparation
  • systemic or local use of steroids due to any cause
  • allergic to ivermectin
  • children and pregnant women.
Interventions
Treatment
Ivermectin
70 mcg/mL by intranasal spray twice a day
Control
Standard care

Participants
Randomized
participants :
Ivermectin=57
Standard care=57
Characteristics of participants
N= 114
Mean age : NR
82 males
Severity : Mild: n= 114/ Asymptomatic: n=0
Number of vaccinated participants: NR
Primary outcome
In the register
Progression of covid 19 clinical picture [ Time Frame: within 14 days after enrollement ]
In the report
Clinical improvements of the presenting manifestations with recording the recovery duration for every manifestation
Documents
available

Protocol

NR

Statistical plan

NR

Data-sharing willing stated in the publication:

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 In addition to the published article, the prospective trial registry was used in data extraction and assessment of risk of bias. Neither protocol nor statistical analysis plan was available. There is no change from the trial registration in the intervention and control treatments. The extracted outcome (negative viral conversion was not explicitly included as an outcome in the registry (progress of Symptoms ( Fever ,Cough, Sore Throat, Myalgia, Diarrhea, Shortness of Breath) with radiological assessment and blood tests). The trial (n = 114) did not achieve its pre-stated target sample size (n = 150).