Trial NCT04784481
Publication Chahla R, Research Square (2021) (preprint)

Funding: Public/non profit (Ministry of Public Health, Tucumán, Argentina)
Conflict of interest: No

Methods
RCT
Blinding: Unblinded
Location : Multicenter / Argentina
Follow-up duration (days): 28
Inclusion criteria
  • Over 18 years of age of any sex
  • Outpatients infected by SARS-CoV-2 conrmed by positive RT-PCR test
  • Women of childbearing age with a negative pregnancy test
  • Mild disease-patients with two or more of the following symptoms: fever less than 38·5°C and higher than 37.5°C according to Ministry of Health, Argentina(16), isolated diarrheal episodes, hyposmia or hypogeusia, mild desaturation (between 96 and 93%), dyspnea, polyarthralgia, persistent headache, abdominal pain, erythema of the kidney, nonspecic rash
Exclusion criteria
  • Hypersensitivity or allergy to ivermectin
  • Pregnant or lactating
  • Children or adolescents under 18 years of age
  • Patients with neurological pathology, renal insuciency, hepatic insuciency
  • Weight less than 40kg
  • Patients with concomitant use of drugs that act on GABA, barbiturate and benzodiazepine receptors
  • Patients who have not completed / signed the informed consent
Interventions
Treatment
Ivermectin
24 mg orally every 7 days for 4 weeks
Control
Standard care

Participants
Randomized
participants :
Standard care=144
Ivermectin=110
Characteristics of participants
N= 254
Mean age : NR
121 males
Severity : Mild: n= 254/ Asymptomatic: n=0
Number of vaccinated participants: NR
Primary outcome
In the register
Proportion of patients with symptoms (fever, diarrhea, taste and/or smell disturbance, SpO2, polyarthralgia, headache, body pain, abdominal pain, ALRI symptoms and signs) [ Time Frame: from 5th to 9th day ]; [ Time Frame: from 10th to 14th day ]
In the report
Increase discharge from outpatient care with COVID-19 mild disease
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 pre-print article, the retrospective study registry was used in data extraction and risk of bias assessment. Protocol or statistical analysis plan were not available. Sample size calculation was presented and target number enrolled was achieved. Number or size of clusters were not reported; results were reported for individuals, not clusters. The study included mild outpatients and the main outcomes were symptoms and discharge from outpatient care, harms/adverse events were not reported.