Ivermectin Versus Standard Treatment in Mild COVID-19
Status:
Not yet recruiting
Trial end date:
2021-11-01
Target enrollment:
Participant gender:
Summary
Rationale: Ivermectin, an inexpensive and available antiparasitic drug, with favourable
safety profile, showed inhibitory effect on SARS-CoV2 viral replication in-vitro and in
animal models. Several research groups investigated Ivermectin in COVID-19, particularly in
mild symptomatic disease. There is high degree of uncertainty on its effects on clinical
outcomes and larger studies are needed.
Objectives: Plan to study the effect of Ivermectin versus standard treatment in patients with
confirmed mild COVID-19.
Study design: Multi-centre prospective cohort study Settings: Assiut University Hospital
(Assiut University), Aswan and others, Egypt.
Study Population: Patients with confirmed mild COVID-19. Intervention: Patients with mild
symptomatic COVID-19 attending the participating out-patient clinics in different centers
will receive either Ivermectin + Standard treatment or Standard treatment only. All new mild
symptomatic COVID-19 patients will receive Ivermectin + Standard treatment for the first two
weeks of the study. During the following four weeks, all new patients will receive standard
treatment only. These cycles will be repeated until 822 patients are recruited in each arm.
Patients assigned to Ivermectin + Standard treatment or standard treatment only will remain
as such throughout the study and during the follow- up period.
Primary outcome measures: The primary outcome will be rate of intensive care admission.
Secondary outcome measures: Secondary outcomes will be time to clinical improvement, the
clinical state using 7-point ordinal scale at different time points, need for home
oxygenation, hospitalization, hospital supplemental oxygen >24 hours, Non- invasive
ventilation ( High- flow nasal cannula, High- velocity nasal insufflation or BiPAP), duration
of hospitalization, duration of ICU stay and deaths within 21 days,.
Power calculation:
With a prospective cohort design, a sample size of 822 cases per group is estimated (1644 for
the whole study). This calculation depends on a rate of ICU admission in mild symptomatic
COVID-19 cases of 8.5%, an assumption that Ivermectin can reduce this rate by 50%, at a study
power of 80%, and confidence limit of 0.95.