Our previous study was a prospective, community-based, randomized, controlled-intervention study registered with Clintrials.gov;
NCT04422561 and approved by the IRB, Faculty
of Medicine, Zagazig
University, Code: 6150-31-5-2020 [6,7]. Asymptomatic home family members who were
in close contact with COVID-19 cases
diagnosed at Zagazig University Hospitals,
and a triage and isolation
hospital. It was planned to include contacts of 50 confirmed RT-PCR COVID-19
patients in each arm. But during
recruitment, and since the trial was unblended, the detected high protective efficacy of ivermectin
caused the researchers to stop the no-intervention arm prematurely.
Inclusion criteria included
asymptomatic close family contacts of a confirmed RT-PCR COVID-19 index case,
with age equal to or greater than 16
years. Two arms (or two groups) were designed
according to the use of ivermectin: The first group (the ivermectin group)
received ivermectin on the day of their index case diagnosis. It was administered as a single dose on an empty stomach on the
first day (the day of diagnosis), and repeated again on the third day (two doses total). The dose has been
adjusted to body weight (BW) as
follows: 15 mg/day for people aged 40-60 kg
body weight; 18 mg / day 60-80 kg; and 24 mg/day for those over 80 kg body weight.
The second group (no-intervention group), none of which received ivermectin.
Both groups were followed for two weeks, to detect the
development of symptoms suggestive of
COVID-19. In the ivermectin group, participants were followed-up for possibility of drug side effects. Our
primary goal was prevention of COVID-19 and early detection
of infection in any of
contacts. Results showed that ivermectin group
included 203 contacts (to 52 index cases) aged 39.75±14.94 years. Nonintervention group included 101 contacts. Fifteen
contacts (7.4%) developed
COVID-19 in the ivermectin group compared to 59 (58.4%)
in the non-intervention arm (P <0.001). The protection
rate for ivermectin was more prominent in contacts aged less than 60-year-old (6.2% infected compared to 58.7% if no treatment). Side effects of ivermectin
were reported in 5.4% of cases;
they were mild and did not require discontinuation of the drug. They included diarrhea, nausea,
fatigue, slight abdominal pain,
heartburn and burning sensation [8,9].
On the other hand, we observed a
great success of ivermectin in treatment of early stages of COVID-19.
Treatment included 4 tablets (each contains 6 mg) of ivermectin, as a single dose per day on an empty stomach for 4 consecutive days. This was concomitant with antihistamine, antipyretic and nasal decongestant tablet, one before bed for 10 days. At the end of
treatment protocol, the cases were
shown to be improved with relief of most symptoms and signs except mild headache that improved with time.