Clinical Trial to "Study the Efficacy and Therapeutic Safety of Ivermectin: (SAINTBO)
Status:
Not yet recruiting
Trial end date:
2021-12-05
Target enrollment:
Participant gender:
Summary
Coronavirus disease (COVID-19) is an infectious disease caused by a new virus. The disease
causes a respiratory illness (such as the flu) with symptoms such as cough, fever, and, in
more severe cases, respiratory distress, even developing Acute Respiratory Distress Syndrome,
evolving in some cases with the death of the patient. Currently, there are no specific
treatments for COVID-19. Currently, there are several ongoing clinical trials evaluating
possible treatments. Recently, Leon Caly reports here that Ivermectin, an FDA-approved
antiparasitic that was shown to have broad-spectrum antiviral activity in vitro, is an
inhibitor of the causative virus (SARS-CoV-2), with a single addition to Vero cells. hours
after infection with SARS-CoV-2 capable of a 5000-fold reduction in viral RNA at 48 h. (1)
Ivermectin, therefore, warrants further investigation for possible benefits in humans. The
reason for this study is to understand the effect of the drug in eradicating the virus.
It is a randomized controlled trial to evaluate the efficacy of Ivermectin in COVID-19. The
recruited patient will be assigned to two groups, (1) a group received ivermectin plus care
treatment (2) the placebo group plus standard care treatment. The result will be recorded by
documenting the RT-PCR reports confirmed at the time of recruitment and at 7 and 14 days
within the framework of the study, then they will be adapted to the national care protocol,
with 9 scheduled clinical and telemedicine interviews.
It will be a randomized controlled trial to be run in RT-PCR confirmed COVID-19 patients who
meet the inclusion criteria (asymptomatic/mild to moderate severity).
They will be divided into groups after randomization. Group A will be administered one (1) a
group received ivermectin plus standard of care treatment (2) the placebo group plus standard
of care treatment, along with the existing inpatient and outpatient management clinical
guidelines of the hospitals participating in the study, these being adapted to the National
standard.
The reverse transcriptase-polymerase chain reaction (RT-PCR) will be carried out on days 7
and 14 after the therapeutic intervention and the duration of time at which the RT-PCR
becomes negative and/or clinical evolution of the patient will be compared in both study
groups. The dose of the drug is not subject to change according to the patient's response or
the possible side effect of being administered in a single dose.