Clinical Trial to "Study the Efficacy and Therapeutic Safety of Ivermectin: (SAINTBO)

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.

Conditions

• Covid19

Interventions

DRUG

Ivermectin

Participants will be randomly assigned to receive a single 600 µg / kg dose of ivermectin or placebo.

DRUG

Placebo

Participants will be randomly assigned to receive a single of placebo.

Sponsors & Collaborators

• Barcelona Institute for Global Health

  collaborator OTHER

• Université Catholique de Louvain

  collaborator OTHER

• Universidad Mayor de San Simón

  lead OTHER

Principal Investigators

• Carlos L Erostegui, MPH · Universidad Mayor de San Simón

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

75 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2021-05-08

Primary Completion

2021-07-08

Completion

2021-12-05

Countries

• Bolivia

Study Locations