Ivermectin in Adults With Severe COVID-19.
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|ClinicalTrials.gov Identifier: NCT04602507|
Recruitment Status : Recruiting
First Posted : October 26, 2020
Last Update Posted : November 15, 2021
Since the onset of the disease, more than 40.5 million people have been diagnosed with COVID-19 and nearly 1.2 million people have died (October 21, 2020). There is no complete understanding of the pathogenesis of SARS-CoV-2 infection and to this day there is no specific therapy or vaccine available. Thus, patient care is based on symptomatic therapy and treatment of complications.
Ivermectin has been used for more than 30 years for the treatment of several diseases. More than one million doses of the drug are administered daily, particularly in low- and middle-income countries. Due to the low prevalence of adverse events with the use of this drug, ivermectin is considered to have a good safety profile and its potential benefit in other diseases is currently under investigation.
An in vitro study of ivermectin in SARS-CoV-2 in Australia showed a significant reduction of viral load in infected cells. Subsequently, a descriptive study of 704 critical patients with COVID-19 showed a reduction in mortality, hospitalization, and intensive care unit length-of-stay in those patients who received the drug. Unfortunately, this study was withdrawn by its authors, leaving more questions than answers.
Some countries in Latin America have authorized its use for the management of patients with COVID-19 even in the absence of solid evidence, and several other countries are conducting clinical trials to evaluate its efficacy for the treatment of moderate and severe disease.
Since there is no specific treatment for COVID-19 and the therapeutic options are scarce, the researchers believe it is completely plausible, urgent, and necessary to evaluate if ivermectin use reduces the risk of admission to an intensive care unit (ICU) in hospitalized adults with severe COVID-19. The proposal is a randomized, double-blind clinical trial, conducted at CES Clinic, Medellin-Colombia. The investigators will randomize 100 patients with severe, non-critical illness, into two groups, one group will receive ivermectin in addition to standard management and the other group will receive placebo plus standard management. Clinical outcomes to evaluate will be ICU admission, need for mechanical ventilation, length of hospital stay, days in the ICU and mechanical ventilation, and finally, the incidence of adverse events related to the intervention. The estimated time to complete the study is approximately five months.
|Condition or disease||Intervention/treatment||Phase|
|Covid19 Severe Acute Respiratory Syndrome||Drug: Ivermectin Other: Placebo||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||
Arm #1: 50 patients with routine care offered in the hospital plus ivermectin 400 µg/kg orally in a single dose.
Arm #2: 50 patients with routine care offered in the hospital plus placebo in a single dose.
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
Once the participant consents, staff will collect relevant demographic and clinical data from the clinical chart and a consecutive code from 001 to 100 will be assigned to each in order of arrival. 100 vials of ivermectin or placebo will be stored in the pharmaceutical service with a randomly assigned number from 001 to 100. After placement of medical order, the qualified nursing staff will dispense ivermectin or placebo. Blinded study physicians will carry on daily medical evaluation. Neither the researchers collecting data nor the analyzers will be aware of the patients' treatment arm.
To achieve blinding, a certified pharmaceutical laboratory produced a placebo identical in color, physical form, sensory perception (appearance, smell, and taste), packaging, and labeling to ivermectin.
|Official Title:||Ivermectin in Adults With Severe COVID-19. Double-blind Randomized Clinical Trial|
|Actual Study Start Date :||December 10, 2020|
|Estimated Primary Completion Date :||December 9, 2021|
|Estimated Study Completion Date :||December 9, 2021|
50 patients with the routine care offered in the hospital plus ivermectin 400 µg/kg (2 drops per kg) orally in a single dose.
Routinary care offered in the hospital plus ivermectin 400 µg/kg (2 drops per kg) orally in a single dose.
Other Name: Intervention
Placebo Comparator: Control
50 patients with routine care offered in the hospital plus placebo orally (2 drops per kg) in a single dose.
Routinary care offered in the hospital plus placebo (2 drops per kg) orally in a single dose
Other Name: Control
- Admission to the intensive care unit. [ Time Frame: 21 days ]Cumulative incidence of ICU admission.
- Hospital length of stay. [ Time Frame: 21 days ]Duration of hospitalization (days).
- Mortality rate. [ Time Frame: 21 days ]21-day mortality.
- ICU length of stay. [ Time Frame: 21 days ]Number of days in ICU.
- Length of stay in ventilator time. [ Time Frame: 21 days ]Number of days with mechanical ventilator.
- Adverse effects of ivermectin. [ Time Frame: 21 days ]Cumulative incidence of adverse effects: headache, rash, pruritus, arthralgia, tachycardia, dizziness, hypotension, uveitis, Steven Johnson Syndrome.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04602507
|Contact: Federico Rodríguez-Vega, MD;||email@example.com|
|Contact: Nora Cardona.-Castro, MD;MSc;PhDfirstname.lastname@example.org|
|Principal Investigator:||Francisco L Ochoa-Jaramillo, MD; MSc||CES University|