A Phase 2 interventional study of Ivermectin and Placebo in Covid19 and Severe Acute Respiratory Syndrome, sponsored by CES University. Terminated at 1 site in Colombia. Open to participants aged 18 Years to 100 Years. Per ClinicalTrials.gov, last updated 2022-01-04.
Sponsored by CES University · Phase 2, Interventional, and Treatment
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 Unfortunately, this study was withdrawn by its authors, leaving more questions than answers.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.
7,990 studies on the registry are indexed under COVID-19; 466 are open to participants now.
This study's enrollment of 75 is below the median of 102 across 4,364 interventional studies indexed under COVID-19.
Browse COVID-19 studies →CES University is the lead sponsor of 29 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
50 patients with the routine care offered in the hospital plus ivermectin 400 µg/kg (2 drops per kg) orally in a single dose.
Drug: Ivermectin
50 patients with routine care offered in the hospital plus placebo orally (2 drops per kg) in a single dose.
Other: Placebo
Routinary care offered in the hospital plus ivermectin 400 µg/kg (2 drops per kg) orally in a single dose.
Also known as: Intervention
Routinary care offered in the hospital plus placebo (2 drops per kg) orally in a single dose
Also known as: Control
Admission to the intensive care unit.
Cumulative incidence of ICU admission.
Time frame: 21 days
Hospital length of stay.
Duration of hospitalization (days).
Time frame: 21 days
Mortality rate.
21-day mortality.
Time frame: 21 days
ICU length of stay.
Number of days in ICU.
Time frame: 21 days
Length of stay in ventilator time.
Number of days with mechanical ventilator.
Time frame: 21 days
Adverse effects of ivermectin.
Cumulative incidence of adverse effects: headache, rash, pruritus, arthralgia, tachycardia, dizziness, hypotension, uveitis, Steven Johnson Syndrome.
Time frame: 21 days
Plan to share: Yes — For a reasonable scientific purpose, we may share individual patient data (IPD) that underlie results in a publication under direct request to the principal investigator. We reserve our right to share IPD.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form
Time frame: One year
Access criteria: Under direct request to principal investigator
Ran from Dec 2020 to primary completion in Dec 2021, 11 months.
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This study is terminated, as verified in Dec 2021. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Ivermectin
CES University