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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
Sponsor:
Information provided by (Responsible Party):
Francisco Luis Ochoa-Jaramillo, MD, CES University

Brief Summary:

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 Unfortunately, this study was withdrawn by its authors, leaving more questions than answers.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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
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)
Masking Description:

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.

Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

Drug Information available for: Ivermectin

Arm Intervention/treatment
Experimental: Intervention
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
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.
Other: Placebo
Routinary care offered in the hospital plus placebo (2 drops per kg) orally in a single dose
Other Name: Control




Primary Outcome Measures :
  1. Admission to the intensive care unit. [ Time Frame: 21 days ]
    Cumulative incidence of ICU admission.


Secondary Outcome Measures :
  1. Hospital length of stay. [ Time Frame: 21 days ]
    Duration of hospitalization (days).

  2. Mortality rate. [ Time Frame: 21 days ]
    21-day mortality.

  3. ICU length of stay. [ Time Frame: 21 days ]
    Number of days in ICU.

  4. Length of stay in ventilator time. [ Time Frame: 21 days ]
    Number of days with mechanical ventilator.

  5. Adverse effects of ivermectin. [ Time Frame: 21 days ]
    Cumulative incidence of adverse effects: headache, rash, pruritus, arthralgia, tachycardia, dizziness, hypotension, uveitis, Steven Johnson Syndrome.



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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Over 18 years old.
  • Confirmed diagnosis of SARS-CoV-2 by polymerase chain reaction (PCR).
  • Diagnosis of severe pneumonia according to criteria of the National Institute of Health and the Colombian Consensus (suspected respiratory infection, organ failure, arterial oxygen saturation (SaO2) ambient air <90% or respiratory rate > 30 resp/min) or diagnosis of acute respiratory distress syndrome according to criteria of the National Institute of Health and the Colombian Consensus (clinical findings, bilateral radiographic infiltrates, + oxygenation deficit as well: mild: 200 mmHg < PaO2/FiO2 (fraction of inspired oxygen) < 300 mm/Hg; moderate: 100 mm/Hg < PaO2/FiO2 < 200 mm/Hg and, severe: PaO2/FiO2 < 100 mm/Hg).
  • Less than 14 days since the onset of symptoms.
  • Hospitalized in a general internal medicine ward, special care unit, or those designated for managing patients with COVID19.

Exclusion Criteria:

  • Pregnant or lactating women.
  • Use of ivermectin in the two weeks before admission to the clinic
  • Diseases affecting the blood-brain barrier (meningitis, encephalocranial trauma, acute subarachnoid hemorrhage)
  • Limitation to understanding the explanations and giving consent, defined by the investigating physician.
  • Patients with HIV/AIDS
  • That the patient is participating in another clinical trial.

Information from the National Library of Medicine

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


Contacts
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Contact: Federico Rodríguez-Vega, MD; 57-3104261578 federicorodriguez@clinicaces.edu.co
Contact: Nora Cardona.-Castro, MD;MSc;PhD 57-3108987451 ncardona@ces.edu.co

Locations
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Colombia
Clinica CES Recruiting
Medellín, Antioquia, Colombia, 050001
Contact: Federico Rodriguez-Vega, MD;Internist    57-3104261578    federicodriguez@clinicaces.edu.co   
Contact: Veronica Posada-Velez, MD;Internist    57-3006523499    veposada@uces.edu.co   
Sponsors and Collaborators
CES University
Investigators
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Principal Investigator: Francisco L Ochoa-Jaramillo, MD; MSc CES University
Publications:

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Responsible Party: Francisco Luis Ochoa-Jaramillo, MD, Principal Investigator, CES University
ClinicalTrials.gov Identifier: NCT04602507    
Other Study ID Numbers: ECA-COVID-CES
First Posted: October 26, 2020    Key Record Dates
Last Update Posted: November 15, 2021
Last Verified: November 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: 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 Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Time Frame: One year
Access Criteria: Under direct request to principal investigator

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Francisco Luis Ochoa-Jaramillo, MD, CES University:
COVID19 drug treatment
Randomized Clinical Trial
Ivermectin
Hospitalized
Intensive Care Unit
SARS-CoV-2
Pneumonia, Viral
Additional relevant MeSH terms:
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COVID-19
Severe Acute Respiratory Syndrome
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases
Ivermectin
Antiparasitic Agents
Anti-Infective Agents