Ivermectin in Adults With Severe COVID-19.

NCT04602507 | Terminated Phase 2 DMC

• 1 other identifier: ECA-COVID-CES
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

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 Unfortunately, this study was withdrawn by its authors, leaving more questions than answers.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

Conditions

Covid19; Severe Acute Respiratory Syndrome

Keywords

COVID19 drug treatment; Randomized Clinical Trial; Ivermectin; Hospitalized; Intensive Care Unit; SARS-CoV-2; Pneumonia, Viral

Outcome Measures

Primary Outcomes (1)

• Admission to the intensive care unit.

  Cumulative incidence of ICU admission.

  21 days

Secondary Outcomes (5)

• Hospital length of stay.

  21 days

• Mortality rate.

  21 days

• ICU length of stay.

  21 days

• Length of stay in ventilator time.

  21 days

• Adverse effects of ivermectin.

  21 days

Study Arms (2)

Intervention

EXPERIMENTAL

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

Control

PLACEBO COMPARATOR

50 patients with routine care offered in the hospital plus placebo orally (2 drops per kg) in a single dose.

Other: Placebo

Interventions

Ivermectin DRUG

Routinary care offered in the hospital plus ivermectin 400 µg/kg (2 drops per kg) orally in a single dose.

Also known as: Intervention

Intervention

Placebo OTHER

Routinary care offered in the hospital plus placebo (2 drops per kg) orally in a single dose

Also known as: Control

Control

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• CES University: lead

Study Sites (1)

Clinica CES

Medellín, Antioquia, 050001, Colombia

Location

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MeSH Terms

Conditions

COVID-19; Severe Acute Respiratory Syndrome; Pneumonia, Viral

Interventions

Ivermectin; Methods

Condition Hierarchy (Ancestors)

Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Macrolides; Polyketides; Lactones; Organic Chemicals; Investigative Techniques

Study Officials

• Francisco L Ochoa-Jaramillo, MD; MSc

  CES University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: October 22, 2020
• First Posted: October 26, 2020
• Study Start: December 10, 2020
• Primary Completion: December 9, 2021
• Study Completion: December 9, 2021
• Last Updated: January 4, 2022

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: One year
• Access Criteria: Under direct request to principal investigator

Locations

CO (1)