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Ivermectin Effect on SARS-CoV-2 Replication in Patients With COVID-19

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04381884
Recruitment Status : Recruiting
First Posted : May 11, 2020
Last Update Posted : May 27, 2020
Sponsor:
Collaborators:
Universidad Nacional de Salta
Centro de Investigación Veterinaria Tandil CIVETAN
Hospital de Pediatría Prof Dr. Juan P. Garrahan
Universidad Nacional de Quilmes
Information provided by (Responsible Party):
Laboratorio Elea Phoenix S.A.

Brief Summary:
In the context of COVID-19 pandemic, a report on ivermectin suppression of SARS-CoV-2 viral replication in cell cultures has been published, and the use of this medication seems to be potentially useful for the therapy. IVM safety profile and IVM wide spectrum enables to move forward with the investigation in patients infected by SARS-CoV-2 as a proof-of-concept of its possible use in the management of patients with COVID-19, given the current pandemic situation.

Condition or disease Intervention/treatment Phase
COVID-19 Drug Treatment Drug: IVERMECTIN (IVER P®) arm will receive IVM 600 µg / kg once daily plus standard care. CONTROL arm will receive standard care. Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 45 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Patients will be randomized to receive Ivermectin 600 µg / kg / once daily plus standard care or standard care upon diagnosis of COVID-19.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Pilot, Proof of Concept Trial to Prove Ivermectin Efficacy in the Reduction of SARS-CoV-2 Replication at Early Stages of COVID-19
Actual Study Start Date : May 18, 2020
Estimated Primary Completion Date : June 30, 2020
Estimated Study Completion Date : June 30, 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Ivermectin

Arm Intervention/treatment
Experimental: IVERMECTIN (IVER P®)
Patients in this group will receive Ivermectin (IVER P®) 600 µg / kg / once daily plus standard care.
Drug: IVERMECTIN (IVER P®) arm will receive IVM 600 µg / kg once daily plus standard care. CONTROL arm will receive standard care.
IVERMECTIN (IVER P®) arm will receive IVM 600 µg / kg once daily plus standard care. CONTROL arm will receive standard care.

No Intervention: CONTROL
Patients in this group will receive standard care.



Primary Outcome Measures :
  1. Reduction in SARS-CoV-2 viral load [ Time Frame: 1 - 5 days ]
    Number of patients in whom the SARS-CoV-2 viral load decreases after Ivermectin treatment


Secondary Outcome Measures :
  1. Number of patients with partial or complete response in COVID-19 clinical symptoms [ Time Frame: 1 - 7 days ]
    Clinical symptoms will be assessed after the treatment with the study drug

  2. Number of patients with worsening in the clinical condition [ Time Frame: 1 - 7 days ]
    Effect of Ivermectin therapy on severity indicators such as need of intensive care unit and assisted ventilation, or mortality

  3. Number of patients with adverse events as a measure of safety and tolerability [ Time Frame: 1 month ]
    Ivermectin safety profile will be evaluated according to Common Terminology Criteria for Adverse Events (CTCAE version 4.0)

  4. Ivermectin concentrations measured in plasma [ Time Frame: 1 month ]
  5. Evaluation of reactivity of the antibodies against SARS-CoV-2 [ Time Frame: 1 month ]
    Effect of Ivermectin therapy on the onset of SARS-CoV-2 antibodies through the determination of serological changes


Other Outcome Measures:
  1. Observed effects to Ivermectin serum concentrations quantified at different treatment time points. [ Time Frame: 1 month ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 69 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patients of both genders, aged between 18 and 69.
  2. Patients infected by SARS-CoV-2 confirmed by PCR.
  3. Hospitalized patients with symptoms onset 5 days before executing the Informed Consent.
  4. No comorbidities affecting the patient´s prognosis, rendering them high risk patients.
  5. Documented acceptance to participate by means of the execution of the Informed Consent.
  6. Female patients of childbearing age must have a negative pregnancy test and must use adequate contraceptive methods (for example, intrauterine devices, hormonal contraceptives, barrier methods, chastity or tubal ligation) during their participation in the study and for one month after the last medication dose in the case of those receiving ivermectin.

Exclusion Criteria:

  1. Allergy or hypersensitivity to ivermectin and/or its inactive ingredients.
  2. Patients meeting COVID-19 severity criteria, with respiratory distress or requiring intensive care.
  3. Using medications having potential activity against SARS-CoV-2 such as hydroxychloroquine, chloroquine, lopinavir, ritonavir, remdesivir, azithromycin in the last 3 months.
  4. Use of immunodepressants (including systemic corticosteroids) in the last 30 days.
  5. Known HIV infection with CD4 count <300 cell/µL.
  6. Pregnant or lactating patients.
  7. Patients with other acute infectious diseases.
  8. Patients with medical conditions such as malabsorption syndromes affecting proper ivermectin absorption.
  9. Patients with acute allergy conditions or with severe allergic reactions background.
  10. Patients with autoimmune disease and/or decompensated chronic diseases.
  11. Patients with uncontrolled, intercurrent diseases including renal impairment, hepatic impairment, symptomatic congestive heart failure, unstable chest angina, heart arrhythmia or psychiatric conditions that may limit adherence to CT requirements.

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): NCT04381884


Contacts
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Contact: Alejandro Krolewiecki, MD +54-911 3183 8673 alekrol@hotmail.com
Contact: Marcelo A Tinelli, MD +54-911 4489 8300 ext 1290 tinellim@elea.com

Locations
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Argentina
Centro de Educación Médica e Investigaciones Clínicas "Norberto Quirno" CEMIC Recruiting
Buenos Aires, Ciudad De Buenos Aires, Argentina
Contact: Mónica Lombardo, MD    +5411-4371 0285    mlombardo@nobeltri.com   
Principal Investigator: Ricardo Valentini, MD         
Sponsors and Collaborators
Laboratorio Elea Phoenix S.A.
Universidad Nacional de Salta
Centro de Investigación Veterinaria Tandil CIVETAN
Hospital de Pediatría Prof Dr. Juan P. Garrahan
Universidad Nacional de Quilmes
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Responsible Party: Laboratorio Elea Phoenix S.A.
ClinicalTrials.gov Identifier: NCT04381884    
Other Study ID Numbers: IVM-AR-1
First Posted: May 11, 2020    Key Record Dates
Last Update Posted: May 27, 2020
Last Verified: May 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Laboratorio Elea Phoenix S.A.:
COVID-19
IVERMECTIN
SARS-CoV-2 viral load
Additional relevant MeSH terms:
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Ivermectin
Antiparasitic Agents
Anti-Infective Agents