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

NCT04381884 | Completed Phase 2

• 1 other identifier: IVM-AR-1
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 3

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.

Conditions

COVID-19 Drug Treatment

Keywords

COVID-19; IVERMECTIN; SARS-CoV-2 viral load

Outcome Measures

Primary Outcomes (1)

• Reduction in SARS-CoV-2 viral load

  Number of patients in whom the SARS-CoV-2 viral load decreases after Ivermectin treatment

  1 - 5 days

Secondary Outcomes (5)

• Number of patients with partial or complete response in COVID-19 clinical symptoms

  1 - 7 days

• Number of patients with worsening in the clinical condition

  1 - 7 days

• Number of patients with adverse events as a measure of safety and tolerability

  1 month

• Ivermectin concentrations measured in plasma

  1 month

• Evaluation of reactivity of the antibodies against SARS-CoV-2

  1 month

Other Outcomes (1)

• Observed effects to Ivermectin serum concentrations quantified at different treatment time points.

  1 month

Study Arms (2)

IVERMECTIN (IVER P®)

EXPERIMENTAL

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.

CONTROL

NO INTERVENTION

Patients in this group will receive standard care.

Interventions

IVERMECTIN (IVER P®) arm will receive IVM 600 µg / kg once daily plus standard care. CONTROL arm will receive 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®)

Eligibility Criteria

• Age: 18 Years - 69 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients of both genders, aged between 18 and 69.
• Patients infected by SARS-CoV-2 confirmed by PCR.
• Hospitalized patients with symptoms onset 5 days before executing the Informed Consent.
• No comorbidities affecting the patient´s prognosis, rendering them high risk patients.
• Documented acceptance to participate by means of the execution of the Informed Consent.
• 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.

You may not qualify if:

• Allergy or hypersensitivity to ivermectin and/or its inactive ingredients.
• Patients meeting COVID-19 severity criteria, with respiratory distress or requiring intensive care.
• Using medications having potential activity against SARS-CoV-2 such as hydroxychloroquine, chloroquine, lopinavir, ritonavir, remdesivir, azithromycin in the last 3 months.
• Use of immunodepressants (including systemic corticosteroids) in the last 30 days.
• Known HIV infection with CD4 count \<300 cell/µL.
• Pregnant or lactating patients.
• Patients with other acute infectious diseases.
• Patients with medical conditions such as malabsorption syndromes affecting proper ivermectin absorption.
• Patients with acute allergy conditions or with severe allergic reactions background.
• Patients with autoimmune disease and/or decompensated chronic diseases.
• 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.

Sponsors & Collaborators

• Laboratorio Elea Phoenix S.A.: lead
• Universidad Nacional de Salta: collaborator
• Centro de Investigación Veterinaria Tandil CIVETAN: collaborator
• Fundación Hospital de Pediatría Prof. Dr. Juan P. Garrahan: collaborator
• Universidad Nacional de Quilmes: collaborator

Study Sites (3)

Hospital de Cuenca Alta

Cañuelas, Buenos Aires, Argentina

Location

Centro de Educación Médica e Investigaciones Clínicas "Norberto Quirno" CEMIC

Buenos Aires, Buenos Aires F.D., Argentina

Location

Hospital de Infecciosas Francisco Javier Muñiz

Buenos Aires, C1282AEN, Argentina

Location

Related Publications (1)

• Krolewiecki A, Lifschitz A, Moragas M, Travacio M, Valentini R, Alonso DF, Solari R, Tinelli MA, Cimino RO, Alvarez L, Fleitas PE, Ceballos L, Golemba M, Fernandez F, Fernandez de Oliveira D, Astudillo G, Baeck I, Farina J, Cardama GA, Mangano A, Spitzer E, Gold S, Lanusse C. Antiviral effect of high-dose ivermectin in adults with COVID-19: A proof-of-concept randomized trial. EClinicalMedicine. 2021 Jun 18;37:100959. doi: 10.1016/j.eclinm.2021.100959. eCollection 2021 Jul.

  PMID: 34189446 DERIVED

MeSH Terms

Conditions

COVID-19

Interventions

Ivermectin

Condition Hierarchy (Ancestors)

Pneumonia, Viral; 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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Patients will be randomized to receive Ivermectin 600 µg / kg / once daily plus standard care or standard care upon diagnosis of COVID-19.

Study Record Dates

• First Submitted: May 5, 2020
• First Posted: May 11, 2020
• Study Start: May 18, 2020
• Primary Completion: September 29, 2020
• Study Completion: September 29, 2020
• Last Updated: October 5, 2020

Record last verified: 2020-10

Locations

AR (3)