Ivermectin Effect on SARS-CoV-2 Replication in Patients With COVID-19
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|ClinicalTrials.gov Identifier: NCT04381884|
Recruitment Status : Completed
First Posted : May 11, 2020
Last Update Posted : October 5, 2020
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|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|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||45 participants|
|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)|
|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|
|Actual Primary Completion Date :||September 29, 2020|
|Actual Study Completion Date :||September 29, 2020|
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.
- 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
- 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
- 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
- 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)
- Ivermectin concentrations measured in plasma [ Time Frame: 1 month ]
- 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
- Observed effects to Ivermectin serum concentrations quantified at different treatment time points. [ Time Frame: 1 month ]
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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|
- 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.
- 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.
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
|Hospital de Cuenca Alta|
|Cañuelas, Buenos Aires, Argentina|
|Centro de Educación Médica e Investigaciones Clínicas "Norberto Quirno" CEMIC|
|Buenos Aires, Ciudad De Buenos Aires, Argentina|
|Hospital de Infecciosas Francisco Javier Muñiz|
|Ciudad Autonoma de Buenos Aires, Argentina, C1282AEN|
|Responsible Party:||Laboratorio Elea Phoenix S.A.|
|Other Study ID Numbers:||
|First Posted:||May 11, 2020 Key Record Dates|
|Last Update Posted:||October 5, 2020|
|Last Verified:||October 2020|
|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|
SARS-CoV-2 viral load
Respiratory Tract Infections
RNA Virus Infections
Respiratory Tract Diseases