Ivermectin Effect on SARS-CoV-2 Replication in Patients With COVID-19
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|ClinicalTrials.gov Identifier: NCT04381884|
Recruitment Status : Recruiting
First Posted : May 11, 2020
Last Update Posted : May 27, 2020
|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)|
|Estimated 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|
|Estimated Primary Completion Date :||June 30, 2020|
|Estimated Study Completion Date :||June 30, 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 ]
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
|Contact: Alejandro Krolewiecki, MD||+54-911 3183 email@example.com|
|Contact: Marcelo A Tinelli, MD||+54-911 4489 8300 ext firstname.lastname@example.org|
|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 email@example.com|
|Principal Investigator: Ricardo Valentini, MD|