A Study to Evaluate the Efficacy and Safety of Ivermectin in COVID-19 Prevention (SAIVE)
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ClinicalTrials.gov Identifier: NCT05305560 |
Recruitment Status :
Completed
First Posted : March 31, 2022
Last Update Posted : January 23, 2023
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
COVID-19 | Drug: Ivermectin Tablets Drug: Matching placebo tablets | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 400 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double (Participant, Investigator) |
Primary Purpose: | Prevention |
Official Title: | A Multicentre Randomised, Double-Blind, Placebo-controlled, Study to Evaluate the efficAcy and Safety of Oral IVErmectin Tablets in the Prevention of COVID-19 |
Actual Study Start Date : | March 25, 2022 |
Actual Primary Completion Date : | September 15, 2022 |
Actual Study Completion Date : | October 13, 2022 |
Arm | Intervention/treatment |
---|---|
Experimental: Active IMP |
Drug: Ivermectin Tablets
Daily ivermectin tablets intake for 28 days ; 200 mcg/kg on D1 then 100 mcg/kg daily from D2 to D28. |
Placebo Comparator: Placebo |
Drug: Matching placebo tablets
Daily placebo tablets intake for 28 days |
- COVID-19 prophylaxis [ Time Frame: From Day 1 to Day 28 ]Proportion of laboratory-confirmed COVID-19 infections between baseline and Day 28
- COVID-19 prophylaxis timeframe [ Time Frame: From Day 1 to Day 28 ]Time to change from baseline in negative RT-PCR to positive RT-PCR
- COVID-19 symptoms development [ Time Frame: From Day 1 to Day 28 ]Change from baseline in the WHO-COVID 19 and NEWS-2 scores
- COVID-19 symptoms development timeframe [ Time Frame: From Day 1 to Day 28 ]Time to change from baseline to first COVID-19 related clinical events
- COVID-19 hospitalisations [ Time Frame: From Day 1 to Day 56 ]Proportion of COVID-19 related hospitalisations
- COVID-19 mortality [ Time Frame: From Day 1 to Day 56 ]Proportion of COVID-19 related mortality
- Safety and tolerability [ Time Frame: From Day 1 to Day 56 ]Safety and Tolerability of ivermectin based on TEAEs and SAEs
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years to 65 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Age between 18 and 65 years, inclusive.
- Body weight >45 kg.
- Body Mass Index >18.5.
- Close contact with a person who has a PCR-confirmed SARS-CoV-2 infection within 5 days before screening.
- Only one member in the same household will be enrolled.
- Participants must be able to give informed consent and comply with the study's scheduled events/visits and study assessments.
- SARS-CoV-2 positive index case must be able to give consent to enable collection of the documented positive PCR test.
- Female participants of childbearing potential must use a highly effective method of contraception for the duration of the trial.
Exclusion Criteria:
- Pregnant or breast-feeding.
- Participants who have been administered COVID-19 vaccine prior to the inclusion or have a planned vaccination during the duration of the study.
- A positive COVID-19 result (PCR or antigen test) within 8 days of screening.
- Presence of typical COVID-19 symptoms (fever >38°C, SpO2 below 93%, dyspnoea, difficulty breathing, chills, repeated shaking with chills, ageusia, anosmia, cough, myalgia, headache) in the past 48 hours prior to screening.
- Hypersensitivity to any component of ivermectin.
- Participants who have been administered ivermectin within 30 days prior to screening.
- Participation in another interventional trial within the last 30 days or 5 half-lives of the IMP of the other trial, whichever comes first.
- Participants with gastrointestinal erosions and ulcers (e.g. erosive esophagitis, stomach ulcers, ulcerative colitis etc.).
- History of neurotoxicity with ivermectin or other para-glycoprotein (p-gp) substrates or inhibitors.
- Current use of monoclonal antibodies for the treatment of COVID-19.
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): NCT05305560
Bulgaria | |
Medical Center Medic Ltd. | |
Sofia, Bulgaria |
Principal Investigator: | Anna Kostova, MD | Medical Center Medic Ltd. |
Responsible Party: | MedinCell S.A |
ClinicalTrials.gov Identifier: | NCT05305560 |
Other Study ID Numbers: |
mdc-TTG-CT-002 2021-001938-19 ( EudraCT Number ) |
First Posted: | March 31, 2022 Key Record Dates |
Last Update Posted: | January 23, 2023 |
Last Verified: | January 2023 |
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 |
Prophylaxis RT-PCR test |
COVID-19 Pneumonia, Viral Pneumonia Respiratory Tract Infections Infections Virus Diseases Coronavirus Infections Coronaviridae Infections |
Nidovirales Infections RNA Virus Infections Lung Diseases Respiratory Tract Diseases Ivermectin Antiparasitic Agents Anti-Infective Agents |