COVID-19
Conditions
Keywords
Prophylaxis, RT-PCR test
Brief summary
A multicenter, randomized, double-blind, placebo-controlled, study to evaluate the efficacy and safety of oral ivermectin tablets versus placebo for COVID-19 prophylaxis
Detailed description
This trial comprises a total observation period of up to 56 days (an on-treatment period of up to 28 days and a safety follow-up of up to 28 days).
Interventions
Daily ivermectin tablets intake for 28 days ; 200 mcg/kg on D1 then 100 mcg/kg daily from D2 to D28.
Daily placebo tablets intake for 28 days
Sponsors
Violaine Desort-Hénin, DVM
MedinCell S.A
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
1. Age between 18 and 65 years, inclusive. 2. Body weight \>45 kg. 3. Body Mass Index \>18.5. 4. Close contact with a person who has a PCR-confirmed SARS-CoV-2 infection within 5 days before screening. 5. Only one member in the same household will be enrolled. 6. Participants must be able to give informed consent and comply with the study's scheduled events/visits and study assessments. 7. SARS-CoV-2 positive index case must be able to give consent to enable collection of the documented positive PCR test. 8. Female participants of childbearing potential must use a highly effective method of contraception for the duration of the trial.
Exclusion criteria
1. Pregnant or breast-feeding. 2. Participants who have been administered COVID-19 vaccine prior to the inclusion or have a planned vaccination during the duration of the study. 3. A positive COVID-19 result (PCR or antigen test) within 8 days of screening. 4. 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. 5. Hypersensitivity to any component of ivermectin. 6. Participants who have been administered ivermectin within 30 days prior to screening. 7. Participation in another interventional trial within the last 30 days or 5 half-lives of the IMP of the other trial, whichever comes first. 8. Participants with gastrointestinal erosions and ulcers (e.g. erosive esophagitis, stomach ulcers, ulcerative colitis etc.). 9. History of neurotoxicity with ivermectin or other para-glycoprotein (p-gp) substrates or inhibitors. 10. Current use of monoclonal antibodies for the treatment of COVID-19.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| COVID-19 Prophylaxis | From Day 1 to Day 28 | Number of laboratory-confirmed COVID-19 infections in each group between baseline and Day 28 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| COVID-19 Symptoms Development | From Day 1 to Day 28 | Number of symptomatic Participants according to the WHO COVID-18 scale |
| COVID-19 Prophylaxis Timeframe | From Day 1 to Day 28 | Time to change from baseline in negative RT-PCR to positive RT-PCR |
| COVID-19 Hospitalisations | From Day 1 to Day 56 | Proportion of COVID-19 related hospitalisations |
| COVID-19 Mortality | From Day 1 to Day 56 | Proportion of COVID-19 related mortality |
| To Assess the Safety and Tolerability of IVM Given for a Period of 28 Days | 56 days | Descriptive comparison of AE rates and severity/seriousness between IVM and placebo |
Countries
Bulgaria
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Active IMP Ivermectin Tablets: Daily ivermectin tablets intake for 28 days ; 200 mcg/kg on D1 then 100 mcg/kg daily from D2 to D28. | 200 |
| Placebo Matching placebo tablets: Daily placebo tablets intake for 28 days | 199 |
| Total | 399 |
Baseline characteristics
| Characteristic | Placebo | Total | Active IMP |
|---|---|---|---|
| Age, Continuous | 39.99 years STANDARD_DEVIATION 12.03 | 40.42 years STANDARD_DEVIATION 11.93 | 40.86 years STANDARD_DEVIATION 11.84 |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Region of Enrollment Bulgaria | 199 participants | 399 participants | 200 participants |
| Sex: Female, Male Female | 90 Participants | 171 Participants | 81 Participants |
| Sex: Female, Male Male | 109 Participants | 228 Participants | 119 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 200 | 0 / 199 |
| other Total, other adverse events | 49 / 200 | 109 / 199 |
| serious Total, serious adverse events | 0 / 200 | 0 / 199 |
Outcome results
Primary
COVID-19 Prophylaxis
Number of laboratory-confirmed COVID-19 infections in each group between baseline and Day 28
Time frame: From Day 1 to Day 28
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Active IMP | COVID-19 Prophylaxis | 30 Participants |
| Placebo | COVID-19 Prophylaxis | 105 Participants |
Secondary
COVID-19 Hospitalisations
Proportion of COVID-19 related hospitalisations
Time frame: From Day 1 to Day 56
Population: Partcipants who had COVID-19 related hospitalisatoin episodes
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Active IMP | COVID-19 Hospitalisations | 0 participants |
| Placebo | COVID-19 Hospitalisations | 0 participants |
Secondary
COVID-19 Mortality
Proportion of COVID-19 related mortality
Time frame: From Day 1 to Day 56
Population: Participants who suffered a COVID-19 related death
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Active IMP | COVID-19 Mortality | 0 participants |
| Placebo | COVID-19 Mortality | 0 participants |
Secondary
COVID-19 Prophylaxis Timeframe
Time to change from baseline in negative RT-PCR to positive RT-PCR
Time frame: From Day 1 to Day 28
Population: Participants who've had a positive RT-PCR during the trial
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Active IMP | COVID-19 Prophylaxis Timeframe | 9 days | Standard Deviation 1.39 |
| Placebo | COVID-19 Prophylaxis Timeframe | 8.10 days | Standard Deviation 2.14 |
Secondary
COVID-19 Symptoms Development
Number of symptomatic Participants according to the WHO COVID-18 scale
Time frame: From Day 1 to Day 28
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Active IMP | COVID-19 Symptoms Development | 28 Participants |
| Placebo | COVID-19 Symptoms Development | 97 Participants |
Secondary
To Assess the Safety and Tolerability of IVM Given for a Period of 28 Days
Descriptive comparison of AE rates and severity/seriousness between IVM and placebo
Time frame: 56 days
Population: All participants who have received at least a single dose of the allocated treatment
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Active IMP | To Assess the Safety and Tolerability of IVM Given for a Period of 28 Days | Adverse events | 49 participants |
| Active IMP | To Assess the Safety and Tolerability of IVM Given for a Period of 28 Days | Serious adverse events | 0 participants |
| Placebo | To Assess the Safety and Tolerability of IVM Given for a Period of 28 Days | Adverse events | 109 participants |
| Placebo | To Assess the Safety and Tolerability of IVM Given for a Period of 28 Days | Serious adverse events | 0 participants |