Study of the efficacy of ivermectin in the treatment and prevention of COVID-19

Phase 1

• Conditions: SARS COVID-19; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2020-001994-66-ES
• Lead Sponsor: Fundació Assistencial Mútua Terrassa

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-05-08
• Last Update Posted: 21 July 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 266

Inclusion Criteria

Sub-study 1:
1. Symptomatic (respiratory) patients with a positive PCR-RT test for COVID-19 and a clinical condition of less than 5 days of evolution.
2. =18 years old.
3. In women of childbearing age, negative pregnancy test and use of contraceptive method during the study period.
4. Accept to take the medication and the complementary test procedures during the study, including analysis and nasal sampling.
5. Able to provide informed consent (oral or written).

Sub-study 2:
1. Contacts of symptomatic (respiratory) patients with a positive PCR-RT test for COVID-19 and a diagnosis of less than 5 days of evolution.
2. Of legal age.
3. In women of childbearing age, negative pregnancy test and use of contraceptive method during the study period.
4. Accept to take the medication and the complementary test procedures during the study, including analysis and nasal sampling.
5. Able to provide informed consent (oral or written).
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 266
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Sub-study 1
1. Moderate or severe forms of infection requiring hospital admission
a.-Respiratory distress with respiratory rate> = 30 breaths / min
b.-Oxygen saturation =93% at rest
c.- Kirby index:(PaO2) /(FIO2)) =300mmHg.
2. Participants taking medications that may interfere with the study medication such as anticoagulants.
3. Inability to take oral medication.
4. Severe liver disorders (Child Pugh C).
5. Impairment of severe renal function (with GFR =30 mL / min / 1.73 m2) or requiring dialysis.
6. Participants with coagulation disorders.
7. Individuals with severe neurological or mental impairment.
8. Pregnant or lactating women.
9. Unable to consent to the study protocol.
10. People with known hypersensitivity to Ivermectin.
11. People who have been treated in any other study in the previous 30 days.
12. Concomitant administration of enzyme inducers (such as carbamazepine) that could affect the effectiveness of the drug and those receiving CYP3A4 substrates (such as statins) due to the risk of increased toxicity.
13. Any other contraindication according to the technical sheet for Ivermectin.

Sub-study 2
1. Participants taking medications that may interfere with study medication.
2. Inability to take oral medication.
3. Severe liver disorders (Child Pugh C) or alcoholism.
4. Impaired severe renal function (with GFR =30 mL / min / 1.73 m2) or requiring dialysis.
5. Participants with coagulation disorders.
6. Individuals with severe neurological or mental impairment.
7. Pregnant or lactating women.
8. Unable to consent to study protocol.
9. People with known hypersensitivity to Ivermectin.
10. People who have been treated in any other study in the previous 30 days.
11. Concomitant administration of enzyme inducers (such as carbamazepine) that could affect the effectiveness of the drug and those receiving CYP3A4 substrates (such as statins) due to the risk of increased toxicity.
12. Any other contraindication according to the technical data sheet for Ivermectin.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Demonstrate the effectiveness of Ivermectin in the prophylaxis and treatment of COVID-19;Secondary Objective: not applicable;Primary end point(s): Sub-study 1<br>Virological clearence at 3, 6, 9 and 12 days after starting treatment with Ivermectin<br><br>Sub-study 2<br>Incidence of secondary cases diagnosed by molecular biology and serology on the 7th, 14th, 21st day after starting prophylaxis with Ivermectin and with placebo;Timepoint(s) of evaluation of this end point: Sub-study 1<br>Day 3rd, 6th, 9th and 12th after starting treatment <br><br>Sub-study 2<br>Day 7th, 14, 21th after starting treatment

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Sub-study 1<br>1. Viral load at 3, 6, 9 and 12 days after starting treatment with Ivermectin and placebo (virological clearance).<br>2. Serological response at 6 and 14 days<br>3. Morbidity and Mortality at 14 days<br>4. Incidence of infection between household contacts<br>5. Analytical values ??at 0 (baseline), 6 and 12 days<br>6. Proportion of participants leaving the study<br>7. Proportion of participants not complying with the study protocol<br><br>Sub-study 2<br>1. Morbidity and mortality at 28 days<br>2. Analytical values ??at 0 (baseline), 7, 12 and 21 days;Timepoint(s) of evaluation of this end point: Sub-study 1<br>Day 3rd, 6th, 9th, 12th and 14 after starting treatment <br><br>Sub-study 2<br>Day 0, 7th, 12, 21th and 28th after starting treatment