Clinical Trial Results:
Pilot study to evaluate the potential of ivermectin to reduce COVID-19 transmission
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Summary
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EudraCT number |
2020-001474-29 |
Trial protocol |
ES |
Global end of trial date |
10 Dec 2020
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Results information
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Results version number |
v1(current) |
This version publication date |
04 Dec 2021
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First version publication date |
04 Dec 2021
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Other versions |
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Summary report(s) |
Saint_Paper |
Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
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Trial identification
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Sponsor protocol code |
SAINT
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
NCT04390022 | ||
WHO universal trial number (UTN) |
- | ||
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Sponsors
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Sponsor organisation name |
Clinica Universidad de Navarra
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Sponsor organisation address |
Pio XII, Pamplona, Spain,
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Public contact |
UCEC, Clinica Universidad de Navarra, +34 948255400, ucicec@unav.es
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Scientific contact |
UCEC, Clinica Universidad de Navarra, +34 948255400, ucicec@unav.es
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Paediatric regulatory details
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Is trial part of an agreed paediatric investigation plan (PIP) |
No
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Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Results analysis stage
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Analysis stage |
Final
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Date of interim/final analysis |
05 Nov 2020
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
07 Oct 2020
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Global end of trial reached? |
Yes
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Global end of trial date |
10 Dec 2020
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Was the trial ended prematurely? |
No
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General information about the trial
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Main objective of the trial |
To determine the efficacy of a single dose of ivermectin, administered to low risk, non-severe COVID-19 patients in the first 48 hours after symptoms onset to reduce the proportion of patients with detectable SARS-CoV-2 RNA by PCR from nasopharyngeal swab at day seven post-treatment.
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Protection of trial subjects |
As a COVID clinical trial, besides all the protecction measures, it also took relevance the possibility of giving the patient the option of doing their follow-up at home, instead of coming to the Clinic due to privacy issues.
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
24 Jul 2020
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Long term follow-up planned |
Yes
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Long term follow-up rationale |
Efficacy | ||
Long term follow-up duration |
3 Months | ||
Independent data monitoring committee (IDMC) involvement? |
No
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Population of trial subjects
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Number of subjects enrolled per country |
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Country: Number of subjects enrolled |
Spain: 24
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Worldwide total number of subjects |
24
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EEA total number of subjects |
24
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Number of subjects enrolled per age group |
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In utero |
0
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Preterm newborn - gestational age < 37 wk |
0
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Newborns (0-27 days) |
0
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Infants and toddlers (28 days-23 months) |
0
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Children (2-11 years) |
0
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Adolescents (12-17 years) |
0
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Adults (18-64 years) |
24
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From 65 to 84 years |
0
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85 years and over |
0
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Recruitment
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Recruitment details |
The recruitment took place only in Spain. First patient recruited is dated the 24/07/2020 and last patient 11/09/2020. | |||||||||
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Pre-assignment
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Screening details |
Patients diagnosed with COVID-19 in the emergency room of the Clínica Universidad de Navarra with a positive SARS-CoV-2 PCR. Residents of the Pamplona basin (“Cuenca de Pamplona”). The patient should be between the ages of 18 and 60 years of age. Negative pregnancy test for women of child bearing age. | |||||||||
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Period 1
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Period 1 title |
overall trial (overall period)
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Is this the baseline period? |
Yes | |||||||||
Allocation method |
Randomised - controlled
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Blinding used |
Double blind | |||||||||
Roles blinded |
Subject, Investigator | |||||||||
Blinding implementation details |
Before the trial begins, the sponsor will assign named independent individuals to code break activity to avoid introducing any bias for the designated safety physician, clinical team, sponsor and statistician teams.
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Arms
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Are arms mutually exclusive |
Yes
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Arm title
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ivermectina | |||||||||
Arm description |
The study will enroll 24 participants, 12 per arm, receiving ivermectin and placebo. | |||||||||
Arm type |
Experimental | |||||||||
Investigational medicinal product name |
ivermectin
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Tablet
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Routes of administration |
Oral use
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Dosage and administration details |
The dose will be administered using scales at the site for tailored administration. Given that dosing is limited by the size of the tablet (3mg) the participants will receive a discrete number of tablets according to their weight band. The individual dose will range from 400 mcg/kg to a maximum of 457 mcg/kg. See annex 2 for a full color-coded table.
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Arm title
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Placebo | |||||||||
Arm description |
The study will enroll 24 participants, 12 per arm, receiving ivermectin and placebo. | |||||||||
Arm type |
placebo | |||||||||
Investigational medicinal product name |
No investigational medicinal product assigned in this arm
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Baseline characteristics reporting groups
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Reporting group title |
overall trial
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Reporting group description |
- | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Subject analysis sets
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Subject analysis set title |
Covid patients
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Subject analysis set type |
Per protocol | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Subject analysis set description |
Paitents with positive PCR for SARS-CoV-2 RNA, obtained from a nasopharyngeal swab in
the first 72 hours after symptoms onset.
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End points reporting groups
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Reporting group title |
ivermectina
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Reporting group description |
The study will enroll 24 participants, 12 per arm, receiving ivermectin and placebo. | ||
Reporting group title |
Placebo
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Reporting group description |
The study will enroll 24 participants, 12 per arm, receiving ivermectin and placebo. | ||
Subject analysis set title |
Covid patients
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Subject analysis set type |
Per protocol | ||
Subject analysis set description |
Paitents with positive PCR for SARS-CoV-2 RNA, obtained from a nasopharyngeal swab in
the first 72 hours after symptoms onset.
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End point title |
Primary Endpoint | |||||||||
End point description |
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End point type |
Primary
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End point timeframe |
Proportion of patients with a positive SARS-CoV-2 PCR from a nasopharyngeal swab at day 7 post-treatment
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Statistical analysis title |
Fisher exact test | |||||||||
Comparison groups |
Placebo v ivermectina
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Number of subjects included in analysis |
24
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Analysis specification |
Pre-specified
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Analysis type |
equivalence | |||||||||
P-value |
= 0.05 | |||||||||
Method |
Fisher exact | |||||||||
Confidence interval |
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Adverse events information
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Timeframe for reporting adverse events |
After treatment
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Assessment type |
Non-systematic | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary version |
24.1
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Reporting groups
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Reporting group title |
Ivermectin
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Reporting group description |
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Reporting group title |
Placebo
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Reporting group description |
- | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Frequency threshold for reporting non-serious adverse events: 1% | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Substantial protocol amendments (globally) |
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| Were there any global substantial amendments to the protocol? Yes | |||
Date |
Amendment |
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14 Aug 2020 |
An exclusion criteria is modified, the time of fever or cough present for more than 48hrs, is changed to 72hrs.
Other changes are related to the possibility of giving patients the option of home follow-up or, for privacy reasons.
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04 Nov 2020 |
In this relevant modification, an annex I to the patient information and informed consent sheet is included to inform the patient of the possibility of participating in a final trial visit, where blood will be collected to measure the antibody titre against SARS-CoV-2. The reason for these measures is due to the fact that one of the trial patients was tested positive for serology on the 21st visit, as per protocol. This patient underwent a serology on his own and his result changed to negative. For this reason, we have added a relevant modification that requires a serology test to be performed within 8-10 weeks. |
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Interruptions (globally) |
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| Were there any global interruptions to the trial? No | |||
Limitations and caveats |
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| Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||
| This trial was designed to preliminarily explore the potential benefit of ivermectin use in patients with COVID-19, but not to provide definitive evidence, which explains its small sample size. | |||
Online references |
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| http://www.ncbi.nlm.nih.gov/pubmed/33495752 |
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