Coronavirus InfectionPhase 2IFORSNCT04431466
A Study to Compare the Efficacy and Safety of Different Doses of Ivermectin for COVID-19
A Phase 2 study testing Ivermectin in people with Coronavirus Infection, run by Universidade Federal de Sao Carlos at 2 sites in Brazil.
Trial summary
In December 2019, a group of patients with pneumonia of unknown cause was linked to a wholesale seafood market in Wuhan, China. The genetic analysis of samples from the lower respiratory tract of these patients indicated a new coronavirus as the causative agent, which was named SARS-CoV-2. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronavirus Infection
- What is being tested?
- Ivermectin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 2 sitesBrazil
- Study dates
- 1 Jul 2020to 1 Dec 2020
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of infection by SARS-CoV-2:
- symptoms of acute respiratory tract infection (sudden onset of at least one of the following: cough, fever, shortness of breath) and biomolecular diagnosis of SARS-CoV-2 infection; OR
- any acute respiratory disease AND biomolecular diagnosis of SARS-CoV-2 infection; OR
- severe acute respiratory infection (fever and at least one sign / symptom of respiratory disease eg cough, fever, shortness of breath) AND in need of hospitalization AND biomolecular diagnosis of SARS-CoV-2 infection;
- Eastern Cooperative Oncology Group Performance Status score 0 to 1;
- National Early Warning Score 0 to 4;
- Ability to understand and consent to participate in this clinical trial, manifested by signing the Informed Consent Form (ICF).
Who cannot join
- Inability to ingest / absorb the study drug orally through spontaneous ingestion or use of gastro / enteral tubes;
- Any finding of clinical observation (history / physical evaluation) that is interpreted by the investigating physician as a risk to participate in the trial;
- Any laboratory test findings that the investigating physician considers as a risk to the research participant as to his / her participation in the clinical study;
- Any ECG examination finding that the investigating physician considers as a risk to the research participant as to his / her participation in the trial;
- Known hypersensitivity to the components of the drugs used during the study;
- Women in pregnancy or breastfeeding;
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- Body weight less than 15kg;
- Estimated glomerular filtration rate (CKD-Epidemiology Collaboration, CKD-EPI) <30 mL / min;
- Aspartate aminotransaminase (AST) or alanine aminotransaminase (ALT)> 5 times the upper limit of normality;
- Refusal to participate;
- Refusal to sign the informed consent form.
Trial locations and contacts
2 sites in 1 country.
Brazil2 sites
Hospital Univeristário da Universidade Federal de São Carlos (HU-UFSCar)
São Carlos, São Paulo, 13565-905
Hospital Universitário da Universidade Federal de São Carlos (HU-UFSCar)
São Carlos, São Paulo, 13566-448
About this study
Official title: Phase 2 Clinical Trial to Compare the Efficacy and Safety of Different Doses of Ivermectin in Patients Diagnosed With the New Coronavirus Infection (SARS-CoV-2)
In December 2019, a group of patients with pneumonia of unknown cause was linked to a wholesale seafood market in Wuhan, China. The genetic analysis of samples from the lower respiratory tract of these patients indicated a new coronavirus as the causative agent, which was named SARS-CoV-2. The virus spread rapidly to more than 45 countries, including Brazil, causing an international alarm. However, in spite of its epidemiological magnitude, so far, there is no antiviral treatment or vaccine approved for the treatment of this infection. With about 15% to 20% of SARS-CoV-2 patients suffering from serious illnesses and overburdened hospitals, therapeutic options are desperately needed. So, instead of creating compounds from scratch that can take years to develop and test, researchers and public health agencies have sought to redirect drugs already approved for other diseases and known to be widely safe. In this context, the analysis of the international literature shows the existence of an in vitro antiviral activity of ivermectin against SARS-CoV-2. However, there are no studies that have evaluated its clinical effectiveness in patients diagnosed with SARS-CoV-2 infection. Therefore, and considering this knowledge gap, the present study aims to determine the clinical efficacy and safety of different doses of ivermectin in patients diagnosed with SARS-CoV-2 infection.
- Conditions
- Coronavirus Infection
- Being tested
- Ivermectin, Standard of Care
- Keywords
- coronavirus infections, SARS-CoV-2, COVID-19, ivermectin, clinical trial
- Medical subject headings
- Coronavirus Infections, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IvermectinDrug
SOC plus different dosing regimens of Ivermectin
Standard of CareOther
Standard treatment for COVID-19
| Study group | Role | What they receive |
|---|---|---|
| Standard of care | Active comparator | Standard of care (SOC) treatment Receives: Other: Standard of Care |
| SOC plus ivermectin 100 mcg/kg | Experimental | SOC plus ivermectin 100 mcg/kg Receives: Drug: Ivermectin |
| SOC plus ivermectin 200 mcg/kg | Experimental | SOC plus ivermectin 200 mcg/kg Receives: Drug: Ivermectin |
| SOC plus ivermectin 400 mcg/kg | Experimental | SOC plus ivermectin 400 mcg/kg Receives: Drug: Ivermectin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Undetectable viral load during 7 days of follow-up.
Proportion of patients who achieved undetectable viral load during 7 days of follow-up.
Measured: 7 days following intervention
Secondary outcomes (4)
Viral load variation in the nasopharyngeal swab.
Viral load variation in the nasopharyngeal swab during treatment.
Measured: 7 days following intervention.
Time to undetectable SARS-CoV-2 viral load in the nasopharyngeal swab.
Variation of serum lymphocyte counts during treatment.
Measured: 7 days following intervention.
Incidence of Treatment-Emergent Self-reported Adverse Events
Incidence of Treatment-Emergent Adverse Events as assessed by clinical history and physical examination
Measured: 28 days following intervention.
Incidence of Treatment-Emergent Laboratory-based Adverse Events
Incidence of Treatment-Emergent Adverse Events as assessed by laboratory tests
Measured: 28 days following intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2020
- Study start1 Jul 2020
- Primary completion1 Dec 2020
- Study completion1 Dec 2020
Why it stopped: Preliminary data from a pilot study suggest that the administration of ivermectin in patients with SARS-CoV-2 is safe, reducing symptoms and viral load. The antiviral effects of ivermectin appear to depend on the dose administered.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Coronavirus InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidade Federal de Sao Carlos
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Henrique Pott Junior, Universidade Federal de Sao Carlos
- Investigators
- Henrique Pott Junior, MD PhD, Principal investigator, Universidade Federal de Sao Carlos
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04431466
- Sponsor's protocol ID
- IFORS
- Acronym
- IFORS
- Status last verified
- Oct 2021
- First submitted
- 10 Jun 2020
- Last updated
- 12 Oct 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Pott-Junior H, Paoliello MMB, Miguel AQC, da Cunha AF, de Melo Freire CC, Neves FF, da Silva de Avo LR, Roscani MG, Dos Santos SS, Chacha SGF. Use of ivermectin in the treatment of Covid-19: A pilot trial. Toxicol Rep. 2021;8:505-510. doi: 10.1016/j.toxrep.2021.03.003. Epub 2021 Mar 9.
PubMed 33723507
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 2 Clinical Trial to Compare the Efficacy and Safety of Different Doses of Ivermectin in Patients Diagnosed With the New Coronavirus Infection (SARS-CoV-2)
- ClinicalTrials.gov ID
- NCT04431466
- Acronym / sponsor ID
- IFORS / IFORS
- Conditions
- Coronavirus Infection
- Keywords
- coronavirus infections, SARS-CoV-2, COVID-19, ivermectin, clinical trial
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Preliminary data from a pilot study suggest that the administration of ivermectin in patients with SARS-CoV-2 is safe, reducing symptoms and viral load. The antiviral effects of ivermectin appear to depend on the dose administered.
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Universidade Federal de Sao CarlosUniversity, hospital or other
- Study start
- 1 Jul 2020 (actual)
- Primary completion
- 1 Dec 2020 (actual)
- Study completion
- 1 Dec 2020 (actual)
- First posted
- 16 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In December 2019, a group of patients with pneumonia of unknown cause was linked to a wholesale seafood market in Wuhan, China. The genetic analysis of samples from the lower respiratory tract of these patients indicated a new coronavirus as the causative agent, which was named SARS-CoV-2. The virus spread rapidly to more than 45 countries, including Brazil, causing an international alarm. However, in spite of its epidemiological magnitude, so far, there is no antiviral treatment or vaccine approved for the treatment of this infection. With about 15% to 20% of SARS-CoV-2 patients suffering from serious illnesses and overburdened hospitals, therapeutic options are desperately needed. So, instead of creating compounds from scratch that can take years to develop and test, researchers and public health agencies have sought to redirect drugs already approved for other diseases and known to be widely safe. In this context, the analysis of the international literature shows the existence of an in vitro antiviral activity of ivermectin against SARS-CoV-2. However, there are no studies that have evaluated its clinical effectiveness in patients diagnosed with SARS-CoV-2 infection. Therefore, and considering this knowledge gap, the present study aims to determine the clinical efficacy and safety of different doses of ivermectin in patients diagnosed with SARS-CoV-2 infection.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Standard of care | Active comparator | Other: Standard of CareStandard of care (SOC) treatment |
| SOC plus ivermectin 100 mcg/kg | Experimental | Drug: IvermectinSOC plus ivermectin 100 mcg/kg |
| SOC plus ivermectin 200 mcg/kg | Experimental | Drug: IvermectinSOC plus ivermectin 200 mcg/kg |
| SOC plus ivermectin 400 mcg/kg | Experimental | Drug: IvermectinSOC plus ivermectin 400 mcg/kg |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Diagnosis of infection by SARS-CoV-2:
- Eastern Cooperative Oncology Group Performance Status score 0 to 1;
- National Early Warning Score 0 to 4;
- Ability to understand and consent to participate in this clinical trial, manifested by signing the Informed Consent Form (ICF).
Key exclusion criteria (11 listed)
- Inability to ingest / absorb the study drug orally through spontaneous ingestion or use of gastro / enteral tubes;
- Any finding of clinical observation (history / physical evaluation) that is interpreted by the investigating physician as a risk to participate in the trial;
- Any laboratory test findings that the investigating physician considers as a risk to the research participant as to his / her participation in the clinical study;
- Any ECG examination finding that the investigating physician considers as a risk to the research participant as to his / her participation in the trial;
- Known hypersensitivity to the components of the drugs used during the study;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IvermectinSOC plus different dosing regimens of Ivermectin | Drug | SOC plus ivermectin 100 mcg/kg, SOC plus ivermectin 200 mcg/kg, SOC plus ivermectin 400 mcg/kg |
| Standard of CareStandard treatment for COVID-19 | Other | Standard of care |
Primary outcome
Undetectable viral load during 7 days of follow-up.
Time frame: 7 days following intervention
Proportion of patients who achieved undetectable viral load during 7 days of follow-up.
4 secondary outcomes
Viral load variation in the nasopharyngeal swab.
Time frame: 7 days following intervention.
Time to undetectable SARS-CoV-2 viral load in the nasopharyngeal swab.
Time frame: 7 days following intervention.
Incidence of Treatment-Emergent Self-reported Adverse Events
Time frame: 28 days following intervention.
Incidence of Treatment-Emergent Laboratory-based Adverse Events
Time frame: 28 days following intervention.
Results and safety
The study was stopped early (reason given: Preliminary data from a pilot study suggest that the administration of ivermectin in patients with SARS-CoV-2 is safe, reducing symptoms and viral load. The antiviral effects of ivermectin appear to depend on the dose administered.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Oct 2021.
- Derived from this study: PubMed 33723507Pott-Junior H, Paoliello MMB, Miguel AQC, da Cunha AF, de Melo Freire CC, Neves FF, da Silva de Avo LR, Roscani MG, Dos Santos SS, Chacha SGF. Use of ivermectin in the treatment of Covid-19: A pilot trial. Toxicol Rep. 2021;8:505-510. doi: 10.1016/j.toxrep.2021.03.003. Epub 2021 Mar 9.
- Hospital Universitário da UFSCarLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Henrique Pott Junior, MD PhD principal investigator
Universidade Federal de Sao Carlos
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Ivermectin in people with Coronavirus Infection, run by Universidade Federal de Sao Carlos at 2 sites in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 12 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Preliminary data from a pilot study suggest that the administration of ivermectin in patients with SARS-CoV-2 is safe, reducing symptoms and viral load. The antiviral effects of ivermectin appear to depend on the dose administered.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Undetectable viral load during 7 days of follow-up. (time frame: 7 days following intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04431466, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Oct 2021.