COVID-19Phase 3CCOVID-19NCT04681053
Inhaled Ivermectin and COVID-19
A Phase 3 study testing Ivermectin Powder in people with COVID-19, run by Mansoura University at 1 site in Egypt.
Trial summary
Coronavirus disease-19 is global healthcare crisis. Till May 20, 2020, there were approximately 4,789,205 cases and 318,789 related mortalities were identified globally. This dramatic situation led to healthcare service collapse in many countries. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- COVID-19
- What is being tested?
- Ivermectin Powder
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteEgypt
- Study dates
- 25 Feb 2021to 31 Dec 2021
- Phase
- Phase 3
- 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 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Both sexes
- Age above 18
- Test positive for COVID-19 using Reverse transcription polymerase chain reaction (RT-PCR) prior to the start of study.
- Willing to participate in the study
- Mild to moderate severity index according to the WHO criteria
Who cannot join
- Hypersensitivity to the study drug.
- History of co-morbid conditions such as: uncontrolled hypertension and diabetes, retinal problems and chronic liver and renal disease.
- Women who are pregnant or breastfeeding.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Mansoura Faculty of Medicine
Al Mansurah, Dakahlyia, 35516
Mahmoud El-Bendary, M.D, 00201002592205, mmelbendary@gmail.com
About this study
Official title: Efficacy and Safety of Inhaled Ivermectin in the Treatment of SARS-COV-2 (COVID-19)
Coronavirus disease-19 is global healthcare crisis. Till May 20, 2020, there were approximately 4,789,205 cases and 318,789 related mortalities were identified globally. This dramatic situation led to healthcare service collapse in many countries. Each country developed its own action plan depending on healthcare expertise and the available resources. There is no definitive therapy for Coronavirus disease-19 up till now. Many current and investigational drugs are used nowadays. Recent reports suggest a beneficial role of Ivermectin in the management of Coronavirus disease-19. A notice that necessitates further clinical studies.
The aim of this study is to assess the efficacy and safety of the usage of inhaled ivermectin in the management of Coronavirus disease-19.
Read the detailed description
Coronavirus disease-19 (COVID-19) is a pandemic disease which is caused by the SARS-CoV2 virus. It is one of the biggest single-stranded RNA viruses. SARS-CoV2 Viral polyproteins are responsible for viral replication and transcription while its protease enzymes are responsible for polypeptides cleaving and immune system blockage. They are considered to be an important therapeutic target.
Host immunological response against SARS-CoV2 could affect the disease outcome. Patients requiring ICU admission have higher levels of interleukins 6 - 10, tumor necrosis factor α (TNF-α), and fewer CD4+ and CD8+ T cells. The level of cytokines and lymphopenia is associated with pulmonary damage and respiratory distress.
Till now, there is no definitive therapy for COVID-19. Multiple current and investigational drugs are used such as Hydroxychloroquine, lopinavir/ritonavir, and Remdesivir.
Ivermectin: A potent anti-parasitic drug has shown to have an in-vitro antiviral activity against a broad range of viruses. It inhibits the interaction between the human immunodeficiency virus-1 (HIV-1) integrase protein (IN) and the importin (IMP) α/β1. But on the other hand, Ivermectin showed limited efficacy against DENV in phase III clinical trial that was done in Thailand in 2014-2017. Recent Studies proved the In-vitro effect and "subsequently" the possible therapeutic role of Ivermectin in the management of SARS-CoV2.
- Conditions
- COVID-19
- Being tested
- Ivermectin Powder
- Keywords
- COVID, Ivermectin, Inhalation, Antiviral, safety
- Medical subject headings
- COVID-19, Respiratory Aspiration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ivermectin PowderDrug
Also called Direct antiviarl agents
- Administration through inhalation (6mg) BID for 3 days
| Study group | Role | What they receive |
|---|---|---|
| Group (A) received both oral and inhaled ivermectin in addition to the standard of care. | Active comparator | use oral and inhaled ivermectin Receives: Drug: Ivermectin Powder |
| B) received oral ivermectin in addition to the standard of care | Active comparator | receive oral ivermectin Receives: Drug: Ivermectin Powder |
| c) received inhaled ivermectin in addition to the standard of care | Active comparator | received inhaled ivermectin Receives: Drug: Ivermectin Powder |
| Group (d) received the current standard of care only | No intervention | received standard of care only |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of virological cure by Rt -PCR for COVID -19 using ivermectin when compared to standard treatment
All PCR for COVID-19 must be negative
Measured: througout the study completion up to one year(for every case must be done after 2 weeks from the start of treatment).
Secondary outcomes (1)
resolution of pneumonia
The score severity index of pneumonia will be measured before and after receiving treatment by computed tomography (CT)(index from 0-20)increasing the index means increase severity.
Measured: througout the study completion up to one year (for every case must be done after 2 weeks from the start of treatment).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2020
- Study start25 Feb 2021 (estimated)
- Primary completion30 Apr 2021 (estimated)
- Study completion31 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies 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 3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- All current study participants will be classified into 4 equal groups : Group (A) received both oral and inhaled ivermectin in addition to the standard of care. Group (B)received inhaled ivermectin only Group (C) received oral ivermectin in addition to the standard of care, Group (D) received the current standard of care only
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mahmoud Elbendary, Mansoura University
- Investigators
- Mahmoud El-Bendary, M.D, Principal investigator, Mansoura University- Faculty of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04681053
- Sponsor's protocol ID
- R.20.11.1090.R1
- Acronym
- CCOVID-19
- Status last verified
- Dec 2020
- First submitted
- 16 Dec 2020
- Last updated
- 24 Feb 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Inhaled Ivermectin in the Treatment of SARS-COV-2 (COVID-19)
- ClinicalTrials.gov ID
- NCT04681053
- Acronym / sponsor ID
- CCOVID-19 / R.20.11.1090.R1
- Conditions
- COVID-19
- Keywords
- COVID, Ivermectin, Inhalation, Antiviral, safety
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 25 Feb 2021 (estimated)
- Primary completion
- 30 Apr 2021 (estimated)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 23 Dec 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.
Coronavirus disease-19 is global healthcare crisis. Till May 20, 2020, there were approximately 4,789,205 cases and 318,789 related mortalities were identified globally. This dramatic situation led to healthcare service collapse in many countries. Each country developed its own action plan depending on healthcare expertise and the available resources. There is no definitive therapy for Coronavirus disease-19 up till now. Many current and investigational drugs are used nowadays. Recent reports suggest a beneficial role of Ivermectin in the management of Coronavirus disease-19. A notice that necessitates further clinical studies.
The aim of this study is to assess the efficacy and safety of the usage of inhaled ivermectin in the management of Coronavirus disease-19.
Detailed description
Coronavirus disease-19 (COVID-19) is a pandemic disease which is caused by the SARS-CoV2 virus. It is one of the biggest single-stranded RNA viruses. SARS-CoV2 Viral polyproteins are responsible for viral replication and transcription while its protease enzymes are responsible for polypeptides cleaving and immune system blockage. They are considered to be an important therapeutic target.
Host immunological response against SARS-CoV2 could affect the disease outcome. Patients requiring ICU admission have higher levels of interleukins 6 - 10, tumor necrosis factor α (TNF-α), and fewer CD4+ and CD8+ T cells. The level of cytokines and lymphopenia is associated with pulmonary damage and respiratory distress.
Till now, there is no definitive therapy for COVID-19. Multiple current and investigational drugs are used such as Hydroxychloroquine, lopinavir/ritonavir, and Remdesivir.
Ivermectin: A potent anti-parasitic drug has shown to have an in-vitro antiviral activity against a broad range of viruses. It inhibits the interaction between the human immunodeficiency virus-1 (HIV-1) integrase protein (IN) and the importin (IMP) α/β1. But on the other hand, Ivermectin showed limited efficacy against DENV in phase III clinical trial that was done in Thailand in 2014-2017. Recent Studies proved the In-vitro effect and "subsequently" the possible therapeutic role of Ivermectin in the management of SARS-CoV2.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- All current study participants will be classified into 4 equal groups : Group (A) received both oral and inhaled ivermectin in addition to the standard of care. Group (B)received inhaled ivermectin only Group (C) received oral ivermectin in addition to the standard of care, Group (D) received the current standard of care only
| Arm | Type | Receives |
|---|---|---|
| Group (A) received both oral and inhaled ivermectin in addition to the standard of care. | Active comparator | Drug: Ivermectin Powderuse oral and inhaled ivermectin |
| B) received oral ivermectin in addition to the standard of care | Active comparator | Drug: Ivermectin Powderreceive oral ivermectin |
| c) received inhaled ivermectin in addition to the standard of care | Active comparator | Drug: Ivermectin Powderreceived inhaled ivermectin |
| Group (d) received the current standard of care only | No intervention | –received standard of care only |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Both sexes
- Age above 18
- Test positive for COVID-19 using Reverse transcription polymerase chain reaction (RT-PCR) prior to the start of study.
- Willing to participate in the study
- Mild to moderate severity index according to the WHO criteria
Key exclusion criteria (3 listed)
- Hypersensitivity to the study drug.
- History of co-morbid conditions such as: uncontrolled hypertension and diabetes, retinal problems and chronic liver and renal disease.
- Women who are pregnant or breastfeeding.
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 |
|---|---|---|
| Ivermectin PowderAlso: Direct antiviarl agents- Administration through inhalation (6mg) BID for 3 days | Drug | B) received oral ivermectin in addition to the standard of care, Group (A) received both oral and inhaled ivermectin in addition to the standard of care., c) received inhaled ivermectin in addition to the standard of care |
Primary outcome
Rate of virological cure by Rt -PCR for COVID -19 using ivermectin when compared to standard treatment
Time frame: througout the study completion up to one year(for every case must be done after 2 weeks from the start of treatment).
All PCR for COVID-19 must be negative
1 secondary outcome
resolution of pneumonia
Time frame: througout the study completion up to one year (for every case must be done after 2 weeks from the start of treatment).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2021.
- 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.
Mahmoud El-Bendary, M.D principal investigator
Mansoura University- Faculty of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Ivermectin Powder in people with COVID-19, run by Mansoura University at 1 site in Egypt.
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 5 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 24 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mahmoud El-Bendary, M.D (00201002592205, mmelbendary@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of virological cure by Rt -PCR for COVID -19 using ivermectin when compared to standard treatment (time frame: througout the study completion up to one year(for every case must be done after 2 weeks from the start of treatment).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 Feb 2021.