Covid19Phase 2NCT04510233
Ivermectin Nasal Spray for COVID19 Patients
A Phase 2 study testing Ivermectin nasal and Ivermectin oral in people with Covid19, run by Tanta University.
Trial summary
The global escalation of COVID19 pandemic has put the health care system under pressure with urgent need for treatment. In the absence of vaccine and approved drug against SARS-COV2 over the past 6 months, the health authorities were obliged to re-purpose existing drugs to fight this pandemic. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Covid19
- What is being tested?
- Ivermectin nasal and Ivermectin oral
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- Sep 2020to 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 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- mild to moderate severity who are confirmed to be positive for SARS COV 2.
Who cannot join
- patients with severe form of COVID-19 or those who are on ventilatory support or those with cytokine storm
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Ivermectin Inhalation Forms in the Management of COVID-19 Egyptian Patients
The global escalation of COVID19 pandemic has put the health care system under pressure with urgent need for treatment. In the absence of vaccine and approved drug against SARS-COV2 over the past 6 months, the health authorities were obliged to re-purpose existing drugs to fight this pandemic.
Read the detailed description
Ivermectin is a well-known FDA-approved pan antiparasitic drug with high safety profile and potential therapeutic effects against COVID 19. It has been previously investigated as an antiviral agent. It showed 5000 fold reduction of SARS COV 2 viral RNA in-vitro studies.
However, some researchers questioned its efficacy in the oral form as very high doses will be required to achieve a proper tissue concentration and viricidal effect in the respiratory system.
Our hypothesis is that, since COVID-19 has shown to be particularly damaging to the respiratory system, using inhaled forms of Ivermectin will deliver the drug directly to the infection site and make it a treatment option.
- Conditions
- Covid19
- Being tested
- Ivermectin nasal, Ivermectin oral, standard care
- Keywords
- COVID19
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ivermectin nasalDrug
Also called ivermectin
Ivermectin nasal spray one ml in each nostril two times daily
Ivermectin oralDrug
Also called ivermectin
Ivermectin oral (one tablet 6 mg three times daily)
standard careOther
oxygen via masks or ventilators
| Study group | Role | What they receive |
|---|---|---|
| Ivermectin nasal spray | Experimental | Ivermectin administered as nasal spray (one ml in each nostril two times daily) Receives: Drug: Ivermectin nasal |
| Ivermectin oral | Experimental | Ivermectin administered orally (one tablet 6 mg three times daily) for 72 hours plus the standard care of COVID-19 cases. Receives: Drug: Ivermectin oral |
| standard care | Experimental | COVID-19 cases will receive standard of care [oxygen via masks or ventilators] Receives: Other: standard care |
What is being measured
The primary outcome is the main question the study is designed to answer.
PCR of SARS-Cov2 RNA
Negative PCR result of SARS-Cov2 RNA in COVID19 patients
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2020
- Study startSep 2020 (estimated)
- Primary completionOct 2020 (estimated)
- Study completionDec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Covid19Studies of the same condition, open and under way.
- More trials run by Tanta UniversityThe sponsor's other registered studies.
- 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
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. Dr. Kamal Mohammed Okasha, Tanta University
- Investigators
- Kamal Okasha, PhD, Principal investigator, Tanta Univesity faculty of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04510233
- Sponsor's protocol ID
- IvrInh
- Status last verified
- Aug 2020
- First submitted
- 10 Aug 2020
- Last updated
- 12 Aug 2020
- 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 12 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ivermectin Inhalation Forms in the Management of COVID-19 Egyptian Patients
- ClinicalTrials.gov ID
- NCT04510233
- Acronym / sponsor ID
- IvrInh
- Conditions
- Covid19
- Keywords
- COVID19
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- Sep 2020 (estimated)
- Primary completion
- Oct 2020 (estimated)
- Study completion
- Dec 2020 (estimated)
- First posted
- 12 Aug 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.
The global escalation of COVID19 pandemic has put the health care system under pressure with urgent need for treatment. In the absence of vaccine and approved drug against SARS-COV2 over the past 6 months, the health authorities were obliged to re-purpose existing drugs to fight this pandemic.
Detailed description
Ivermectin is a well-known FDA-approved pan antiparasitic drug with high safety profile and potential therapeutic effects against COVID 19. It has been previously investigated as an antiviral agent. It showed 5000 fold reduction of SARS COV 2 viral RNA in-vitro studies.
However, some researchers questioned its efficacy in the oral form as very high doses will be required to achieve a proper tissue concentration and viricidal effect in the respiratory system.
Our hypothesis is that, since COVID-19 has shown to be particularly damaging to the respiratory system, using inhaled forms of Ivermectin will deliver the drug directly to the infection site and make it a treatment option.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Ivermectin nasal spray | Experimental | Drug: Ivermectin nasalIvermectin administered as nasal spray (one ml in each nostril two times daily) |
| Ivermectin oral | Experimental | Drug: Ivermectin oralIvermectin administered orally (one tablet 6 mg three times daily) for 72 hours plus the standard care of COVID-19 cases. |
| standard care | Experimental | Other: standard careCOVID-19 cases will receive standard of care [oxygen via masks or ventilators] |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- mild to moderate severity who are confirmed to be positive for SARS COV 2.
Key exclusion criteria (1 listed)
- patients with severe form of COVID-19 or those who are on ventilatory support or those with cytokine storm
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 nasalAlso: ivermectinIvermectin nasal spray one ml in each nostril two times daily | Drug | Ivermectin nasal spray |
| Ivermectin oralAlso: ivermectinIvermectin oral (one tablet 6 mg three times daily) | Drug | Ivermectin oral |
| standard careoxygen via masks or ventilators | Other | standard care |
Primary outcome
PCR of SARS-Cov2 RNA
Time frame: 14 days
Negative PCR result of SARS-Cov2 RNA in COVID19 patients
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2020.
- 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.
Kamal Okasha, PhD principal investigator
Tanta Univesity faculty of Medicine
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Ivermectin nasal and Ivermectin oral in people with Covid19, run by Tanta University.
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 1 inclusion and 1 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 12 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kamal Okasha, PhD (201140403709, okasha70@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PCR of SARS-Cov2 RNA (time frame: 14 days). 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 12 Aug 2020.