COVID-19Phase 4NCT05246072
Effect of Combined Use of Ivermectin and Colchicine in COVID-19 Patients
A Phase 4 study testing Ivermectin + colchicine and Colchicine in people with COVID-19, run by Ain Shams University at 1 site in Egypt.
Trial summary
The aim of this study will be to investigate the efficacy of use of combination of Ivermectin and colchicine on severity and outcome Of COVID 19 infection. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- COVID-19
- What is being tested?
- Ivermectin + colchicine and Colchicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 135 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Nov 2021to 28 Feb 2022
- Phase
- Phase 4
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Willing and able to provide written informed consent prior to performing study procedures.
- Currently hospitalized and requiring medical care for non-sever COVID-19.
- One or more of the following: (positive PCR test or positive antibodies) or (CT Chest consistent with COVID19 infection).
Who cannot join
- Tocilizumab use.
- Mechanical ventilation
- Requirement of oxygen supplementation >8L/min on admission
Trial locations and contacts
1 site in 1 country.
About this study
The aim of this study will be to investigate the efficacy of use of combination of Ivermectin and colchicine on severity and outcome Of COVID 19 infection.
- Conditions
- COVID-19
- Being tested
- Ivermectin + colchicine, Colchicine
- 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 + colchicineDrug
In addition to the local standard of care for COVID 19 patients, the patient will receive Ivermectin + colchicine
ColchicineDrug
In addition to the local standard of care for COVID 19 patients, the patient will receive colchicine
| Study group | Role | What they receive |
|---|---|---|
| Ivermectin + colchicine + standard care | Active comparator | In addition to the local standard of care for COVID 19 patients, the patient will receive:
Ivermectin + Colchicine Receives: Drug: Ivermectin + colchicine |
| Colchicine + standard care | Active comparator | In addition to the local standard of care for COVID 19 patients, the patient will receive:
Colchicine Receives: Drug: Colchicine |
| standard care | No intervention | Patients will receive Standard care |
What is being measured
The primary outcome is the main question the study is designed to answer.
length of oxygen requirement
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2022
- Study start1 Nov 2021
- Primary completion28 Feb 2022
- Study completion28 Feb 2022
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.
- More trials run by Ain Shams 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 135 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05246072
- Sponsor's protocol ID
- FAMSU R 179 / 2021
- Status last verified
- Oct 2021
- First submitted
- 16 Feb 2022
- Last updated
- 7 Apr 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Combined Use of Ivermectin and Colchicine in COVID-19 Patients
- ClinicalTrials.gov ID
- NCT05246072
- Acronym / sponsor ID
- FAMSU R 179 / 2021
- Conditions
- COVID-19
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 135 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 1 Nov 2021 (actual)
- Primary completion
- 28 Feb 2022 (actual)
- Study completion
- 28 Feb 2022 (actual)
- First posted
- 18 Feb 2022 (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 aim of this study will be to investigate the efficacy of use of combination of Ivermectin and colchicine on severity and outcome Of COVID 19 infection.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Ivermectin + colchicine + standard care | Active comparator | Drug: Ivermectin + colchicineIn addition to the local standard of care for COVID 19 patients, the patient will receive: Ivermectin + Colchicine |
| Colchicine + standard care | Active comparator | Drug: ColchicineIn addition to the local standard of care for COVID 19 patients, the patient will receive: Colchicine |
| standard care | No intervention | –Patients will receive Standard care |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Willing and able to provide written informed consent prior to performing study procedures.
- Currently hospitalized and requiring medical care for non-sever COVID-19.
- One or more of the following: (positive PCR test or positive antibodies) or (CT Chest consistent with COVID19 infection).
Key exclusion criteria (3 listed)
- Tocilizumab use.
- Mechanical ventilation
- Requirement of oxygen supplementation >8L/min on admission
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 + colchicineIn addition to the local standard of care for COVID 19 patients, the patient will receive Ivermectin + colchicine | Drug | Ivermectin + colchicine + standard care |
| ColchicineIn addition to the local standard of care for COVID 19 patients, the patient will receive colchicine | Drug | Colchicine + standard care |
Primary outcome
length of oxygen requirement
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2022.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ivermectin + colchicine and Colchicine in people with COVID-19, run by Ain Shams 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 3 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: finished, as of the sponsor's last update on 7 Apr 2022. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
length of oxygen requirement (time frame: 3 months). 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 7 Apr 2022.