Covid19Phase 4NCT04944082
Remdesivir- Ivermectin Combination Therapy in Severe Covid-19
A Phase 4 study testing Ivermectin in people with Covid19, run by Assiut University.
Trial summary
Recent study reported in vitro synergistic interaction between two FDA approved drugs, remdesivir (RDV) and ivermectin (IVM) resulting in enhanced antiviral activity against SARS-CoV-2, the causative pathogen of COVID-19. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Covid19
- What is being tested?
- Ivermectin
- 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
- 1 Jul 2021to 31 Dec 2021
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult, hospitalized severe COVID-19 patients; both genders; given informed consent (COVID-19 infection confirmed by PCR, severe illness is defined as patients with SpO2 ≤94% on room air, including patients on supplemental oxygen).
Who cannot join
- patients under 18 years old, pregnant ladies, advanced renal diseases (cr. Clearance < 30 ml/hr), raised liver enzymes> 3 folds of normal, arrhythmia.
About this study
Official title: Remdesivir Versus Remdesivir- Ivermectin Combination Therapy in Severe and Critically Ill Covid-19
Recent study reported in vitro synergistic interaction between two FDA approved drugs, remdesivir (RDV) and ivermectin (IVM) resulting in enhanced antiviral activity against SARS-CoV-2, the causative pathogen of COVID-19. The aim of the current study is comparing the efficacy and safety of combining remdesivir and ivermectin versus using remdesivir alone in patients with severe COVID-19.
- Conditions
- Covid19
- Being tested
- Ivermectin
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IvermectinDrug
(The same remdesivir dose as mentioned + ivermectin 4 tablet (6mg) once daily before meal for four days)
| Study group | Role | What they receive |
|---|---|---|
| Remdesivir only | No intervention | (Dose 200 mg day one, 100 mg daily days 2-5), duration may extend to 10 days of remdesivir (200 mg day one, 100 mg daily days 2-10) |
| Combination remdesivir plus ivermectin group | Experimental | (The same remdesivir dose as mentioned + ivermectin 4 tablet (6mg) once daily before meal for four days) Receives: Drug: Ivermectin |
What is being measured
The primary outcome is the main question the study is designed to answer.
1- Improvement in level of oxygenation
Change in partial pressure of Oxygen and oxygen saturation
Measured: By arterial blood gas and non-invasive pulse oximeter at date of randomisation, after 1 hour then on daily bases in stable cases till time of patient discharge or death
2- Need for ventilator support
either noninvasive or invasive mechanical ventilation.
Measured: From date of randomisation to patient discharge from hospital or death.
3- Length of hospital stay
duration of admission in days
Measured: From date of randomisation to date of patient discharge from hospital or death.
4- Development of complication
allergic reactions, arrhythmia, hepatic toxicity.....
Measured: From starting to the end of ivermectin therapy (0 to the end of 4th day)
5- Mortality
mortality rates in both groups
Measured: Through study completion, an average of 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2021
- Study start1 Jul 2021 (estimated)
- Primary completion31 Dec 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.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Covid19Studies of the same condition, open and under way.
- More trials run by Assiut 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
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maiada K. Hashem, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04944082
- Sponsor's protocol ID
- Remdesivir-Ivermectin
- Status last verified
- Jun 2021
- First submitted
- 23 Jun 2021
- Last updated
- 29 Jun 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Caly L, Druce JD, Catton MG, Jans DA, Wagstaff KM. The FDA-approved drug ivermectin inhibits the replication of SARS-CoV-2 in vitro. Antiviral Res. 2020 Jun;178:104787. doi: 10.1016/j.antiviral.2020.104787. Epub 2020 Apr 3.
PubMed 32251768Pizzorno A, Padey B, Dubois J, Julien T, Traversier A, Duliere V, Brun P, Lina B, Rosa-Calatrava M, Terrier O. In vitro evaluation of antiviral activity of single and combined repurposable drugs against SARS-CoV-2. Antiviral Res. 2020 Sep;181:104878. doi: 10.1016/j.antiviral.2020.104878. Epub 2020 Jul 15.
PubMed 32679055
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Remdesivir Versus Remdesivir- Ivermectin Combination Therapy in Severe and Critically Ill Covid-19
- ClinicalTrials.gov ID
- NCT04944082
- Acronym / sponsor ID
- Remdesivir-Ivermectin
- Conditions
- Covid19
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Jul 2021 (estimated)
- Primary completion
- 31 Dec 2021 (estimated)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 29 Jun 2021 (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.
Recent study reported in vitro synergistic interaction between two FDA approved drugs, remdesivir (RDV) and ivermectin (IVM) resulting in enhanced antiviral activity against SARS-CoV-2, the causative pathogen of COVID-19. The aim of the current study is comparing the efficacy and safety of combining remdesivir and ivermectin versus using remdesivir alone in patients with severe COVID-19.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Remdesivir only | No intervention | –(Dose 200 mg day one, 100 mg daily days 2-5), duration may extend to 10 days of remdesivir (200 mg day one, 100 mg daily days 2-10) |
| Combination remdesivir plus ivermectin group | Experimental | Drug: Ivermectin(The same remdesivir dose as mentioned + ivermectin 4 tablet (6mg) once daily before meal for four days) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adult, hospitalized severe COVID-19 patients; both genders; given informed consent (COVID-19 infection confirmed by PCR, severe illness is defined as patients with SpO2 ≤94% on room air, including patients on supplemental oxygen).
Key exclusion criteria (1 listed)
- patients under 18 years old, pregnant ladies, advanced renal diseases (cr. Clearance < 30 ml/hr), raised liver enzymes> 3 folds of normal, arrhythmia.
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(The same remdesivir dose as mentioned + ivermectin 4 tablet (6mg) once daily before meal for four days) | Drug | Combination remdesivir plus ivermectin group |
Primary outcome
1- Improvement in level of oxygenation
Time frame: By arterial blood gas and non-invasive pulse oximeter at date of randomisation, after 1 hour then on daily bases in stable cases till time of patient discharge or death
Change in partial pressure of Oxygen and oxygen saturation
2- Need for ventilator support
Time frame: From date of randomisation to patient discharge from hospital or death.
either noninvasive or invasive mechanical ventilation.
3- Length of hospital stay
Time frame: From date of randomisation to date of patient discharge from hospital or death.
duration of admission in days
4- Development of complication
Time frame: From starting to the end of ivermectin therapy (0 to the end of 4th day)
allergic reactions, arrhythmia, hepatic toxicity.....
5- Mortality
Time frame: Through study completion, an average of 3 months
mortality rates in both groups
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2021.
- Background: PubMed 32251768Caly L, Druce JD, Catton MG, Jans DA, Wagstaff KM. The FDA-approved drug ivermectin inhibits the replication of SARS-CoV-2 in vitro. Antiviral Res. 2020 Jun;178:104787. doi: 10.1016/j.antiviral.2020.104787. Epub 2020 Apr 3.
- Background: PubMed 32679055Pizzorno A, Padey B, Dubois J, Julien T, Traversier A, Duliere V, Brun P, Lina B, Rosa-Calatrava M, Terrier O. In vitro evaluation of antiviral activity of single and combined repurposable drugs against SARS-CoV-2. Antiviral Res. 2020 Sep;181:104878. doi: 10.1016/j.antiviral.2020.104878. Epub 2020 Jul 15.
- Individual participant dataSharing planned: Yes
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ivermectin in people with Covid19, run by Assiut 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 29 Jun 2021. 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 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?
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?
1- Improvement in level of oxygenation (time frame: By arterial blood gas and non-invasive pulse oximeter at date of randomisation, after 1 hour then on daily bases in stable cases till time of patient discharge or death). The study lists 5 primary outcomes in all. 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 NCT04944082, which also lists 2 linked publications.
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 29 Jun 2021.