Covid19Phase 1/2NCT04591600
Effectiveness of Ivermectin and Doxycycline on COVID-19 Patients
A Phase 1/2 study testing Ivermectin and Doxycyline in people with Covid19, run by Alkarkh Health Directorate-Baghdad at 1 site in Iraq.
Trial summary
A randomized controlled trial on using Ivermectin and doxycycline to treat mild-moderate outpatients, severe, and critical inpatients of Coronavirus disease 19 (COVID-19) along with standard of care. Read more about this study
- Who is it for?
- Ages 16 to 86 years
- Conditions the study is for
- Covid19
- What is being tested?
- Ivermectin and Doxycyline
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteIraq
- Study dates
- 1 Jul 2020to 14 Oct 2020
- Phase
- Phase 1/2
- 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 16 to 86 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- COVID-19 patients at any stage of this disease
Who cannot join
- Patients of allergic history to Ivermectin or to doxycyline
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Controlled Randomized Clinical Trial on Using Ivermectin With Doxycycline for Treating COVID-19 Patients in Baghdad, Iraq
A randomized controlled trial on using Ivermectin and doxycycline to treat mild-moderate outpatients, severe, and critical inpatients of Coronavirus disease 19 (COVID-19) along with standard of care. Seventy Iraqi COVID-19 patients received Ivermectin and Doxycycline plus standard of care versus seventy Iraqi COVID-19 patients received standard of care only. .
Read the detailed description
Objectives: COVID-19 patients suffer from the lack of curative therapy. Hence, there is an urgent need to try old re-purposed drugs on COVID-19. Methods: Randomized controlled study on 70 COVID-19 patients (48 mild-moderate, 11 severe, and 11 critical patients) treated with 200ug/kg PO of Ivermectin per day for 2 days along with 100mg PO doxycycline twice per day for 5-10 days plus standard therapy; the second arm is 70 COVID-19 patients (48 mild-moderate and 22 severe and zero critical patients) on standard therapy. The time to recovery, the progression of the disease, and the mortality rate were the outcome-assessing parameters.
- Conditions
- Covid19
- Being tested
- Ivermectin and Doxycyline, Standard of care
- Keywords
- Ivermectin, Doxycycline, COVID-19, Coronavirus, SARS-CoV-2
- Medical subject headings
- COVID-19, Coronavirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ivermectin and DoxycylineDrug
Also called Stromectol and Doxycin
Ivermectin 200ug/kg PO per day for two days, and in some patients who needed more time to recover, a third dose 200ug/kg PO per day was given 7 days after the first dose. Doxycycline 100mg capsule PO every 12h per day was given for 5-10 days, based on the clinical improvement of patients. In addition, standard care was given to the patients of Ivermectin-Doxycycline group based on the clinical condition of each patient.
Standard of careDrug
Also called Control arm
Standard care
- Acetaminophen 500mg on need
- Vitamin C 1000mg twice/ day
- Zinc 75-125 mg/day
- Vitamin D3 5000IU/day
- Azithromycin 250mg/day for 5 days
- Oxygen therapy/ C-Pap if needed
- dexamethasone 6 mg/day or methylprednisolone 40mg twice per day, if needed
- Mechanical ventilation, if needed
| Study group | Role | What they receive |
|---|---|---|
| Ivermectin-Doxycycline | Experimental | Ivermectin 200ug/kg PO per day for two days, and in some patients who needed more time to recover, a third dose 200ug/kg PO per day was given 7 days after the first dose. Doxycycline 100mg capsule PO every 12h per day was given for 5-10 days, based on the clinical improvement of patients. In addition, standard of care was given to the patients of Ivermectin-Doxycycline group based on the clinical condition of each patient. Receives: Drug: Ivermectin and Doxycyline; Drug: Standard of care |
| Control | Active comparator | Control group: The patients in this group received only standard care which included all or some of the following, according to the clinical condition of each patient. Receives: Drug: Standard of care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality rate
The effect of the experimental drugs to reduce the mortality rate (death rate) of treated patients
Measured: Up to 8 weeks
Rate of progression disease
rate of patients under treatment who undergo progression of disease to a more advanced stage
Measured: up to 8 weeks
Secondary outcomes (1)
Time to recovery
time needed by treated patients to recover (become symptoms free and polymerase chain reaction, or PCR, negative)
Measured: Up to 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2020
- Study start1 Jul 2020
- Primary completion30 Sep 2020
- Study completion14 Oct 2020
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.
- 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alkarkh Health Directorate-Baghdad
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Ahmed Sahib Abdulamir, Alkarkh Health Directorate-Baghdad
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04591600
- Sponsor's protocol ID
- IVM-DOX
- Status last verified
- Oct 2020
- First submitted
- 15 Oct 2020
- Last updated
- 19 Oct 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 19 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Controlled Randomized Clinical Trial on Using Ivermectin With Doxycycline for Treating COVID-19 Patients in Baghdad, Iraq
- ClinicalTrials.gov ID
- NCT04591600
- Acronym / sponsor ID
- IVM-DOX
- Conditions
- Covid19
- Keywords
- Ivermectin, Doxycycline, COVID-19, Coronavirus, SARS-CoV-2
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- Alkarkh Health Directorate-BaghdadOther government
- Study start
- 1 Jul 2020 (actual)
- Primary completion
- 30 Sep 2020 (actual)
- Study completion
- 14 Oct 2020 (actual)
- First posted
- 19 Oct 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.
A randomized controlled trial on using Ivermectin and doxycycline to treat mild-moderate outpatients, severe, and critical inpatients of Coronavirus disease 19 (COVID-19) along with standard of care. Seventy Iraqi COVID-19 patients received Ivermectin and Doxycycline plus standard of care versus seventy Iraqi COVID-19 patients received standard of care only. .
Detailed description
Objectives: COVID-19 patients suffer from the lack of curative therapy. Hence, there is an urgent need to try old re-purposed drugs on COVID-19. Methods: Randomized controlled study on 70 COVID-19 patients (48 mild-moderate, 11 severe, and 11 critical patients) treated with 200ug/kg PO of Ivermectin per day for 2 days along with 100mg PO doxycycline twice per day for 5-10 days plus standard therapy; the second arm is 70 COVID-19 patients (48 mild-moderate and 22 severe and zero critical patients) on standard therapy. The time to recovery, the progression of the disease, and the mortality rate were the outcome-assessing parameters.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ivermectin-Doxycycline | Experimental | Drug: Ivermectin and Doxycyline, Drug: Standard of careIvermectin 200ug/kg PO per day for two days, and in some patients who needed more time to recover, a third dose 200ug/kg PO per day was given 7 days after the first dose. Doxycycline 100mg capsule PO every 12h per day was given for 5-10 days, based on the clinical improvement of patients. In addition, standard of care was given to the patients of Ivermectin-Doxycycline group based on the clinical condition of each patient. |
| Control | Active comparator | Drug: Standard of careControl group: The patients in this group received only standard care which included all or some of the following, according to the clinical condition of each patient. |
Who may qualify
- Ages
- 16 to 86 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- COVID-19 patients at any stage of this disease
Key exclusion criteria (1 listed)
- Patients of allergic history to Ivermectin or to doxycyline
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 and DoxycylineAlso: Stromectol and DoxycinIvermectin 200ug/kg PO per day for two days, and in some patients who needed more time to recover, a third dose 200ug/kg PO per day was given 7 days after the first dose. Doxycycline 100mg capsule PO every 12h per day was given for 5-10 days, based on the clinical improvement of patients. In addition, standard care was given to the patients of Ivermectin-Doxycycline group based on the clinical condition of each patient. | Drug | Ivermectin-Doxycycline |
| Standard of careAlso: Control armStandard care * Acetaminophen 500mg on need * Vitamin C 1000mg twice/ day * Zinc 75-125 mg/day * Vitamin D3 5000IU/day * Azithromycin 250mg/day for 5 days * Oxygen therapy/ C-Pap if needed * dexamethasone 6 mg/day or methylprednisolone 40mg twice per day, if needed * Mechanical ventilation, if needed | Drug | Control, Ivermectin-Doxycycline |
Primary outcome
Mortality rate
Time frame: Up to 8 weeks
The effect of the experimental drugs to reduce the mortality rate (death rate) of treated patients
Rate of progression disease
Time frame: up to 8 weeks
rate of patients under treatment who undergo progression of disease to a more advanced stage
1 secondary outcome
Time to recovery
Time frame: Up to 8 weeks
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 19 Oct 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.
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 1/2 study testing Ivermectin and Doxycyline in people with Covid19, run by Alkarkh Health Directorate-Baghdad at 1 site in Iraq.
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: finished, as of the sponsor's last update on 19 Oct 2020. 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 Iraq. 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 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?
Mortality rate (time frame: Up to 8 weeks). The study lists 2 primary outcomes in all. 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 19 Oct 2020.