COVIDNCT04392713
Efficacy of Ivermectin in COVID-19
A study testing Ivermectin 6 MG Oral Tablet (2 tablets) in people with COVID, run by Combined Military Hospital, Pakistan at 1 site in Pakistan.
Trial summary
It is a randomized controlled trial to assess the efficacy of Ivermectin in COVID-19. Patient recruited will be assigned to two groups one group will be given ivermectin with standard chloroquine regimen and the other group will be receiving chloroquine only. Read more about this study
- Who is it for?
- Ages 15 to 65 years
- Conditions the study is for
- COVID
- What is being tested?
- Ivermectin 6 MG Oral Tablet (2 tablets)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 sitePakistan
- Study dates
- 15 Apr 2020to Jul 2020
- Phase
- Interventional
- 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 15 to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Provision of signed and dated informed consent form
- Stated willingness to comply with all study procedures and availability for the duration of the study
- Male or female, aged 15 to 65 years
- In good general health with no or mild to moderate symptoms of Corona virus disease
- PCR positive for SARS-Cov-2.
- Ability to take oral medication and be willing to adhere to the drug intake regimen
Who cannot join
- Severe symptoms likely attributed to Cytokine Release Storm.
- Malignant diseases, diabetes mellitus, chronic kidney disease and cirrhosis liver with CPT class B or C.
Trial locations and contacts
1 site in 1 country.
Najma Parveen, FCPS med contact
Pakistan1 site, 1 recruiting
- Recruiting
Combined Military Hospital Lahore
Lahore, Punjab Province
Najma Parveen, FCPS MED, 00923225335786, Najma.med@gmail.com
About this study
Official title: Efficacy of Ivermectin in COVID-19 : A Randomized Controlled Trial
It is a randomized controlled trial to assess the efficacy of Ivermectin in COVID-19. Patient recruited will be assigned to two groups one group will be given ivermectin with standard chloroquine regimen and the other group will be receiving chloroquine only. Out come will be recorded by documenting PCR reports at 48, 96 and 144 hours.
Read the detailed description
INTERVENTION It will be a randomized controlled trial which will be done on COVID-19 patients proven by PCR fulfilling the criteria (asymptomatic/mild to moderate severity). They will be divided into two groups after randomization. Group A will be administered Ivermectin single dose of 12grams along with Chloroquine as per existing hospital guidelines and group B will be given Chloroquine alone. Dose of Ivermectin to be repeated at 1 week if PCR stays negative. PCR will be done on alternate days (48, 96 and 144hours) and the duration at which the PCR becomes negative will be compared. Dose of drug subject to change in accordance with patient response or possible side effect.
ELIGIBILITY CRITERIA INCLUSION CRITERIA
In order to be eligible to participate in this study, an individual must meet all of the following criteria:
Provision of signed and dated informed consent form Stated willingness to comply with all study procedures and availability for the duration of the study Male or female, aged 15 to 65 years In good general health with no or mild symptoms of Corona virus disease PCR positive for SARS-Cov-2. Ability to take oral medication and be willing to adhere to the drug intake regimen EXCLUSION CRITERIA
An individual who meets any of the following criteria will be excluded from participation in this study:
Severe symptoms likely attributed to Cytokine Release Storm. Malignant diseases, diabetes mellitus, chronic kidney disease and cirrhosis liver with CPT class B or C.
- Conditions
- COVID
- Being tested
- Ivermectin 6 MG Oral Tablet (2 tablets)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ivermectin 6 MG Oral Tablet (2 tablets)Drug
12 mg single dose of Ivermectin will be given to intervention arm
| Study group | Role | What they receive |
|---|---|---|
| Ivermectin arm | Active comparator | Participants will be administered Ivermectin with standard chloroquine regimen Receives: Drug: Ivermectin 6 MG Oral Tablet (2 tablets) |
| Control arm | No intervention | This arm will only receive chloroquine as per existing policy of hospital |
What is being measured
The primary outcome is the main question the study is designed to answer.
Negative PCR
PCR will be done at 48, 96 and 144 hours
Measured: 144 hours
Secondary outcomes (1)
Need for mechanical ventilation
All patients will be assessed for requirement of mechanical ventilation in both the groups
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2020
- Study start15 Apr 2020
- Primary completionJul 2020 (estimated)
- Study completionJul 2020 (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 COVIDStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Combined Military Hospital, Pakistan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Asma Asghar, Combined Military Hospital, Pakistan
- Investigators
- Karamat Hu Bukhari, FCPS MED, Study director, Combined military hospital lahore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04392713
- Sponsor's protocol ID
- IVE-COV
- Status last verified
- May 2020
- First submitted
- 5 May 2020
- Last updated
- 19 May 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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 32251768Simsek Yavuz S, Unal S. Antiviral treatment of COVID-19. Turk J Med Sci. 2020 Apr 21;50(SI-1):611-619. doi: 10.3906/sag-2004-145.
PubMed 32293834
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Ivermectin in COVID-19 : A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04392713
- Acronym / sponsor ID
- IVE-COV
- Conditions
- COVID
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Combined Military Hospital, PakistanUniversity, hospital or other
- Study start
- 15 Apr 2020 (actual)
- Primary completion
- Jul 2020 (estimated)
- Study completion
- Jul 2020 (estimated)
- First posted
- 19 May 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.
It is a randomized controlled trial to assess the efficacy of Ivermectin in COVID-19. Patient recruited will be assigned to two groups one group will be given ivermectin with standard chloroquine regimen and the other group will be receiving chloroquine only. Out come will be recorded by documenting PCR reports at 48, 96 and 144 hours.
Detailed description
INTERVENTION It will be a randomized controlled trial which will be done on COVID-19 patients proven by PCR fulfilling the criteria (asymptomatic/mild to moderate severity). They will be divided into two groups after randomization. Group A will be administered Ivermectin single dose of 12grams along with Chloroquine as per existing hospital guidelines and group B will be given Chloroquine alone. Dose of Ivermectin to be repeated at 1 week if PCR stays negative. PCR will be done on alternate days (48, 96 and 144hours) and the duration at which the PCR becomes negative will be compared. Dose of drug subject to change in accordance with patient response or possible side effect.
ELIGIBILITY CRITERIA INCLUSION CRITERIA
In order to be eligible to participate in this study, an individual must meet all of the following criteria:
Provision of signed and dated informed consent form Stated willingness to comply with all study procedures and availability for the duration of the study Male or female, aged 15 to 65 years In good general health with no or mild symptoms of Corona virus disease PCR positive for SARS-Cov-2. Ability to take oral medication and be willing to adhere to the drug intake regimen EXCLUSION CRITERIA
An individual who meets any of the following criteria will be excluded from participation in this study:
Severe symptoms likely attributed to Cytokine Release Storm. Malignant diseases, diabetes mellitus, chronic kidney disease and cirrhosis liver with CPT class B or C.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ivermectin arm | Active comparator | Drug: Ivermectin 6 MG Oral Tablet (2 tablets)Participants will be administered Ivermectin with standard chloroquine regimen |
| Control arm | No intervention | –This arm will only receive chloroquine as per existing policy of hospital |
Who may qualify
- Ages
- 15 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Provision of signed and dated informed consent form
- Stated willingness to comply with all study procedures and availability for the duration of the study
- Male or female, aged 15 to 65 years
- In good general health with no or mild to moderate symptoms of Corona virus disease
- PCR positive for SARS-Cov-2.
Key exclusion criteria (2 listed)
- Severe symptoms likely attributed to Cytokine Release Storm.
- Malignant diseases, diabetes mellitus, chronic kidney disease and cirrhosis liver with CPT class B or C.
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 6 MG Oral Tablet (2 tablets)12 mg single dose of Ivermectin will be given to intervention arm | Drug | Ivermectin arm |
Primary outcome
Negative PCR
Time frame: 144 hours
PCR will be done at 48, 96 and 144 hours
1 secondary outcome
Need for mechanical ventilation
Time frame: 4 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2020.
- 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.
- Results publication: PubMed 32293834Simsek Yavuz S, Unal S. Antiviral treatment of COVID-19. Turk J Med Sci. 2020 Apr 21;50(SI-1):611-619. doi: 10.3906/sag-2004-145.
- 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.
Najma Parveen, FCPS med contact
Karamat Hu Bukhari, FCPS MED study director
Combined military hospital lahore
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ivermectin 6 MG Oral Tablet (2 tablets) in people with COVID, run by Combined Military Hospital, Pakistan at 1 site in Pakistan.
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 6 inclusion and 2 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 19 May 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 Pakistan. 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.
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 Asma Asghar, FCPS MED (00923225141033, Asghar.asma79@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Negative PCR (time frame: 144 hours). 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 NCT04392713, 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 19 May 2020.