Covid19Phase 4NCT04739410
Effectiveness of Ivermectin in SARS-CoV-2/COVID-19 Patients
A Phase 4 study testing Ivermectin in people with Covid19, run by FMH College of Medicine and Dentistry at 1 site in Pakistan.
Trial summary
Background: The first case of Infection with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) were diagnosed in Wuhan, China in 2019. In the first half of 2020 this disease has already converted into a global pandemic. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Covid19
- What is being tested?
- Ivermectin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 sitePakistan
- Study dates
- 1 May 2020to 30 Jun 2020
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All patients diagnosed with COVID-19 infection with positive reverse transcriptase RT-PCR test, who were willing to participate in this study
- Patients having age of 18-75 years
- Patients of both genders male and female
- Patients who had mild symptoms of Corona virus disease and RT- PCR positive for SARS-Cov-2
- Ability to take oral medication and were willing to adhere to the drug intake regimen
Who cannot join
- Known severe allergic reactions to Ivermectin
- Pregnancy or breastfeeding
- Severe symptoms likely attributed to Cytokine Release Storm
- Malignant diseases
- Chronic kidney disease
- Cirrhosis liver with Child class B or C
Trial locations and contacts
1 site in 1 country.
About this study
Background:
The first case of Infection with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) were diagnosed in Wuhan, China in 2019. In the first half of 2020 this disease has already converted into a global pandemic. Objectives: To assess the efficacy of Ivermectin in mild cases of COVID-19 patients on the basis of predefined assessment criteria. Study Settings: Fatima Memorial Hospital, Lahore Study Design: Open label randomized control trial. Duration of Study: From 1st May, 2020 to 30th June, 2020.Patients \& Methods: Sample size and technique: Sample size was 50 patients; 25 patients were kept in control group and 25 patients were kept in experimental group
Read the detailed description
The first case of Infection with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) were diagnosed in Wuhan, China in 2019. In the first half of 2020 this disease has already converted into a global pandemic, having different forms of presentation in different patients.
Exponential rise in its cases along with associated mortality has shaken the world.
The severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is a single-stranded ribonucleic acid (RNA) virus that causes a severe acute respiratory syndrome. The virus was originally called SARS-CoV-2 named officially by World Health Organization as COVID-19 and a global health emergency. The first known case of infection was recorded in early December 2019 and subsequently spread to various continents, including Europe and the United States.Generally, 75 percent of patients recover without any notable complication however 25 percent can experience associated complications leading to intensive care unit transfer and even mortality.
Ivermectin has different effects to treat variety of diseases and it has proven antimicrobial, antiviral, and anti-cancer properties and considered as a wonder drug. It is highly effective against many microorganisms including some viruses. Many studies revealed its antiviral effects on RNA viruses such as Zika, dengue, yellow fever, West Nile, Hendra, Newcastle, Venezuelan equine encephalitis, chikungunya, Semliki Forest, Sindbis, Avian influenza A, Porcine Reproductive and Respiratory Syndrome, Human immunodeficiency virus(HIV) type 1, and severe acute respiratory syndrome coronavirus SARS-CoV-2. Fon other hand there are few studies showing antiviral effects of ivermectin against DNA viruses such as Equine herpes type 1, BK polyomavirus, pseudorabies, porcine circovirus 2, and bovine herpesvirus 1.5 Ivermectin plays a vital role in several biological mechanisms, therefore it could emerge as a potential candidate in the treatment of a wide range of viruses including COVID-19 as well as other types of positive-sense single-stranded RNA viruses. In vivo studies of animal models revealed a broad range of antiviral effects of ivermectin, however, more clinical trials are necessary as it's the need of the hour to do so, as we can validate the potential efficacy of ivermectin in clinical settings.
The recent report by Caly et al.6 describing the antiviral potential of ivermectin against the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in vitro arrive to the agenda of potential candidates for COVID-19 treatment.
Currently, there is not any Food and drug administration (FDA) approved specific effective antiviral treatment available for COVID-19.Although most of the COVID-19 patients have mild or moderate courses, up to 5%-10% can have severe, potentially life threatening course, there is an urgent need for development of effective \& safe drugs to deal with this novel virus. Optimized supportive care remains the mainstay of therapy. There are more than 300 clinical trials going on, various antiviral and immunomodulating agents are in different stages of evaluation for COVID-19 in those trials and results/ primary end points of few trials will be published in the next couple of months. Despite the urgent need to find an effective and safe antiviral treatment for COVID-19 through randomized controlled studies, certain agents are being used all over the world based on either in-vitro or conclusive evidence or observational studies.
The clinical efficacy and utility of ivermectin in SARS-CoV-2-infected patients is unpredictable at this stage, as we are dealing with a completely novel virus.
There is an urgent need for investigation of the mortality causes and development of novel therapeutic options for severe COVID-19.
- Conditions
- Covid19
- Being tested
- Ivermectin
- Keywords
- Corona virus, SARS-COv-2, Ivermectin, pandemic, antiviral
- 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
Also called Experimental
Ivermectin Prescribing protocol: Participants were prescribed Ivermectin 12 mg per oral stat and then 12 mg per oral after 12 hours and 12 mg per oral after 24 hours and we looked at the response at day 7 on follow up in terms of improvement of symptoms like (Fever, Cough, sore throat, Headache, Shortness of breath, lethargy, and fatigue.Any side effects of the drugs were noted as well
| Study group | Role | What they receive |
|---|---|---|
| Ivermectin | Experimental | Ivermectin Prescribing protocol: Participants were prescribed Ivermectin 12mg stat per oral and then 12 mg per oral after 12 hours and 12mg per oral after 24 hours and we looked at the response at day 7 on follow up in terms of improvement of symptoms like (Fever, Cough, sore throat, Headache, Shortness of breath, lethargy, and fatigue. and any side effects of the drugs were noted as well. Receives: Drug: Ivermectin |
| SOC standard of care | Placebo comparator | These participants were given standard of care without Ivermectin standard of care only symptomatic treatment Receives: Drug: Ivermectin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Resolution of symptoms
Will look for resolution of Fever, Fatigue, myalgias, cough and we had an questionaire for that as well and followed up on their chest x rays for progression of the disease
Measured: 7 days
Progression of the disease
did the disease progress from mild to moderate severity, like follow up chest x ray showed more infiltrates or their oxygen saturations in % dropped from their baseline and baseline symptoms persisted and got worse
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 posted4 Feb 2021
- Study start1 May 2020
- Primary completion30 Jun 2020
- Study completion30 Jun 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Response of the patients after Ivermectin prescription and response of the patients without Ivermectin prescription was recorded. Response was recorded on the basis of clinical parameters (Fever, Cough, sore throat, Headache, Shortness of breath, lethargy, and fatigue. Any side effects noted after prescription of Ivermectin was recorded.
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- FMH College of Medicine and Dentistry
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aijaz Zeeshan Khan Chachar, FMH College of Medicine and Dentistry
- Investigators
- Aijaz Zeeshan Khan Chachar, MBBS,FCPS, Principal investigator, FMH College of Medicine & Dentistry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04739410
- Sponsor's protocol ID
- IRB#FMH-07-2020-IRB-766-M
- Status last verified
- Feb 2021
- First submitted
- 2 Feb 2021
- Last updated
- 4 Feb 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: whatever is needed, will share if needed at any time
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Ivermectin in SARS-CoV-2/COVID-19 Patients
- ClinicalTrials.gov ID
- NCT04739410
- Acronym / sponsor ID
- IRB#FMH-07-2020-IRB-766-M
- Conditions
- Covid19
- Keywords
- Corona virus, SARS-COv-2, Ivermectin, pandemic, antiviral
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- FMH College of Medicine and DentistryUniversity, hospital or other
- Study start
- 1 May 2020 (actual)
- Primary completion
- 30 Jun 2020 (actual)
- Study completion
- 30 Jun 2020 (actual)
- First posted
- 4 Feb 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.
Background:
The first case of Infection with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) were diagnosed in Wuhan, China in 2019. In the first half of 2020 this disease has already converted into a global pandemic. Objectives: To assess the efficacy of Ivermectin in mild cases of COVID-19 patients on the basis of predefined assessment criteria. Study Settings: Fatima Memorial Hospital, Lahore Study Design: Open label randomized control trial. Duration of Study: From 1st May, 2020 to 30th June, 2020.Patients \& Methods: Sample size and technique: Sample size was 50 patients; 25 patients were kept in control group and 25 patients were kept in experimental group
Detailed description
The first case of Infection with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) were diagnosed in Wuhan, China in 2019. In the first half of 2020 this disease has already converted into a global pandemic, having different forms of presentation in different patients.
Exponential rise in its cases along with associated mortality has shaken the world.
The severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is a single-stranded ribonucleic acid (RNA) virus that causes a severe acute respiratory syndrome. The virus was originally called SARS-CoV-2 named officially by World Health Organization as COVID-19 and a global health emergency. The first known case of infection was recorded in early December 2019 and subsequently spread to various continents, including Europe and the United States.Generally, 75 percent of patients recover without any notable complication however 25 percent can experience associated complications leading to intensive care unit transfer and even mortality.
Ivermectin has different effects to treat variety of diseases and it has proven antimicrobial, antiviral, and anti-cancer properties and considered as a wonder drug. It is highly effective against many microorganisms including some viruses. Many studies revealed its antiviral effects on RNA viruses such as Zika, dengue, yellow fever, West Nile, Hendra, Newcastle, Venezuelan equine encephalitis, chikungunya, Semliki Forest, Sindbis, Avian influenza A, Porcine Reproductive and Respiratory Syndrome, Human immunodeficiency virus(HIV) type 1, and severe acute respiratory syndrome coronavirus SARS-CoV-2. Fon other hand there are few studies showing antiviral effects of ivermectin against DNA viruses such as Equine herpes type 1, BK polyomavirus, pseudorabies, porcine circovirus 2, and bovine herpesvirus 1.5 Ivermectin plays a vital role in several biological mechanisms, therefore it could emerge as a potential candidate in the treatment of a wide range of viruses including COVID-19 as well as other types of positive-sense single-stranded RNA viruses. In vivo studies of animal models revealed a broad range of antiviral effects of ivermectin, however, more clinical trials are necessary as it's the need of the hour to do so, as we can validate the potential efficacy of ivermectin in clinical settings.
The recent report by Caly et al.6 describing the antiviral potential of ivermectin against the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in vitro arrive to the agenda of potential candidates for COVID-19 treatment.
Currently, there is not any Food and drug administration (FDA) approved specific effective antiviral treatment available for COVID-19.Although most of the COVID-19 patients have mild or moderate courses, up to 5%-10% can have severe, potentially life threatening course, there is an urgent need for development of effective \& safe drugs to deal with this novel virus. Optimized supportive care remains the mainstay of therapy. There are more than 300 clinical trials going on, various antiviral and immunomodulating agents are in different stages of evaluation for COVID-19 in those trials and results/ primary end points of few trials will be published in the next couple of months. Despite the urgent need to find an effective and safe antiviral treatment for COVID-19 through randomized controlled studies, certain agents are being used all over the world based on either in-vitro or conclusive evidence or observational studies.
The clinical efficacy and utility of ivermectin in SARS-CoV-2-infected patients is unpredictable at this stage, as we are dealing with a completely novel virus.
There is an urgent need for investigation of the mortality causes and development of novel therapeutic options for severe COVID-19.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Response of the patients after Ivermectin prescription and response of the patients without Ivermectin prescription was recorded. Response was recorded on the basis of clinical parameters (Fever, Cough, sore throat, Headache, Shortness of breath, lethargy, and fatigue. Any side effects noted after prescription of Ivermectin was recorded.
| Arm | Type | Receives |
|---|---|---|
| Ivermectin | Experimental | Drug: IvermectinIvermectin Prescribing protocol: Participants were prescribed Ivermectin 12mg stat per oral and then 12 mg per oral after 12 hours and 12mg per oral after 24 hours and we looked at the response at day 7 on follow up in terms of improvement of symptoms like (Fever, Cough, sore throat, Headache, Shortness of breath, lethargy, and fatigue. and any side effects of the drugs were noted as well. |
| SOC standard of care | Placebo comparator | Drug: IvermectinThese participants were given standard of care without Ivermectin standard of care only symptomatic treatment |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- All patients diagnosed with COVID-19 infection with positive reverse transcriptase RT-PCR test, who were willing to participate in this study
- Patients having age of 18-75 years
- Patients of both genders male and female
- Patients who had mild symptoms of Corona virus disease and RT- PCR positive for SARS-Cov-2
- Ability to take oral medication and were willing to adhere to the drug intake regimen
Key exclusion criteria (6 listed)
- Known severe allergic reactions to Ivermectin
- Pregnancy or breastfeeding
- Severe symptoms likely attributed to Cytokine Release Storm
- Malignant diseases
- Chronic kidney disease
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 |
|---|---|---|
| IvermectinAlso: ExperimentalIvermectin Prescribing protocol: Participants were prescribed Ivermectin 12 mg per oral stat and then 12 mg per oral after 12 hours and 12 mg per oral after 24 hours and we looked at the response at day 7 on follow up in terms of improvement of symptoms like (Fever, Cough, sore throat, Headache, Shortness of breath, lethargy, and fatigue.Any side effects of the drugs were noted as well | Drug | Ivermectin, SOC standard of care |
Primary outcome
Resolution of symptoms
Time frame: 7 days
Will look for resolution of Fever, Fatigue, myalgias, cough and we had an questionaire for that as well and followed up on their chest x rays for progression of the disease
Progression of the disease
Time frame: 14 days
did the disease progress from mild to moderate severity, like follow up chest x ray showed more infiltrates or their oxygen saturations in % dropped from their baseline and baseline symptoms persisted and got worse
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 4 Feb 2021.
- Individual participant dataSharing planned: Yes. whatever is needed, will share if needed at any time
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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.
Aijaz Zeeshan Khan Chachar, MBBS,FCPS principal investigator
FMH College of Medicine & Dentistry
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 in people with Covid19, run by FMH College of Medicine and Dentistry 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 5 inclusion and 6 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 4 Feb 2021. 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. Some participants in this study may receive a placebo. 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?
Resolution of symptoms (time frame: 7 days). 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 4 Feb 2021.