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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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.

Pakistan1 site
  • Aijaz Zeeshan Khan Chachar

    Lahore, Punjab Province, 54000

Other trials in Pakistan

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 groups in NCT04739410
Study groupRoleWhat they receive
IvermectinExperimentalIvermectin 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 carePlacebo comparatorThese 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.

  1. 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

  2. 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.

  1. First posted4 Feb 2021
  2. Study start1 May 2020
  3. Primary completion30 Jun 2020
  4. Study completion30 Jun 2020

Resources

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)
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

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.

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