Covid19Phase 2NCT04602507
Ivermectin in Adults With Severe COVID-19.
A Phase 2 study testing Ivermectin in people with Covid19 and Severe Acute Respiratory Syndrome, run by CES University at 1 site in Colombia.
Trial summary
Since the onset of the disease, more than 40.5 million people have been diagnosed with COVID-19 and nearly 1.2 million people have died (October 21, 2020). There is no complete understanding of the pathogenesis of SARS-CoV-2 infection and to this day there is no specific therapy or vaccine available. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Covid19, Severe Acute Respiratory Syndrome
- 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
- 75 participants
- Where
- 1 siteColombia
- Study dates
- 10 Dec 2020to 9 Dec 2021
- Phase
- Phase 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 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Over 18 years old.
- Confirmed diagnosis of SARS-CoV-2 by polymerase chain reaction (PCR).
- Diagnosis of severe pneumonia according to criteria of the National Institute of Health and the Colombian Consensus (suspected respiratory infection, organ failure, arterial oxygen saturation (SaO2) ambient air <90% or respiratory rate > 30 resp/min) or diagnosis of acute respiratory distress syndrome according to criteria of the National Institute of Health and the Colombian Consensus (clinical findings, bilateral radiographic infiltrates, + oxygenation deficit as well: mild: 200 mmHg < PaO2/FiO2 (fraction of inspired oxygen) < 300 mm/Hg; moderate: 100 mm/Hg < PaO2/FiO2 < 200 mm/Hg and, severe: PaO2/FiO2 < 100 mm/Hg).
- Less than 14 days since the onset of symptoms.
- Hospitalized in a general internal medicine ward, special care unit, or those designated for managing patients with COVID19.
Who cannot join
- Pregnant or lactating women.
- Use of ivermectin in the two weeks before admission to the clinic
- Diseases affecting the blood-brain barrier (meningitis, encephalocranial trauma, acute subarachnoid hemorrhage)
- Limitation to understanding the explanations and giving consent, defined by the investigating physician.
- Patients with HIV/AIDS
- That the patient is participating in another clinical trial.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Ivermectin in Adults With Severe COVID-19. Double-blind Randomized Clinical Trial
Since the onset of the disease, more than 40.5 million people have been diagnosed with COVID-19 and nearly 1.2 million people have died (October 21, 2020). There is no complete understanding of the pathogenesis of SARS-CoV-2 infection and to this day there is no specific therapy or vaccine available. Thus, patient care is based on symptomatic therapy and treatment of complications.
Ivermectin has been used for more than 30 years for the treatment of several diseases. More than one million doses of the drug are administered daily, particularly in low- and middle-income countries. Due to the low prevalence of adverse events with the use of this drug, ivermectin is considered to have a good safety profile and its potential benefit in other diseases is currently under investigation.
Read more
An in vitro study of ivermectin in SARS-CoV-2 in Australia showed a significant reduction of viral load in infected cells. Subsequently, a descriptive study of 704 critical patients with COVID-19 showed a reduction in mortality, hospitalization, and intensive care unit length-of-stay in those patients who received the drug. Unfortunately, this study was withdrawn by its authors, leaving more questions than answers.
Some countries in Latin America have authorized its use for the management of patients with COVID-19 even in the absence of solid evidence, and several other countries are conducting clinical trials to evaluate its efficacy for the treatment of moderate and severe disease.
Since there is no specific treatment for COVID-19 and the therapeutic options are scarce, the researchers believe it is completely plausible, urgent, and necessary to evaluate if ivermectin use reduces the risk of admission to an intensive care unit (ICU) in hospitalized adults with severe COVID-19. The proposal is a randomized, double-blind clinical trial, conducted at CES Clinic, Medellin-Colombia. The investigators will randomize 100 patients with severe, non-critical illness, into two groups, one group will receive ivermectin in addition to standard management and the other group will receive placebo plus standard management. Clinical outcomes to evaluate will be ICU admission, need for mechanical ventilation, length of hospital stay, days in the ICU and mechanical ventilation, and finally, the incidence of adverse events related to the intervention. The estimated time to complete the study is approximately five months.
- Conditions
- Covid19, Severe Acute Respiratory Syndrome
- Being tested
- Ivermectin, Placebo
- Keywords
- COVID19 drug treatment, Randomized Clinical Trial, Ivermectin, Hospitalized, Intensive Care Unit, SARS-CoV-2, Pneumonia, Viral
- Medical subject headings
- COVID-19, Severe Acute Respiratory Syndrome, Pneumonia, Viral
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IvermectinDrug
Also called Intervention
Routinary care offered in the hospital plus ivermectin 400 µg/kg (2 drops per kg) orally in a single dose.
PlaceboOther
Also called Control
Routinary care offered in the hospital plus placebo (2 drops per kg) orally in a single dose
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | 50 patients with the routine care offered in the hospital plus ivermectin 400 µg/kg (2 drops per kg) orally in a single dose. Receives: Drug: Ivermectin |
| Control | Placebo comparator | 50 patients with routine care offered in the hospital plus placebo orally (2 drops per kg) in a single dose. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Admission to the intensive care unit.
Cumulative incidence of ICU admission.
Measured: 21 days
Secondary outcomes (5)
Hospital length of stay.
Duration of hospitalization (days).
Measured: 21 days
Mortality rate.
21-day mortality.
Measured: 21 days
ICU length of stay.
Number of days in ICU.
Measured: 21 days
Length of stay in ventilator time.
Number of days with mechanical ventilator.
Measured: 21 days
Adverse effects of ivermectin.
Cumulative incidence of adverse effects: headache, rash, pruritus, arthralgia, tachycardia, dizziness, hypotension, uveitis, Steven Johnson Syndrome.
Measured: 21 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2020
- Study start10 Dec 2020
- Primary completion9 Dec 2021
- Study completion9 Dec 2021
Why it stopped: Lack of severe COVID-19 cases in the place of study
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (32)Papers the sponsor has linked to this study.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Arm #1: 50 patients with routine care offered in the hospital plus ivermectin 400 µg/kg orally in a single dose. Arm #2: 50 patients with routine care offered in the hospital plus placebo in a single dose.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- CES University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Francisco Luis Ochoa-Jaramillo, MD, CES University
- Investigators
- Francisco L Ochoa-Jaramillo, MD; MSc, Principal investigator, CES University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04602507
- Sponsor's protocol ID
- ECA-COVID-CES
- Status last verified
- Dec 2021
- First submitted
- 22 Oct 2020
- Last updated
- 4 Jan 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: For a reasonable scientific purpose, we may share individual patient data (IPD) that underlie results in a publication under direct request to the principal investigator. We reserve our right to share IPD.
Publications
He F, Deng Y, Li W. Coronavirus disease 2019: What we know? J Med Virol. 2020 Jul;92(7):719-725. doi: 10.1002/jmv.25766. Epub 2020 Mar 28.
PubMed 32170865Epidemiology Working Group for NCIP Epidemic Response, Chinese Center for Disease Control and Prevention. [The epidemiological characteristics of an outbreak of 2019 novel coronavirus diseases (COVID-19) in China]. Zhonghua Liu Xing Bing Xue Za Zhi. 2020 Feb 10;41(2):145-151. doi: 10.3760/cma.j.issn.0254-6450.2020.02.003. Chinese.
PubMed 32064853Huang C, Wang Y, Li X, Ren L, Zhao J, Hu Y, Zhang L, Fan G, Xu J, Gu X, Cheng Z, Yu T, Xia J, Wei Y, Wu W, Xie X, Yin W, Li H, Liu M, Xiao Y, Gao H, Guo L, Xie J, Wang G, Jiang R, Gao Z, Jin Q, Wang J, Cao B. Clinical features of patients infected with 2019 novel coronavirus in Wuhan, China. Lancet. 2020 Feb 15;395(10223):497-506. doi: 10.1016/S0140-6736(20)30183-5. Epub 2020 Jan 24.
PubMed 31986264Wang D, Hu B, Hu C, Zhu F, Liu X, Zhang J, Wang B, Xiang H, Cheng Z, Xiong Y, Zhao Y, Li Y, Wang X, Peng Z. Clinical Characteristics of 138 Hospitalized Patients With 2019 Novel Coronavirus-Infected Pneumonia in Wuhan, China. JAMA. 2020 Mar 17;323(11):1061-1069. doi: 10.1001/jama.2020.1585.
PubMed 32031570Cascella M, Rajnik M, Aleem A, Dulebohn SC, Di Napoli R. Features, Evaluation, and Treatment of Coronavirus (COVID-19). 2023 Aug 18. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2026 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK554776/
PubMed 32150360Caly 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 32251768Wang N, Shang J, Jiang S, Du L. Subunit Vaccines Against Emerging Pathogenic Human Coronaviruses. Front Microbiol. 2020 Feb 28;11:298. doi: 10.3389/fmicb.2020.00298. eCollection 2020.
PubMed 32265848Arentz M, Yim E, Klaff L, Lokhandwala S, Riedo FX, Chong M, Lee M. Characteristics and Outcomes of 21 Critically Ill Patients With COVID-19 in Washington State. JAMA. 2020 Apr 28;323(16):1612-1614. doi: 10.1001/jama.2020.4326.
PubMed 32191259Zhang L, Liu Y. Potential interventions for novel coronavirus in China: A systematic review. J Med Virol. 2020 May;92(5):479-490. doi: 10.1002/jmv.25707. Epub 2020 Mar 3.
PubMed 32052466Andersen KG, Rambaut A, Lipkin WI, Holmes EC, Garry RF. The proximal origin of SARS-CoV-2. Nat Med. 2020 Apr;26(4):450-452. doi: 10.1038/s41591-020-0820-9. No abstract available.
PubMed 32284615Zhang Y, Xiao M, Zhang S, Xia P, Cao W, Jiang W, Chen H, Ding X, Zhao H, Zhang H, Wang C, Zhao J, Sun X, Tian R, Wu W, Wu D, Ma J, Chen Y, Zhang D, Xie J, Yan X, Zhou X, Liu Z, Wang J, Du B, Qin Y, Gao P, Qin X, Xu Y, Zhang W, Li T, Zhang F, Zhao Y, Li Y, Zhang S. Coagulopathy and Antiphospholipid Antibodies in Patients with Covid-19. N Engl J Med. 2020 Apr 23;382(17):e38. doi: 10.1056/NEJMc2007575. Epub 2020 Apr 8.
PubMed 32268022Bhimraj A, Morgan RL, Shumaker AH, Lavergne V, Baden L, Cheng VC, Edwards KM, Gandhi R, Muller WJ, O'Horo JC, Shoham S, Murad MH, Mustafa RA, Sultan S, Falck-Ytter Y. Infectious Diseases Society of America Guidelines on the Treatment and Management of Patients with COVID-19. Clin Infect Dis. 2020 Apr 27:ciaa478. doi: 10.1093/cid/ciaa478. Online ahead of print.
PubMed 32338708Hanson KE, Caliendo AM, Arias CA, Englund JA, Lee MJ, Loeb M, Patel R, El Alayli A, Kalot MA, Falck-Ytter Y, Lavergne V, Morgan RL, Murad MH, Sultan S, Bhimraj A, Mustafa RA. Infectious Diseases Society of America Guidelines on the Diagnosis of COVID-19. Clin Infect Dis. 2020 Jun 16:ciaa760. doi: 10.1093/cid/ciaa760. Online ahead of print.
PubMed 32556191Chen W, Lan Y, Yuan X, Deng X, Li Y, Cai X, Li L, He R, Tan Y, Deng X, Gao M, Tang G, Zhao L, Wang J, Fan Q, Wen C, Tong Y, Tang Y, Hu F, Li F, Tang X. Detectable 2019-nCoV viral RNA in blood is a strong indicator for the further clinical severity. Emerg Microbes Infect. 2020 Feb 26;9(1):469-473. doi: 10.1080/22221751.2020.1732837. eCollection 2020.
PubMed 32102625Bhatraju PK, Ghassemieh BJ, Nichols M, Kim R, Jerome KR, Nalla AK, Greninger AL, Pipavath S, Wurfel MM, Evans L, Kritek PA, West TE, Luks A, Gerbino A, Dale CR, Goldman JD, O'Mahony S, Mikacenic C. Covid-19 in Critically Ill Patients in the Seattle Region - Case Series. N Engl J Med. 2020 May 21;382(21):2012-2022. doi: 10.1056/NEJMoa2004500. Epub 2020 Mar 30.
PubMed 32227758
Study at a glance
From the registry record, last updated by the sponsor on 4 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ivermectin in Adults With Severe COVID-19. Double-blind Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT04602507
- Acronym / sponsor ID
- ECA-COVID-CES
- Conditions
- Covid19, Severe Acute Respiratory Syndrome
- Keywords
- COVID19 drug treatment, Randomized Clinical Trial, Ivermectin, Hospitalized, Intensive Care Unit, SARS-CoV-2, Pneumonia, Viral
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Lack of severe COVID-19 cases in the place of study
- Enrolment
- 75 participants (actual)
- Lead sponsor
- CES UniversityUniversity, hospital or other
- Study start
- 10 Dec 2020 (actual)
- Primary completion
- 9 Dec 2021 (actual)
- Study completion
- 9 Dec 2021 (actual)
- First posted
- 26 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.
Since the onset of the disease, more than 40.5 million people have been diagnosed with COVID-19 and nearly 1.2 million people have died (October 21, 2020). There is no complete understanding of the pathogenesis of SARS-CoV-2 infection and to this day there is no specific therapy or vaccine available. Thus, patient care is based on symptomatic therapy and treatment of complications.
Ivermectin has been used for more than 30 years for the treatment of several diseases. More than one million doses of the drug are administered daily, particularly in low- and middle-income countries. Due to the low prevalence of adverse events with the use of this drug, ivermectin is considered to have a good safety profile and its potential benefit in other diseases is currently under investigation.
An in vitro study of ivermectin in SARS-CoV-2 in Australia showed a significant reduction of viral load in infected cells. Subsequently, a descriptive study of 704 critical patients with COVID-19 showed a reduction in mortality, hospitalization, and intensive care unit length-of-stay in those patients who received the drug. Unfortunately, this study was withdrawn by its authors, leaving more questions than answers.
Some countries in Latin America have authorized its use for the management of patients with COVID-19 even in the absence of solid evidence, and several other countries are conducting clinical trials to evaluate its efficacy for the treatment of moderate and severe disease.
Since there is no specific treatment for COVID-19 and the therapeutic options are scarce, the researchers believe it is completely plausible, urgent, and necessary to evaluate if ivermectin use reduces the risk of admission to an intensive care unit (ICU) in hospitalized adults with severe COVID-19. The proposal is a randomized, double-blind clinical trial, conducted at CES Clinic, Medellin-Colombia. The investigators will randomize 100 patients with severe, non-critical illness, into two groups, one group will receive ivermectin in addition to standard management and the other group will receive placebo plus standard management. Clinical outcomes to evaluate will be ICU admission, need for mechanical ventilation, length of hospital stay, days in the ICU and mechanical ventilation, and finally, the incidence of adverse events related to the intervention. The estimated time to complete the study is approximately five months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Arm #1: 50 patients with routine care offered in the hospital plus ivermectin 400 µg/kg orally in a single dose. Arm #2: 50 patients with routine care offered in the hospital plus placebo in a single dose.
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Drug: Ivermectin50 patients with the routine care offered in the hospital plus ivermectin 400 µg/kg (2 drops per kg) orally in a single dose. |
| Control | Placebo comparator | Other: Placebo50 patients with routine care offered in the hospital plus placebo orally (2 drops per kg) in a single dose. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Over 18 years old.
- Confirmed diagnosis of SARS-CoV-2 by polymerase chain reaction (PCR).
- Diagnosis of severe pneumonia according to criteria of the National Institute of Health and the Colombian Consensus (suspected respiratory infection, organ failure, arterial oxygen saturation (SaO2) ambient air <90% or respiratory rate > 30 resp/min) or diagnosis of acute respiratory distress syndrome according to criteria of the National Institute of Health and the Colombian Consensus (clinical findings, bilateral radiographic infiltrates, + oxygenation deficit as well: mild: 200 mmHg < PaO2/FiO2 (fraction of inspired oxygen) < 300 mm/Hg; moderate: 100 mm/Hg < PaO2/FiO2 < 200 mm/Hg and, severe: PaO2/FiO2 < 100 mm/Hg).
- Less than 14 days since the onset of symptoms.
- Hospitalized in a general internal medicine ward, special care unit, or those designated for managing patients with COVID19.
Key exclusion criteria (6 listed)
- Pregnant or lactating women.
- Use of ivermectin in the two weeks before admission to the clinic
- Diseases affecting the blood-brain barrier (meningitis, encephalocranial trauma, acute subarachnoid hemorrhage)
- Limitation to understanding the explanations and giving consent, defined by the investigating physician.
- Patients with HIV/AIDS
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: InterventionRoutinary care offered in the hospital plus ivermectin 400 µg/kg (2 drops per kg) orally in a single dose. | Drug | Intervention |
| PlaceboAlso: ControlRoutinary care offered in the hospital plus placebo (2 drops per kg) orally in a single dose | Other | Control |
Primary outcome
Admission to the intensive care unit.
Time frame: 21 days
Cumulative incidence of ICU admission.
5 secondary outcomes
Hospital length of stay.
Time frame: 21 days
Mortality rate.
Time frame: 21 days
ICU length of stay.
Time frame: 21 days
Length of stay in ventilator time.
Time frame: 21 days
Adverse effects of ivermectin.
Time frame: 21 days
Results and safety
The study was stopped early (reason given: Lack of severe COVID-19 cases in the place of study). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jan 2022.
- Background: PubMed 32170865He F, Deng Y, Li W. Coronavirus disease 2019: What we know? J Med Virol. 2020 Jul;92(7):719-725. doi: 10.1002/jmv.25766. Epub 2020 Mar 28.
- Background: PubMed 32064853Epidemiology Working Group for NCIP Epidemic Response, Chinese Center for Disease Control and Prevention. [The epidemiological characteristics of an outbreak of 2019 novel coronavirus diseases (COVID-19) in China]. Zhonghua Liu Xing Bing Xue Za Zhi. 2020 Feb 10;41(2):145-151. doi: 10.3760/cma.j.issn.0254-6450.2020.02.003. Chinese.
- Background: PubMed 31986264Huang C, Wang Y, Li X, Ren L, Zhao J, Hu Y, Zhang L, Fan G, Xu J, Gu X, Cheng Z, Yu T, Xia J, Wei Y, Wu W, Xie X, Yin W, Li H, Liu M, Xiao Y, Gao H, Guo L, Xie J, Wang G, Jiang R, Gao Z, Jin Q, Wang J, Cao B. Clinical features of patients infected with 2019 novel coronavirus in Wuhan, China. Lancet. 2020 Feb 15;395(10223):497-506. doi: 10.1016/S0140-6736(20)30183-5. Epub 2020 Jan 24.
- Background: PubMed 32031570Wang D, Hu B, Hu C, Zhu F, Liu X, Zhang J, Wang B, Xiang H, Cheng Z, Xiong Y, Zhao Y, Li Y, Wang X, Peng Z. Clinical Characteristics of 138 Hospitalized Patients With 2019 Novel Coronavirus-Infected Pneumonia in Wuhan, China. JAMA. 2020 Mar 17;323(11):1061-1069. doi: 10.1001/jama.2020.1585.
- Background: PubMed 32150360Cascella M, Rajnik M, Aleem A, Dulebohn SC, Di Napoli R. Features, Evaluation, and Treatment of Coronavirus (COVID-19). 2023 Aug 18. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2026 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK554776/
- 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 32265848Wang N, Shang J, Jiang S, Du L. Subunit Vaccines Against Emerging Pathogenic Human Coronaviruses. Front Microbiol. 2020 Feb 28;11:298. doi: 10.3389/fmicb.2020.00298. eCollection 2020.
- Background: PubMed 32191259Arentz M, Yim E, Klaff L, Lokhandwala S, Riedo FX, Chong M, Lee M. Characteristics and Outcomes of 21 Critically Ill Patients With COVID-19 in Washington State. JAMA. 2020 Apr 28;323(16):1612-1614. doi: 10.1001/jama.2020.4326.
- Background: PubMed 32052466Zhang L, Liu Y. Potential interventions for novel coronavirus in China: A systematic review. J Med Virol. 2020 May;92(5):479-490. doi: 10.1002/jmv.25707. Epub 2020 Mar 3.
- Background: PubMed 32284615Andersen KG, Rambaut A, Lipkin WI, Holmes EC, Garry RF. The proximal origin of SARS-CoV-2. Nat Med. 2020 Apr;26(4):450-452. doi: 10.1038/s41591-020-0820-9. No abstract available.
- Background: PubMed 32268022Zhang Y, Xiao M, Zhang S, Xia P, Cao W, Jiang W, Chen H, Ding X, Zhao H, Zhang H, Wang C, Zhao J, Sun X, Tian R, Wu W, Wu D, Ma J, Chen Y, Zhang D, Xie J, Yan X, Zhou X, Liu Z, Wang J, Du B, Qin Y, Gao P, Qin X, Xu Y, Zhang W, Li T, Zhang F, Zhao Y, Li Y, Zhang S. Coagulopathy and Antiphospholipid Antibodies in Patients with Covid-19. N Engl J Med. 2020 Apr 23;382(17):e38. doi: 10.1056/NEJMc2007575. Epub 2020 Apr 8.
- Background: PubMed 32338708Bhimraj A, Morgan RL, Shumaker AH, Lavergne V, Baden L, Cheng VC, Edwards KM, Gandhi R, Muller WJ, O'Horo JC, Shoham S, Murad MH, Mustafa RA, Sultan S, Falck-Ytter Y. Infectious Diseases Society of America Guidelines on the Treatment and Management of Patients with COVID-19. Clin Infect Dis. 2020 Apr 27:ciaa478. doi: 10.1093/cid/ciaa478. Online ahead of print.
- Individual participant dataSharing planned: Yes. For a reasonable scientific purpose, we may share individual patient data (IPD) that underlie results in a publication under direct request to the principal investigator. We reserve our right to share IPD.
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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.
Francisco L Ochoa-Jaramillo, MD; MSc principal investigator
CES University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Ivermectin in people with Covid19 and Severe Acute Respiratory Syndrome, run by CES University at 1 site in Colombia.
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: stopped early, as of the sponsor's last update on 4 Jan 2022. 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 Colombia. 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 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 was stopped early (reason given: Lack of severe COVID-19 cases in the place of 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?
Admission to the intensive care unit. (time frame: 21 days). 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 NCT04602507, which also lists 32 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 4 Jan 2022.