Covid19Phase 2/3IVERCORCOVID19NCT04529525
Ivermectin to Prevent Hospitalizations in COVID-19
A Phase 2/3 study testing Ivermectin in people with Covid19, run by Instituto de Cardiología de Corrientes at 1 site in Argentina.
Trial summary
It is a single-center, prospective, randomized, double-blind, placebo-controlled study carried out by the Ministry of Public Health of the Province of Corrientes, Argentina, in coordination with the Corrientes Institute of Cardiology "Juana F. Cabral". Read more about this study
- Who is it for?
- Ages 18 years and older
- 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
- 501 participants
- Where
- 1 siteArgentina
- Study dates
- 19 Aug 2020to 22 Feb 2021
- Phase
- Phase 2/3
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Over 18 years of age who reside in the province of Corrientes at the time of diagnosis;
- Confirmed diagnosis of COVID-19 by polymerase chain reaction test for detection of SARS-CoV2 in the last 48 hours;
- In the case of women of childbearing age, they must be using a contraceptive method of proven efficacy and safety (barrier, hormonal or permanent contraceptives) for at least 3 months prior to inclusion in the present study and for the entire period of time for the duration of the study and until at least 30 days after the end of this study. A woman will be considered to have no reproductive capacity if she is postmenopausal (at least 2 years without her menstrual cycles) or if she has undergone surgical sterilization (at least one month before the time of inviting her to participate in this study);
- Weight at the time of inclusion greater than 48,000 kilograms;
- That they sign the informed consent for participation in the study.
Who cannot join
- Pregnant or breastfeeding women;
- Known allergy to ivermectin or some of the components of ivermectin tablets or placebo;
- Current use of home oxygen;
- That require hospitalization due to COVID-19 at the time of diagnosis or history of hospitalization for COVID-19;
- Presence of mal-absorptive syndrome;
- Presence of any other concomitant acute infectious disease;
Show all 12Show fewer
- Known history of severe liver disease, for example liver cirrhosis;
- Need or use of antiviral drugs at the time of admission for another viral pathology other than COVID-19;
- Need or use of hydroxychloroquine or chloroquine;
- Use of ivermectin up to 7 days prior to randomization;
- Patients on dialysis or who have required it in the last 2 months or who plan to do it in the next 2 months;
- Current participation or in the last 30 days in a research study that has included the administration of a drug.
Trial locations and contacts
1 site in 1 country.
Argentina1 site
Ministry of Public Health of the Province of Corrientes
Corrientes, 3400
About this study
Official title: Ivermectin to Prevent Hospitalizations in COVID-19: Randomized, Double-blind, Placebo-controlled
It is a single-center, prospective, randomized, double-blind, placebo-controlled study carried out by the Ministry of Public Health of the Province of Corrientes, Argentina, in coordination with the Corrientes Institute of Cardiology "Juana F. Cabral". Patients who meet all the inclusion criteria and none of the exclusion criteria are randomized via the web system to receive placebo or ivermectin. The need for hospitalization in patients with COVID-19 is assessed as the primary end point. As secondary end points are evaluated: time to hospitalization (in days); use of invasive mechanical ventilation; time to invasive mechanical ventilation (in days); dialysis; all-cause mortality; negative of the swab at 3 ± 1 days and 12 ± 2 days after entering the study and ivermectin safety.
Intermediate internal analyzes of study objectives and serious adverse events will be performed, including 125; 250 and 375 patients in order to assess the possible need for early termination of the study. For these intermediate internal analyzes, the Haybittle-Peto rule will be followed, therefore a value of p <0.001 will be considered significant
Read the detailed description
The study will be carried out in the province of Corrientes, in the Argentine Republic. All patients must be domiciled in this province. In the province of Corrientes, the care of patients with COVID19 is in charge of a single group of professionals (Crisis Committee) and patients who require hospitalization will be carried out in a single hospital destined for this purpose
- Conditions
- Covid19
- Being tested
- Ivermectin, Placebo
- Keywords
- Ivermectin
- 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
Patients will receive the tablet from the branch to which they were randomized only at the time of inclusion and 24 hours after the first dose.
PlaceboDrug
Patients will receive the tablet from the branch to which they were randomized only at the time of inclusion and 24 hours after the first dose.
| Study group | Role | What they receive |
|---|---|---|
| Ivermectin | Active comparator | The dose of ivermectin in patients who are randomized to the active substance depends on the weight of the patient:
More than 48 kg and less than 80 kg: Two tablets of 6 mg each (12 mg in total) at the time of inclusion and the same dose at 24 hours.
More than 80 kg and less than 110 kg: Three tablets of 6 mg each (18 mg in total) at the time of inclusion and the same dose at 24 hours.
More than 110 Kg: Four tablets of 6 mg each (24 mg in total) at the time of inclusion and the same dose at 24 hours. Receives: Drug: Ivermectin |
| Placebo | Placebo comparator | The dose of placebo in patients who are randomized to the this depends on the weight of the patient:
More than 48 kg and less than 80 kg: Two tablets of 6 mg each (12 mg in total) at the time of inclusion and the same dose at 24 hours.
More than 80 kg and less than 110 kg: Three tablets of 6 mg each (18 mg in total) at the time of inclusion and the same dose at 24 hours.
More than 110 Kg: Four tablets of 6 mg each (24 mg in total) at the time of inclusion and the same dose at 24 hours. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Hospitalization of medical cause in patients with COVID-19 in each arm
Hospitalization will be considered when at least 24 hours have elapsed in a health institution, in any of its services.
Measured: through study completion, an average of 30 days
Secondary outcomes (7)
Time to hospitalization
Number of days elapsed
Measured: through study completion, an average of 30 days
Percentage of Use of invasive mechanical ventilation support in each arm
All patients who are connected to invasive mechanical ventilation support
Measured: through study completion, an average of 30 days
Time to invasive mechanical ventilation support
Number of days elapsed
Measured: through study completion, an average of 30 days
Percentage of dialysis in each arm
All patients who require temporary or permanent renal replacement therapy
Measured: through study completion, an average of 30 days
All-cause mortality
Death of the patient, from any cause.
Measured: through study completion, an average of 30 days
Negative of the swab at 3±1 days and 12±2 days after entering the study
Negative Nasal Swab Using Polymerase Chain Reaction Technique
Measured: At days 3±1 and 12±2
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability])
According to the adverse events that patients may present.
Measured: through study completion, an average of 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2020
- Study start19 Aug 2020
- Primary completion22 Feb 2021
- Study completion22 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 501 participants (actual)
Sponsor and investigators
- Lead sponsor
- Instituto de Cardiología de Corrientes
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04529525
- Sponsor's protocol ID
- IVERCORCOVID19MSPICC
- Acronym
- IVERCORCOVID19
- Status last verified
- Sep 2020
- First submitted
- 21 Aug 2020
- Last updated
- 7 Jul 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Simsek 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 32293834Gonzalez Canga A, Sahagun Prieto AM, Diez Liebana MJ, Fernandez Martinez N, Sierra Vega M, Garcia Vieitez JJ. The pharmacokinetics and interactions of ivermectin in humans--a mini-review. AAPS J. 2008;10(1):42-6. doi: 10.1208/s12248-007-9000-9. Epub 2008 Jan 25.
PubMed 18446504Gotz V, Magar L, Dornfeld D, Giese S, Pohlmann A, Hoper D, Kong BW, Jans DA, Beer M, Haller O, Schwemmle M. Influenza A viruses escape from MxA restriction at the expense of efficient nuclear vRNP import. Sci Rep. 2016 Mar 18;6:23138. doi: 10.1038/srep23138.
PubMed 26988202Lundberg L, Pinkham C, Baer A, Amaya M, Narayanan A, Wagstaff KM, Jans DA, Kehn-Hall K. Nuclear import and export inhibitors alter capsid protein distribution in mammalian cells and reduce Venezuelan Equine Encephalitis Virus replication. Antiviral Res. 2013 Dec;100(3):662-72. doi: 10.1016/j.antiviral.2013.10.004. Epub 2013 Oct 22.
PubMed 24161512Tay MY, Fraser JE, Chan WK, Moreland NJ, Rathore AP, Wang C, Vasudevan SG, Jans DA. Nuclear localization of dengue virus (DENV) 1-4 non-structural protein 5; protection against all 4 DENV serotypes by the inhibitor Ivermectin. Antiviral Res. 2013 Sep;99(3):301-6. doi: 10.1016/j.antiviral.2013.06.002. Epub 2013 Jun 14.
PubMed 23769930Wagstaff KM, Sivakumaran H, Heaton SM, Harrich D, Jans DA. Ivermectin is a specific inhibitor of importin alpha/beta-mediated nuclear import able to inhibit replication of HIV-1 and dengue virus. Biochem J. 2012 May 1;443(3):851-6. doi: 10.1042/BJ20120150.
PubMed 22417684Chi NC, Adam EJ, Adam SA. Sequence and characterization of cytoplasmic nuclear protein import factor p97. J Cell Biol. 1995 Jul;130(2):265-74. doi: 10.1083/jcb.130.2.265.
PubMed 7615630Gorlich D, Mattaj IW. Nucleocytoplasmic transport. Science. 1996 Mar 15;271(5255):1513-8. doi: 10.1126/science.271.5255.1513.
PubMed 8599106Rowland RR, Chauhan V, Fang Y, Pekosz A, Kerrigan M, Burton MD. Intracellular localization of the severe acute respiratory syndrome coronavirus nucleocapsid protein: absence of nucleolar accumulation during infection and after expression as a recombinant protein in vero cells. J Virol. 2005 Sep;79(17):11507-12. doi: 10.1128/JVI.79.17.11507-11512.2005.
PubMed 16103202Timani KA, Liao Q, Ye L, Zeng Y, Liu J, Zheng Y, Ye L, Yang X, Lingbao K, Gao J, Zhu Y. Nuclear/nucleolar localization properties of C-terminal nucleocapsid protein of SARS coronavirus. Virus Res. 2005 Dec;114(1-2):23-34. doi: 10.1016/j.virusres.2005.05.007. Epub 2005 Jun 29.
PubMed 15992957Caly 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 32251768Vallejos J, Zoni R, Bangher M, Villamandos S, Bobadilla A, Plano F, Campias C, Chaparro Campias E, Medina MF, Achinelli F, Guglielmone HA, Ojeda J, Farizano Salazar D, Andino G, Kawerin P, Dellamea S, Aquino AC, Flores V, Martemucci CN, Martinez SM, Segovia JE, Reynoso PI, Sosa NC, Robledo ME, Guarrochena JM, Vernengo MM, Ruiz Diaz N, Meza E, Aguirre MG. Ivermectin to prevent hospitalizations in patients with COVID-19 (IVERCOR-COVID19) a randomized, double-blind, placebo-controlled trial. BMC Infect Dis. 2021 Jul 2;21(1):635. doi: 10.1186/s12879-021-06348-5.
PubMed 34215210Vallejos J, Zoni R, Bangher M, Villamandos S, Bobadilla A, Plano F, Campias C, Chaparro Campias E, Achinelli F, Guglielmone HA, Ojeda J, Medina F, Farizano Salazar D, Andino G, Ruiz Diaz NE, Kawerin P, Meza E, Dellamea S, Aquino A, Flores V, Martemucci CN, Vernengo MM, Martinez SM, Segovia JE, Aguirre MG. Ivermectin to prevent hospitalizations in patients with COVID-19 (IVERCOR-COVID19): a structured summary of a study protocol for a randomized controlled trial. Trials. 2020 Nov 24;21(1):965. doi: 10.1186/s13063-020-04813-1.
PubMed 33234158
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ivermectin to Prevent Hospitalizations in COVID-19: Randomized, Double-blind, Placebo-controlled
- ClinicalTrials.gov ID
- NCT04529525
- Acronym / sponsor ID
- IVERCORCOVID19 / IVERCORCOVID19MSPICC
- Conditions
- Covid19
- Keywords
- Ivermectin
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 501 participants (actual)
- Lead sponsor
- Instituto de Cardiología de CorrientesUniversity, hospital or other
- Study start
- 19 Aug 2020 (actual)
- Primary completion
- 22 Feb 2021 (actual)
- Study completion
- 22 Feb 2021 (actual)
- First posted
- 27 Aug 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 single-center, prospective, randomized, double-blind, placebo-controlled study carried out by the Ministry of Public Health of the Province of Corrientes, Argentina, in coordination with the Corrientes Institute of Cardiology "Juana F. Cabral". Patients who meet all the inclusion criteria and none of the exclusion criteria are randomized via the web system to receive placebo or ivermectin. The need for hospitalization in patients with COVID-19 is assessed as the primary end point. As secondary end points are evaluated: time to hospitalization (in days); use of invasive mechanical ventilation; time to invasive mechanical ventilation (in days); dialysis; all-cause mortality; negative of the swab at 3 ± 1 days and 12 ± 2 days after entering the study and ivermectin safety.
Intermediate internal analyzes of study objectives and serious adverse events will be performed, including 125; 250 and 375 patients in order to assess the possible need for early termination of the study. For these intermediate internal analyzes, the Haybittle-Peto rule will be followed, therefore a value of p <0.001 will be considered significant
Detailed description
The study will be carried out in the province of Corrientes, in the Argentine Republic. All patients must be domiciled in this province. In the province of Corrientes, the care of patients with COVID19 is in charge of a single group of professionals (Crisis Committee) and patients who require hospitalization will be carried out in a single hospital destined for this purpose
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ivermectin | Active comparator | Drug: IvermectinThe dose of ivermectin in patients who are randomized to the active substance depends on the weight of the patient: More than 48 kg and less than 80 kg: Two tablets of 6 mg each (12 mg in total) at the time of inclusion and the same dose at 24 hours. More than 80 kg and less than 110 kg: Three tablets of 6 mg each (18 mg in total) at the time of inclusion and the same dose at 24 hours. More than 110 Kg: Four tablets of 6 mg each (24 mg in total) at the time of inclusion and the same dose at 24 hours. |
| Placebo | Placebo comparator | Drug: PlaceboThe dose of placebo in patients who are randomized to the this depends on the weight of the patient: More than 48 kg and less than 80 kg: Two tablets of 6 mg each (12 mg in total) at the time of inclusion and the same dose at 24 hours. More than 80 kg and less than 110 kg: Three tablets of 6 mg each (18 mg in total) at the time of inclusion and the same dose at 24 hours. More than 110 Kg: Four tablets of 6 mg each (24 mg in total) at the time of inclusion and the same dose at 24 hours. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Over 18 years of age who reside in the province of Corrientes at the time of diagnosis;
- Confirmed diagnosis of COVID-19 by polymerase chain reaction test for detection of SARS-CoV2 in the last 48 hours;
- In the case of women of childbearing age, they must be using a contraceptive method of proven efficacy and safety (barrier, hormonal or permanent contraceptives) for at least 3 months prior to inclusion in the present study and for the entire period of time for the duration of the study and until at least 30 days after the end of this study. A woman will be considered to have no reproductive capacity if she is postmenopausal (at least 2 years without her menstrual cycles) or if she has undergone surgical sterilization (at least one month before the time of inviting her to participate in this study);
- Weight at the time of inclusion greater than 48,000 kilograms;
- That they sign the informed consent for participation in the study.
Key exclusion criteria (12 listed)
- Pregnant or breastfeeding women;
- Known allergy to ivermectin or some of the components of ivermectin tablets or placebo;
- Current use of home oxygen;
- That require hospitalization due to COVID-19 at the time of diagnosis or history of hospitalization for COVID-19;
- Presence of mal-absorptive syndrome;
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 |
|---|---|---|
| IvermectinPatients will receive the tablet from the branch to which they were randomized only at the time of inclusion and 24 hours after the first dose. | Drug | Ivermectin |
| PlaceboPatients will receive the tablet from the branch to which they were randomized only at the time of inclusion and 24 hours after the first dose. | Drug | Placebo |
Primary outcome
Percentage of Hospitalization of medical cause in patients with COVID-19 in each arm
Time frame: through study completion, an average of 30 days
Hospitalization will be considered when at least 24 hours have elapsed in a health institution, in any of its services.
7 secondary outcomes
Time to hospitalization
Time frame: through study completion, an average of 30 days
Percentage of Use of invasive mechanical ventilation support in each arm
Time frame: through study completion, an average of 30 days
Time to invasive mechanical ventilation support
Time frame: through study completion, an average of 30 days
Percentage of dialysis in each arm
Time frame: through study completion, an average of 30 days
All-cause mortality
Time frame: through study completion, an average of 30 days
Negative of the swab at 3±1 days and 12±2 days after entering the study
Time frame: At days 3±1 and 12±2
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability])
Time frame: through study completion, an average of 30 days
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 7 Jul 2021.
- 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.
- Results publication: PubMed 18446504Gonzalez Canga A, Sahagun Prieto AM, Diez Liebana MJ, Fernandez Martinez N, Sierra Vega M, Garcia Vieitez JJ. The pharmacokinetics and interactions of ivermectin in humans--a mini-review. AAPS J. 2008;10(1):42-6. doi: 10.1208/s12248-007-9000-9. Epub 2008 Jan 25.
- Results publication: PubMed 26988202Gotz V, Magar L, Dornfeld D, Giese S, Pohlmann A, Hoper D, Kong BW, Jans DA, Beer M, Haller O, Schwemmle M. Influenza A viruses escape from MxA restriction at the expense of efficient nuclear vRNP import. Sci Rep. 2016 Mar 18;6:23138. doi: 10.1038/srep23138.
- Results publication: PubMed 24161512Lundberg L, Pinkham C, Baer A, Amaya M, Narayanan A, Wagstaff KM, Jans DA, Kehn-Hall K. Nuclear import and export inhibitors alter capsid protein distribution in mammalian cells and reduce Venezuelan Equine Encephalitis Virus replication. Antiviral Res. 2013 Dec;100(3):662-72. doi: 10.1016/j.antiviral.2013.10.004. Epub 2013 Oct 22.
- Results publication: PubMed 23769930Tay MY, Fraser JE, Chan WK, Moreland NJ, Rathore AP, Wang C, Vasudevan SG, Jans DA. Nuclear localization of dengue virus (DENV) 1-4 non-structural protein 5; protection against all 4 DENV serotypes by the inhibitor Ivermectin. Antiviral Res. 2013 Sep;99(3):301-6. doi: 10.1016/j.antiviral.2013.06.002. Epub 2013 Jun 14.
- Results publication: PubMed 22417684Wagstaff KM, Sivakumaran H, Heaton SM, Harrich D, Jans DA. Ivermectin is a specific inhibitor of importin alpha/beta-mediated nuclear import able to inhibit replication of HIV-1 and dengue virus. Biochem J. 2012 May 1;443(3):851-6. doi: 10.1042/BJ20120150.
- Results publication: PubMed 7615630Chi NC, Adam EJ, Adam SA. Sequence and characterization of cytoplasmic nuclear protein import factor p97. J Cell Biol. 1995 Jul;130(2):265-74. doi: 10.1083/jcb.130.2.265.
- Results publication: PubMed 8599106Gorlich D, Mattaj IW. Nucleocytoplasmic transport. Science. 1996 Mar 15;271(5255):1513-8. doi: 10.1126/science.271.5255.1513.
- Results publication: PubMed 16103202Rowland RR, Chauhan V, Fang Y, Pekosz A, Kerrigan M, Burton MD. Intracellular localization of the severe acute respiratory syndrome coronavirus nucleocapsid protein: absence of nucleolar accumulation during infection and after expression as a recombinant protein in vero cells. J Virol. 2005 Sep;79(17):11507-12. doi: 10.1128/JVI.79.17.11507-11512.2005.
- Results publication: PubMed 15992957Timani KA, Liao Q, Ye L, Zeng Y, Liu J, Zheng Y, Ye L, Yang X, Lingbao K, Gao J, Zhu Y. Nuclear/nucleolar localization properties of C-terminal nucleocapsid protein of SARS coronavirus. Virus Res. 2005 Dec;114(1-2):23-34. doi: 10.1016/j.virusres.2005.05.007. Epub 2005 Jun 29.
- Results publication: 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.
- Derived from this study: PubMed 34215210Vallejos J, Zoni R, Bangher M, Villamandos S, Bobadilla A, Plano F, Campias C, Chaparro Campias E, Medina MF, Achinelli F, Guglielmone HA, Ojeda J, Farizano Salazar D, Andino G, Kawerin P, Dellamea S, Aquino AC, Flores V, Martemucci CN, Martinez SM, Segovia JE, Reynoso PI, Sosa NC, Robledo ME, Guarrochena JM, Vernengo MM, Ruiz Diaz N, Meza E, Aguirre MG. Ivermectin to prevent hospitalizations in patients with COVID-19 (IVERCOR-COVID19) a randomized, double-blind, placebo-controlled trial. BMC Infect Dis. 2021 Jul 2;21(1):635. doi: 10.1186/s12879-021-06348-5.
- Individual participant dataSharing planned: Undecided
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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 2/3 study testing Ivermectin in people with Covid19, run by Instituto de Cardiología de Corrientes at 1 site in Argentina.
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 12 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 7 Jul 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 Argentina. 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 combined 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.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Percentage of Hospitalization of medical cause in patients with COVID-19 in each arm (time frame: through study completion, an average of 30 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 NCT04529525, which also lists 13 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 7 Jul 2021.