Clinical Trial to "Study the Efficacy and Therapeutic Safety of Ivermectin: (SAINTBO)
NCT ID: NCT04836299
Last Updated: 2021-04-08
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
UNKNOWN
Clinical Phase
PHASE2
Total Enrollment
90 participants
Study Classification
INTERVENTIONAL
Study Start Date
2021-05-08
Study Completion Date
2021-12-05
Brief Summary
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Coronavirus disease (COVID-19) is an infectious disease caused by a new virus. The disease causes a respiratory illness (such as the flu) with symptoms such as cough, fever, and, in more severe cases, respiratory distress, even developing Acute Respiratory Distress Syndrome, evolving in some cases with the death of the patient. Currently, there are no specific treatments for COVID-19. Currently, there are several ongoing clinical trials evaluating possible treatments. Recently, Leon Caly reports here that Ivermectin, an FDA-approved antiparasitic that was shown to have broad-spectrum antiviral activity in vitro, is an inhibitor of the causative virus (SARS-CoV-2), with a single addition to Vero cells. hours after infection with SARS-CoV-2 capable of a 5000-fold reduction in viral RNA at 48 h. (1) Ivermectin, therefore, warrants further investigation for possible benefits in humans. The reason for this study is to understand the effect of the drug in eradicating the virus.
It is a randomized controlled trial to evaluate the efficacy of Ivermectin in COVID-19. The recruited patient will be assigned to two groups, (1) a group received ivermectin plus care treatment (2) the placebo group plus standard care treatment. The result will be recorded by documenting the RT-PCR reports confirmed at the time of recruitment and at 7 and 14 days within the framework of the study, then they will be adapted to the national care protocol, with 9 scheduled clinical and telemedicine interviews.
It will be a randomized controlled trial to be run in RT-PCR confirmed COVID-19 patients who meet the inclusion criteria (asymptomatic/mild to moderate severity).
They will be divided into groups after randomization. Group A will be administered one (1) a group received ivermectin plus standard of care treatment (2) the placebo group plus standard of care treatment, along with the existing inpatient and outpatient management clinical guidelines of the hospitals participating in the study, these being adapted to the National standard.
The reverse transcriptase-polymerase chain reaction (RT-PCR) will be carried out on days 7 and 14 after the therapeutic intervention and the duration of time at which the RT-PCR becomes negative and/or clinical evolution of the patient will be compared in both study groups. The dose of the drug is not subject to change according to the patient's response or the possible side effect of being administered in a single dose.
It is a randomized controlled trial to evaluate the efficacy of Ivermectin in COVID-19. The recruited patient will be assigned to two groups, (1) a group received ivermectin plus care treatment (2) the placebo group plus standard care treatment. The result will be recorded by documenting the RT-PCR reports confirmed at the time of recruitment and at 7 and 14 days within the framework of the study, then they will be adapted to the national care protocol, with 9 scheduled clinical and telemedicine interviews.
It will be a randomized controlled trial to be run in RT-PCR confirmed COVID-19 patients who meet the inclusion criteria (asymptomatic/mild to moderate severity).
They will be divided into groups after randomization. Group A will be administered one (1) a group received ivermectin plus standard of care treatment (2) the placebo group plus standard of care treatment, along with the existing inpatient and outpatient management clinical guidelines of the hospitals participating in the study, these being adapted to the National standard.
The reverse transcriptase-polymerase chain reaction (RT-PCR) will be carried out on days 7 and 14 after the therapeutic intervention and the duration of time at which the RT-PCR becomes negative and/or clinical evolution of the patient will be compared in both study groups. The dose of the drug is not subject to change according to the patient's response or the possible side effect of being administered in a single dose.
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Detailed Description
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STUDY DESIGN It is a double-blind, randomized, placebo-controlled superiority trial with two parallel arms. Participants will be randomized to receive a single 600 µg / kg dose of ivermectin or placebo, and the number of patients in the treatment and placebo groups will be in a 2: 1 ratio for the intervention group.
The trial statistician will generate the randomization code using blocks of four individuals to ensure the balance between groups. The assignment will be carried out by the main investigator using opaque envelopes, after obtaining informed consent and verification of compliance with all the inclusion and exclusion criteria. The investigational product will be administered by personnel who are not involved in patient care or monitoring of study participants.
Participants will be followed up at their homes for a period of 28 days. A patient can discontinue her participation in the study at any time and for any reason. The principal investigator and the panel of experts that make up the safety and adverse effects committee may also withdraw a patient from the study if they believe it is in the best interest of the patient.
Serious adverse events (SAEs) related to ivermectin will be followed until they resolve or up to 28 days after the participant's final visit, whichever occurs first. All other SAEs deemed unrelated to ivermectin will be followed up until the participant's final visit or for a specified period at the discretion of the principal investigator.
The study will end when the final randomized patient has completed the study, all planned visits have been completed, and inconsistencies in the data have been resolved.
OBJECTIVES Primary objective
• To explore the efficacy and therapeutic safety of Ivermectin in patients with non-severe and low-risk COVID-19 in the first 72 hours after the onset of symptoms, through the negativization of the polymerase chain in real time. RT-PCR (nasopharyngeal swab) and clinical improvement on day 7 and 28 after treatment, to explore its possible use in the fight against the pandemic.
Secondary objectives
1. To evaluate the efficacy of ivermectin in reducing the SARS-CoV-2 viral load in the nasopharyngeal swab on day 7 after treatment.
2. To evaluate the efficacy of ivermectin in improving the progression of symptoms in treated patients.
3. Assess the proportion of seroconversions in patients treated on day 21.
4. Evaluate the safety of ivermectin at the proposed dose.
5. Determine the magnitude of the immune response against SARS-CoV-2
6. Evaluate the early kinetics of immunity against SARS-CoV-2
The trial statistician will generate the randomization code using blocks of four individuals to ensure the balance between groups. The assignment will be carried out by the main investigator using opaque envelopes, after obtaining informed consent and verification of compliance with all the inclusion and exclusion criteria. The investigational product will be administered by personnel who are not involved in patient care or monitoring of study participants.
Participants will be followed up at their homes for a period of 28 days. A patient can discontinue her participation in the study at any time and for any reason. The principal investigator and the panel of experts that make up the safety and adverse effects committee may also withdraw a patient from the study if they believe it is in the best interest of the patient.
Serious adverse events (SAEs) related to ivermectin will be followed until they resolve or up to 28 days after the participant's final visit, whichever occurs first. All other SAEs deemed unrelated to ivermectin will be followed up until the participant's final visit or for a specified period at the discretion of the principal investigator.
The study will end when the final randomized patient has completed the study, all planned visits have been completed, and inconsistencies in the data have been resolved.
OBJECTIVES Primary objective
• To explore the efficacy and therapeutic safety of Ivermectin in patients with non-severe and low-risk COVID-19 in the first 72 hours after the onset of symptoms, through the negativization of the polymerase chain in real time. RT-PCR (nasopharyngeal swab) and clinical improvement on day 7 and 28 after treatment, to explore its possible use in the fight against the pandemic.
Secondary objectives
1. To evaluate the efficacy of ivermectin in reducing the SARS-CoV-2 viral load in the nasopharyngeal swab on day 7 after treatment.
2. To evaluate the efficacy of ivermectin in improving the progression of symptoms in treated patients.
3. Assess the proportion of seroconversions in patients treated on day 21.
4. Evaluate the safety of ivermectin at the proposed dose.
5. Determine the magnitude of the immune response against SARS-CoV-2
6. Evaluate the early kinetics of immunity against SARS-CoV-2
Conditions
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Covid19
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
Randomized, double-blind, Placebo-controlled parallel clinical trial to "Study the efficacy and therapeutic safety of Ivermectin associated with standard of care treatment versus placebo with standard of care treatment in the early phase of coronavirus infection (COVID19).
A PHASE II pilot study.
A PHASE II pilot study.
Primary Study Purpose
TREATMENT
Blinding Strategy
DOUBLE
Participants
Caregivers
The participants, care providers and also investigator will be blinded for this study design.
Study Groups
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Ivermectin
Participants will receive a single 600 µg / kg dose of ivermectin.
Group Type
EXPERIMENTAL
Ivermectin
Intervention Type
DRUG
Participants will be randomly assigned to receive a single 600 µg / kg dose of ivermectin or placebo.
Placebo Comparator
Participants will receive a single dose of placebo.
Group Type
PLACEBO_COMPARATOR
Placebo
Intervention Type
DRUG
Participants will be randomly assigned to receive a single of placebo.
Interventions
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Ivermectin
Participants will be randomly assigned to receive a single 600 µg / kg dose of ivermectin or placebo.
Intervention Type
DRUG
Placebo
Participants will be randomly assigned to receive a single of placebo.
Intervention Type
DRUG
Other Intervention Names
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A
B
Eligibility Criteria
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Inclusion Criteria
* Confirmed case of COVID-19 in national reference hospitals - COVID sentinel hospitals.
* Male and female patients 18 to 75 years (inclusive) of age.
* Supply of signed and dated informed consent form
* Declared availability to comply with all study procedures and availability for the duration of the study.
* In good general health with mild or moderate symptoms during the first week of disease evolution (onset of symptoms maximum 7 days before recruitment).
* Ability to take oral medications and be willing to adhere to the medication consumption regimen prescribed in the study.
* The patient must, in the opinion of the principal investigator, be able to comply with all the requirements of the clinical trial (including home monitoring during isolation).
* The patient is able and willing to comply with the requirements of this test protocol. Voluntarily signed informed consent obtained prior to any proceeding related to the trial.
* Male and female patients 18 to 75 years (inclusive) of age.
* Supply of signed and dated informed consent form
* Declared availability to comply with all study procedures and availability for the duration of the study.
* In good general health with mild or moderate symptoms during the first week of disease evolution (onset of symptoms maximum 7 days before recruitment).
* Ability to take oral medications and be willing to adhere to the medication consumption regimen prescribed in the study.
* The patient must, in the opinion of the principal investigator, be able to comply with all the requirements of the clinical trial (including home monitoring during isolation).
* The patient is able and willing to comply with the requirements of this test protocol. Voluntarily signed informed consent obtained prior to any proceeding related to the trial.
Exclusion Criteria
1. Known history of ivermectin allergy
2. Hypersensitivity to any component of ivermectin or the excipients of the brand to be used.
3. COVID-19 pneumonia
* Diagnosed by the treating physician
* Identified on a chest x-ray
4. Fever or cough present for more than 48 hours.
5. immunoglobulin G (IgG) positive against SARS-CoV-2 by a rapid diagnostic test
8\. Recent travel history to loa endemic countries (Angola, Cameroon, Central African Republic, Chad, the Democratic Republic of the Congo, Ethiopia, Equatorial Guinea, Gabon, Republic of the Congo, Nigeria, and Sudan) 9. Current use of quinidine, amiodarone, diltiazem, spironolactone, verapamil, clarithromycin, erythromycin, itraconazole, ketoconazole, cyclosporine, tacrolimus, indinavir, ritonavir, or cobicistat. Use of critical drugs such as warfarin.
2. Hypersensitivity to any component of ivermectin or the excipients of the brand to be used.
3. COVID-19 pneumonia
* Diagnosed by the treating physician
* Identified on a chest x-ray
4. Fever or cough present for more than 48 hours.
5. immunoglobulin G (IgG) positive against SARS-CoV-2 by a rapid diagnostic test
8\. Recent travel history to loa endemic countries (Angola, Cameroon, Central African Republic, Chad, the Democratic Republic of the Congo, Ethiopia, Equatorial Guinea, Gabon, Republic of the Congo, Nigeria, and Sudan) 9. Current use of quinidine, amiodarone, diltiazem, spironolactone, verapamil, clarithromycin, erythromycin, itraconazole, ketoconazole, cyclosporine, tacrolimus, indinavir, ritonavir, or cobicistat. Use of critical drugs such as warfarin.
Minimum Eligible Age
18 Years
Maximum Eligible Age
75 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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Barcelona Institute for Global Health
OTHER
Sponsor Role
collaborator
Université Catholique de Louvain
OTHER
Sponsor Role
collaborator
Universidad Mayor de San Simón
OTHER
Sponsor Role
lead
Responsible Party
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Jorge Luis Aviles
MD. MPH. PhDc.
Responsibility Role
PRINCIPAL_INVESTIGATOR
Principal Investigators
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Carlos L Erostegui, MPH
Role: STUDY_DIRECTOR
Universidad Mayor de San Simón
Locations
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Universidad Mayor de San Simón
Cochabamba, , Bolivia
Site Status
Countries
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Bolivia
Central Contacts
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References
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Heidary F, Gharebaghi R. Ivermectin: a systematic review from antiviral effects to COVID-19 complementary regimen. J Antibiot (Tokyo). 2020 Sep;73(9):593-602. doi: 10.1038/s41429-020-0336-z. Epub 2020 Jun 12.
Reference Type
BACKGROUND
Choudhary R, Sharma AK. Potential use of hydroxychloroquine, ivermectin and azithromycin drugs in fighting COVID-19: trends, scope and relevance. New Microbes New Infect. 2020 Apr 22;35:100684. doi: 10.1016/j.nmni.2020.100684. eCollection 2020 May.
Reference Type
BACKGROUND
Guzzo CA, Furtek CI, Porras AG, Chen C, Tipping R, Clineschmidt CM, Sciberras DG, Hsieh JY, Lasseter KC. Safety, tolerability, and pharmacokinetics of escalating high doses of ivermectin in healthy adult subjects. J Clin Pharmacol. 2002 Oct;42(10):1122-33. doi: 10.1177/009127002401382731.
Reference Type
BACKGROUND
Schmith VD, Zhou JJ, Lohmer LRL. The Approved Dose of Ivermectin Alone is not the Ideal Dose for the Treatment of COVID-19. Clin Pharmacol Ther. 2020 Oct;108(4):762-765. doi: 10.1002/cpt.1889. Epub 2020 Jun 7.
Reference Type
BACKGROUND
Rizzo E. Ivermectin, antiviral properties and COVID-19: a possible new mechanism of action. Naunyn Schmiedebergs Arch Pharmacol. 2020 Jul;393(7):1153-1156. doi: 10.1007/s00210-020-01902-5. Epub 2020 May 27.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
Sharun K, Dhama K, Patel SK, Pathak M, Tiwari R, Singh BR, Sah R, Bonilla-Aldana DK, Rodriguez-Morales AJ, Leblebicioglu H. Ivermectin, a new candidate therapeutic against SARS-CoV-2/COVID-19. Ann Clin Microbiol Antimicrob. 2020 May 30;19(1):23. doi: 10.1186/s12941-020-00368-w. No abstract available.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
Bray M, Rayner C, Noel F, Jans D, Wagstaff K. Ivermectin and COVID-19: A report in Antiviral Research, widespread interest, an FDA warning, two letters to the editor and the authors' responses. Antiviral Res. 2020 Jun;178:104805. doi: 10.1016/j.antiviral.2020.104805. Epub 2020 Apr 21. No abstract available.
Reference Type
BACKGROUND
Chaccour C, Hammann F, Ramon-Garcia S, Rabinovich NR. Ivermectin and COVID-19: Keeping Rigor in Times of Urgency. Am J Trop Med Hyg. 2020 Jun;102(6):1156-1157. doi: 10.4269/ajtmh.20-0271. No abstract available.
Reference Type
BACKGROUND
Patri A, Fabbrocini G. Hydroxychloroquine and ivermectin: A synergistic combination for COVID-19 chemoprophylaxis and treatment? J Am Acad Dermatol. 2020 Jun;82(6):e221. doi: 10.1016/j.jaad.2020.04.017. Epub 2020 Apr 10. No abstract available.
Reference Type
BACKGROUND
Badhan R, Zakaria Z, Olafuyi O. The Repurposing of Ivermectin for Malaria: A Prospective Pharmacokinetics-Based Virtual Clinical Trials Assessment of Dosing Regimen Options. J Pharm Sci. 2018 Aug;107(8):2236-2250. doi: 10.1016/j.xphs.2018.03.026. Epub 2018 Apr 5.
Reference Type
BACKGROUND
Aroke D, Tchouakam DN, Awungia AT, Mapoh SY, Ngassa SN, Kadia BM. Ivermectin induced Steven-Johnsons syndrome: case report. BMC Res Notes. 2017 May 8;10(1):179. doi: 10.1186/s13104-017-2500-5.
Reference Type
BACKGROUND
Alout H, Foy BD. Ivermectin: a complimentary weapon against the spread of malaria? Expert Rev Anti Infect Ther. 2017 Mar;15(3):231-240. doi: 10.1080/14787210.2017.1271713. Epub 2016 Dec 29.
Reference Type
BACKGROUND
Chosidow A, Gendrel D. [Safety of oral ivermectin in children]. Arch Pediatr. 2016 Feb;23(2):204-9. doi: 10.1016/j.arcped.2015.11.002. Epub 2015 Dec 14. French.
Reference Type
BACKGROUND
Foletto VR, Vanz F, Gazarini L, Stern CA, Tonussi CR. Efficacy and security of ivermectin given orally to rats naturally infected with Syphacia spp., Giardia spp. and Hymenolepis nana. Lab Anim. 2015 Jul;49(3):196-200. doi: 10.1177/0023677214562850. Epub 2014 Dec 5.
Reference Type
BACKGROUND
Zhu N, Zhang D, Wang W, Li X, Yang B, Song J, Zhao X, Huang B, Shi W, Lu R, Niu P, Zhan F, Ma X, Wang D, Xu W, Wu G, Gao GF, Tan W; China Novel Coronavirus Investigating and Research Team. A Novel Coronavirus from Patients with Pneumonia in China, 2019. N Engl J Med. 2020 Feb 20;382(8):727-733. doi: 10.1056/NEJMoa2001017. Epub 2020 Jan 24.
Reference Type
BACKGROUND
Chen N, Zhou M, Dong X, Qu J, Gong F, Han Y, Qiu Y, Wang J, Liu Y, Wei Y, Xia J, Yu T, Zhang X, Zhang L. Epidemiological and clinical characteristics of 99 cases of 2019 novel coronavirus pneumonia in Wuhan, China: a descriptive study. Lancet. 2020 Feb 15;395(10223):507-513. doi: 10.1016/S0140-6736(20)30211-7. Epub 2020 Jan 30.
Reference Type
BACKGROUND
Wang 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.
Reference Type
BACKGROUND
Related Links
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https://www.isglobal.org/healthisglobal/-/custom-blog-portlet/ivermectin-and-covid-19-how-a-flawed-database-shaped-the-covid-19-response-of-several-latin-american-countries/2877257/0
SARS-CoV-2 Ivermectin Navarra-ISGlobal Trial (SAINT)
Other Identifiers
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RCT01
Identifier Type: -
Identifier Source: org_study_id
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