Clinical Trial to "Study the Efficacy and Therapeutic Safety of Ivermectin: (SAINTBO)

NCT04836299 | Unknown Phase 2

• 1 other identifier: RCT01
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Covid19

Keywords

Efficacy; Safety; Ivermectin

Outcome Measures

Primary Outcomes (2)

• Evolution of viral load

  A comparison will be made between the initial viral load before the dose of ivermectin with respect to the viral load on the third day after the administration of the drug. The primary outcome of interest will be the correlation between the use of a treatment regimen containing Ivermectin plus the standard of care, with the endpoint of measurement relative to the difference in viral loads.

  3 days

• Clinical remission

  Clinical remission, defined as a remission of all the patient's symptoms based on the clinical management protocol. The primary outcome of interest will be the correlation between the use of a treatment regimen containing Ivermectin plus the standard of care, initiated early after the confirmed diagnosis of COVID-19 with the endpoint of measurement relative to the difference in clinical evolution.

  28 days

Secondary Outcomes (1)

• Clinical signs of toxicity

  28 days

Other Outcomes (3)

• Need for supplemental oxygen

  28 days

• Hospital stay

  3 months

• Need for mechanical ventilation

  21 days

Study Arms (2)

Ivermectin

EXPERIMENTAL

Participants will receive a single 600 µg / kg dose of ivermectin.

Drug: Ivermectin

Placebo Comparator

PLACEBO COMPARATOR

Participants will receive a single dose of placebo.

Drug: Placebo

Interventions

Ivermectin DRUG

Participants will be randomly assigned to receive a single 600 µg / kg dose of ivermectin or placebo.

Also known as: A

Ivermectin

Placebo DRUG

Participants will be randomly assigned to receive a single of placebo.

Also known as: B

Placebo Comparator

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Known history of ivermectin allergy
• Hypersensitivity to any component of ivermectin or the excipients of the brand to be used.
• COVID-19 pneumonia
• Diagnosed by the treating physician
• Identified on a chest x-ray
• Fever or cough present for more than 48 hours.
• immunoglobulin G (IgG) positive against SARS-CoV-2 by a rapid diagnostic test
• \. 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.

Sponsors & Collaborators

• Universidad Mayor de San Simón: lead
• Barcelona Institute for Global Health: collaborator
• Université Catholique de Louvain: collaborator

Study Sites (1)

Universidad Mayor de San Simón

Cochabamba, Bolivia

Location

Related Publications (19)

• 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.

  PMID: 32533071 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.

  PMID: 32322397 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.

  PMID: 12362927 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.

  PMID: 32378737 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.

  PMID: 32462282 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.

  PMID: 32251768 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.

  PMID: 32473642 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.

  PMID: 32293834 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.

  PMID: 32330482 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.

  PMID: 32314704 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.

  PMID: 32283237 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.

  PMID: 29626533 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.

  PMID: 28482929 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.

  PMID: 27960597 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.

  PMID: 26697814 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.

  PMID: 25480657 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.

  PMID: 31978945 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.

  PMID: 32007143 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.

  PMID: 32031570 BACKGROUND

Related Links

• SARS-CoV-2 Ivermectin Navarra-ISGlobal Trial (SAINT)

MeSH Terms

Conditions

COVID-19

Interventions

Ivermectin

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Macrolides; Polyketides; Lactones; Organic Chemicals

Study Officials

• Carlos L Erostegui, MPH

  Universidad Mayor de San Simón

  STUDY DIRECTOR

Central Study Contacts

Jorge L Aviles, MPH

CONTACT

+59170745106; georgeavi@hotmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: The participants, care providers and also investigator will be blinded for this study design.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD. MPH. PhDc.

Model Details: 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.

Study Record Dates

• First Submitted: March 2, 2021
• First Posted: April 8, 2021
• Study Start: May 8, 2021
• Primary Completion: July 8, 2021
• Study Completion: December 5, 2021
• Last Updated: April 8, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: until August 2021
• Access Criteria: unrestricted access

Locations

BO (1)