Ivermectin Reproposing for Mild Stage COVID-19 Outpatients

NCT04784481 | Completed Phase 1 DMC

• 1 other identifier: 5077-410-CH2020
• Study Type: interventional
• Target: 254
• Locations: 1 country
• Sites: 1

Brief Summary

Background: The emergency of COVID-19, along with the current difficulties in responding to the high demand for vaccines, requests to the scientific community to find alternative treatments based on reuse of drugs as a strategy to prevent the progression of the disease in patients infected with SARS COV 2. Objetive This study aims to evaluate the use of ivermectin in mild-stage patients to increase outpatient discharge and prevent the progression to moderate or severe stages of the disease. Added value of this study We found that an intervention with ivermectin has impacted on the PPS in a population of outpatients care, between the 5th and 9th day. Also, the treatment increased the probability to obtain outpatient discharge, even in the presence of comorbidities. Implications of all available evidence. Research in Context According to the COVID-19 Treatment Guidelines by the NIH, most trials have several limitations. It needs results from adequately powered and well-designed clinical trials to provide evidence-based guidance on the role of ivermectin in the treatment of COVID- 19. However, our study shows overlaps in benefits with other authors, and taking together, these results are encouraging for further study about repurposing ivermectin for the treatment of COVID-19.

Conditions

Covid19; SARS (Severe Acute Respiratory Syndrome)

Keywords

Ivermectin; Outpatient; Mild stage; Health Primary Center

Outcome Measures

Primary Outcomes (2)

• Proportion test

  a) Proportion of patients with symptoms (fever, diarrhea, taste and/or smell disturbance, SpO2, polyarthralgia, headache, body pain, abdominal pain, ALRI symptoms and signs)

  from 5th to 9th day.

• Proportion test

  Proportion of patientts with symptoms (fever, diarrhea, taste and/or smell disturbance, SpO2, polyarthralgia, headache, body pain, abdominal pain, ALRI symptoms and signs)

  from 10th to 14th day.

Secondary Outcomes (2)

• Odd Ratio

  28 days after enrollment

• Odd Ratio and logistic regression test

  28 days after enrollment

Study Arms (2)

Experimental Group

EXPERIMENTAL

The EG received Ivermectin orally 4 tablets of 6 mg = 24 mg every 7 days for 4 weeks. All participants were evaluated by physical examination COVID-19 diagnosed with positive RT-PCR at the beginning, and final of the protocol

Drug: Ivermectin

Control Group

NO INTERVENTION

Conventional treatment. All participants were evaluated by physical examination COVID-19 diagnosed with positive RT-PCR at the beginning, and final of the protocol

Interventions

Ivermectin DRUG

Experimental Group received Ivermectin orally 4 tablets of 6 mg = 24 mg every 7 days for 4 weeks.

Also known as: N/D

Experimental Group

Eligibility Criteria

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

You may qualify if:

• Outpatients infected by SARSCoV-2 confirmed either by RT-PCR test, Neo Kit or rapid test authorized by ANMAT or by close contact or epidemiological link;
• Women of childbearing age with a negative pregnancy test;
• Mild disease-patients with two or more of the following symptoms: fever less than 38·5°C and higher than 37.5°C according to Ministry of Health, Argentina(16), isolated diarrheal episodes, hyposmia or hypogeusia, mild desaturation (between 96 and 93%), dyspnea, polyarthralgia, persistent headache, abdominal pain, erythema of the kidney, nonspecific rash.

You may not qualify if:

• Hypersensitivity or allergy to Ivermectin;
• Pregnant or lactating;
• Children or adolescents under 18 years of age;
• Patients with Neurological Pathology, Renal Insufficiency, Hepatic Insufficiency;
• Weight less than 40kg;
• Patients with concomitant use of drugs that act on GABA, barbiturate and benzodiazepine receptors;
• Patients who have not completed / signed the informed consent.

Sponsors & Collaborators

• Ministry of Public Health, Argentina: lead

Study Sites (1)

SI.PRO.SA, Ministerio de Salud Pública

San Miguel de Tucumán, 4000, Argentina

Location

Related Publications (6)

• Bacchetti P, Leung JM. Sample size calculations in clinical research. Anesthesiology. 2002 Oct;97(4):1028-9; author reply 1029-32. doi: 10.1097/00000542-200210000-00050. No abstract available.

  PMID: 12357184 BACKGROUND

• Wu Z, McGoogan JM. Characteristics of and Important Lessons From the Coronavirus Disease 2019 (COVID-19) Outbreak in China: Summary of a Report of 72 314 Cases From the Chinese Center for Disease Control and Prevention. JAMA. 2020 Apr 7;323(13):1239-1242. doi: 10.1001/jama.2020.2648. No abstract available.

  PMID: 32091533 BACKGROUND

• Ashburn TT, Thor KB. Drug repositioning: identifying and developing new uses for existing drugs. Nat Rev Drug Discov. 2004 Aug;3(8):673-83. doi: 10.1038/nrd1468. No abstract available.

  PMID: 15286734 BACKGROUND

• Liu Z, Fang H, Reagan K, Xu X, Mendrick DL, Slikker W Jr, Tong W. In silico drug repositioning: what we need to know. Drug Discov Today. 2013 Feb;18(3-4):110-5. doi: 10.1016/j.drudis.2012.08.005. Epub 2012 Aug 28.

  PMID: 22935104 BACKGROUND

• Gonzalez 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.

  PMID: 18446504 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 RESULT

MeSH Terms

Conditions

COVID-19; Severe Acute Respiratory Syndrome

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

• Rossana E. Chahla, MD. Ph.D.

  Ministery of Health, Tucumán, Argentina

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Each of the health centers (cluster of health centers) was randomly assigned to receive or not the intervention under study. The conglomerate of outpatients randomly assigned to the Experimental Group (EG) and Control Group (CG) belongs to the urban and peri-urban areas from Tucumán, and the selection of the centers was carried out considering a homogeneous socioeconomic profile in relation to the operating areas in which it is organized the Public Health Systems. Participants were recruited prior to cluster randomisation. Staff of each assistance center knew what intervention was being implemented as well as patients. Data processing group was blind to analyze the database.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Research - Ministry of Health of Tucumán

Model Details: Cluster-randomised trials.

Study Record Dates

• First Submitted: February 20, 2021
• First Posted: March 5, 2021
• Study Start: September 20, 2020
• Primary Completion: December 20, 2020
• Study Completion: January 18, 2021
• Last Updated: April 26, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

AR (1)