ClinicalTrials.gg
CompletedNCT05445089Updated Jul 8, 2022

Study to Verify the Effectiveness and Safety of Isothymol or Carvacrol Compound Against SARS-CoV-2 in COVID-19 Patients

A Phase 2/3 interventional study of Carvacrol and Control group in COVID-19, COVID-19 Pneumonia and COVID-19 Respiratory Infection, sponsored by Instituto Venezolano de Investigaciones Cientificas. Completed at 1 site in Venezuela. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2022-07-08.

Sponsored by Instituto Venezolano de Investigaciones Cientificas · Phase 2/3, Interventional, and Treatment

From the registry’s dates

  • Registered 1 year 10 months after the study started (first participant enrolled Aug 2020, registered Jun 2022).
Phase
Phase 2/3
Study type
Interventional
Enrollment
600
Allocation
Randomized
Ages
18 Years to 70 Years
Sex
All
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Study summary

  • Check the efficacy, safety and tolerability of the compound Modified isothymol against the SARS-CoV-2 agent in patients COVID-19.
Read the detailed description
  • Evaluate the inhibition of the terminal glycosylation of the Enzyme Angiotensin II converter (ECE2).
  • Check the inhibition of the main protease function (Mpro) of the SARS-CoV-2 agent by stable binding of the drug/protein to control viral replication.
  • Check the oxidation reaction of the amine R-CH2-NH2 involved in the hyperactivation of macrophages (immune system innate), by interference of modified Isothymol.
  • Evaluate the increase in tolerance to hypersensitivity of the immunoglobulins G (IgG) and immunoglobulins M (IgM) in patients COVID-19.
  • Check the suppression of production and adhesion of superoxides in neutrophils (Immunostimulatory effect) through the regulation of cytokines and IL-6 (interleukins) for the inhibition of cytokine storm (Stage 2 and 3, infected patient).
02

Conditions studied

  • COVID-19
  • COVID-19 Pneumonia
  • COVID-19 Respiratory Infection
  • COVID-19 Acute Respiratory Distress Syndrome
  • COVID-19 Lower Respiratory Infection

Keywords

  • SARS-CoV-2
  • Isothymol
  • Carvacrol
  • Antiviral
  • COVID-19
  • RNA
  • Cytokine storm
03

In context

COVID-19

7,990 studies on the registry are indexed under COVID-19; 466 are open to participants now.

This study's enrollment of 600 is above the median of 102 across 4,364 interventional studies indexed under COVID-19.

Browse COVID-19 studies →

Lead sponsor

Instituto Venezolano de Investigaciones Cientificas is the lead sponsor of 5 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

The study population will be patients aged ≥18 years with RT-PCR positive (detection of genetic material from SARS-CoV-2 in the analyzed sample), eligible for COVID-19, who attend a center physician with an active primary care program, in the early hours from the onset of symptoms. In the case of asymptomatic the analysis of the nasopharyngeal swab will be verified in the triage, and in Depending on the result, they may or may not be included in the clinical protocol.

A sample size of 600 patients is expected, which must be randomize for parallel administration of experimental drug (300 patients) and placebo (300 patients).

It should be evaluated prior to the start of the clinical trial: Tests of rapid diagnosis (PDR test), chain reaction of the Reverse Transcriptase Polymerase (RT-PCR test), pressure blood pressure, pulse, temperature, body weight, blood tests, detection of and infectious diseases (, lupus, rheumatoid arthritis, hepatitis, syphilis), detection of antibodies (immunoglobulin G and immunoglobulin and M), urine tests for detect drugs and pregnancy (in the case of women) and other comorbid conditions characterized. In addition, chest x-ray should be performed on each patient included in the test, and if possible perform a computerized tomography (before and after treatment with modified Isothymol).

There will be an electronic system to load all the variables scientific and clinical protocol established in data collection, and will also allow processing of expedited output variables, which can be audited in real time.

Participant inclusion criteria:

  1. Positive test PDR, positive test RT-PCR, patients diagnosed with COVID-19
  2. Chest pain or other symptom consistent with bilateral pneumonia atypical, with one of the following paraclinical alterations and imaging:
  3. Oxygen saturation (SpO2) ≤93%.
  4. Elevation of D-dimer ≥10 mg/mL.
  5. Elevation of Ferritin ≥120 ng/mL.
  6. Elevation of Fibrinogen ≥400 mg/dL
  7. Elevation of Immunoglobulin M (IgM) ≥200 mg/dL.
  8. Elevation of Interleukin 6 (IL-6) ≥1800 pg/mL.
  9. Rx. chest and CT showing thickening of the bronchi, consolidation and ground glass opacities.

Participant exclusion criteria:

Negative test PDR, negative test RT-PCR and Inadequate administration of antiviral (for non-compliance with indicated intervals or death of the patient before 15 days treatment indications).

Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Autoimmune disease

A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.

Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

05

Study design

Phase
Phase 2 / Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
600 participants (actual)

Study arms

  • Experimental
    Isothymol or Carvacrol group

    * Each ml contains 6mg of Isothymol or Carvacrol (2-Methyl-5-(1-methylethyl)-phenol modified) at 1% v/v. (GRAS lipophilic modified with isothymol). * Oral solution (dispersion L/L). Dilute lipophilic aqueous solution of light or medium yellow. * Excipients: Cis-9-octadecenoic acid with Squalene (99%).

    Drug: Carvacrol

  • Placebo comparator
    Control

    •Placebo

    Other: Control group

Interventions

  • DrugCarvacrol

    Carvativir 6 mg/ml diluted for oral solution.

    Also known as: CARVATIVIR

  • OtherControl group

    Placebo

06

What researchers measure

Primary outcomes

  1. Mortality Rate Among COVID-19 Patients

    The incidence of mortality in the first 15 days.

    Time frame: Day 1 to Day 15

  2. Quantitative Evaluation of Inflammatory Mediator Interleukin 6 (IL-6) by test ELISA as Collected Over Time to Day 15

    Interleukin 6 (IL-6) in pg/ml

    Time frame: Day 1 to Day 15

  3. Quantitative Evaluation of Immunoglobulin M (IgM) by test ELISA as Collected Over Time to Day 15

    IgM in mg/dl

    Time frame: Day 1 to Day 15

  4. Quantitative Evaluation of Immunoglobulin G (IgG) by test ELISA as Collected Over Time to Day 15

    IgG in mg/dl

    Time frame: Day 1 to Day 15

  5. Proportion of Patients with COVID-19 who Require Intensive Care Unit (ICU)-Level Care, Mechanical Ventilatory Support (MV), and/or Extracorporeal Membrane Oxygenation (ECMO) Over Time to Day 15

    As a measure of disease acuity and severity.

    Time frame: Day 1 to Day 15

  6. Requirement for Extracorporeal Membrane Oxygenation (ECMO) in COVID-19 Patients Over Time to Day 15

    A measure of disease morbidity.

    Time frame: Day 1 to Day 15

Secondary outcomes

  1. Longitudinal Assessment of Viral Load by Semi-Quantitative Polymerase Chain Reaction (PCR) Over Time to Day 15

    Ribonucleic acid (RNA) from the nasal swab will be used to assess SARS-CoV-2 viral load.

    Time frame: Day 1 to Day 15

07

Study locations

1 site
  • Hospital Dr. Leopoldo Manrique Terrero - Periférico de Coche.
    Caracas, Miranda 1090, Venezuela
08

References and documents

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 8, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05445089
Lead sponsor
Instituto Venezolano de Investigaciones Cientificas
Responsible party
Raul Antonio Ojeda Rondon (Principal Investigator, Instituto Venezolano de Investigaciones Cientificas) — Principal investigator
First posted
Jul 6, 2022
Start date
Aug 1, 2020
Primary completion
Nov 1, 2020
Completion
Dec 15, 2020
Last update
Jul 8, 2022

Study contacts

Raul Ojeda, MsC
principal investigator · Biosynthesis Medical

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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