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COVID-19Phase 2/3NCT05445089

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

A Phase 2/3 study testing Carvacrol in people with COVID-19 and COVID-19 Pneumonia, run by Instituto Venezolano de Investigaciones Cientificas at 1 site in Venezuela.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Check the efficacy, safety and tolerability of the compound Modified isothymol against the SARS-CoV-2 agent in patients COVID-19. Read more about this study

Who is it for?
Ages 18 to 70 years
What is being tested?
Carvacrol
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
600 participants
Where
1 siteVenezuela
Study dates
1 Aug 2020to 15 Dec 2020
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 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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 autoimmune and infectious diseases (HIV, 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).

Trial locations and contacts

1 site in 1 country.

Venezuela1 site

  • Hospital Dr. Leopoldo Manrique Terrero - Periférico de Coche.

    Caracas, Miranda, 1090

Other trials in Venezuela

About this study

Official title: Multicenter, Randomized, Double-blind Study With Placebo to Verify the Efficacy, Safety and Tolerability of the Modified Isothymol or Carvacrol Compound Against the SARS-CoV-2 Agent in COVID-19 Patients

  • 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).
Being tested
Carvacrol, Control group
Keywords
SARS-CoV-2, Isothymol, Carvacrol, Antiviral, COVID-19, RNA, Cytokine storm
Medical subject headings
COVID-19, Cytokine Release Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CarvacrolDrug

    Also called CARVATIVIR

    Carvativir 6 mg/ml diluted for oral solution.

  • Control groupOther

    Placebo

Study groups in NCT05445089
Study groupRoleWhat they receive
Isothymol or Carvacrol groupExperimental* 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%).
Receives: Drug: Carvacrol
ControlPlacebo comparator•Placebo
Receives: Other: Control group

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Mortality Rate Among COVID-19 Patients

    The incidence of mortality in the first 15 days.

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: 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.

    Measured: 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.

    Measured: Day 1 to Day 15

Secondary outcomes (1)

  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.

    Measured: Day 1 to Day 15

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Jul 2022
  2. Study start1 Aug 2020
  3. Primary completion1 Nov 2020
  4. Study completion15 Dec 2020

Resources

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
Model description
Randomized, double-blind, multicenter study with blind evaluation of events, designed to compare the efficacy and safety of Isothymol modified with placebo in patients ≥18 years of age who meet the inclusion criteria. * Drug administration scheme: Randomized and parallel (modified isothymol and placebo). * Statistical design: Superiority. It will allow to detect difference between drug and placebo after parallel administration.
Masking
Single blind
Who is masked
Participant
Enrolment
600 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05445089
Sponsor's protocol ID
LAB-2020-01
Other IDs
ISRCTN registry
Status last verified
Jul 2022
First submitted
21 Jun 2022
Last updated
8 Jul 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Carvacrol in people with COVID-19 and COVID-19 Pneumonia, run by Instituto Venezolano de Investigaciones Cientificas at 1 site in Venezuela.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

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 8 Jul 2022. 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 Venezuela. 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?

Mortality Rate Among COVID-19 Patients (time frame: Day 1 to Day 15). The study lists 6 primary outcomes in all. 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 NCT05445089.

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 8 Jul 2022.

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