Study to Verify the Effectiveness and Safety of the Modified Isothymol or Carvacrol Compound Against SARS-CoV-2

• Status: Completed
• Trial end date: 2020-12-15
• Target enrollment: 0
• Participant gender: All

Summary

• Check the efficacy, safety and tolerability of the compound Modified isothymol against the SARS-CoV-2 agent in patients COVID-19.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Instituto Venezolano de Investigaciones Cientificas

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 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).