ISRCTN15363958
Completed
Phase 2
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
Instituto Venezolano de Investigaciones Científicas0 sites600 target enrollmentJune 23, 2022
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- COVID-19 (SARS-CoV-2 infection)
- Sponsor
- Instituto Venezolano de Investigaciones Científicas
- Enrollment
- 600
- Status
- Completed
- Last Updated
- 3 years ago
Overview
Brief Summary
2021 Results article in http://cesdi.net/campus-virtual/mod/data/view.php?d=1&rid=93 page 151 (added 22/06/2022) 2022 Results article in https://www.longdom.org/abstract/clinical-study-to-verify-the-effectiveness-and-safety-of-the-modified-isothymol-or-carvacrol-compound-against-sarscov2-i-94562.html (added 07/10/2022)
Investigators
Eligibility Criteria
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.
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).
Outcomes
Primary Outcomes
Not specified
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