Study to verify the effectiveness and safety of the modified isothymol or carvacrol compound against SARS-CoV-2 in COVID-19 patients

Phase 2

Completed

• Conditions: COVID-19 (SARS-CoV-2 infection); Infections and Infestations

• Registration Number: ISRCTN15363958
• Lead Sponsor: Instituto Venezolano de Investigaciones Científicas

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)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2020-11-01
• Study Start: 2022-06-23
• Last Update Posted: 17 October 2022

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 600

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).

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br> 1. Diagnosis of the presence of COVID-19 infection by RT-PCR: day 0 (start of treatment) and in case of withdrawal due to infection.<br> 2. Diagnosis of COVID-19 infection due to absence of acute respiratory infection: day 0 (start of treatment), day +15 (end of treatment) and day 0 and +45 (end of follow-up).<br> 3. Therapeutic compliance: day 0 and +15 (end of treatment).<br> 4. Completion of the study (yes/no): day 0 and +45 (end of follow-up).<br>

Secondary Outcome Measures

Name	Time	Method
<br> 1. Vital signs (heart rate, respiratory rate, temperature, blood oxygen saturation (SpO2) and blood pressure): day 0 (beginning of treatment), +15 (end of treatment) and +45 (end of follow-up).<br> 2. Basic analysis (Complete hematology (Hg, Hto, WCB, Neutrophils, Lymphocytes, Platelets), CRP, PT – PTT, Ferritin, Fibrinogen, D-dimer, IL-6, IgM and IgG, Chest CT): day 0 (start of treatment), +15 (end of treatment) and +45 (end of follow-up).<br> 3. Adverse events: day +15 (end of treatment) and 45 (end of tracing).<br> 4. Death: at the time of death.<br> 5. Use of PPE: day +15 (end of treatment) and +45 (end of follow-up).<br>