COVID-19 trials registries data warehouse

https://www.isrctn.com/ISRCTN15363958

Raul Antonio Ojeda Rondon

ojeda.raul.antonio@gmail.com

2022-06-23

Not recruiting

RCT

Randomized

Parallel

Blind label

multi-center

Treatment

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.

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).

2

Instituto Venezolano de Investigaciones Científicas

0

100

Venezuela

No restriction on type of patients

0: No restriction on type of patients

600

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. 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). 3. Therapeutic compliance: day 0 and +15 (end of treatment). 4. Completion of the study (yes/no): day 0 and +45 (end of follow-up).

Phase 2/Phase 3

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