COVID-19 trials registries data warehouse

https://rpcec.sld.cu/en/trials/RPCEC00000383-En

Rodolfo Suarez Iznaga

rodolfo.suarez@infomed.sld.cu

2021-07-15

Not recruiting

RCT

Randomized

Parallel

Open label

unclear

Treatment

1) Hospitalized patients 2) between 19 and 80 years of age, 3) of both sexes4) with a confirmed diagnosis of COVID-19 by TR-PCR.5) That they have signed the informed consent to participate in the study.6) Reported care patients with high risk mild and moderate symptoms according to hospital diagnostic criteria. High-risk patient (RA): patient 65 years of age or older, with or without comorbidities, and patient under 65 years of age with comorbidities.

1) Pregnant or lactating patients.2) Patients with glucose-6-phosphate-dehydrogenase deficiency proven analytically or by their medical history.3) Chronic non-communicable diseases decompensated at the time of initiation of the trial4) Cancer patients for being immunocompromised.5) Patients with uncontrolled hyperthyroidism.6) Patients with psychiatric illnesses, mental retardation or cognitive impairment that imply the psychological incompetence of the subject.7) Scheduled surgery or other procedures that require general anesthesia during the study.8) Patients who use immunosuppressants continuously, or who undergo an organ transplant within 6 months.9) Patients with bleeding disorders, thrombocytopenia, active bleeding or who are under anticoagulant treatment.10) Patients who participated in other clinical trials within the previous three months (eg. Vaccination with COVID 19 candidates)11) Patients who were previously ill with COVID 1912) People with allergies or hypersensitivity to medical ozone.13) Patients with motor disabilities that make it difficult or impossible for them to move autonomously14) Patients with more than two diarrhea a day.

2

National Center for Scientific Research (CNIC)

19

80

Cuba

Mild disease at enrollment

1: Mild disease at enrollment

292

1- RT-PCR (Negativization of the test) (Positive or negative). Measurement time: Baseline; on the 5th; 7th and 10th days of treatment. 2- Clinical signs (mild; moderate; severe; critical). Measurement time: Every day until finalizing the treatment. Will be classified as:Mild: Fever; cough; sore throat; nasal congestion; slight headache; general malaise; diarrhea and / or vomiting. Normal radiology. Oxygen saturation greater than 95%.Moderate: Fever; cough; polypnea; slight changes in the Rx or lung ultrasound. Oxygen saturation greater than or equal to 90%.Severe: Fever; cough; polypnea; infiltrate / condensation Rx or lung ultrasound. Oxygen saturation less than 90% or requires VAM.Critical: ARDS; Sepsis or Septic Shock.3- Evolution of the symptom (the same; better or worse). Measurement time: Every day until finalizing the treatment. 4- Dyspnea (dysnea scale using the BORG method). Measurement time: Every day until finalizing the treatment. 5- Oximetry (determination by digital oximetro). Measurement time: Every day until finalizing the treatment.

Phase 3

[{"arm_notes": "", "treatment_id": 1092, "treatment_name": "Rectal ozone therapy", "treatment_type": "Others non pharmacological treatment", "pharmacological_treatment": "Non pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2188, "treatment_name": "Standard of care", "treatment_type": "Standard of care", "pharmacological_treatment": "Standard of care"}]