COVID-19 trials registries data warehouse

https://rpcec.sld.cu/en/trials/RPCEC00000320-En

Zullyt Zamora Rodriguez

zullyt.zamora@cnic.edu.cu

2020-06-05

Not recruiting

RCT

Randomized

Parallel

Open label

unclear

Treatment

1- Hospitalized patients between 19 and 80 years, of either sex with a diagnosis confirmed by COVID-19 PCR-TR. 2- Patients who signed the informed consent to participate in the study. 3- Reported care patients with mild and moderate symptoms according to hospital diagnostic criteria (fever, dry cough and sore throat)

1- Pregnant or lactating patients. 2- Patients with uncontrolled hyperthyroidism. 3- Patients with glucose-6-phosphate dehydrogenase deficiency verified analytically or due to their medical history. 4- Chronic non-communicable diseases decompensated at the start of the trial. 5- Cancer patients due to being immunocompromised. 6- Patients with psychiatric illnesses that imply the 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 or active bleeding. 10- People with allergies or hypersensitivity to medical ozone. 11- Patients who participated in other clinical trials within the previous three months.

2

National Center for Scientific Research (CNIC)

19

80

Cuba

Mild/moderate disease at enrollment

2: Mild/moderate disease at enrollment

32

Real-time polymerase chain reaction test-TR-PCR (Positive/Negative). Measurement time: day 0; day 6; day 11 Clinical signs (fever; pain head; fatigue; sore throat; dry cough; dyspnea. Every signs evaluted like Yes/No). Measurement time: day 0 to day 11; day 15 Progression of clinical signs (equal; better; worse). Measurement time : day 0 to day 11; day 15

| Declared number of arm (2.0) differs from found arms (3.0)

Not reported

[{"arm_notes": "rectal", "treatment_id": 952, "treatment_name": "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"}]