COVID-19 trials registries data warehouse

https://rpcec.sld.cu/en/trials/RPCEC00000309-En

Juan Paz Garcia

dr_juanpaz@hotmail.com

2020-05-05

Recruiting

RCT

Randomized

Parallel

Open label

unclear

Treatment

A) For outpatients treated at home (without pneumonia and with peripheral blood oxygen saturation equal to or greater than 90% breathing ambient air): 1. Patients diagnosed with COVID-19, with uncomplicated disease. 2. Age: 18 years - 75 years old. 3. Acceptance in writing, with prior information. B) For hospitalized patients (with pneumonia or peripheral blood oxygen saturation less than 90% breathing ambient air or requiring mechanical ventilation): 1. Patients diagnosed with COVID-19, with mild or severe pneumonia hospitalized. 2. Age: 18 years - 75 years old. 3. Acceptance in writing, with prior information.

FOR ALL PATIENTS 1. Rheumatoid arthritis. 2. Autoimmune diseases. 3. Previously diagnosed cardiac diseases (ischemic). 4. Chronic decompensated systemic disease prior to the diagnosis of COVID-19. 5. Creatinine 1.25 times higher than the normal value or creatinine clearance less than 50 milliliters / minute (Cockfrot and Gault method), prior to the diagnosis of COVID-19. 6. Blood hemoglobin less than 10g / Dl, prior to the diagnosis of COVID-19. 7. Increase in the last month of diastolic blood pressure to 110 mmHg or more and / or appearance of hematuria or proteinuria greater than 300 milligrams / day. 8. Intestinal pseudo-obstruction. Defined as abdominal pain, with airborne levels on radiographs of the AP abdomen and lateral foot. 9. Pregnant and lactating women. 10. Drug addiction (illicit drugs). 11. Known liver disease prior to the diagnosis of COVID-19 with a doubling of liver function tests (Aspartatoamine transferase (AST), Alaninoamine transferase (ALT), Alkaline phosphatase, Bilirubins). 12. Presence of Cancer. 13. Other pathologies at the discretion of the researcher.

5

Cancerology State Institute; Colima State Health Service (SSA-Colima); Mexico.

18

75

Mexico

No restriction on type of patients

0: No restriction on type of patients

200

Disease progression (present or absent). Measurement time: Daily until 20th day or until patient outcome (cure or progression). Patients treated at home. The progression will be present when hospitalization or death occurs. In hospitalized patients: The progression will be present when they are in the usual hospital floor and without a ventilator; progression is considered when there is death or admission to the Intensive Care Unit (ICU) or requiring mechanical ventilation. Patients enrolled in the trial after admission to the ICU or already on mechanical ventilation. The progression will be present when death occurred.

Phase 1/Phase 2

[{"arm_notes": "nubilization", "treatment_id": 586, "treatment_name": "Homeostec", "treatment_type": "Others pharmacological treatment", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "nebulization+IV", "treatment_id": 586, "treatment_name": "Homeostec", "treatment_type": "Others pharmacological treatment", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "IV", "treatment_id": 586, "treatment_name": "Homeostec", "treatment_type": "Others pharmacological treatment", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}, {"arm_notes": "", "treatment_id": 2188, "treatment_name": "Standard of care", "treatment_type": "Standard of care", "pharmacological_treatment": "Standard of care"}]