COVID-19 trials registries data warehouse

https://rpcec.sld.cu/en/trials/RPCEC00000388-En

Jose Guzman-Esquivel

pepeguzman_esquivel@outlook.com

2021-08-31

Not recruiting

RCT

Randomized

Parallel

Blind label

unclear

Treatment

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 - 85 years old. 3. Acceptance in writing, with prior information.

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.

2

Medical School of the University of Colima; Mexico

18

85

Mexico

Mild/moderate disease at enrollment

2: Mild/moderate disease at enrollment

40

Acceptable symptom status of the patient. (Days to reach a state of acceptable symptoms; determined as the number of days that elapsed from the start of treatment until the patient answered with a Yes to the following question: Considering all the different ways your disease is affecting you; if you were to stay in this state for the next few months; do you consider that your current state is satisfactory? ”: Yes or No.) Measurement time: Daily; from patient randomization (baseline) to day 20.

Phase 2

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