COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT04407182

Martha Heras Veloz

martha.heras@iess.gob.ec

2020-05-29

Completed

RCT

Randomized

Parallel

Blind label

single-center

Treatment

inclusion criteria: - population over 18 years of age up to 70, sample size 30. - subjects with mild to moderate* symptoms of respiratory illness caused by 2019 coronavirus infection as defined below: mild disease (uncomplicated): - diagnosed with covid-19 by a standardized rt-pcr assay and mild symptoms, such as fever, runny nose, mild cough, sore throat, malaise, headache, muscle pain, or discomfort, but no shortness of breath and no signs of more serious lower airway disease. - rr <20, hr <90, oxygen saturation (pulse oximetry)> 93% in ambient air. *moderate illness: - diagnosed with covid-19 by a standardized rt-pcr assay and - in addition to the above symptoms, more significant lower respiratory symptoms, including difficulty breathing (at rest or with exertion) or - signs of moderate pneumonia, including rr ≥ 20 but <30, hr ≥ 90 but less than 125, oxygen saturation (pulse oximetry)> 93% in ambient air, and - if available, x-ray or computed tomography-based lung infiltrates <50% present 3. 12-lead ecg at rest clinically normal at the screening visit or, if abnormal, not considered clinically significant by the lead investigator. 4. the subject (or legally authorized representative) provides her informed written consent before starting any study procedure. 5. understand and agree to comply with planned study procedures. 6. women of childbearing potential must agree to use at least one medically accepted method of contraception (eg, barrier contraceptives [condom or diaphragm with a spermicidal gel], hormonal contraceptives [implants, injectables, combined oral contraceptives, transdermal patches or rings) ] or intrauterine devices) for the duration of the study.

- none

2

Catalysis SL

18

70

Ecuador

Mild/moderate disease at enrollment

2: Mild/moderate disease at enrollment

60

Symptom resolution

None

Phase 2

[{"arm_notes": "", "treatment_id": 2251, "treatment_name": "Asbrip+viusid", "treatment_type": "Vitamins and dietary supplements+nutrition", "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"}]