COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT04853199

Not reported

Not reported

2021-04-21

Completed

RCT

Randomized

Parallel

Blind label

multi-center

Treatment

inclusion criteria: - • clinical score greater than 6 - patients with clinical symptoms less than 5 days old. - men and women at least 40 years old, able and willing to give informed consent; - any patient over the age of 18 with a ct scan in favor of covid-19; - ambulatory or hospitalized environment; - patient with dyspnea or with a positive gait test; - the patient must have at least one of the following high risk criteria: 70 years or older, obesity (bmi ≥ 30 kg / m2), diabetes mellitus, uncontrolled hypertension (systolic blood pressure ≥ 150 mm hg), respiratory disease known (including asthma or chronic obstructive pulmonary disease), known heart failure, known coronary artery disease, fever ≥ 38.4 ° c within the last 48 hours, dyspnea at the time of presentation, bicytopenia, pancytopenia or a combination of a number high neutrophils and low lymphocytes count; - the patient is not of childbearing age, defined as postmenopausal for at least 1 year or surgically sterile, or is of childbearing age and uses at least one method of contraception and preferably two complementary forms of contraception comprising a method of barrier throughout the study and for 30 days after the end of the study; - the patient must be able and willing to comply with the requirements of this study protocol.

- • patient currently in shock or exhibiting hemodynamic instability; - patient with inflammatory bowel disease (crohn's disease or ulcerative colitis), chronic diarrhea or malabsorption; - pregnant or breastfeeding patient - patient with a history of allergic reaction or significant sensitivity to nigella; - the patient is considered by the investigator, for whatever reason, to be an unsuitable candidate for the study.

2

Hôpital Universitaire Sahloul

18

100

Tunisia

Severe disease at enrollment

6: Severe disease at enrollment

200

Mortality rate;Need for ICU admission;treatment safety

None

Phase 1

[{"arm_notes": "", "treatment_id": 1051, "treatment_name": "Quercetin", "treatment_type": "Others pharmacological treatment", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]