COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT04330495

Javier Crespo, MDPhD

javiercrespo1991@gmail.com

2020-04-01

Withdrawn

RCT

Randomized

Parallel

Blind label

unclear

Prevention

inclusion criteria: patients who meet the requirements of the new coronavirus infection diagnosis (acute respiratory infection symptoms or acute cough alone and positive pcr) aged ≥18 and < 75 years male or female; in women of childbearing potential, negative pregnancy test and commitment to use contraceptive method throughout the study. willing to take study medication willing to comply with all study procedures, diagnosis of ibd disease, rheumatoid arthritis, seronegative spondyloarthritis or psoriasis for more than 6 months. be on stable treatment with biological agents, for a minimum period of 6 months, including treatment with infliximab, etanercept, adalimumab, certolizumab, golimumab, rituximab, abatacept, tocilizumab, sarilumab, secukinumab, vedolizumab, natalizumab, ustekinumab, tofacit able to provide oral and written informed consent exclusion criteria previous infection with sars-cov-2. current treatment with hydroxychloroquine / chloroquine. previous or current treatment with tamoxifen or raloxifene. previous eye disease, especially maculopathy. known heart failure grade iii-iv of the classification of the new york heart association). any type of cancer (except basal cell) in the last 5 years. pregnancy. refusal to give informed consent. evidence of any other unstable or clinically significant unstable, clinically significant, immunological, endocrine, hematologic, gastrointestinal, neurological, neoplastic, or psychiatric illness. instability or mental incompetence, so that the validity of the informed consent or the ability to complete the study is uncertain. positive antibodies to the human immunodeficiency virus. data on decompensated liver disease: to. aspartate aminotransferase (ast) and / or alt> 10 x upper limit of normal (lsn). b. total bilirubin> 25 μmol / l (1.5 mg / dl). c. international normalized index> 1.4. d. platelet count <100,000 / mm3. 17. serum creatinine levels> 135 μmol / l (> 1.53 mg / dl) in men and> 110 μmol / l (> 24 mg / dl) in women. 18.significant kidney disease, including nephrotic syndrome, chronic kidney disease (patients with markers of liver injury or estimated glomerular filtration rate [egfr] of less than 60 ml / min / 1.73 m2). if an abnormal value is obtained at the first screening visit, the measurement of egfr may be repeated before randomization within the following time frame: minimum 4 weeks after the initial test and maximum 2 weeks before the planned randomization. repeated abnormal egfr (less than 60 ml / min / 1.73 m2) leads to exclusion from the study.pregnant or lactating women; 19. inability to consent and/or comply with study protocol; 20. individuals with known hypersensitivity to the study drugs. 21. any contraindications as per the data sheet of or hydroxychloroquine.

None

2

Instituto de Investigación Marqués de Valdecilla

18

75

None

High risk patients

N/A

0

Intensive Care Unit (CU) admission rate secondary to COVID-19 cases in both groups;Mortality rate secondary to COVID-19 cases in both groups;Prevalence of COVID-19 cases in both arms;Incidence rate of new COVID-19 cases in both arms

None

Phase 4

[{"arm_notes": "", "treatment_id": 607, "treatment_name": "Hydroxychloroquine", "treatment_type": "Antimalarials", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]