COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT04354597

Iyad Sultan

isultan@khcc.jo

2020-04-21

Withdrawn

RCT

Randomized

Parallel

Open label

single-center

Prevention

inclusion criteria: - medical doctors, nurses and respiratory therapists caring for covid-19 patients in er and icu and dedicated covid19 units. - age between 18 and 70 years old. - male or non-pregnant, non- lactating female. - availability for follow up by phone. - willing to participate and provide signed informed consent.

- subjects with a history of retinopathy, sickle cell disease or trait, psoriasis, or porphyria. - subjects who take certain prescribed or over the counter (otc) concomitant medication including ampicillin, cimetidine, digoxin, statins, cyclosporine, warfarin, fluconazole, within 2 weeks of dosing start, and during the duration of the study. - current symptoms of fever, cough, or shortness of breath. - pcr confirmed positive test of covid-19. - weight < 40 kg. - pregnant (positive β-human chorionic gonadotropin test, β-hcg) or lactating female at the screening. - allergy to any of the study medications. - history of splenectomy. - infection with hepatitis b or c viruses. - chronic or active neurologic disease including seizure disorder and chronic migraine headaches. - any abnormal baseline laboratory screening tests listed below - aspartate aminotransferase (ast) or alanine aminotransferase (alt)above twice the upper limit of normal for the reference lab. - creatinine above the normal range. - hemoglobin for males <12.5 g/dl and females <10.5 g/dl. - platelet count of <150 x 103/l. - total white blood cell (wbc) count out of normal range note: if screening lab values are out of the normal range but are expected to be temporary (e.g. due to dehydration), they may be re-assessed one more time at the discretion of the investigator. - an abnormal baseline screening ecg suggestive of cardiac disease as determined by a clinical investigator. qtcf of >450 msec for males and >470 msec for females. - any other significant finding that based on the judgment of the pi would increase the risk of having an adverse outcome from participating in this study - subjects known to have a mental illness - subjects who have skin disorders (including rash, dermatitis, and psoriasis) - hematological disease. - cardiovascular disease. - g6pd deficiency. - lactose intolerance.

2

King Hussein Cancer Center

25

70

Jordan

Health workers

N/A

0

Effect of HCQ and AZ in preventing infection with COVID-19 among healthcare workers working with COVID-19 patients

None

Not reported

[{"arm_notes": "", "treatment_id": 1534, "treatment_name": "Azithromycin+hydroxychloroquine", "treatment_type": "Antibiotics+antimalarials", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2188, "treatment_name": "Standard of care", "treatment_type": "Standard of care", "pharmacological_treatment": "Standard of care"}]