COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT04597775

Munir A Abu-Helalah, PhD

mabuhelalah@yahoo.co.uk

2020-10-22

Unknown

RCT

Randomized

Adaptive

Open label

multi-center

Prevention

inclusion criteria: - primary contacts, described below, aged 18 to 65 years and having provide written informed consent by the patient, by the patient's legal /authorized representative as applicable. according to below criteria, as soon as a new subject in identified, he/she will be consented for reaching his contacts according to below criteria. the research team within 48 hours of index case identification will call his/her contacts who fulfill below criteria for participation in the trial. all potential participants will be tested using rt-pcr and igm and igg antibodies to rule out current or previous disease status. contact is a person free from covid-19 who experienced any one of the following exposures during the 2 days before and the 14 days after the onset of symptoms of a probable or confirmed case: - a person living in the same household as a covid-19 case - a person having had direct physical contact with a covid-19 case (e.g. shaking hands) - a person having unprotected direct contact with infectious secretions of a covid-19 case (e.g. being coughed on, touching used paper tissues with a bare hand) - a person having had face-to-face contact with a covid-19 case within 2 meters [2] and > 15 minutes - a person who was in a closed environment (e.g. classroom, meeting room, hospital waiting room, etc.) with a covid-19 case for 15 minutes or more and at a distance of less than 2 meters - a healthcare worker (hcw) or other person providing direct care for a covid-19 case, or laboratory workers handling specimens from a covid-19 case without recommended personal protective equipment or with a possible breach of personal protective equipment use policies - a contact in an aircraft sitting within two seats (in any direction) of the covid-19 case, travel companions or persons providing care, and crew members serving in the section of the aircraft where the index case was seated (if severity of symptoms or movement of the case indicate more extensive exposure, passengers seated in the entire section or all passengers on the aircraft may be considered close contacts)

- women who are pregnant (at the time of screening) or breastfeeding - known hypersensitivity or allergy to hydroxychloroquine or other aminoquinoline compounds - history of severe skin reactions such as stevens-johnson syndrome and toxic epidermal necrolysis - history of pre-existing retinopathy or maculopathy, - concomitant use of tamoxifen - history of congenital or acquired long qt-interval, current use of drugs that prolong the qt interval, - family history of long qt arrythmia, cardiac disease such as heart failure, myocardial infarction - concurrent use of anti-arrhythmic drugs, or family history of sudden cardiac death, or sudden cardiac death, bradycardia < 50 beats/min, uncorrected hypokalemia or hypomagnesemia - severe renal disease or patients receiving dialysis - patients less than 35 kg bodyweight - currently taking hydroxychloroquine - suspected or confirmed current covid-19, defined as: (1) temperature > 38 celsius; (2) cough; (3) shortness of breath; (4) sore throat; or, if available (not required), (5) positive confirmatory testing for covid-19 - inability to take medications orally - inability to provide written consent - with significantly abnormal liver function - participants with psoriasis, myasthenia, hematopoietic and retinal diseases, cns-related hearing loss; - rt-pcr positive for sars-cov-2, igm and igg antibodies for sars-cov-2 - currently using another treatment regimen or medication that is being investigated for efficacy in the management of covid-19.

3

Regional Center for Disease Control and Prevention, Jordan

18

65

None

Close contacts to covid patients

N/A

93

Incidence rate of COVID-19 on day 14 according to positive results of RT-PCR rate at day 14;Safety and adverse events (AEs) incidence rate at day 14

None

Phase 2/Phase 3

[{"arm_notes": "800mg (day 1), 400mg (day 2,3,4 and 5)", "treatment_id": 607, "treatment_name": "Hydroxychloroquine", "treatment_type": "Antimalarials", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "400mg (day 1), 200mg (day 2,3,4 and 5)", "treatment_id": 607, "treatment_name": "Hydroxychloroquine", "treatment_type": "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"}]