COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT04344444

Meredith Clement

Jeannine Ascani, jeannine.ascani@lcmchealth.org (PI email not reported)

2020-04-14

Terminated

RCT

Randomized

Parallel

Open label

single-center

Treatment

inclusion criteria: - age greater than 18 years - positive sars-cov-2 testing or consistent clinical syndrome (based on clinical picture e.g. characteristic infiltrates on chest x-ray, laboratory findings, and with agreement by two physicians) in patients under investigation (puis). - onset of symptoms < 7 days from date of enrollment - oxygen saturation of >94% on room air with defined risk factors (table 1) consistent with moderate disease or oxygen saturation of < 94% on room air consistent with severe disease - ability and willingness to comply with study procedures

- qtc greater than 450 milliseconds on screening ekg - pregnant or lactating women - inability to take oral pills or inability to use a feeding tube - inability to obtain informed consent either from the patient or from the next of kin if patient is incapacitated. for the purpose of this study obtaining a verbal consent from a family member on the phone with a witness will be considered acceptable since there is a 'no visitor' policy in force at hospitals. - patients requiring icu level care - use of azithromycin or hydroxychloroquine within 30 days prior to admission

3

LCMC Health

18

100

United States

Moderate/severe disease at enrollment

4: Moderate/severe disease at enrollment

22

Most severe outcome

None

Phase 3

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