COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT04332991

Boyd Taylor Thompson, MD

Katie Oldmixon, coldmixon@mgh.harvard.edu (PI email not reported)

2020-04-03

Completed

RCT

Randomized

Parallel

Blind label

multi-center

Treatment

inclusion criteria: age ≥18 years currently hospitalized or in an emergency department with anticipated hospitalization. symptoms of acute respiratory infection, defined as one or more of the following: cough fever (> 37.5° c / 99.5° f) shortness of breath (operationalized as any of the following: subjective shortness of breath reported by patient or surrogate; tachypnea with respiratory rate ≥22 /minute; hypoxemia, defined as spo2 <92% on room air, new receipt of supplemental oxygen to maintain spo2 ≥92%, or increased supplemental oxygen to maintain spo2 ≥92% for a patient on chronic oxygen therapy). sore throat laboratory-confirmed sars-cov-2 infection within the past 10 days prior to randomization.

prisoner pregnancy breast feeding symptoms of acute respiratory infection for >10 days before randomization >48 hours between meeting inclusion criteria and randomization seizure disorder porphyria cutanea tarda diagnosis of long qt syndrome qtc >500 ms on electrocardiogram within 72 hours prior to enrollment known allergy to hydroxychloroquine, chloroquine, or amodiaquine receipt in the 12 hours prior to enrollment, or planned administration during the 5-day study period that treating clinicians feel cannot be substituted for another medication, of any of the following: amiodarone; cimetidine; dofetilide; phenobarbital; phenytoin; sotalol receipt of >1 dose of hydroxychloroquine or chloroquine in the 10 days prior to enrollment inability to receive enteral medications refusal or inability to be contacted on day 15 for clinical outcome assessment if discharged prior to day 15 previous enrollment in this trial the treating clinical team does not believe equipoise exists regarding the use of hydroxychloroquine for the treatment of this patient

2

Massachusetts General Hospital

18

None

United States

Moderate/severe disease at enrollment

4: Moderate/severe disease at enrollment

479

COVID Outcomes Scale Score on Study Day 15 (14 Days After Randomization)

None

Phase 3

[{"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"}]