COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT04354428

Christine Johnston, MD, MPH

cjohnsto@uw.edu

2020-04-21

Terminated

RCT

Randomized

Parallel

Blind label

multi-center

Treatment

inclusion criteria: men or women 18 to 80 years of age, inclusive, at the time of signing the informed consent willing and able to provide informed consent laboratory confirmed sars-cov-2 infection, with test results within past 72 hours covid-19 symptoms, based on the following criteria: at least two of the following symptoms: fever (≥ 38ºc), chills, rigors, myalgia, headache, sore throat, new olfactory and taste disorder(s), or o at least one of the following symptoms: cough, shortness of breath or difficulty breathing (lopinavir-ritonavir platform) access to device and internet for telehealth visits at increased risk of developing severe covid-19 disease (at least one of the following) age ≥60 years presence of pulmonary disease, specifically moderate or severe persistent asthma, chronic obstructive pulmonary disease, pulmonary hypertension, emphysema diabetes mellitus (type 1 or type 2), requiring oral medication or insulin for treatment hypertension, requiring at least 1 oral medication for treatment immunocompromised status due to disease (e.g., those living with human immunodeficiency virus with a cd4 t-cell count of <200/mm3) immunocompromised status due to medication (e.g., persons taking 20 mg or more of prednisone equivalents a day, anti-inflammatory monoclonal antibody therapies, or cancer therapies) body mass index ≥30 (self-reported)

- known hypersensitivity to hcq or other 4-aminoquinoline compounds - known hypersensitivity to azithromycin or other azalide or macrolide antibiotics - currently hospitalized - signs of respiratory distress prior to randomization, including respiratory rate >24 - current medications include hcq - concomitant use of other anti-malarial treatment or chemoprophylaxis - history of retinopathy of any etiology - psoriasis - porphyria - chronic kidney disease (stage iv or receiving dialysis) - known bone marrow disorders with significant neutropenia (polymorphonuclear leukocytes <1500) or thrombocytopenia (<100 k) - concomitant use of digoxin, cyclosporin, cimetidine, amiodarone, or tamoxifen - known cirrhosis - known personal or family history of long qt syndrome - history of coronary artery disease with a history of graft or stent - history of heart failure, class 2 or greater using the new york heart association functional class - taking medications associated with prolonged qt and known risk of torsades de points. these medications may include some antipsychotic and antidepressant medications. (lopinavir-ritonavir platform) - taking medications associated with prolonged qt such as antipsychotic medications or antidepressants (e.g., citalopram, venlafaxine, and bupropion) and unable to stop during the trial - taking warfarin (coumadin or jantoven) - known history of glucose-6-phosphate-dehydrogenase deficiency - history of myasthenia gravis

4

University of Washington

18

80

United States

No restriction on type of patients

0: No restriction on type of patients

289

Number of Participants With Hospitalization or Mortality;Number of Persons With Lower Respiratory Tract Infection (LRTI), Defined as Resting Blood Oxygen Saturation (SpO2<93%) Level Sustained for 2 Readings 2 Hours Apart and Presence of Subjective Dyspnea or Cough;Time to Clearance of Nasal SARS-CoV-2;Time to Resolution of COVID-19 Symptom Resolution in Days

None

Phase 2/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": 1604, "treatment_name": "Lopinavir+ritonavir", "treatment_type": "Antivirals", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]