COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT04358068

Davey Smith

Not reported

2020-04-22

Terminated

RCT

Randomized

Parallel

Blind label

multi-center

Treatment

inclusion criteria: - documentation of confirmed active severe acute respiratory syndrome coronavirus (sars-cov-2) infection from any respiratory specimen collected ≤7 days from when the first dose of study treatment was expected to be taken. - experienced at least one of the following sars-cov-2 infection symptoms within 24 hours of screening (symptom(s) must be new or worse compared to pre-covid-19 health status): - fever (can be subjective) or feeling feverish - cough - shortness of breath or difficulty breathing at rest or with exertion - sore throat - body pain or muscle pain - fatigue - headache - agreed to not participate in another clinical trial for the treatment of covid-19 or sars-cov-2 during the study period up until reaching hospitalization or 20 days, whichever is earliest. - agreed to not obtain study medications outside of the a5395 study.

- need for hospitalization or immediate medical attention in the clinical opinion of the study investigator. - history of or current hospitalization for covid-19. - history of ventricular arrhythmia or use of antiarrhythmics within 30 days prior to entry. - personal or family history of long qt syndrome. - history of kidney disease. - history of ischemic or structural heart disease. - history of hypokalemia or hypomagnesemia or taking potassium supplementation or magnesium supplementation - personal medical history of porphyria, retinopathy, severe hepatic impairment, or glucose-6-phosphate dehydrogenase (g6pd) deficiency. - used drugs with possible anti-sars-cov-2 activity within 30 days prior to study entry, e.g., remdesivir, lopinavir/ritonavir fixed dose combination, ribavirin, chloroquine, hydroxychloroquine, and azithromycin, or participation in a clinical trial involving any of these drugs whether for treatment or prophylaxis. - requirement or expected requirement for a medication that significantly prolongs qt intervals or increases risk for qt prolongation. - loop diuretics are exceptions to above exclusion criterion but these cannot be used within 30 days prior to study entry. - participated in a study where co-enrollment was not allowed. - receipt of a sars-cov-2 vaccination prior to study entry. - known allergy/sensitivity or any hypersensitivity to components of hcq, azithromycin, or their formulation. - more than 10 days of any of the following symptoms attributed to the sars-cov-2 infection at study entry: - fever (can be subjective) or feeling feverish - cough - shortness of breath or difficulty breathing at rest or with exertion - sore throat - body pain or muscle pain - fatigue - headache - chills - nasal obstruction or congestion - loss of taste or smell - nausea or vomiting - diarrhea

2

National Institute of Allergy and Infectious Diseases (NIAID)

18

None

United States

No restriction on type of patients

0: No restriction on type of patients

20

Number of Participants Who Died From Any Cause or Were Hospitalized

None

Phase 2

[{"arm_notes": "", "treatment_id": 1534, "treatment_name": "Azithromycin+hydroxychloroquine", "treatment_type": "Antibiotics+antimalarials", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]