COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT04358081

Novartis Pharmaceuticals

novartis.email@novartis.com

2020-04-22

Completed

RCT

Randomized

Parallel

Blind label

multi-center

Treatment

inclusion criteria: informed consent must be obtained prior to participation in the study adult patient ≥ 18 years old severe acute respiratory syndrome coronavirus (sars-cov)-2 infection confirmed by polymerase chain reaction (pcr) test from respiratory tract specimen (e.g nasopharyngeal swab) onset of signs and symptoms of covid19 illness ≤ 7 days prior to randomization (including but not limited to fever, cough, myalgias, fatigue, abnormal chest imaging) currently hospitalized or requiring hospitalization due to covid-19 disease

use of other investigational drugs or newly approved covid-19 treatments within 5-half lives or 30 days of enrolment history of hypersensitivity to any of the study treatments or its excipients or to drugs of similar chemical classes participation in any other clinical trial of an experimental treatment for covid-19 expectation of concurrent treatment with any other agents or potential direct acting antiviral activity against sars-co v-2 during study drug dosing requires, in the judgement of the investigator, admission to the intensive care unit (icu) or mechanical ventilatory support (invasive or non-invasive) prior to first dose of study drug (there might be a patient who cannot be admitted to the icu, even if the patient's condition is severe enough, due to administrative reasons under the current circumstances. this case is also considered under admission to the icu judged by the investigator) evidence of cytokine storm syndrome or multi-organ system failure confirmed co-infection with influenza creatinine clearance < 45 ml/min or requiring acute renal replacement therapy history or current diagnosis of ecg abnormalities indicating significant risk of safety for participants participating in the study any other condition which in the opinion of the investigator, would put the safety of the participant at risk, impede compliance or hinder completion of the study pregnant or nursing (lactating) women women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they agree to use basic methods of contraception during dosing of study treatment.

3

Novartis Pharmaceuticals

18

None

United States

Moderate/severe disease at enrollment

4: Moderate/severe disease at enrollment

20

Number of Participants Who Achieved Clinical Response by Day 15

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": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]