COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT04377711

Covis Pharma S.à.r.l.

Dr Clemency, bc34@buffalo.edu (PI email not reported)

2020-05-06

Completed

RCT

Randomized

Parallel

Blind label

single-center

Treatment

inclusion criteria patients eligible for enrollment in the study must meet all the following criteria: male and female adults and adolescents (12 years of age and above). positive sars-cov-2 rapid molecular diagnostic test within 72 hours prior to enrollment. patient is not currently hospitalized or under immediate consideration for hospitalization at the time of enrollment. patient is currently experiencing symptoms of fever, cough, and/or dyspnea. patient has an oxygen saturation level greater than 93%. ability to show adequate use of mdi, including inhalation technique. patient, parent/legal guardian, or legally-authorized representative must have signed a written informed consent before administration of any study-specific procedures. exclusion criteria patients meeting any of the following criteria are not eligible for participation in the study: existence of any life-threatening co-morbidity or any other medical condition which, in the opinion of the investigator, makes the patient unsuitable for inclusion. history of hypersensitivity to ciclesonide. treatment with inhaled or intranasal corticosteroids within 14 days of the screening/ enrollment/randomization visit. treatment with oral corticosteroids within 90 days of the screening/enrollment/randomization visit. participation in any other clinical trial or use of any investigational agent within 30 days of the screening/enrollment/randomization visit. currently receiving treatment with hydroxychloroquine/chloroquine. patients with cystic fibrosis. patients with idiopathic pulmonary fibrosis.

None

2

Covis Pharma S.à.r.l.

12

100

United States

Mild disease at enrollment

1: Mild disease at enrollment

400

Time to alleviation of COVID-19-related symptoms by Day 30

None

Phase 3

[{"arm_notes": "", "treatment_id": 282, "treatment_name": "Ciclesonide", "treatment_type": "Corticosteroids", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]