Inhaled Ciclesonide for Outpatients With COVID19

Phase 3TerminatedNCT04435795

McGill University Health Centre/Research Institute of the McGill University Health Centre215 enrolled

Overview

The CONTAIN (CiclesOnide cliNical TriAl covId-19 treatmeNt) is a randomized control study of ciclesonide vs placebo for mild covid-19 disease. The need for potential therapy for COVID-19 patients is urgent. Ciclesonide has shown encouraging in vitro results, is easy to be used and is readily available. It has a low rate of side effects and few interactions with other drugs. It is unusual to use an inhaled steroid drug for COVID-19 but there has been new data suggesting steroids may have an antiviral effect in addition to an anti-inflammatory effect. Investigators propose to use inhaled and nasal ciclesonide to stop viral replication in the nose and airways. Investigators hope this will accelerate recovery from COVID-19 illness in individuals who are not admitted to hospital at time of diagnosis of COVID-19.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

215

Conditions

COVID 19

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: Symptomatic adult patients positive by PCR for COVID-19 within 5 days of enrollment with fever, cough, or shortness of breath. Provision of Informed Consent At day 0, patients should be at home Exclusion Criteria: * Already on inhaled corticosteroid medication * Currently using systemic steroids (oral or intravenous or intramuscular such as Prednisone) or use of steroids 7 days prior to enrolment * Severely ill patients at enrollment (i.e., admitted to ICU at admission) * Unable to self-administer the inhaler * Known or suspected pregnancy and breastfeeding * Known allergy to study medication or its components (non-medicinal ingredients; including lactose allergy (type I)) * Patients with untreated fungal, bacterial, or tubercular infections of the respiratory tract * Current hospitalization * Current use of oxygen at home or in the hospital

Locations (3)

University of British Columbia

Vancouver, British Columbia, Canada

Sunnybrook Hospital

Toronto, Ontario, Canada

McGill University Health Center

Montreal, Quebec, Canada

Outcomes

Primary Outcomes

Proportion of Participants With no Symptoms of Cough, Fever or Dyspnea

Proportion of participants with no symptoms of cough, fever or dyspnea at day 7

Time frame: day 7

Secondary Outcomes

Proportion of Participants With no Symptoms of Cough, Fever or Dyspnea

Proportion of participants with no symptoms of cough, fever or dyspnea at Day 14

Time frame: Day 14

Overall Feeling: Proportion Who Are Reporting That They Are "Very Much Improved" or "Much Improved" at Day 7

Proportion who are reporting that they are "very much improved" or "much improved"

Time frame: Day 7

Overall Feeling: Proportion Who Are Reporting That They Are "Very Much Improved" or "Much Improved" at Day 14

Proportion who are reporting that they are "very much improved" or "much improved"

Time frame: Day 14

Improvement in Dyspnea: Resolution of Dyspnea at Day 7

Dyspnea was defined as reporting "shortness of breath" or "chest congestion" or "chest tightness". In those who reported dyspnea at baseline, resolution will be defined as having no symptoms in these three areas.

Time frame: day 7

Improvement in Cough at Day 7: Proportion of Patient With a Reduction of Cough Symptoms at Day 7

Improvement of wet or dry cough. Analysis limited to patients who reported cough at baseline. Defined as a 2 point decrease, or a decrease to 0 on a visual analogue scale that ranged from 0 for no symptoms to 10 for severe symptoms

Time frame: day 7

Proportion of Participants Hospitalized for SARS-CoV-2

Hospitalization for SARS-CoV-2 related illness

Time frame: day 14

Mortality

All cause mortality

Time frame: day 29