Inhaled Ciclesonide for Outpatients With COVID19 (CONTAIN)

McGill University

Status and phase: Terminated; Phase 3; Phase 2

Conditions: COVID 19

Treatments: Drug: Ciclesonide nasal; Drug: Ciclesonide; Drug: Normal Saline intranasal and placebo inhaler

Study type: Interventional

Funder types: Other

Identifiers

NCT04435795

2021-6696

Details and patient eligibility

About

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.

Enrollment: 215 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Triple Blind

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215 participants in 2 patient groups, including a placebo group

Ciclesonide inhaled and nasal

Active Comparator group

Description:

Intranasal ciclesonide BID 50mcg BID to each nostril and inhaled ciclesonide 600mcg BID x 14 days

Treatment:

Drug: Ciclesonide

Drug: Ciclesonide nasal

Placebo

Placebo Comparator group

Description:

Normal Saline intranasal BID and Placebo 3 puff MDI inhaled BID

Treatment:

Drug: Normal Saline intranasal and placebo inhaler