Inhaled Ciclesonide for Outpatients With COVID19

NCT04435795 | Terminated Phase 2 Results

• 1 other identifier: 2021-6696
• Study Type: interventional
• Target: 215
• Locations: 1 country
• Sites: 3

Brief Summary

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.

Conditions

COVID 19

Outcome Measures

Primary Outcomes (1)

• 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

  day 7

Secondary Outcomes (7)

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

  Day 14

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

  Day 7

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

  Day 14

• Improvement in Dyspnea: Resolution of Dyspnea at Day 7

  day 7

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

  day 7

Study Arms (2)

Ciclesonide inhaled and nasal

ACTIVE COMPARATOR

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

Drug: Ciclesonide; Drug: Ciclesonide nasal

Placebo

PLACEBO COMPARATOR

Normal Saline intranasal BID and Placebo 3 puff MDI inhaled BID

Drug: Normal Saline intranasal and placebo inhaler

Interventions

Normal Saline intranasal and placebo inhaler DRUG

Normal Saline intranasal BID and Placebo 3 puff MDI inhaled BID

Placebo

Ciclesonide DRUG

Ciclesonide 600mcg BID inhaled with aero chamber

Also known as: Alvesco

Ciclesonide inhaled and nasal

Ciclesonide nasal DRUG

intranasal ciclesonide 200 mcg DIE

Also known as: Omnaris

Ciclesonide inhaled and nasal

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• McGill University Health Centre/Research Institute of the McGill University Health Centre: lead

Study Sites (3)

University of British Columbia

Vancouver, British Columbia, Canada

Location

Sunnybrook Hospital

Toronto, Ontario, M4N 3M5, Canada

Location

McGill University Health Center

Montreal, Quebec, H3K 2M2, Canada

Location

Related Publications (1)

• Ezer N, Belga S, Daneman N, Chan A, Smith BM, Daniels SA, Moran K, Besson C, Smyth LY, Bartlett SJ, Benedetti A, Martin JG, Lee TC, McDonald EG. Inhaled and intranasal ciclesonide for the treatment of covid-19 in adult outpatients: CONTAIN phase II randomised controlled trial. BMJ. 2021 Nov 2;375:e068060. doi: 10.1136/bmj-2021-068060.

  PMID: 34728476 DERIVED

Related Links

• Trial website

MeSH Terms

Conditions

COVID-19

Interventions

ciclesonide

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Limitations and Caveats

We were unable to recruit the intended sample size given a rapid decline in cases of covid-19 in Canada following increases in vaccination. In addition, we did not enrich the study population for older high risk people and cannot exclude a possible benefit in earlier symptom resolution and prevention of clinical deterioration in this group. As our trial was stopped prematurely, we might have been underpowered to show a small benefit of ciclesonide on early symptom resolution

Results Point of Contact

• Title: Dr Nicole EZER
• Organization: Research Institute of the McGill University Health Center

nicole.ezer@mcgill.ca

514-934-1934

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Medicine

Study Record Dates

• First Submitted: June 16, 2020
• First Posted: June 17, 2020
• Study Start: September 15, 2020
• Primary Completion: June 8, 2021
• Study Completion: July 8, 2021
• Last Updated: June 10, 2022
• Results First Posted: April 29, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

CA (3)