Other substances

Ciclesonide

Pharmaceutical and therapeutic agent

Phase of research

Potential treatment - pre-clinical evidence

How it helps

Antiviral

Drug status

Used to treat other disease

Supporting references

Contradictory references

AI-suggested references

Clinical trials

Marketed as

Alvesco

Supporting references

Link	Tested on	Impact factor	Notes	Publication date
Screening of FDA-approved drugs using a MERS-CoV clinical isolate from South Korea identifies potential therapeutic options for COVID-19 Preprint Screening	VERO cells			Mar/19/2020
The inhaled corticosteroid ciclesonide blocks coronavirus RNA replication by targeting viral NSP15 Preprint	VERO E6 cell cultures			Mar/12/2020
Comparative analysis of antiviral efficacy of FDA-approved drugs against SARS-CoV-2 in human lung cells: Nafamostat is the most potent antiviral drug candidate Preprint	Calu-3 human airway epithelial cells		higher IC50 value in Calu-3 cells than VERO E6 cells	May/12/2020

AI-suggested references

Link	Publication date
Exploring potential inhibitor of SARS-CoV2 replicase from FDA approved drugs using insilico drug discovery methods.	Jan/25/2021
Identification of Antiviral Drug Candidates against SARS-CoV-2 from FDA-Approved Drugs	Jun/24/2021
Prolonged presence of SARS-CoV-2 in a COVID-19 case with rheumatoid arthritis taking iguratimod treated with ciclesonide	Apr/07/2022
Development of ciclesonide analogues that block SARS-CoV-2 RNA replication.	Apr/20/2021
Ciclesonide activates glucocorticoid signaling in neonatal rat lung but does not trigger adverse effects in the cortex and cerebellum.	Jun/11/2021
PAK1-blockers: Potential Therapeutics against COVID-19	Aug/11/2021
Tocilizumab and PMX-DHP have efficacy for severe COVID-19 pneumonia.	Feb/01/2021
The Inhaled Steroid Ciclesonide Blocks SARS-CoV-2 RNA Replication by Targeting the Viral Replication-Transcription Complex in Cultured Cells	Dec/09/2020
Major ongoing clinical trials for COVID-19 treatment and studies currently being conducted or scheduled in Japan.	Apr/30/2020
The peripheral lymphocyte count as a predictor of severe COVID-19 and the effect of treatment with ciclesonide	Sep/17/2020
Transcriptome network analyses in human coronavirus infections suggest a rational use of immunomodulatory drugs for COVID-19 therapy	Jan/20/2021
Efficacy and Safety of Inhaled Ciclesonide in Treating Patients With Asymptomatic or Mild COVID-19 in the RACCO Trial: Protocol for a Multicenter, Open-label, Randomized Controlled Trial	Oct/06/2020
COVID-19 pneumonia suspected to be co-infection with Mycoplasma pneumoniae and improved by early administration of favipiravir and ciclesonide.	Aug/03/2021
Inhaled and intranasal ciclesonide for the treatment of covid-19 in adult outpatients: CONTAIN phase II randomised controlled trial	Jan/21/2022
Triple therapy with hydroxychloroquine, azithromycin, and ciclesonide for COVID-19 pneumonia.	Oct/05/2020
Ciclesonide Inhaler Treatment for Mild-to-Moderate COVID-19: A Randomized, Open-Label, Phase 2 Trial.	Aug/12/2021
Efficacy of Inhaled Ciclesonide for Outpatient Treatment of Adolescents and Adults With Symptomatic COVID-19: A Randomized Clinical Trial.	Nov/22/2022
Inhaled ciclesonide for outpatient treatment of COVID-19 in adults at risk of adverse outcomes: a randomised controlled trial (COVERAGE)	May/06/2020
Revisiting activity of some glucocorticoids as a potential inhibitor of SARS-CoV-2 main protease: theoretical study.	Mar/09/2021

Clinical trials

ID	Title	Status	Phase	Start date	Completion date
NCT04377711	A Study of the Safety and Efficacy of Ciclesonide in the Treatment of Non-hospitalized COVID-19 Patients	Completed	Phase 3	Jun/08/2020	Jan/05/2021
Alternative id - ALV-020-001 Interventions - Drug: Ciclesonide\|Drug: Placebo Study type - Interventional Study results - Has Results Locations - University of Buffalo, Buffalo, New York, United States Study designs - Allocation: Randomized\|Intervention Model: Parallel Assignment\|Masking: Double (Participant, Investigator)\|Primary Purpose: Treatment Enrollment - 400 Age - 12 Years to 100 Years (Child, Adult, Older Adult) Outcome measures - Time to Alleviation of COVID-19-related Symptoms by Day 30\|Percentage of Patients With Hospital Admission or Death by Day 30\|All-cause Mortality by Day 30\|COVID-19-related Mortality by Day 30\|Percentage of Patients With Subsequent Emergency Department Visit or Hospital Admission for Reasons Attributable to COVID-19 by Day 30\|Percentage of Patients With Alleviation of COVID-19-related Symptoms Defined as Symptom-free for a Continuous Period of More Than 24 Hours (ie, Later Than 3 AM/PM Assessments) by Day 7, by Day 14, and by Day 30
NCT04870333	PROphylaxis for paTiEnts at Risk of COVID-19 infecTion -V	Recruiting	Phase 2\|Phase 3	Feb/19/2021	Oct/01/2024
Alternative id - CCTU0307\|2020-004144-28 Interventions - Drug: Niclosamide\|Drug: Placebo\|Drug: Ciclesonide\|Drug: Sotrovimab Study type - Interventional Study results - No Results Available Locations - Cambridge University Hospitals NHS Foundation Trust, Cambridge, Cambridgeshire, United Kingdom\|University Hospitals Birmingham NHS Foundation Trust, Birmingham, United Kingdom\|Betsi Cadwaladr University Health Board, Bodelwyddan, United Kingdom\|Brighton and Sussex University Hospitals NHS Trust, Brighton, United Kingdom\|North Bristol NHS Trust, Bristol, United Kingdom\|East Kent Hospitals University NHS Foundation Trust, Canterbury, United Kingdom\|Cardiff & Vale University Health Board, Cardiff, United Kingdom\|Epsom and St Helier University Hospitals NHS Trust, Carshalton, United Kingdom\|Ayrshire & Arran NHS Trust, Crosshouse, United Kingdom\|Dartford and Gravesham NHS Trust, Dartford, United Kingdom\|University Hospitals of Derby and Burton NHS Trust, Derby, United Kingdom\|Dorset County Hospital NHS Foundation Trust, Dorchester, United Kingdom\|NHS Tayside, Dundee, United Kingdom\|The Royal Devon and Exeter NHS Foundation Trust, Exeter, United Kingdom\|James Paget University Hospital NHS Foundation Trust, Great Yarmouth, United Kingdom\|Hull University Teaching Hospitals NHS Trust, Hull, United Kingdom\|Queen Elizabeth Hospital, King's Lynn, NHS Foundation Trust, King's Lynn, United Kingdom\|University Hospitals of Leicester NHS Trust, Leicester, United Kingdom\|Royal Liverpool and Broadgreen University Hospitals NHS Trust, Liverpool, United Kingdom\|Barts Health NHS Trust, London, United Kingdom\|Guy's and St Thomas' NHS Foundation Trust, London, United Kingdom\|Imperial College Healthcare NHS Trust, London, United Kingdom\|King's College Hospital NHS Foundation Trust, London, United Kingdom\|Royal Free NHS Foundation Trust, London, United Kingdom\|St George's University Hospitals NHS Foundation Trust, London, United Kingdom\|Nottingham University Hospitals NHS Trust, Nottingham, United Kingdom\|Oxford University Hospitals NHS Foundation Trust, Oxford, United Kingdom\|Royal Berkshire NHS Foundation, Reading, United Kingdom\|Salford Royal NHS Foundation, Salford, United Kingdom\|Sheffield Teaching Hospitals NHS Foundation Trust, Sheffield, United Kingdom\|East and North Hertfordshire NHS Trust, Stevenage, United Kingdom\|South Tyneside and Sunderland NHS Foundation Trust, Sunderland, United Kingdom\|Wirral University Teaching Hospital NHS Foundation Trust, Wirral, United Kingdom\|The Royal Wolverhampton NHS Trust, Wolverhampton, United Kingdom\|York Teaching Hospital NHS Foundation Trust, York, United Kingdom Study designs - Allocation: Randomized\|Intervention Model: Parallel Assignment\|Masking: Triple (Participant, Care Provider, Investigator)\|Primary Purpose: Prevention Enrollment - 5000 Age - 18 Years and older (Adult, Older Adult) Outcome measures - Confirmed symptomatic COVID-19 infection during treatment\|Time to confirmed SARS-Cov-2 infection from the date of randomisation including asymptomatic cases\|Safety\|All-cause mortality\|Severity of COVID-19 disease
NCT04381364	Inhalation of Ciclesonide for Patients With COVID-19: A Randomised Open Treatment Study (HALT COVID-19)	Active, not recruiting	Phase 2	May/29/2020	Jan/31/2022
Alternative id - 2020-02183 Interventions - Drug: Ciclesonide Inhalation Aerosol Study type - Interventional Study results - No Results Available Locations - Södra Älvsborg hospital, Borås, Sweden\|Danderyd Hospital, Danderyd, Sweden\|Halmstad hospital, Halmstad, Sweden\|Karlskoga Hospital, Karlskoga, Sweden\|Capio S:t Görans Hospital, Stockholm, Sweden\|Karolinska University Hospital Huddinge, Stockholm, Sweden\|Visby Hospital, Visby, Sweden\|Västmanland County Hospital Västerås, Västerås, Sweden\|Växsjö Hospital, Växjö, Sweden\|Örebro University Hospital, Örebro, Sweden\|Östersund hospital, Östersund, Sweden Study designs - Allocation: Randomized\|Intervention Model: Parallel Assignment\|Masking: None (Open Label)\|Primary Purpose: Treatment Enrollment - 98 Age - 18 Years and older (Adult, Older Adult) Outcome measures - Duration of received supplemental oxygen therapy\|Invasive mechanical ventilation or all-cause death (key secondary outcome)\|All cause death\|Invasive mechanical ventilation\|Remaining dyspnea symptoms\|Need for intensive care\|Proportion of discharged from the hospital to their home or a nursery home
NCT04330586	A Trial of Ciclesonide in Adults With Mild-to-moderate COVID-19	Completed	Phase 2	Apr/01/2020	Mar/31/2021
Alternative id - KUMC-COVID-19 Interventions - Drug: Ciclesonide Metered Dose Inhaler [Alvesco] Study type - Interventional Study results - No Results Available Locations - Korea University Guro Hospital, Seoul, Korea, Republic of Study designs - Allocation: Randomized\|Intervention Model: Parallel Assignment\|Masking: None (Open Label)\|Primary Purpose: Treatment Enrollment - 68 Age - 19 Years to 80 Years (Adult, Older Adult) Outcome measures - Rate of SARS-CoV-2 eradication at day 14 from study enrollment\|Rate of SARS-CoV-2 eradication at day 7 from study enrollment\|Time to SARS-CoV-2 eradication (days)\|Viral load area-under-the-curve (AUC) reduction versus control\|Time to clinical improvement (days)\|Proportion of clinical failure
NCT04435795	Inhaled Ciclesonide for Outpatients With COVID19	Terminated	Phase 2\|Phase 3	Sep/14/2020	Jul/08/2021
Alternative id - 2021-6696 Interventions - Drug: Normal Saline intranasal and placebo inhaler\|Drug: Ciclesonide\|Drug: Ciclesonide nasal Study type - Interventional Study results - No Results Available Locations - University of British Columbia, Vancouver, British Columbia, Canada\|Sunnybrook Hospital, Toronto, Ontario, Canada\|McGill University Health Center, Montreal, Quebec, Canada Study designs - Allocation: Randomized\|Intervention Model: Factorial Assignment\|Masking: Triple (Participant, Care Provider, Investigator)\|Primary Purpose: Treatment Enrollment - 215 Age - 18 Years and older (Adult, Older Adult) Outcome measures - Proportion of participants with no symptoms of cough, fever or dyspnea\|Overall feeling\|Improvement in dyspnea\|Visual Analog scale for Cough\|Hospitalization for SARS-CoV-2\|Changes in Promis dyspnea characteristics scale\|Change in dyspnea severity Promis scale\|Incidence of new oxygen use\|Mortality\|Anxiety\|Sleep Disturbance
NCT04356495	Trial of COVID-19 Outpatient Treatment in Individuals With Risk Factors for Aggravation	Completed	Phase 2\|Phase 3	Jul/29/2020	Oct/22/2021
Alternative id - CHUBX 2020/12 Interventions - Dietary Supplement: Vitamins\|Drug: Telmisartan\|Drug: Ciclesonide\|Drug: interferon β-1b Study type - Interventional Study results - No Results Available Locations - Bordeaux university Hospital, Bordeaux, France\|CHU de Dijon-Bourgogne, Dijon, France\|CHU de Montpellier, Montpellier, France\|CHRU de Nancy, Nancy, France\|Groupe hospitalier Paris Saint Joseph, Paris, France\|CNGE, Paris, France\|CHU de Toulouse, Toulouse, France Study designs - Allocation: Randomized\|Intervention Model: Parallel Assignment\|Masking: None (Open Label)\|Primary Purpose: Treatment Enrollment - 412 Age - 50 Years and older (Adult, Older Adult) Outcome measures - Pilot Phase: Proportion of participants who had a Grade 3 or 4 adverse event\|Efficacy phase: Death\|Efficacy phase: oxygen therapy\|Efficacy phase: hospitalization\|Proportion of hospitalizations, overall and by cause, in each group\|Death and causes of death\|Proportion of intensive care hospitalizations, overall and by cause, in each group\|Proportion of participants with negative SARS-CoV-2 RT-PCR\|Haematological markers evolution\|Inflammatory markers evolution\|Adverse events\|Adverse reactions\|Acceptability of the treatment\|Antibiotic consumption\|Oxygen saturation worsening\|protocol follow-up