Coronavirus InfectionPhase 4NCT04355637
Inhaled Corticosteroid Treatment of COVID19 Patients With Pneumonia
A Phase 4 study testing Inhaled budesonide in people with Coronavirus Infection, run by Sara Varea at 14 sites in 2 countries.
Trial summary
Randomized, prospective, controlled open label clinical trial aimed at investigating if the addition of inhaled corticosteroids (budesonide) reduces treatment failure (defined as a composite variable by the initiation of treatment with high flow-O2 therapy, non-invasive or invasive ventilation, systemic steroids, use… Read more about this study
- Who is it for?
- Ages 18 to 79 years
- Conditions the study is for
- Coronavirus Infection
- What is being tested?
- Inhaled budesonide
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 14 sitesin 2 countries
- Study dates
- 21 Apr 2020to 30 Jun 2021
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- COVID19 positive
- hospitalized because of pneumonia (status #3 - #4 World Health Organization (WHO) scale)
- without contraindications to receive study treatment
- informed consent
Who cannot join
- receiving corticoids (inhaled or systemic)
- receiving anti Interleukin-1 (IL-1) or anti-IL-6 drugs
- receiving high flow oxygen therapy
- receiving mechanical ventilation
- pregnancy
- participating in another intervention trial for COVID19
Trial locations and contacts
14 sites in 2 countries.
14 sites in 2 countries
Argentina7 sites
Hospital de Infecciosas "Francisco Javier Muñiz"
Ciudad Autonoma de Buenos Aires, Buenos Aires, C1282AEN
CEMIC (Centro de Educación Médica e Investigaciones Clínicas "Norberto Quirno")
Ciudad Autonoma de Buenos Aires, Buenos Aires, C1425DQK
Hospital de Rehabilitación Respiratoria "María Ferrer"
Ciudad Autónoma de Buenos Aires, Buenos Aires, C1272AAA
Hospital Donación "Francisco Santojanni"
Ciudad Autónoma de Buenos Aires, Buenos Aires, C1408INH
Hospital San Juan de Dios
La Plata, B1900
Clínica Monte Grande
Monte Grande, Buenos Aires, B1842
Hospital Centro de Salud Zenón J. Santillán
San Miguel de Tucumán, Tucumán Province, T4000
Spain7 sites
Hospital Universitari Germans Trias i Pujol
Badalona, Barcelona, 08916
Hospital del Mar
Barcelona, 08003
Hospital Universitari Vall d'Hebron
Barcelona, 08035
Hospital Clinic of Barcelona
Barcelona, 08036
Hospital de la Santa Creu i Sant Pau
Barcelona, 08041
Hospital Universitari de Bellvitge
L'Hospitalet de Llobregat, Barcelona, 08907
Hospital de Santiago
Santiago de Compostela, A Coruña, 15706
About this study
Official title: Treatment With Inhaled Corticosteroids in Patients Hospitalized Because of COVID19 Pneumonia
Randomized, prospective, controlled open label clinical trial aimed at investigating if the addition of inhaled corticosteroids (budesonide) reduces treatment failure (defined as a composite variable by the initiation of treatment with high flow-O2 therapy, non-invasive or invasive ventilation, systemic steroids, use of biologics (anti IL-6 or anti IL-1) and/or death) according to hospital standard of care guidance) at day 15 after initiation of therapeutic intervention.
- Conditions
- Coronavirus Infection
- Being tested
- Inhaled budesonide
- Medical subject headings
- Coronavirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Inhaled budesonideDrug
adding budesonide to standard of care for pneumonia in COVID19 positive patients
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | patients receiving standard of care to treat their pneumonia |
| Intervention | Experimental | patients receiving standard of care to treat their pneumonia + inhaled budesonide Receives: Drug: Inhaled budesonide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients in both arms fulfilling the criteria for treatment failure
composite variable that includes the initiation of treatment with high flow-O2 therapy, non-invasive or invasive ventilation and/or death) at day 15 after initiation of therapeutic intervention
Measured: 15 days after treatment
Secondary outcomes (8)
ICU admission
Yes/no
Measured: baseline, day 3, day 7, day 15, day 30
ICU refusal
yes/no and reason
Measured: baseline, day3, day 7, day 15, day 30
Occurrence of complications
infectious cardiovascular and /or metabolic complications as well as variation in the 7 point WHO scale.
Measured: baseline, day3, day 7, day 15, day 30
lactate dehydrogenase (LDH)
U/L
Measured: at baseline, day 3, day 7, day 15, day 30
C Reactive Protein (CRP)
mg/dL
Measured: at baseline, day 3, day 7, day 15, day 30
ferritin
ng/mL
Measured: at baseline, day 3, day 7, day 15, day 30
D-dimer
ng/mL
Measured: at baseline, day 3, day 7, day 15, day 30
leukocyte counts
x10^9/L
Measured: at baseline, day 3, day 7, day 15, day 30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2020
- Study start21 Apr 2020
- Primary completion30 Jun 2021
- Study completion30 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Coronavirus InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sara Varea
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Sara Varea, Fundacion Clinic per a la Recerca Biomédica
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04355637
- Sponsor's protocol ID
- TACTIC-COVID
- Other IDs
- 2020-001616-18
- Status last verified
- Sep 2021
- First submitted
- 15 Apr 2020
- Last updated
- 22 Sep 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Agusti A, De Stefano G, Levi A, Munoz X, Romero-Mesones C, Sibila O, Lopez-Giraldo A, Plaza Moral V, Curto E, Echazarreta AL, Marquez SE, Pascual-Guardia S, Santos S, Marin A, Valdes L, Saldarini F, Salgado C, Casanovas G, Varea S, Rios J, Faner R. Add-on inhaled budesonide in the treatment of hospitalised patients with COVID-19: a randomised clinical trial. Eur Respir J. 2022 Mar 10;59(3):2103036. doi: 10.1183/13993003.03036-2021. Print 2022 Mar.
PubMed 35144989Agusti A, Torres F, Faner R. Early treatment with inhaled budesonide to prevent clinical deterioration in patients with COVID-19. Lancet Respir Med. 2021 Jul;9(7):682-683. doi: 10.1016/S2213-2600(21)00171-5. Epub 2021 Apr 9. No abstract available.
PubMed 33844998Farne H, Singanayagam A. Reply. J Allergy Clin Immunol. 2021 Mar;147(3):1117-1118. doi: 10.1016/j.jaci.2020.11.019. Epub 2020 Dec 30. No abstract available.
PubMed 33388170Nicolau DV, Bafadhel M. Inhaled corticosteroids in virus pandemics: a treatment for COVID-19? Lancet Respir Med. 2020 Sep;8(9):846-847. doi: 10.1016/S2213-2600(20)30314-3. Epub 2020 Jul 30. No abstract available.
PubMed 32738928
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment With Inhaled Corticosteroids in Patients Hospitalized Because of COVID19 Pneumonia
- ClinicalTrials.gov ID
- NCT04355637
- Acronym / sponsor ID
- TACTIC-COVID
- Conditions
- Coronavirus Infection
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Sara VareaUniversity, hospital or other
- Study start
- 21 Apr 2020 (actual)
- Primary completion
- 30 Jun 2021 (actual)
- Study completion
- 30 Jun 2021 (actual)
- First posted
- 21 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Randomized, prospective, controlled open label clinical trial aimed at investigating if the addition of inhaled corticosteroids (budesonide) reduces treatment failure (defined as a composite variable by the initiation of treatment with high flow-O2 therapy, non-invasive or invasive ventilation, systemic steroids, use of biologics (anti IL-6 or anti IL-1) and/or death) according to hospital standard of care guidance) at day 15 after initiation of therapeutic intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –patients receiving standard of care to treat their pneumonia |
| Intervention | Experimental | Drug: Inhaled budesonidepatients receiving standard of care to treat their pneumonia + inhaled budesonide |
Who may qualify
- Ages
- 18 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- COVID19 positive
- hospitalized because of pneumonia (status #3 - #4 World Health Organization (WHO) scale)
- without contraindications to receive study treatment
- informed consent
Key exclusion criteria (6 listed)
- receiving corticoids (inhaled or systemic)
- receiving anti Interleukin-1 (IL-1) or anti-IL-6 drugs
- receiving high flow oxygen therapy
- receiving mechanical ventilation
- pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Inhaled budesonideadding budesonide to standard of care for pneumonia in COVID19 positive patients | Drug | Intervention |
Primary outcome
Proportion of patients in both arms fulfilling the criteria for treatment failure
Time frame: 15 days after treatment
composite variable that includes the initiation of treatment with high flow-O2 therapy, non-invasive or invasive ventilation and/or death) at day 15 after initiation of therapeutic intervention
8 secondary outcomes
ICU admission
Time frame: baseline, day 3, day 7, day 15, day 30
ICU refusal
Time frame: baseline, day3, day 7, day 15, day 30
Occurrence of complications
Time frame: baseline, day3, day 7, day 15, day 30
lactate dehydrogenase (LDH)
Time frame: at baseline, day 3, day 7, day 15, day 30
C Reactive Protein (CRP)
Time frame: at baseline, day 3, day 7, day 15, day 30
ferritin
Time frame: at baseline, day 3, day 7, day 15, day 30
D-dimer
Time frame: at baseline, day 3, day 7, day 15, day 30
leukocyte counts
Time frame: at baseline, day 3, day 7, day 15, day 30
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2021.
- Derived from this study: PubMed 35144989Agusti A, De Stefano G, Levi A, Munoz X, Romero-Mesones C, Sibila O, Lopez-Giraldo A, Plaza Moral V, Curto E, Echazarreta AL, Marquez SE, Pascual-Guardia S, Santos S, Marin A, Valdes L, Saldarini F, Salgado C, Casanovas G, Varea S, Rios J, Faner R. Add-on inhaled budesonide in the treatment of hospitalised patients with COVID-19: a randomised clinical trial. Eur Respir J. 2022 Mar 10;59(3):2103036. doi: 10.1183/13993003.03036-2021. Print 2022 Mar.
- Derived from this study: PubMed 33844998Agusti A, Torres F, Faner R. Early treatment with inhaled budesonide to prevent clinical deterioration in patients with COVID-19. Lancet Respir Med. 2021 Jul;9(7):682-683. doi: 10.1016/S2213-2600(21)00171-5. Epub 2021 Apr 9. No abstract available.
- Derived from this study: PubMed 33388170Farne H, Singanayagam A. Reply. J Allergy Clin Immunol. 2021 Mar;147(3):1117-1118. doi: 10.1016/j.jaci.2020.11.019. Epub 2020 Dec 30. No abstract available.
- Derived from this study: PubMed 32738928Nicolau DV, Bafadhel M. Inhaled corticosteroids in virus pandemics: a treatment for COVID-19? Lancet Respir Med. 2020 Sep;8(9):846-847. doi: 10.1016/S2213-2600(20)30314-3. Epub 2020 Jul 30. No abstract available.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
14 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Inhaled budesonide in people with Coronavirus Infection, run by Sara Varea at 14 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in Argentina, Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients in both arms fulfilling the criteria for treatment failure (time frame: 15 days after treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04355637, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2021.