Covid19Phase 2/3NCT04492358
Treatment for Moderate/Severe COVID-19 in a Fragile and Vulnerable Population, Admitted to a Geriatric Hospital Unit or in a Transicional Care Center
A Phase 2/3 study testing Colchicine and Prednisone tablet in people with Covid19, run by Maria Joyera Rodríguez at 3 sites in Spain.
Trial summary
Study to compare the efficacy and safety of colchicine and glucocorticoids compared with the standard of treatment for moderate/severe COVID-19 in a fragile and vulnerable population, admitted to a geriatric hospital unit or in a transicional care center Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Covid19
- What is being tested?
- Colchicine and Prednisone tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 3 sitesSpain
- Study dates
- 22 Oct 2020to 31 May 2021
- Phase
- Phase 2/3
- 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Be at least 65 years old and be admitted to the Geriatrics Unit of the Internal Medicine Service (Hospital Clínic de Barcelona) or to a transicional care center
- Clinical diagnosis compatible with COVID-19 (in a favourable epidemiological context), with a disease considered moderate (grade 3-4) or severe (grade 5) according to the WHO 8-point ordinal scale for assessing clinical severity (https://www.who.int/publications/i/item/covid-19-therapeutic-trial-synopsis). This same scale will also be used to evaluate the evolution after the application of the corresponding treatment. Baseline clinical parameters will include the presentation of fever and any respiratory symptoms, both of upper respiratory tract and dyspnea, affecting the general state or gastrointestinal manifestations, since it is known that in elderly people the COVID-19 can present with atypical symptoms for a time that is difficult to determine, but it also tends to evolve to respiratory failure quickly and is associated with high mortality. For this reason, regardless of the time that has elapsed since the estimated onset of symptoms, patients with moderate - WHO grade 3, in whom the presence of fever, mild dyspnea or any gastrointestinal manifestation attributable to COVID-19 make an admission (in the case of hospital) and directed treatment (in all cases) advisable, will be candidates for inclusion in the study. Patients with moderate disease and oxygen requirements (WHO grade 4) and patients with severe pneumonia, but who can be managed initially with high flow oxygen therapy (WHO grade 5) may also be included in the study. The clinical diagnosis may be supported by radiological changes (via chest radiography, if available) suggestive of bilateral (established or incipient) pneumonia. At the time of diagnosis, biomarkers will also be collected, in an analysis that will include increased levels of C-reactive protein [PCR] and/or ferritin and microbiological confirmation of SARS-CoV-2.
- Patients in whom the current clinical situation and the basal functional situation condition a prognosis that makes them consider a limited therapeutic ceiling, which includes the contraindication of applying more aggressive (e.g. non-invasive ventilation) or invasive measures (e.g. cardiopulmonary resuscitation or orotracheal intubation and mechanical ventilation), both in patients admitted to the Geriatric Unit (Hospital Clínic de Barcelona) and in those admitted to a transicional care center. The latter patients are also not considered for transfer to a third level hospital (according to the criteria of fragility, available on page 14 of the CatSalut action protocols (https://canalsalut.gencat.cat/web/.content/_A-Z/C/coronavirus-2019-ncov/material-divulgatiu/recull-protocol-pneumonia.pdf).
- Patient with a general condition that allows him/her to take the medication orally, without risk of bronchial aspiration.
- Acceptance by the patient or responsible family member to participate in the study (written consent).
Who cannot join
- The clinical situation of an advanced or terminal illness, according to the clinical judgment of the doctor in charge and as defined by the Spanish Society for Palliative Care (SECPAL), which describes it as an advanced illness in an evolutionary and irreversible phase with multiple symptoms, emotional impact, loss of autonomy, with very little or no capacity to respond to specific treatment and with a life expectancy limited to weeks or months, in a context of progressive fragility (http://envejecimiento.csic.es/documentos/documentos/navarro-cuidadospaliativos-01.pdf).
- Clinical status which is advanced and severe or in which the level of consciousness has deteriorated and the oral route of taking the medication is not safely tolerated (in the opinion of the doctor in charge)
- Taking any of the drugs in the trial (colchicine or prednisone) chronically or intermittently in the 7 days prior to study inclusion.
- Absolute contraindication to the use of the study medication, including hypersensitivity to the active substance or to any of its excipients, severe renal failure (glomerular filtration [GF] creatinine clearance or Clcr <30 ml/min) and patients undergoing haemodialysis, severe liver failure, severe gastrointestinal disorders, gastric ulcer or blood dyscrasias.
- Concomitant treatment with macrolides (clarithromycin, erythromycin, telithromycin), antifungals (itraconazole, ketoconazole), cyclosporine and antivirals (lopinavir/ritonavir, indinavir, nelfinavir, saquinavir), all potent inhibitors of CYP3A4 (key cytochrome in the colchicine metabolism pathway).
Trial locations and contacts
3 sites in 1 country.
Spain3 sites
Centre Blauclínic Dolors Aleu
Barcelona, 08023
Hospital Clinic, Department of Internal Medicine
Barcelona, 08036
Clinica Sant Antoni
Barcelona, 08038
About this study
Official title: Phase 2/3, Randomized, Open Study to Compare the Efficacy and Safety of Colchicine and Glucocorticoids Compared With the Standard of Treatment for Moderate/Severe COVID-19 in a Fragile and Vulnerable Population, Admitted to a Geriatric Hospital Unit or in a Transicional Care Center
Study to compare the efficacy and safety of colchicine and glucocorticoids compared with the standard of treatment for moderate/severe COVID-19 in a fragile and vulnerable population, admitted to a geriatric hospital unit or in a transicional care center
- Conditions
- Covid19
- Being tested
- Colchicine, Prednisone tablet, standard of care
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ColchicineDrug
Colchicine: ideal dose of 0.3 mg/kg/day (or the dose that approximates that adjusted for age, weight and kidney function, and 0.5 mg and 1 mg tablets)
Prednisone tabletDrug
Prednisone 60 mg/day, in a single dose, during 3 days
standard of careDrug
The standard treatment used in each site will be administered to the patients assigned to the control group.
| Study group | Role | What they receive |
|---|---|---|
| colchicine + prednisone | Experimental | Prednisone should be administered for 3 consecutive days (60 mg/d) together with colchicine (at doses of 0.5 to 1.5 mg/d, adjusted for weight and renal function) for 3 days and maintained for 14 days in total (0.5 mg/d). Receives: Drug: Colchicine; Drug: Prednisone tablet |
| Standard treatment | Active comparator | The standard treatment used in each site will be administered to the patients assigned to the control group. Receives: Drug: standard of care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients that a short cycle of steroids administered together with colchicine reduces mortality from COVID-19
Number of patients that a short cycle of steroids (with prednisone 60 mg/d, in a single dose, for 3 consecutive days) administered together with colchicine (at doses of 0.5 to 1.5 mg/d, adjusted for weight and renal function, for 3 days and maintenance of 0.5 mg/d for 14 days in total) reduces mortality from COVID-19 in this population by at least 20%, compared to the approved standard treatment at participating centers.
Measured: 28 days
Secondary outcomes (3)
Number and grade of adverse events at group of colchicine and glucocorticoids throughout the treatment and in the two weeks following treatment
Number and grade of adverse events at group of colchicine and glucocorticoids throughout the treatment and in the two weeks following treatment according to the incidence of:
- mild adverse event
- serious adverse events
- hypersensitivity (allergic) reactions of grade >=2
Measured: 28 days
Percentage of patients who stop medication due to adverse events.
Percentage of patients who stop medication due to adverse events.
Measured: 28 days
Severity of symptoms by COVID-19 in the two treatment arms
Severity of symptoms by COVID-19 in the two treatment arms (response to treatment to be assessed by overall survival at 28 days from the start of treatment).
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2020
- Study start22 Oct 2020
- Primary completion31 May 2021
- Study completion31 May 2021
Why it stopped: No candidates for the recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Covid19Studies 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maria Joyera Rodríguez
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Maria Joyera Rodríguez, Fundacion Clinic per a la Recerca Biomédica
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04492358
- Sponsor's protocol ID
- 2020-002462-14
- Status last verified
- Feb 2023
- First submitted
- 28 Jul 2020
- Last updated
- 21 Feb 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Hernandez-Rodriguez J, Duran-Sanclemente J, Prieto-Gonzalez S, Araujo O, Hospital-Vidal T, Casanovas G, Sapena V, Blanco JL, Lopez-Soto A; FRAGILE-COLCOVID19 Study Group. FRAGILE-COLCOVID19: A Clinical Trial Based on Early Administration of an Oral Combination of Colchicine and Prednisone in Elderly Patients with COVID-19 in Geriatric Facilities. Clin Drug Investig. 2022 Nov;42(11):949-964. doi: 10.1007/s40261-022-01201-2. Epub 2022 Sep 29.
PubMed 36173596
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 2/3, Randomized, Open Study to Compare the Efficacy and Safety of Colchicine and Glucocorticoids Compared With the Standard of Treatment for Moderate/Severe COVID-19 in a Fragile and Vulnerable Population, Admitted to a Geriatric Hospital Unit or in a Transicional Care Center
- ClinicalTrials.gov ID
- NCT04492358
- Acronym / sponsor ID
- 2020-002462-14
- Conditions
- Covid19
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: No candidates for the recruitment
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Maria Joyera RodríguezUniversity, hospital or other
- Study start
- 22 Oct 2020 (actual)
- Primary completion
- 31 May 2021 (actual)
- Study completion
- 31 May 2021 (actual)
- First posted
- 30 Jul 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.
Study to compare the efficacy and safety of colchicine and glucocorticoids compared with the standard of treatment for moderate/severe COVID-19 in a fragile and vulnerable population, admitted to a geriatric hospital unit or in a transicional care center
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| colchicine + prednisone | Experimental | Drug: Colchicine, Drug: Prednisone tabletPrednisone should be administered for 3 consecutive days (60 mg/d) together with colchicine (at doses of 0.5 to 1.5 mg/d, adjusted for weight and renal function) for 3 days and maintained for 14 days in total (0.5 mg/d). |
| Standard treatment | Active comparator | Drug: standard of careThe standard treatment used in each site will be administered to the patients assigned to the control group. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- Be at least 65 years old and be admitted to the Geriatrics Unit of the Internal Medicine Service (Hospital Clínic de Barcelona) or to a transicional care center
- Clinical diagnosis compatible with COVID-19 (in a favourable epidemiological context), with a disease considered moderate (grade 3-4) or severe (grade 5) according to the WHO 8-point ordinal scale for assessing clinical severity (https://www.who.int/publications/i/item/covid-19-therapeutic-trial-synopsis). This same scale will also be used to evaluate the evolution after the application of the corresponding treatment. Baseline clinical parameters will include the presentation of fever and any respiratory symptoms, both of upper respiratory tract and dyspnea, affecting the general state or gastrointestinal manifestations, since it is known that in elderly people the COVID-19 can present with atypical symptoms for a time that is difficult to determine, but it also tends to evolve to respiratory failure quickly and is associated with high mortality. For this reason, regardless of the time that has elapsed since the estimated onset of symptoms, patients with moderate - WHO grade 3, in whom the presence of fever, mild dyspnea or any gastrointestinal manifestation attributable to COVID-19 make an admission (in the case of hospital) and directed treatment (in all cases) advisable, will be candidates for inclusion in the study. Patients with moderate disease and oxygen requirements (WHO grade 4) and patients with severe pneumonia, but who can be managed initially with high flow oxygen therapy (WHO grade 5) may also be included in the study. The clinical diagnosis may be supported by radiological changes (via chest radiography, if available) suggestive of bilateral (established or incipient) pneumonia. At the time of diagnosis, biomarkers will also be collected, in an analysis that will include increased levels of C-reactive protein [PCR] and/or ferritin and microbiological confirmation of SARS-CoV-2.
- Patients in whom the current clinical situation and the basal functional situation condition a prognosis that makes them consider a limited therapeutic ceiling, which includes the contraindication of applying more aggressive (e.g. non-invasive ventilation) or invasive measures (e.g. cardiopulmonary resuscitation or orotracheal intubation and mechanical ventilation), both in patients admitted to the Geriatric Unit (Hospital Clínic de Barcelona) and in those admitted to a transicional care center. The latter patients are also not considered for transfer to a third level hospital (according to the criteria of fragility, available on page 14 of the CatSalut action protocols (https://canalsalut.gencat.cat/web/.content/_A-Z/C/coronavirus-2019-ncov/material-divulgatiu/recull-protocol-pneumonia.pdf).
- Patient with a general condition that allows him/her to take the medication orally, without risk of bronchial aspiration.
- Acceptance by the patient or responsible family member to participate in the study (written consent).
Key exclusion criteria (5 listed)
- The clinical situation of an advanced or terminal illness, according to the clinical judgment of the doctor in charge and as defined by the Spanish Society for Palliative Care (SECPAL), which describes it as an advanced illness in an evolutionary and irreversible phase with multiple symptoms, emotional impact, loss of autonomy, with very little or no capacity to respond to specific treatment and with a life expectancy limited to weeks or months, in a context of progressive fragility (http://envejecimiento.csic.es/documentos/documentos/navarro-cuidadospaliativos-01.pdf).
- Clinical status which is advanced and severe or in which the level of consciousness has deteriorated and the oral route of taking the medication is not safely tolerated (in the opinion of the doctor in charge)
- Taking any of the drugs in the trial (colchicine or prednisone) chronically or intermittently in the 7 days prior to study inclusion.
- Absolute contraindication to the use of the study medication, including hypersensitivity to the active substance or to any of its excipients, severe renal failure (glomerular filtration [GF] creatinine clearance or Clcr <30 ml/min) and patients undergoing haemodialysis, severe liver failure, severe gastrointestinal disorders, gastric ulcer or blood dyscrasias.
- Concomitant treatment with macrolides (clarithromycin, erythromycin, telithromycin), antifungals (itraconazole, ketoconazole), cyclosporine and antivirals (lopinavir/ritonavir, indinavir, nelfinavir, saquinavir), all potent inhibitors of CYP3A4 (key cytochrome in the colchicine metabolism pathway).
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 |
|---|---|---|
| ColchicineColchicine: ideal dose of 0.3 mg/kg/day (or the dose that approximates that adjusted for age, weight and kidney function, and 0.5 mg and 1 mg tablets) | Drug | colchicine + prednisone |
| Prednisone tabletPrednisone 60 mg/day, in a single dose, during 3 days | Drug | colchicine + prednisone |
| standard of careThe standard treatment used in each site will be administered to the patients assigned to the control group. | Drug | Standard treatment |
Primary outcome
Number of patients that a short cycle of steroids administered together with colchicine reduces mortality from COVID-19
Time frame: 28 days
Number of patients that a short cycle of steroids (with prednisone 60 mg/d, in a single dose, for 3 consecutive days) administered together with colchicine (at doses of 0.5 to 1.5 mg/d, adjusted for weight and renal function, for 3 days and maintenance of 0.5 mg/d for 14 days in total) reduces mortality from COVID-19 in this population by at least 20%, compared to the approved standard treatment at participating centers.
3 secondary outcomes
Number and grade of adverse events at group of colchicine and glucocorticoids throughout the treatment and in the two weeks following treatment
Time frame: 28 days
Percentage of patients who stop medication due to adverse events.
Time frame: 28 days
Severity of symptoms by COVID-19 in the two treatment arms
Time frame: 28 days
Results and safety
The study was stopped early (reason given: No candidates for the recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2023.
- Derived from this study: PubMed 36173596Hernandez-Rodriguez J, Duran-Sanclemente J, Prieto-Gonzalez S, Araujo O, Hospital-Vidal T, Casanovas G, Sapena V, Blanco JL, Lopez-Soto A; FRAGILE-COLCOVID19 Study Group. FRAGILE-COLCOVID19: A Clinical Trial Based on Early Administration of an Oral Combination of Colchicine and Prednisone in Elderly Patients with COVID-19 in Geriatric Facilities. Clin Drug Investig. 2022 Nov;42(11):949-964. doi: 10.1007/s40261-022-01201-2. Epub 2022 Sep 29.
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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.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Colchicine and Prednisone tablet in people with Covid19, run by Maria Joyera Rodríguez at 3 sites in Spain.
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 5 inclusion and 5 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: stopped early, as of the sponsor's last update on 21 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in 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 combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 was stopped early (reason given: No candidates for the recruitment). Results are not available in the source record.
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?
Number of patients that a short cycle of steroids administered together with colchicine reduces mortality from COVID-19 (time frame: 28 days). 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 NCT04492358, which also lists 1 linked publication.
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 21 Feb 2023.