COVID19 InfectionPhase 4NCT04392531
Clinical Trial to Assess Efficacy of cYclosporine Plus Standard of Care in Hospitalized Patients With COVID19
A Phase 4 study testing Cyclosporine and Standard treatment in people with COVID19 Infection, run by Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz at 7 sites in Spain.
Trial summary
The study hypothesis is that cyclosporine, added to standard treatment of hospitalized patients with COVID19 infection may improve their prognosis. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- COVID19 Infection
- What is being tested?
- Cyclosporine and Standard treatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 111 participants
- Where
- 7 sitesSpain
- Study dates
- 16 Apr 2020to 31 Mar 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Women and men over 18 years old
- Clinical diagnosis of COVID19 infection (to be subsequently confirmed by PCR or specific IgM isotype Ac and with entry criteria according to the protocol of action (see Annex 2)
- Acceptance and signing of the consent for the study after having received the appropriate information.
Who cannot join
- Known allergy or hypersensitivity to any of the medications included in the treatment arms or to any of their components.
- Contraindication for the use of any of the medications included (*)
- CsA: IR EST 4.5 (FG <30 ml / min according to the Cockcroft-Gault formula)
- Antimalarials (Chloroquine, hydroxychloroquine): Retinopathy, Myasthenia gravis.
- Lopinavir / ritonavir: severe liver failure
- Remdesivir, darunovir-ritonavir
Show all 15Show fewer
- Doxycycline, Azithromycin
- Kidney failure (Stages 4 and 5: GFR <30 ml / min according to the cockcroft-Gault formula).
- Decompensated liver disease (Child-Pugh stages B or C) or chronic infection with virus B
- Pregnancy or lactation
- Age over 75 years
- Participants in another clinical trial with medication in the 28 days prior to the start of recruitment. Participation in observational studies is allowed.
- Refusal to participate
- Patient with a poor state of health or nutrition who, in the opinion of the researcher, has sufficient criteria of severity to interfere with the development of the study or its conclusions
- At the investigator's discretion, the patient's inability to understand or comply with the study procedures
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
Spain7 sites
Complejo Hospitalario Universitario La Coruña
A Coruña, Galicia
Hospital Quiron La Coruña
A Coruña, Galicia
Fundacion Jimenez Diaz
Madrid, 28040
Clinica Universitaria de Navarra
Madrid
Hospital Rey Juan Carlos
Móstoles, Madrid, 28933
Hospital Infanta Elena
Valdemoro, Madrid, 28342
Hospital General de Villalba
Villalba, Madrid, 28400
About this study
Official title: Open, Controlled, Randomized Clinical Trial to Evaluate the Efficacy and Safety of Cyclosporine Plus Standard Treatment vs Standard Treatment Only in Hospitalized Patients With COVID-19 Infection
The study hypothesis is that cyclosporine, added to standard treatment of hospitalized patients with COVID19 infection may improve their prognosis.
- Conditions
- COVID19 Infection
- Being tested
- Cyclosporine, Standard treatment
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CyclosporineDrug
In the experimental group, cyclosporine will be started according to patient weight, and then increased depending on patient tolerance (monitoring renal function and blood pressure)
Standard of care according to hospital protocol
| Study group | Role | What they receive |
|---|---|---|
| Group A (control) | Active comparator | The control group will consist on the standard treatment that patients will receive according to hospital standard of care protocol. Receives: Drug: Standard treatment |
| Group B (experimental) | Experimental | The experimental group will consist on cyclosporine added to the standard treatment that patients will receive according to hospital standard of care protocol. Receives: Drug: Cyclosporine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Severity Category
efficacy of the association of CsA with standard treatment in reducing the severity of COVID19 infection in hospitalized patients.
Measured: 12 days
Secondary outcomes (14)
Mortality Rate
efficacy of CsA in combination with standard treatment in reducing mortality
Measured: through study completion, an average of 6 weeks
Number of Days in hospital
efficacy of CsA in combination with standard treatment in reducing days in hospital
Measured: through study completion, an average of 6 weeks
Number of days in ICU beds
efficacy of CsA in combination with standard treatment in reducing days in ICU beds
Measured: through study completion, an average of 6 weeks
Fio2 Needs
efficacy of CsA in combination with standard treatment in reducing FiO2 needs.
Measured: through study completion, an average of 6 weeks
Adverse events rate
safety and tolerability of cyclosporine vs standard treatment administration
Measured: through study completion, an average of 6 weeks
Change in CRP
change from baseline in C reactive protein levels
Measured: every 48 hours from randomization until patient discharge, and at the end of study visit (14 days after discharge or 14 days after end of study treatment, depending of what applies)
Change in ferritin
change from baseline in ferritin levels
Measured: every 48 hours from randomization until patient discharge, and at the end of study visit (14 days after discharge or 14 days after end of study treatment, depending of what applies)
Change in LDH
change from baseline in LDH levels
Measured: every 48h during hospitalization and end of study visit (14 days after discharge or 14 days after end of study treatment)
Change in CPK
change from baseline in Creatin phosphokinase levels
Measured: every 48 hours from randomization until patient discharge, and at the end of study visit (14 days after discharge or 14 days after end of study treatment, depending of what applies)
Change in D Dimer
change from baseline in D Dimer levels
Measured: every 48 hours from randomization until patient discharge, and at the end of study visit (14 days after discharge or 14 days after end of study treatment, depending of what applies)
Change in IL-6
change from baseline in IL-6 levels
Measured: Days 1, 8, 15 and end of study visit (14 days after discharge or 14 days after end of study treatment)
Change in KL-6
change from baseline in KL-6 levels
Measured: Days 1, 8, 15 and end of study visit (14 days after discharge or 14 days after end of study treatment)
Change in Viral Load
COVID19 Viral load determination
Measured: Days 1,8,15 and end of study visit (14 days after discharge or 14 days after end of study treatment)
Change specific antibodies
Specific IgG and IgM determination
Measured: Days 1,8,15 and end of study visit (14 days after discharge or 14 days after end of study treatment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2020
- Study start16 Apr 2020
- Primary completion31 Mar 2021
- Study completion31 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID19 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
- 111 participants (actual)
Sponsor and investigators
- Lead sponsor
- Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Olga Sanchez Pernaute, MD, PhD, Principal investigator, FUNDACION JIMENEZ DIAZ
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04392531
- Sponsor's protocol ID
- FJD-COVID19-20-01
- Status last verified
- Jul 2022
- First submitted
- 3 May 2020
- Last updated
- 14 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open, Controlled, Randomized Clinical Trial to Evaluate the Efficacy and Safety of Cyclosporine Plus Standard Treatment vs Standard Treatment Only in Hospitalized Patients With COVID-19 Infection
- ClinicalTrials.gov ID
- NCT04392531
- Acronym / sponsor ID
- FJD-COVID19-20-01
- Conditions
- COVID19 Infection
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 111 participants (actual)
- Lead sponsor
- Instituto de Investigación Sanitaria de la Fundación Jiménez DíazUniversity, hospital or other
- Study start
- 16 Apr 2020 (actual)
- Primary completion
- 31 Mar 2021 (actual)
- Study completion
- 31 Mar 2021 (actual)
- First posted
- 19 May 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.
The study hypothesis is that cyclosporine, added to standard treatment of hospitalized patients with COVID19 infection may improve their prognosis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A (control) | Active comparator | Drug: Standard treatmentThe control group will consist on the standard treatment that patients will receive according to hospital standard of care protocol. |
| Group B (experimental) | Experimental | Drug: CyclosporineThe experimental group will consist on cyclosporine added to the standard treatment that patients will receive according to hospital standard of care protocol. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Women and men over 18 years old
- Clinical diagnosis of COVID19 infection (to be subsequently confirmed by PCR or specific IgM isotype Ac and with entry criteria according to the protocol of action (see Annex 2)
- Acceptance and signing of the consent for the study after having received the appropriate information.
Key exclusion criteria (15 listed)
- Known allergy or hypersensitivity to any of the medications included in the treatment arms or to any of their components.
- Contraindication for the use of any of the medications included (*)
- Kidney failure (Stages 4 and 5: GFR <30 ml / min according to the cockcroft-Gault formula).
- Decompensated liver disease (Child-Pugh stages B or C) or chronic infection with virus B
- Pregnancy or lactation
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 |
|---|---|---|
| CyclosporineIn the experimental group, cyclosporine will be started according to patient weight, and then increased depending on patient tolerance (monitoring renal function and blood pressure) | Drug | Group B (experimental) |
| Standard treatmentStandard of care according to hospital protocol | Drug | Group A (control) |
Primary outcome
Severity Category
Time frame: 12 days
efficacy of the association of CsA with standard treatment in reducing the severity of COVID19 infection in hospitalized patients.
14 secondary outcomes
Mortality Rate
Time frame: through study completion, an average of 6 weeks
Number of Days in hospital
Time frame: through study completion, an average of 6 weeks
Number of days in ICU beds
Time frame: through study completion, an average of 6 weeks
Fio2 Needs
Time frame: through study completion, an average of 6 weeks
Adverse events rate
Time frame: through study completion, an average of 6 weeks
Change in CRP
Time frame: every 48 hours from randomization until patient discharge, and at the end of study visit (14 days after discharge or 14 days after end of study treatment, depending of what applies)
Change in ferritin
Time frame: every 48 hours from randomization until patient discharge, and at the end of study visit (14 days after discharge or 14 days after end of study treatment, depending of what applies)
Change in LDH
Time frame: every 48h during hospitalization and end of study visit (14 days after discharge or 14 days after end of study treatment)
Change in CPK
Time frame: every 48 hours from randomization until patient discharge, and at the end of study visit (14 days after discharge or 14 days after end of study treatment, depending of what applies)
Change in D Dimer
Time frame: every 48 hours from randomization until patient discharge, and at the end of study visit (14 days after discharge or 14 days after end of study treatment, depending of what applies)
Change in IL-6
Time frame: Days 1, 8, 15 and end of study visit (14 days after discharge or 14 days after end of study treatment)
Change in KL-6
Time frame: Days 1, 8, 15 and end of study visit (14 days after discharge or 14 days after end of study treatment)
Change in Viral Load
Time frame: Days 1,8,15 and end of study visit (14 days after discharge or 14 days after end of study treatment)
Change specific antibodies
Time frame: Days 1,8,15 and end of study visit (14 days after discharge or 14 days after end of study treatment)
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 14 Jul 2022.
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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.
Olga Sanchez Pernaute, MD, PhD principal investigator
FUNDACION JIMENEZ DIAZ
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Cyclosporine and Standard treatment in people with COVID19 Infection, run by Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz at 7 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 3 inclusion and 15 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 14 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 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 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?
Severity Category (time frame: 12 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 Jul 2022.