Covid19Phase 2/3SWITCH-COVIDNCT04493359
Switch of Renin-Angiotensin System Inhibitors in Patients With Covid-19
A Phase 2/3 study testing Renin-angiotensin system inhibitors in people with Covid19 and Angiotensin II Receptor Antagonist Adverse Reaction, run by University of Sao Paulo at 1 site in Brazil.
Trial summary
The SWITCH-COVID trial will randomize patients with COVID-19 that are currently using renin-angiotensin system inhibitors for treating hypertension to maintain the therapy during in-hospital stay or switch the therapy to other antihypertensive classes. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Covid19, Angiotensin II Receptor Antagonist Adverse Reaction
- What is being tested?
- Renin-angiotensin system inhibitors
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteBrazil
- Study dates
- 25 Jul 2020to 28 Sep 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Hypertension in use of renin-angiotensin system inhibitors
- Confirmed COVID-19 infection by rt-PCR, serology tests or typical clinical presentation and chest CT.
- Symptoms onset < 96h
- Need for hospitalization
Who cannot join
- Heart failure
- Previous cerebrovascular disease
- Previous myocardial infarction
- Blood pressure > 180 x 100 mmHg
- Need for 3 or more anti-hypertensive classes
- Use os spironolactone
- Severe pulmonary disease
- Contraindication for using other anti-hypertensive classes (calcium channel blockers, hydralazine, diuretics or nitrates)
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Instituto do Coração - Incor HCFMUSP
São Paulo, São Paulo, 05403-900
About this study
Official title: Switch or Maintenance of Renin-Angiotensin System Inhibitors in Patients With Covid-19: A Randomized Proof of Concept Trial
The SWITCH-COVID trial will randomize patients with COVID-19 that are currently using renin-angiotensin system inhibitors for treating hypertension to maintain the therapy during in-hospital stay or switch the therapy to other antihypertensive classes.
Read the detailed description
Patients eligible for the study, after signing informed consent will be randomized 1:1 for maintenance of renin-angiotensin system inhibitors or switching the antihypertensive therapy for other classes according to a pre-specified protocol.
Patients are going to be followed during hospital stay for evaluation of clinical endpoints. Also blood and urine samples will be acquired for evaluation of renin-angiotensin system activation.
- Being tested
- Renin-angiotensin system inhibitors
- Keywords
- covid19, ace inhibitors, ace2
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Renin-angiotensin system inhibitorsDrug
switch anti-hypertensive class
| Study group | Role | What they receive |
|---|---|---|
| Switch therapy | Experimental | Renin-angiotensin system inhibitors will be changed for other anti-hypertensive classes. Receives: Drug: Renin-angiotensin system inhibitors |
| Maintenance therapy | No intervention | Renin-angiotensin system inhibitors will be kept during in-hospital stay |
What is being measured
The primary outcome is the main question the study is designed to answer.
Need for ICU or mortality
Combined of need for ICU or mortality
Measured: 30 days
Secondary outcomes (4)
High sensitivity troponin levels and covid-19 severity
Evaluate correlation between hs-TnT and covid-19 severity
Measured: 30 days
ACE-2 activity and disease severity
Evaluate correlation of ACE-2 activity and disease severity
Measured: 30 days
ACE-2 activity with different Renin-angiotensin system inhibitors
Evaluate correlation of ACE-2 activity and Renin-angiotensin system inhibitors
Measured: 30 days
Blood control and acute renal failure
Evaluate blood pressure control and acute renal failure in each arm (safety)
Measured: 30 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 start25 Jul 2020
- Primary completion28 Sep 2021
- Study completion28 Sep 2021
Why it stopped: Dificulteis in enrolling patients
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Covid19Studies of the same condition, open and under way.
- More trials run by University of Sao PauloThe sponsor's other registered studies.
- 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
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bruno Caramelli, University of Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04493359
- Sponsor's protocol ID
- 33575220.9.0000.0068
- Acronym
- SWITCH-COVID
- Status last verified
- Sep 2021
- First submitted
- 29 Jul 2020
- Last updated
- 6 Oct 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Data may be requested for collaboration projects
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Switch or Maintenance of Renin-Angiotensin System Inhibitors in Patients With Covid-19: A Randomized Proof of Concept Trial
- ClinicalTrials.gov ID
- NCT04493359
- Acronym / sponsor ID
- SWITCH-COVID / 33575220.9.0000.0068
- Keywords
- covid19, ace inhibitors, ace2
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Dificulteis in enrolling patients
- Enrolment
- 18 participants (actual)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Study start
- 25 Jul 2020 (actual)
- Primary completion
- 28 Sep 2021 (actual)
- Study completion
- 28 Sep 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.
The SWITCH-COVID trial will randomize patients with COVID-19 that are currently using renin-angiotensin system inhibitors for treating hypertension to maintain the therapy during in-hospital stay or switch the therapy to other antihypertensive classes.
Detailed description
Patients eligible for the study, after signing informed consent will be randomized 1:1 for maintenance of renin-angiotensin system inhibitors or switching the antihypertensive therapy for other classes according to a pre-specified protocol.
Patients are going to be followed during hospital stay for evaluation of clinical endpoints. Also blood and urine samples will be acquired for evaluation of renin-angiotensin system activation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Switch therapy | Experimental | Drug: Renin-angiotensin system inhibitorsRenin-angiotensin system inhibitors will be changed for other anti-hypertensive classes. |
| Maintenance therapy | No intervention | –Renin-angiotensin system inhibitors will be kept during in-hospital stay |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Hypertension in use of renin-angiotensin system inhibitors
- Confirmed COVID-19 infection by rt-PCR, serology tests or typical clinical presentation and chest CT.
- Symptoms onset < 96h
- Need for hospitalization
Key exclusion criteria (8 listed)
- Heart failure
- Previous cerebrovascular disease
- Previous myocardial infarction
- Blood pressure > 180 x 100 mmHg
- Need for 3 or more anti-hypertensive classes
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 |
|---|---|---|
| Renin-angiotensin system inhibitorsswitch anti-hypertensive class | Drug | Switch therapy |
Primary outcome
Need for ICU or mortality
Time frame: 30 days
Combined of need for ICU or mortality
4 secondary outcomes
High sensitivity troponin levels and covid-19 severity
Time frame: 30 days
ACE-2 activity and disease severity
Time frame: 30 days
ACE-2 activity with different Renin-angiotensin system inhibitors
Time frame: 30 days
Blood control and acute renal failure
Time frame: 30 days
Results and safety
The study was stopped early (reason given: Dificulteis in enrolling patients). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2021.
- Individual participant dataSharing planned: Undecided. Data may be requested for collaboration projects
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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.
1 site 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 Renin-angiotensin system inhibitors in people with Covid19 and Angiotensin II Receptor Antagonist Adverse Reaction, run by University of Sao Paulo at 1 site in Brazil.
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 8 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 6 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. 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: Dificulteis in enrolling patients). 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?
Need for ICU or mortality (time frame: 30 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 6 Oct 2021.