COVID-19Phase 2/3ReCOVery-SIRIONCT04351763
Amiodarone or Verapamil in COVID-19 Hospitalized Patients With Symptoms
A Phase 2/3 study testing Amiodarone and Verapamil in people with COVID-19, run by Nicolaus Copernicus University at 1 site in Poland.
Trial summary
There is an urgent need for effective therapies against the novel COVID-19 virus. Studies have shown that amiodarone and verapamil can interfere with coronavirus entry and amplification by blocking ion channels. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- COVID-19
- What is being tested?
- Amiodarone and Verapamil
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 804 participants
- Where
- 1 sitePoland
- Study dates
- 20 May 2020to 5 Jun 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 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Hospitalized patients with confirmed COVID-19 infection and symptoms, with an oxygenation index defined as quotient of partial pressure of oxygen in arterial blood (PaO2, in mmHg) and fraction of inspired oxygen (FiO2) > 200.
Who cannot join
- Acute respiratory distress syndrome (ARDS)
- Contraindications for or known hypersensitivity to amiodarone or calcium channel blockers
- Long QT syndrome
- Prolonged baseline QTc interval (≥450 ms).
- Cardiogenic shock or severe hypotension (SBP< 90 mmHg)
- Severe left ventricle dysfunction (left ventricular ejection fraction ≤35%)
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- Severe sinus - node dysfunction with marked sinus bradycardia
- 2nd/3rd degree heart block
- Bradycardia without pacemaker that has caused syncope
- History of severe dysthyroidism
- A-Fib/flutter conducted via accessory pathway (ie,Wolff -Parkinson-White)
Trial locations and contacts
1 site in 1 country.
About this study
There is an urgent need for effective therapies against the novel COVID-19 virus. Studies have shown that amiodarone and verapamil can interfere with coronavirus entry and amplification by blocking ion channels. ReCOVery-SIRIO is a randomized study to investigate amiodarone or verapamil compared with usual care in symptomatic patients hospitalized with confirmed COVID-19 infection.
- Conditions
- COVID-19
- Being tested
- Amiodarone, Verapamil
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AmiodaroneDrug
Ion channel blocker
VerapamilDrug
Ion channel blocker
| Study group | Role | What they receive |
|---|---|---|
| Amiodarone | Experimental | Amiodarone - administered intravenously
Bolus of 150 mg is given over a minimum of 10 min, with subsequent continuous infusion of 1 mg/min for 6 h, next continuous infusion of 0.5 mg/min for 18 h, then switch to oral administration.
Oral administration
200 to 400 mg/day (adjust dosage based on cardiac response and age) up to discharge. Receives: Drug: Amiodarone |
| Verapamil | Experimental | Verapamil - administered intravenously
Bolus of 0.075-0.15 mg/kg (5-10 mg) over at least 3 minutes, then switch to oral administration.
Oral administration
120 to 480 mg/day in divided doses every 6-8 hours (adjust dosage based on cardiac response and age) up to discharge. Receives: Drug: Verapamil |
| Usual Care | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical improvement
Time to first occurrence of clinical improvement assessed on a seven category scale ranging from 1 to 7
Measured: Randomization to day 15
Secondary outcomes (9)
Clinical improvement
Time to first occurrence of clinical improvement assessed on a seven category scale ranging from 1 to 7
Measured: Randomization to day 7 and 28
Cardiac troponins
assessed serially
Measured: 7, 10 and 15 days after randomization
Mortality
Individual endpoint
Measured: Randomization to day 28
Time to resolution of fever
Defined as body temperature (≤36.6°C [axilla], or ≤37.2 °C [oral], or ≤37.8°C [rectal]) for at least 48 hours without antipyretics or until discharge, whichever is sooner.
Measured: Randomization to day 28
Tachyarrhythmias
defined as atrial fibrillation, supraventricular or ventricular tachycardia requiring treatment
Measured: Randomization to day 28
Time to clinical improvement from admission using the 7-point ordinal scale
Clinical improvement assessed on a seven category scale ranging from 1 to 7.
Measured: Randomization to day 28
Change in NEWS2 score
The National Early Warning Score (NEWS2) score. A Higher score is worse.
Measured: Randomization to day 7 and 15
Duration of hospitalization
Length of hospitalization in days
Measured: Randomization to day 28
PO2/FIO2
oxygenation index defined as quotient of partial pressure of oxygen in arterial blood (PaO2, in mmHg) and fraction of inspired oxygen (FiO2)
Measured: Randomization to day 7 and 15
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2020
- Study start20 May 2020
- Primary completion25 May 2021
- Study completion5 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies 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
- Model description
- parallel group, randomized trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 804 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nicolaus Copernicus University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eliano Pio Navarese, Nicolaus Copernicus University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04351763
- Sponsor's protocol ID
- NCU-COVID19
- Acronym
- ReCOVery-SIRIO
- Status last verified
- Aug 2021
- First submitted
- 14 Apr 2020
- Last updated
- 5 Sep 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Amiodarone or Verapamil in COVID-19 Hospitalized Patients With Symptoms
- ClinicalTrials.gov ID
- NCT04351763
- Acronym / sponsor ID
- ReCOVery-SIRIO / NCU-COVID19
- Conditions
- COVID-19
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 804 participants (actual)
- Lead sponsor
- Nicolaus Copernicus UniversityUniversity, hospital or other
- Study start
- 20 May 2020 (actual)
- Primary completion
- 25 May 2021 (actual)
- Study completion
- 5 Jun 2021 (actual)
- First posted
- 17 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.
There is an urgent need for effective therapies against the novel COVID-19 virus. Studies have shown that amiodarone and verapamil can interfere with coronavirus entry and amplification by blocking ion channels. ReCOVery-SIRIO is a randomized study to investigate amiodarone or verapamil compared with usual care in symptomatic patients hospitalized with confirmed COVID-19 infection.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- parallel group, randomized trial
| Arm | Type | Receives |
|---|---|---|
| Amiodarone | Experimental | Drug: AmiodaroneAmiodarone - administered intravenously Bolus of 150 mg is given over a minimum of 10 min, with subsequent continuous infusion of 1 mg/min for 6 h, next continuous infusion of 0.5 mg/min for 18 h, then switch to oral administration. Oral administration 200 to 400 mg/day (adjust dosage based on cardiac response and age) up to discharge. |
| Verapamil | Experimental | Drug: VerapamilVerapamil - administered intravenously Bolus of 0.075-0.15 mg/kg (5-10 mg) over at least 3 minutes, then switch to oral administration. Oral administration 120 to 480 mg/day in divided doses every 6-8 hours (adjust dosage based on cardiac response and age) up to discharge. |
| Usual Care | No intervention | – |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Hospitalized patients with confirmed COVID-19 infection and symptoms, with an oxygenation index defined as quotient of partial pressure of oxygen in arterial blood (PaO2, in mmHg) and fraction of inspired oxygen (FiO2) > 200.
Key exclusion criteria (11 listed)
- Acute respiratory distress syndrome (ARDS)
- Contraindications for or known hypersensitivity to amiodarone or calcium channel blockers
- Long QT syndrome
- Prolonged baseline QTc interval (≥450 ms).
- Cardiogenic shock or severe hypotension (SBP< 90 mmHg)
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 |
|---|---|---|
| AmiodaroneIon channel blocker | Drug | Amiodarone |
| VerapamilIon channel blocker | Drug | Verapamil |
Primary outcome
Clinical improvement
Time frame: Randomization to day 15
Time to first occurrence of clinical improvement assessed on a seven category scale ranging from 1 to 7
9 secondary outcomes
Clinical improvement
Time frame: Randomization to day 7 and 28
Cardiac troponins
Time frame: 7, 10 and 15 days after randomization
Mortality
Time frame: Randomization to day 28
Time to resolution of fever
Time frame: Randomization to day 28
Tachyarrhythmias
Time frame: Randomization to day 28
Time to clinical improvement from admission using the 7-point ordinal scale
Time frame: Randomization to day 28
Change in NEWS2 score
Time frame: Randomization to day 7 and 15
Duration of hospitalization
Time frame: Randomization to day 28
PO2/FIO2
Time frame: Randomization to day 7 and 15
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 5 Sep 2021.
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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 Amiodarone and Verapamil in people with COVID-19, run by Nicolaus Copernicus University at 1 site in Poland.
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 1 inclusion and 11 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 5 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 1 site in Poland. 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 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?
Clinical improvement (time frame: Randomization to day 15). 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 5 Sep 2021.