COVID-19Phase 2MARACOVIDNCT04441385

Study to Evaluate the Efficacy and Safety of Maraviroc in SARS-CoV-2 Infection (COVID-19).

A Phase 2 study testing Maraviroc 300 mg in people with COVID-19, run by Hospital Universitario Infanta Leonor at 2 sites in Spain.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

This is a bicentric, phase 2, randomized, open-label study to evaluate the efficacy and safety of maraviroc associated with standard treatment in hospitalized patients with pulmonary SARS-CoV-2 infection (COVID-19). Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: COVID-19
What is being tested?: Maraviroc 300 mg
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 60 participants
Where: 2 sitesSpain
Study dates: 26 Jun 2020to 8 Feb 2021
Phase: Phase 2
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 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

1. Male or female adult ≥ 18 years of age at the time of giving informed consent.
2. Subject is hospitalized.
3. SARS-CoV-2 infection confirmed by PCR or other commercial or public health tests, in any biological sample obtained up to 4 days prior to randomization, or that meets locally accepted criteria for clinical diagnosis of COVID-19.
4. Lung involvement confirmed by at least one of the following criteria:
Radiological infiltrates on imaging test (conventional radiography, computed tomography (CT) or other)
In the absence of radiological infiltrates, an SpO2 < 95% without oxygen supporting therapy (breathing ambient air), combined with cough, crackles on physical exam, or an LDH > 300 U/L with no other cause.

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5. Symptom onset ≤ 8 days prior to randomization.
6. Understands and agrees to comply with planned study procedures.
7. Women of childbearing potential must have a negative test for pregnancy (blood or urine) before their inclusion and agree to use an accepted method of contraception for the duration of the study.
8. Subject (or legally authorized representative) provides written informed consent prior to initiation of any study procedures.

Who cannot join

1. SpO2 ≤ 91% breathing ambient air and SpO2 < 95% with oxygen in nasal cannula at 2 lpm.
2. Patient's attending physician considers the study is not the best medical option, or follow-up after discharge will be difficult.
3. A patient who, in the investigator's opinion, is unlikely to survive > 48 hours from inclusion in the study.
4. Patients with severe chronic kidney disease (ClCr < 30 ml/min/1.73 m2 or receiving renal replacement therapy in any of its modalities).
5. Severe liver disease (Child-Pugh C, ALT > 5 times above upper limit of normal (LSN).
6. COPD with FEV1 < 70.

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7. Known active neoplasia.
8. HIV infection. Patients with known HIV infection, under follow-up, and immunovirological stability (CD4> 500 and undetectable viral load) for at least 6 months before inclusion in this study may be included.
9. Hemoglobin < 9 gr/dL.
10. Prolonged QT, defined as a QT interval > 460 ms. (or > 450 ms. in case of family history of sudden death or long QT syndrome or personal history of repeat syncope without an etiological diagnosis). This criterion will only apply if the standard treatment contains drugs with an effect on the duration (prolongation) of the QT interval.
11.Significant cardiovascular disease, including:
History of acute myocardial infarction, acute coronary syndrome (unstable angina, coronary by-pass surgery, angioplasty, or coronary stenting) ≤ 6 months prior to randomization
Symptomatic heart failure (NYHA grade 2 or more) history, or current evidence of cardiac arrhythmia (except atrial fibrillation or flutter and paroxysmal supraventricular tachycardia) and/or conduction abnormalities (excluding branch blocks or Wenckebach grade I and II atrioventricular blocks).
12. Known or suspected active autoimmune disease
13. Pregnancy or breastfeeding, or positive pregnancy test at baseline or screening visit
14. Patients who are expected to be transferred to another facility sooner than 72 hours after inclusion in the study.
15. Patients who have received experimental treatment (off-label, compassionate use, or in clinical trials) within 30 days prior to the screening visit, except for treatment considered standard initiated on admission to hospital, up to 48 hours before inclusion in the study.
16. Patients who have a history of allergic reactions to maraviroc or any of its components.

Trial locations and contacts

2 sites in 1 country.

Spain2 sites

Hospital Clínic
Barcelona, 08036
Hospital Universitario Infanta Leonor
Madrid, 28031

Other trials in Spain

About this study

Official title: Bicentric, Phase 2, Randomized, Open-label Study to Evaluate the Efficacy and Safety of Maraviroc Associated With Standard Treatment in Hospitalized Patients With Pulmonary SARS-CoV-2 Infection (COVID-19).

Read the detailed description

Patients will be randomized to receive maraviroc (300 mg BID for 14 days) plus standard treatment, or standard treatment alone.

200 subjects will be enrolled and randomized 1:1 in this study.

Conditions: COVID-19
Being tested: Maraviroc 300 mg, Standard care therapy
Keywords: SARS-CoV-2, ARDS, Acute respiratory distress syndrome, maraviroc
Medical subject headings: COVID-19, Respiratory Distress Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Maraviroc 300 mgDrug
Also called Celsentri, Selzentry
Patients will receive maraviroc 300 mg twice daily for 14 days
Standard care therapyOther
Subjects randomized to control group will be on standard care treatment according to the Ministry of Health and Local Guidelines and Protocols.

Study groups in NCT04441385
Study group	Role	What they receive
Test arm	Experimental	100 subjects will be randomly assigned to this arm. Patients in the test group will receive 300 mg of maraviroc BID for 14 days (added to standard care). Receives: Drug: Maraviroc 300 mg
Control arm	Other	100 subjects will be randomized in this arm and will be treated according to the standard care. The Ministry of Health has issued detailed guidelines for the management of COVID-19. Local Institutional Guidelines and Protocols for supportive management will also be implemented. Receives: Other: Standard care therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

Proportion of patients developing severe ARDS.
A patient with a saturation of 90% or less despite the use of a reservoir mask without rebreathing with a flow of 7 liters per minute (FiO2 0.6 or higher), will be considered to have severe ARDS. These oximetric criteria have a close correlation with a PaO2 / FiO2 of 100 or less, which defines severe ARDS.
Measured: 28 days

Secondary outcomes (7)

All-cause mortality.
Measured: 28 days
Percentage of patients requiring tracheal intubation, use of Non-invasive Ventilation NIV or High Flow Nasal Cannula (HFNC) devices during the study period
Measured: 28 days
Percentage of patients who progress to severe ARDS, death or ICU admission.
Measured: 28 days
Differences in Time to Clinical Improvement
Defined as the time (in hours) from the start of the treatment under study to the normalization of temperature, normalization of respiratory rate and SpO2.
1. Axillary temperature < 37.5ºC (oral < 37.2ºC) for 48 hours, without antipyretic treatment.
2. Breathing rate < 24 rpm during the clinical evaluation and at least two consecutive daily evaluations (48 hours).
3. SpO2 > 93% breathing ambient air during clinical assessment and at least two consecutive daily assessments (48 hours).
Measured: 28 days
Change in clinical status of subject on a 7-point ordinal scale.
The ordinal scale of 7 categories of patient health status ranges from:
1. Death.
2. Hospitalized, with invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO).
3. Hospitalized, with non-invasive ventilation or high flow oxygen devices.
4. Hospitalized, requiring supplemental oxygen.
5. Hospitalized, not requiring supplemental oxygen.
6. Non-hospitalized, activity limitation.
7. Non-hospitalized, no activity limitation.
Measured: 28 days
Percentage of patients requiring immunosuppressive/immunomodulatory treatment as a rescue medication.
Measured: 28 days
Proportion of patients developing adverse effects, serious adverse reactions, laboratory or physical examination findings, EKG abnormalities acquired during the trial, death and adverse events leading to early discontinuation of treatment.
Classification according to the WHO toxicity scale
Measured: 28 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

26 Jun 20208 Feb 2021

First posted22 Jun 2020
Study start26 Jun 2020
Primary completion8 Feb 2021
Study completion8 Feb 2021

Why it stopped: lack of viability

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
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 60 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04441385
Sponsor's protocol ID: MARACOVID
Other IDs: 2020-002011-21
Acronym: MARACOVID
Status last verified: Jul 2020
First submitted: 18 Jun 2020
Last updated: 11 Mar 2022
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 11 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Bicentric, Phase 2, Randomized, Open-label Study to Evaluate the Efficacy and Safety of Maraviroc Associated With Standard Treatment in Hospitalized Patients With Pulmonary SARS-CoV-2 Infection (COVID-19).
ClinicalTrials.gov ID: NCT04441385
Acronym / sponsor ID: MARACOVID / MARACOVID
Conditions: COVID-19
Keywords: SARS-CoV-2, ARDS, Acute respiratory distress syndrome, maraviroc
Phase: Phase 2
Study type: Interventional
Recruitment status: TerminatedReason stopped: lack of viability
Enrolment: 60 participants (actual)
Lead sponsor: Hospital Universitario Infanta LeonorUniversity, hospital or other
Collaborators: Hospital Clinic of Barcelona, ViiV Healthcare
Study start: 26 Jun 2020 (actual)
Primary completion: 8 Feb 2021 (actual)
Study completion: 8 Feb 2021 (actual)
First posted: 22 Jun 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.

Detailed description

Patients will be randomized to receive maraviroc (300 mg BID for 14 days) plus standard treatment, or standard treatment alone.

200 subjects will be enrolled and randomized 1:1 in this study.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Test arm	Experimental	Drug: Maraviroc 300 mg100 subjects will be randomly assigned to this arm. Patients in the test group will receive 300 mg of maraviroc BID for 14 days (added to standard care).
Control arm	Other	Other: Standard care therapy100 subjects will be randomized in this arm and will be treated according to the standard care. The Ministry of Health has issued detailed guidelines for the management of COVID-19. Local Institutional Guidelines and Protocols for supportive management will also be implemented.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (10 listed)

1. Male or female adult ≥ 18 years of age at the time of giving informed consent.
2. Subject is hospitalized.
3. SARS-CoV-2 infection confirmed by PCR or other commercial or public health tests, in any biological sample obtained up to 4 days prior to randomization, or that meets locally accepted criteria for clinical diagnosis of COVID-19.
4. Lung involvement confirmed by at least one of the following criteria:
5. Symptom onset ≤ 8 days prior to randomization.

Key exclusion criteria (18 listed)

1. SpO2 ≤ 91% breathing ambient air and SpO2 < 95% with oxygen in nasal cannula at 2 lpm.
2. Patient's attending physician considers the study is not the best medical option, or follow-up after discharge will be difficult.
3. A patient who, in the investigator's opinion, is unlikely to survive > 48 hours from inclusion in the study.
4. Patients with severe chronic kidney disease (ClCr < 30 ml/min/1.73 m2 or receiving renal replacement therapy in any of its modalities).
5. Severe liver disease (Child-Pugh C, ALT > 5 times above upper limit of normal (LSN).

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
Maraviroc 300 mgAlso: Celsentri, SelzentryPatients will receive maraviroc 300 mg twice daily for 14 days	Drug	Test arm
Standard care therapySubjects randomized to control group will be on standard care treatment according to the Ministry of Health and Local Guidelines and Protocols.	Other	Control arm

Primary outcome

Proportion of patients developing severe ARDS.
Time frame: 28 days
A patient with a saturation of 90% or less despite the use of a reservoir mask without rebreathing with a flow of 7 liters per minute (FiO2 0.6 or higher), will be considered to have severe ARDS. These oximetric criteria have a close correlation with a PaO2 / FiO2 of 100 or less, which defines severe ARDS.

7 secondary outcomes

All-cause mortality.
Time frame: 28 days
Percentage of patients requiring tracheal intubation, use of Non-invasive Ventilation NIV or High Flow Nasal Cannula (HFNC) devices during the study period
Time frame: 28 days
Percentage of patients who progress to severe ARDS, death or ICU admission.
Time frame: 28 days
Differences in Time to Clinical Improvement
Time frame: 28 days
Change in clinical status of subject on a 7-point ordinal scale.
Time frame: 28 days
Percentage of patients requiring immunosuppressive/immunomodulatory treatment as a rescue medication.
Time frame: 28 days
Proportion of patients developing adverse effects, serious adverse reactions, laboratory or physical examination findings, EKG abnormalities acquired during the trial, death and adverse events leading to early discontinuation of treatment.
Time frame: 28 days

Results and safety

The study was stopped early (reason given: lack of viability). Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 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.

Víctor Domínguez, MD principal investigator

Hospital Universitario Infanta Leonor

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Maraviroc 300 mg in people with COVID-19, run by Hospital Universitario Infanta Leonor at 2 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 10 inclusion and 18 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 11 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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: lack of viability). 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?

Proportion of patients developing severe ARDS. (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 NCT04441385.

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 11 Mar 2022.